#huepoe

[gaiakoraidon]

Klonoa is another game series I like. The discontinued webcomic Dream Traveler of Noctis Sol is pretty underrated, so I drew Klonoa in his outfit from the comic since it's my favorite of them all. It just does a good job at blending both the old and new designs.

[gaschka]

[gal-vanized]

the things that connect door to phantomile with lunatea's veil is really neat

huepoe summoned klonoa to restore the balance of dreams, but when it was done klonoa was forcibly ripped back into his own world, crying

the intro of the sequel is klonoa hearing a cry for help before falling into the sea of tears. the voice crying for help is later revealed to be the king of sorrow, who called klonoa into lunatea to help people remember sorrow.

the king has an uncanny resemblance to klonoa, specifically the klonoa of the first game (with the collar thats too big for them) in a way he is an incarnation of klonoa's sadness after losing his grandpa and huepoe, and huepoe's sadness after losing klonoa.

klonoa grows throughout both games. he's clearly a child in door to phantomile, while in lunatea's veil he clearly matured and is coming to terms with loss and sadness.

idk its cool :-)

[transmorolians]

huepo

hyūpō

[mythicmarbles]

The real villain in klonoa

[thecrystalring]

#Inktober Day 11: Cruel (feat. #Klonoa)

"Klonoa . . . It's time for you to go home, back to your Phantomile." "But! I don't want to! I don't want to!" #Inktober2018

[merriway]

The Hue System

The Hue System (Name is pending) is one of the planetary systems in the Merriway, named after the creatures who created it, the Hueminns. 

The Hueminns are 12 Dreamons from MerreM gifted with powers of creation and each representing a different hue and dream type. With permission from Merrilee they claimed a series of worlds to serve as their personal workshops where they could explore the limits of their power and inspiration.

While the Hueminn’s would technically be considered gods on this system they are very hands off. The twelve do not seek to maintain any sort of strict control over their creations nor do they seek anything like worship (though they do appreciate a little praise, but what artist doesnt?) Rather they tend to travel to other places across the universe seeking inspiration so they can return to their ‘studios’ and create more. 

Each world has a main group of ‘attendants’ that are basically tasked with caring for their world. However, they have the freedom to design their own civilization such as government and laws. The attendants do naturally tend to build their culture around the values of their creators. For example, the attendants of Chartrand’s world would most likely possess a very laissez-faire style of government if not pure anarchy as Chartrand tends to be the type to be a major hedonist who does as he likes. Concepts and Characters © MerriMonster

[freespeechwyngro]

You know, i just looked at all the Last Notch Huepoe family bios. It's pretty wack to me that the entire family fucking hates Wenn or just thinks shes "weird" and that being an asshole to your family member with an "illness" for no reason at all is a viable story element to explore but not LGBTQ+ topics. intersting. its just. interesting.

.

[drinstadiscourse]

Klonoa is good in this essay I

hHHGzmehmevemehdk

i literally donr know what happened i just wanted to make a little post about klonoa then my autism brain was activated and i wrote all of that about it. AND I DIDNT EVEN GET TO THE STORY IN DEPTH WHICH I COULD DISCUSS SO MUCH ... an essay on why huepoe is not a bad person is sitting in my brain i am rotating my thoughts about him and the rest of the klonoa series's story in my head at all times

[avatar-index]

Statement 457103

Klonoa is an Avatar of the Dark.

A key theme of the Dark is pure ignorance; what is not known to many or at all, and all that is kept a secret. It is the antithesis to the Eye for a very good reason- while the Eye sees all that it gazes upon, the Dark keeps it all away from their gaze as what surrounds them in their oblivion is what they made up with their imagination.

Aside from his fabricated family life and backstory shown to us in his first game, “Door to Phantomile”, we don’t exactly know much about this kid- who is he? Where did he come from? How does he find pathways to these fantastical lands? The only piece of backstory we’ve gotten so far is that, in the real world, he currently lives in Breezegale, an area reflected in his dream in Door to Phantomile. To dub Klonoa as an enigma wouldn’t be too farfetched.

Another key element in his games, aside from his dubious origins, is the knowledge of what was once kept hidden. In Door to Phantomile, he was unaware of the knowledge that his entire world, his memories, and even friendship with Huepoe were all parts of the dream he was in- and by the game’s end, he was supposed to forget it all when he awoke, but the intro made it clear to us that it hasn’t left his mind since.

The entity now has him in its grasp, if it already hadn’t while he was already asleep and is on his way to rescue

Later, in the sequel, he was called to Lunatea by a voice only he was able to hear- the voice of the King of Sorrow, who was forgotten by all in the lands. When he made the connection between the pleading voice and the dying final boss in his arms, he made the promise that Lunatea would never forget sorrow once more by ringing the kingdom’s bells.

Now, I need to point something out before I continue- There has been a theory running around back then that, based on the level design of their levels and each of their plots, it is possible that every game Klonoa stars in could each be a separate dream of his, i.e they aren’t exactly in the realm of reality. It has been confirmed in Dream Traveler of Noctis Sol that he is a, you guessed it, Dream Traveler, though he really isn’t aware of it himself.

Go to bed, start dreaming, save the world, and wake up. Rinse and repeat.

The reason why I had placed “imagination” in the Dark’s domain is that if you put any monster to mind, whether it was an urban legend or a cautionary tale made up by your parents on the spot, chances are you will begin imagining this creature once you are all alone in the dark of your room; only you can see them, for they are your own, personal beasts to ward off. How can the Eye see what is only imaginary to all but the mind of a single person?

And that element is exactly why Klonoa would be a perfect fit to serve the Dark. All of his work is kept in the shadows from all, including himself. The lands he travels around and a good set of characters are either reflections of how he perceives the real world, actual residents of whatever “dream dimension” that exists, or are pure figments of his own imagination. In spite of everything, it all falls on him to preserve the stability of the world of dreams he crash-lands into; help keep a staple of the Dark in place, safe, and sound.

[catofblue]

Finished my first ever fanart of 'Klonoa'! Gosh, this game is so close to my heart and will always be a precious game to me growing up. ♡〜٩( ╹▿╹ )۶

[alejandro-mery]

Esta es una crema de #huepo que estaba alucinante!!! Un recomendado del #restaurante Punto Ocho del Hotel Cumbres en #lastarria . #800restaurantes #comidaaustral #comidachina #foodporn #navajas https://www.instagram.com/p/BpDc46xHVT2/?utm_source=ig_tumblr_share&igshid=o2s0jdf2bfil

[greatestlcve]

Aranesp Uses, Dosage, Side Effects, Precautions & Warnings

Drug Online

Therapeutic class: Cancerology and hematology Active ingredients: Darbepoetin alfa

Important to know about Aranesp ?

Darbepoetin alfa injections stimulate the body to produce red blood cells.

In case of severe anemia (as can occur in certain kidney diseases), in cancer chemotherapy and prior to surgery if the doctors expect a lot of blood loss.

It takes 2 to 6 weeks for the number of red blood cells to be up to standard.

You usually receive the injections once every 1, 2 or 3 weeks.

Side effects include: increased blood pressure and swollen ankles and feet. Do you suffer a lot from this? Consult your doctor.

Furthermore: hypersensitivity to this medication. You notice that among other things skin rash, itching, fever or tightness. Then warn a doctor.

A rare side effect is thrombosis (blood clot in a blood vessel). You notice thrombosis of sudden pain or swelling in your leg, or chest tightness or shortness of breath. Then immediately notify a doctor.

What is Aranesp used to treat and indication ?

Treatment of symptomatic anemia related to chronic renal insufficiency (CKD) in adults and children ( see Dosage and Method of Administration ).

Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy.

aranesp injection dosage

Treatment of symptomatic anemia in adults and children with chronic renal failure

The symptoms and consequences of anemia may vary depending on age, sex and the overall clinical picture; It is necessary for a doctor to evaluate the disease and its evolution. Aranesp can be administered subcutaneously or intravenously to increase hemoglobin to a maximum of 12 g / dl (7.5 mmol / l). The subcutaneous route is preferred in patients who are not hemodialysis, in order to preserve the peripheral veins.

Patients should be closely monitored to ensure that the minimum adequate dose of Aranesp is used to control the symptoms of anemia while maintaining hemoglobinemia less than or equal to 12 g / dL (7.5 mmol / L) . Caution is required when increasing doses of Aranesp in patients with chronic renal failure. Alternative explanations for poor response to treatment should be sought in patients treated with Aranesp who have an insufficient increase in hemoglobin (see Warnings and Precautions and Pharmacodynamic Properties section ).

Due to intra-individual variability, point concentrations of hemoglobin can be observed below and above the desired values. The variability of hemoglobin level should be controlled by adjusting the dosage, relative to the target hemoglobin level between 10 g / dl (6.2 mmol / l) and 12 g / dl (7.5 mmol / l) . Maintaining a hemoglobin level above 12 g / dl (7.5 mmol / l) should be avoided; recommendations for dosage adjustment when the hemoglobin level exceeds 12 g / dl (7.5 mmol / l) are detailed below. An increase of hemoglobin above 2 g / dl (1.25 mmol / l) over a period of 4 weeks should be avoided. If this occurs, the dosage should be adjusted.

Treatment with Aranesp is divided into two phases, corrective phase and maintenance phase. Treatment modalities are presented separately for adults and children.

Adults with chronic renal failure

Corrective phase :

The initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, the following initial doses may also be administered subcutaneously as a single injection: 0.75 μg / kg once every two weeks or 1.5 μg / kg once a month. If the increase in hemoglobin is insufficient (less than 1 g / dl [0.6 mmol / l] in four weeks), the dose may be increased by approximately 25%. The dosage should not be increased more than once every four weeks.

If the increase in hemoglobin is greater than 2 g / dl (1.25 mmol / l) over a four-week period, reduce the dose by approximately 25% from the previous dose, depending on the dose. importance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.

The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then the hemoglobin level can be measured at longer intervals.

Maintenance phase :

In dialysis patients, Aranesp can continue to be administered as a once weekly injection or once every two weeks. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered.

In non-dialysis patients, Aranesp can continue to be administered as a single injection once a week or once every two weeks or once a month. In patients treated with Aranesp once every two weeks, and after the target hemoglobin level has been reached, Aranesp can then be administered by subcutaneous injection once a month using an initial dose equivalent to twice the dose used every two weeks.

The dose administered should be evaluated to maintain the target hemoglobin level.

If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose.

If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) over a period of 4 weeks, reduce the dose by approximately 25% depending on the significance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.

After each dose or schedule adjustment, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.

When the route of administration is changed, the same dose should be used and the hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired level.

Clinical trials have shown that adult patients receiving r-HuEPO once, twice or three times a week may receive Aranesp once weekly or once every 2 weeks. The initial weekly dose of Aranesp (μg / week) can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 200. The initial dose of Aranesp administered every 2 weeks (μg / 2 weeks) can be calculated by dividing by 200 the total dose of r-HuEPO administered over a 2-week period. Due to individual variability, the search for the optimal therapeutic dose should be done for each patient. When replacing r-HuEPO with Aranesp, the rate of

Children with chronic renal failure

Treatment of children under 1 year of age has not been studied in randomized clinical trials.

Corrective phase :

In children from 1 year of age, the initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, an initial dose of 0.75 μg / kg can be administered subcutaneously as a single injection once every two weeks. If the increase in hemoglobin is insufficient (less than 1 g / dl [0.6 mmol / l] in four weeks), the dose may be increased by approximately 25% . The dosage should not be increased more than once every four weeks .

If the increase in hemoglobin is greater than 2 g / dl (1.25 mmol / l) over a four-week period, reduce the dose by approximately 25% from the previous dose, depending on the level. increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.

The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then the hemoglobin level can be measured at larger intervals.

Correction of anemia in pediatric patients with a monthly administration frequency of Aranesp has not been studied.

Maintenance phase :

In children from 1 year of age, during the maintenance phase, Aranesp can continue to be administered as a single once-weekly injection or once every two weeks.

In patients younger than 6 years of age, higher doses may be needed to maintain target hemoglobin levels compared to patients 6 years of age and older. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered.

In patients 11 years of age and older who are not on dialysis, once the target hemoglobin level is reached by one dose every two weeks, Aranesp can be administered by subcutaneous injection once a month. using an initial dose equivalent to twice the dose used every two weeks.

Clinical data available in children have shown that patients receiving r-HuEPO two or three times a week can receive Aranesp once a week, and those receiving r-HuEPO once per week could benefit from administration of Aranesp once every two weeks. The initial weekly dose of Aranesp (μg / week) in pediatrics can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 240. The initial dose of Aranesp (μg / week) to be administered every two weeks in pediatrics can be calculated by dividing the total dose of r-HuEPO (UI / week) over two weeks by 240. Due to individual variability, the search for the optimal therapeutic dose should be performed for each patient.

The dose administered should be periodically evaluated to maintain the target hemoglobin level.

If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose.

If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) in 4 weeks, reduce the dose by approximately 25% depending on the importance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.

Patients starting dialysis during Aranesp therapy should be closely monitored for adequate control of their hemoglobin levels.

After each adjustment in dose or rate of administration, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.

When the route of administration is changed, the same dose should be used and hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired hemoglobin level.

Treatment of symptomatic anemia induced by chemotherapy in cancer patients

Aranesp should be administered subcutaneously to patients with anemia (eg, hemoglobin �� 10 g / dl (6.2 mmol / l)) to achieve a hemoglobin level not exceeding 12 g / dl (7.5 mmol / l). The symptoms and consequences of anemia may vary depending on age, sex and the overall clinical picture; It is necessary for a doctor to evaluate the disease and its evolution.

Due to intra-individual variability, point concentrations of hemoglobin can be observed below and above the desired values. The variability in hemoglobin levels should be controlled by adjusting the dose to the target hemoglobin level between 10 g / dl (6.2 mmol / l) and 12 g / dl (7.5 mmol / l). Maintaining a hemoglobin level greater than 12 g / dl (7.5 mmol / l) should be avoided; recommendations for dosage adjustment when the hemoglobin level exceeds 12 g / dl are detailed below.

The recommended starting dose is 500 pg (6.75 μg / kg body weight), administered once every three weeks, or 2.25 μg / kg body weight given once a week. If the clinical response (fatigue, hemoglobin level) is not satisfactory after nine weeks of treatment, continued treatment may be ineffective.

Aranesp treatment should be discontinued approximately four weeks after the end of chemotherapy.

Once the individual therapeutic goal is reached, the dose should be reduced by 25 to 50% to ensure that the appropriate minimum dose of Aranesp is used to maintain hemoglobin levels to control the symptoms of anemia. . The choice of a dose of 500 μg, 300 μg or 150 μg should be considered.

Patients should be closely monitored. If the hemoglobin level exceeds 12 g / dl (7.5 mmol / l), the dose should be reduced by approximately 25-50%. Aranesp treatment should be temporarily discontinued if the hemoglobin level exceeds 13 g / dl (8.1 mmol / l). Treatment will be resumed at approximately 25% lower than the previous dose when the hemoglobin level has dropped to 12 g / dl (7.5 mmol / l) or less.

If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) over a period of four weeks, the dose should be reduced by 25 to 50%.

Administration mode

Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled syringe

Aranesp is administered subcutaneously or intravenously as described under Dosage. Alternate injection sites and inject slowly to avoid discomfort at the injection site.

Aranesp is presented in a pre-filled syringe ready for injection.

Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled pen

Aranesp in pre-filled pen is intended for subcutaneous administration only.

Alternate injection sites to avoid discomfort at the injection site.

Aranesp is presented in pre-filled pen ready for injection.

Aranesp 25, 40, 60, 100, 200, 300 micrograms solution for injection in vial

Aranesp is administered subcutaneously or intravenously as described under Dosage.

Alternate injection sites and inject slowly to avoid discomfort at the injection site.

Aranesp is presented in a ready-to-use bottle.

For instructions on use, handling and disposal, see section Instructions for use, handling and disposal .

what is aranesp contraindications

CONTRA-INDICATED:

– Known hypersensitivity to darbepoetin alfa, to r-HuEPO or to any of the excipients.

– Poorly controlled arterial hypertension.

– Cases of erythroblastopenia due to neutralizing antibodies directed against erythropoietin have been reported with recombinant erythropoietins, including darbepoetin alfa. These neutralizing antibodies cross-react with other erythropoietins and a relay treatment with darbepoetin alfa should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed.

– Breast-feeding: as there is no clinical experience in women during breast-feeding, it is recommended not to administer Aranesp to women who are breast-feeding. When treatment with Aranesp is absolutely indicated, breast-feeding should be discontinued.

ADVISED AGAINST:

Pregnancy: No clinical data are available in pregnant women. Animal studies have not shown any deleterious effects on gestation, embryofoetal development, parturition or postnatal development.

Precautionary measures are required when prescribing in pregnant women.

Aranesp Side Effects

In addition to the desired effect, this medicine can cause side effects.

The main side effects are the following.

Sometimes (from 10 to 30 people in 100)

Increased blood pressure . You should only use this medicine if the blood pressure is good. If necessary, you can give blood pressure reducers to your doctor. Very rarely (in fewer than 1 in 100 people) suddenly a strongly increased blood pressure occurs. Warn your doctor with muscle twitches and sudden migraine-like headaches (vigorous throbbing unilateral headache).

Edema . You will notice this especially with swollen ankles and feet. Consult your doctor if you have a lot of problems with this.

Hypersensitivity to darbepoetin alfa. This can be seen, among other things, in unexplained fatigue, tightness in itching or hives, skin rash, skin redness, flu-like symptoms, fever, muscle pain, tightness or fainting. Stop using and consult your doctor. In very rare cases, a serious skin condition can develop with fever and blistering. The blisters mainly develop on the lips and on the mucous membranes of the mouth and genitals. Then immediately notify a doctor or go to the First Aid Service. You can not use this medicine in the future. Therefore tell the pharmacy that you are hypersensitive to darbepoetin alfa. The pharmacy team can then ensure that you do not get this remedy again.

Rarely (from 1 to 10 in 100 people)

Headache.

Pain at the injection site . This will pass after some time.

Formation of blood clots in the vessels (thrombosis), especially at the site of the injection needle. Do not use this medicine if you have an increased risk of thrombosis or if you have ever had a heart attack or stroke due to thrombosis. Your doctor may combine the treatment of darbepoietin with anticoagulants.

Stroke (cerebral infarction). You will notice this mainly by sudden complaints. These may be paralysis in the face (crooked mouth for example), confused speaking and thinking, paralysis of the arm or leg, loss of vision, and tingling. Tell a doctor immediately.

Very rare (affects less than 1 in 100 people)

Epileptic seizures . Then tell your doctor.

Too much potassium in the blood . This can be seen in an irregular heartbeat (often the first symptom), numbness or strange sensations in the arms and legs, lethargy, confusion and weakness. Consult your doctor for these symptoms.

If there are enough red blood cells in your blood and you still use darbepoietin alfa, it can happen that too many blood cells occur. This causes too much blood and increased blood pressure, especially if the number of red blood cells rises very quickly. That is why the doctor checks the blood regularly and keeps an eye on whether the increase does not go too fast. Consult your doctor if you suffer too much from any of the above mentioned side effects or if you experience other side effects that you are worried about.

Aranesp Interactions

The clinical results available to date have not shown any interaction between darbepoetin alfa and other substances.

However, there is a potential risk of drug interaction with substances with a high binding affinity for red blood cells such as ciclosporin and tacrolimus.

If Aranesp is administered concurrently with any of these treatments, their blood levels should be monitored and their dose adjusted according to the increase in hemoglobin.

Aranesp Warnings and Precautions

Overview

In order to improve the traceability of erythropoiesis stimulating agents (ESAs), the commercial name of the ESA administered should be clearly recorded in the patient’s chart.

Blood pressure should be monitored in all patients, especially during the initiation phase of Aranesp therapy. If blood pressure is difficult to control after appropriate measures are taken, hemoglobin levels can be reduced by decreasing the dosage or by spacing Aranesp injections (see Dosage and Method of Administration ). . Cases of severe hypertension, including hypertensive crises, hypertensive encephalopathy, and seizures have been observed in CKD patients treated with Aranesp.

To ensure effective erythropoiesis, martial status should be controlled in all patients, before and during treatment, iron supplementation may be required.

The lack of response to treatment with Aranesp should lead quickly to investigate the causes. A deficiency of iron, folic acid or vitamin B12 decreases the effectiveness of ESAs and must be corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminum intoxication, underlying hematological disease or myelofibrosis may also alter the erythropoietic response. The count of reticulocytes is an element of evaluation of the medullary activity. If usual causes of no response have been excluded, and if the patient has reticulopenia, bone marrow examination should be considered. If the bone marrow biopsy is compatible with PRCA, a search for

Pure red cell aplasia due to neutralizing antibodies to erythropoietin has been reported with ESAs, including Aranesp. This has mainly been reported in patients with chronic renal failure treated subcutaneously. These neutralizing antibodies cross-react with other epoetins and Aranesp relay therapy should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed (see section 4.8 ).

A paradoxical decrease in hemoglobin and the development of severe anemia associated with a low number of reticulocytes should prompt rapid discontinuation of epoetin and an anti-erythropoietin antibody test. Cases have been reported in patients with hepatitis C treated with interferon and ribavirin when epoetins are used concomitantly. Epoetins are not indicated for the treatment of anemia associated with hepatitis C.

The existence of a progressive liver pathology was an exclusion criterion for all studies with Aranesp. Therefore, no data are available in patients with hepatic impairment. Since the liver is considered the main route of elimination of darbepoetin alfa and r-HuEPO, Aranesp should be used with caution in patients with liver disease.

Aranesp should also be used with caution in patients with sickle cell anemia.

Misuse of Aranesp in healthy subjects may result in an excessive increase in hematocrit. This can be associated with life-threatening cardiovascular complications.

The protective cap of the pre-filled syringe or pre-filled pen contains natural rubber (a derivative of the latex) that can cause allergic reactions.

Aranesp should be used with caution in patients with epilepsy. Seizures have been reported in patients treated with Aranesp.

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie it is considered essentially “sodium-free”.

Chronic renal failure patients

In patients with chronic renal impairment, the hemoglobin level during the maintenance phase should not exceed the upper limit of the target hemoglobin level recommended under Dosage and Method of Administration . In clinical studies, an increase in the number of deaths, serious cardiovascular or cerebrovascular events, including stroke, and vascular thrombosis at the access point was observed when ESAs were administered in order to achieve Hemoglobin targets greater than 12g / dl (7.5 mmol / l).

Caution should be exercised with dose escalation of Aranesp in patients with chronic renal failure, as high cumulative doses of epoetin may be associated with an increased risk of mortality and serious cardiovascular and cerebrovascular events. In patients aynt a poor response to epoetins, other factors behind the poor response should be considered (see Dosage and Administration and Pharmacodynamic properties ).

Controlled clinical trials did not demonstrate any significant benefits attributable to epoetin administration when hemoglobin levels were increased beyond values ​​to control the symptoms of anemia and to avoid the use of transfusions. blood.

Iron supplementation is recommended for all patients with serum ferritin levels below 100 pg / l or transferrin saturation <20%.

Serum potassium should be monitored regularly during treatment with Aranesp. Potassium elevation has been reported in a few patients treated with Aranesp, although the causal link has not been established. If there is a high level or an increase in serum potassium, discontinuation of Aranesp should be considered until serum potassium is normalized.

Cancer patients

Effect on tumor growth

Epoetins are growth factors that essentially stimulate the production of red blood cells. Erythropoietin receptors would be expressed on the surface of different types of tumor cells. Like any growth factor, epoetins may stimulate growth of tumors. In several controlled studies in which epoetins have been administered, there has been no improvement in overall survival or decreased risk of tumor progression in patients with cancer-associated anemia.

In controlled clinical studies, the use of Aranesp and other ESAs has shown:

a shortening of time to tumor progression in patients with advanced head and neck cancer receiving radiotherapy when ESAs were administered to achieve target hemoglobin levels greater than 14 g / dl (8.7 mmol / l). ESAs are not indicated for use in this patient population.

a decrease in overall survival and an increase in the number of deaths at 4 months, attributed to disease progression, in patients with metastatic breast cancer receiving chemotherapy, when ESAs were administered for the purpose of target hemoglobin levels of between 12 and 14 g / dl (7.5-8.7 mmol / l).

an increased risk of death when ESAs were administered to achieve a target hemoglobin level of 12 g / dl (7.5 mmol / l) in patients with active malignancy who were not receiving chemotherapy, nor radiotherapy. ESAs are not indicated for use in this patient population.

In view of the above information, in certain clinical situations, blood transfusion should be the preferred treatment for anemia in cancer patients. The decision to administer recombinant epoetins should be based on a benefit-risk assessment taking into account the patient’s opinion in its specific clinical context. Factors to be considered in this assessment should include the type of tumor and its stage, the degree of anemia, life expectancy, the environment in which the patient is treated and the patient’s preference (see section 5.1 ). .

If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l) in patients with solid tumors or lymphoproliferative malignancies, strictly adhere to the dose adjustment described in section Dosage and method of administration , in order to minimize the possible risks of thromboembolic events. Platelet count and hemoglobin should also be monitored at regular intervals.

Drive and use machines

Aranesp has no or negligible influence on the ability to drive and use machines.

Aranesp and PREGNANCY / BREAST FEEDING

aranesp in pregnancy

There are no relevant and well-conducted studies regarding the use of Aranesp in pregnant women.

Animal studies have not shown deleterious effects on pregnancy, embryo-fetal development, parturition or postnatal development. No alteration of fertility was detected.

Caution is required when prescribing Aranesp in pregnant women.

Women whose pregnancies occur during treatment with Aranesp should be encouraged to enroll in the Amgen Pregnancy Surveillance Program. The contact details are in section 6 of the package leaflet.

aranesp in Breastfeeding

It is not known if Aranesp is excreted in breast milk. A risk for infants can not be ruled out.

The decision to discontinue breastfeeding or discontinue / abstain from treatment with Aranesp should be made with regard to the benefit of breastfeeding for the child and the benefit of treatment for the woman.

What should I do if I miss a dose?

If you inject yourself:

have you forgotten a dose and are you discovering it the same day? 

Use the dose as yet.

Do you discover it the next day? 

Consult your doctor.

 Never use a double dose.

What happens if I overdose from Aranesp ?

The maximum amount of Aranesp that can be safely administered at single or multiple doses has not been determined.

Aranesp treatment may result in polycythemia if the hemoglobin level is not closely monitored and the dose adjusted properly.

Cases of severe arterial hypertension have been observed after an overdose with Aranesp ( see Warnings and Precautions ).

In case of polycythemia, treatment with Aranesp should be temporarily interrupted ( see Dosage and Method of Administration ).

A bleeding can be performed in case of clinical need.

What is  Forms and Composition?

SC or IV solution for injection (clear, colorless) at 10 μg (25 μg / ml):   0.4 ml pre-filled syringe * with 27 G needle, unitary box. Injection solution SC or IV (clear, colorless) at 20 μg (40 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, unitary box.

SC or IV solution for injection (clear, colorless) at 30 μg (100 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, unitary box. SC or IV (clear, colorless) solution for injection at 40 μg (100 μg / ml):   0.4 ml secure * pre-filled syringe with 27 G needle, single unit.

Injection solution SC (clear, colorless) at 40 μg (100 μg / ml):   0.4 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.

Injection solution SC or IV (clear, colorless) at 50 μg (100 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, single box.

SC or IV solution for injection (clear, colorless) at 60 μg (200 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, unitary box.

Solution for injection SC (clear, colorless) at 60 μg (200 μg / ml):   0.3 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.

SC or IV injection solution (clear, colorless) at 80 μg (200 μg / ml):   0.4 ml secure * pre-filled syringe with 27G needle, single unit.

Injection solution SC (clear, colorless) at 80 μg (200 μg / ml):   0.4 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.

SC or IV solution for injection (clear, colorless) at 100 μg (200 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, single unit.

Solution for injection SC (clear, colorless) at 100 μg (200 μg / ml):   0.5 ml pre-filled * pen (SureClick) containing a 27 G needle syringe, unitary box.

SC or IV (clear, colorless) solution for injection at 130 μg (200 μg / ml):   0.65 ml pre-filled * safety syringe with 27 G needle, single unit.

SC or IV solution for injection (clear, colorless) at 150 μg (500 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, single box.

Solution for injection SC (clear, colorless) at 150 μg (500 μg / ml):   0.3 ml pre-filled * pen (SureClick) containing a 27 G needle syringe, unitary box.

SC or IV injection solution (clear, colorless) to 300 micrograms (500 micrograms / ml):   Pre-filled syringe * Secure 0.6 ml with 27 G needle, unitary box.

Solution for injection SC (clear, colorless) 300 μg (500 μg / ml):   * Prefilled pen * (SureClick) 0.6 ml containing a syringe with 27 G needle, unitary box.

Solution for injection SC or IV (clear, colorless) at 500 μg (500 μg / ml):   1 ml pre-filled syringe * with 27 G needle, unitary box.

Solution for injection SC (clear, colorless) 500 μg (500 μg / ml):   1 ml pre-filled *pen (SureClick) containing a 27 G needle syringe, unitary box.

*  The protective cap of the pre-filled syringe or pre-filled pen contains natural rubber (a derivative of the latex): see Warnings and Precautions for Use .

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.

The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

The post Aranesp Uses, Dosage, Side Effects, Precautions & Warnings appeared first on Drug Online.

from Drug Online https://bit.ly/30bOHLm via Edrug Online from Faculty of Medicine https://bit.ly/3gi9D96 via Internal Medicine

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Aranesp Uses, Dosage, Side Effects, Precautions & Warnings

Drug Online

Therapeutic class: Cancerology and hematology Active ingredients: Darbepoetin alfa

Important to know about Aranesp ?

Darbepoetin alfa injections stimulate the body to produce red blood cells.

In case of severe anemia (as can occur in certain kidney diseases), in cancer chemotherapy and prior to surgery if the doctors expect a lot of blood loss.

It takes 2 to 6 weeks for the number of red blood cells to be up to standard.

You usually receive the injections once every 1, 2 or 3 weeks.

Side effects include: increased blood pressure and swollen ankles and feet. Do you suffer a lot from this? Consult your doctor.

Furthermore: hypersensitivity to this medication. You notice that among other things skin rash, itching, fever or tightness. Then warn a doctor.

A rare side effect is thrombosis (blood clot in a blood vessel). You notice thrombosis of sudden pain or swelling in your leg, or chest tightness or shortness of breath. Then immediately notify a doctor.

What is Aranesp used to treat and indication ?

Treatment of symptomatic anemia related to chronic renal insufficiency (CKD) in adults and children ( see Dosage and Method of Administration ).

Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy.

aranesp injection dosage

Treatment of symptomatic anemia in adults and children with chronic renal failure

The symptoms and consequences of anemia may vary depending on age, sex and the overall clinical picture; It is necessary for a doctor to evaluate the disease and its evolution. Aranesp can be administered subcutaneously or intravenously to increase hemoglobin to a maximum of 12 g / dl (7.5 mmol / l). The subcutaneous route is preferred in patients who are not hemodialysis, in order to preserve the peripheral veins.

Patients should be closely monitored to ensure that the minimum adequate dose of Aranesp is used to control the symptoms of anemia while maintaining hemoglobinemia less than or equal to 12 g / dL (7.5 mmol / L) . Caution is required when increasing doses of Aranesp in patients with chronic renal failure. Alternative explanations for poor response to treatment should be sought in patients treated with Aranesp who have an insufficient increase in hemoglobin (see Warnings and Precautions and Pharmacodynamic Properties section ).

Due to intra-individual variability, point concentrations of hemoglobin can be observed below and above the desired values. The variability of hemoglobin level should be controlled by adjusting the dosage, relative to the target hemoglobin level between 10 g / dl (6.2 mmol / l) and 12 g / dl (7.5 mmol / l) . Maintaining a hemoglobin level above 12 g / dl (7.5 mmol / l) should be avoided; recommendations for dosage adjustment when the hemoglobin level exceeds 12 g / dl (7.5 mmol / l) are detailed below. An increase of hemoglobin above 2 g / dl (1.25 mmol / l) over a period of 4 weeks should be avoided. If this occurs, the dosage should be adjusted.

Treatment with Aranesp is divided into two phases, corrective phase and maintenance phase. Treatment modalities are presented separately for adults and children.

Adults with chronic renal failure

Corrective phase :

The initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, the following initial doses may also be administered subcutaneously as a single injection: 0.75 μg / kg once every two weeks or 1.5 μg / kg once a month. If the increase in hemoglobin is insufficient (less than 1 g / dl [0.6 mmol / l] in four weeks), the dose may be increased by approximately 25%. The dosage should not be increased more than once every four weeks.

If the increase in hemoglobin is greater than 2 g / dl (1.25 mmol / l) over a four-week period, reduce the dose by approximately 25% from the previous dose, depending on the dose. importance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.

The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then the hemoglobin level can be measured at longer intervals.

Maintenance phase :

In dialysis patients, Aranesp can continue to be administered as a once weekly injection or once every two weeks. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered.

In non-dialysis patients, Aranesp can continue to be administered as a single injection once a week or once every two weeks or once a month. In patients treated with Aranesp once every two weeks, and after the target hemoglobin level has been reached, Aranesp can then be administered by subcutaneous injection once a month using an initial dose equivalent to twice the dose used every two weeks.

The dose administered should be evaluated to maintain the target hemoglobin level.

If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose.

If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) over a period of 4 weeks, reduce the dose by approximately 25% depending on the significance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.

After each dose or schedule adjustment, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.

When the route of administration is changed, the same dose should be used and the hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired level.

Clinical trials have shown that adult patients receiving r-HuEPO once, twice or three times a week may receive Aranesp once weekly or once every 2 weeks. The initial weekly dose of Aranesp (μg / week) can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 200. The initial dose of Aranesp administered every 2 weeks (μg / 2 weeks) can be calculated by dividing by 200 the total dose of r-HuEPO administered over a 2-week period. Due to individual variability, the search for the optimal therapeutic dose should be done for each patient. When replacing r-HuEPO with Aranesp, the rate of

Children with chronic renal failure

Treatment of children under 1 year of age has not been studied in randomized clinical trials.

Corrective phase :

In children from 1 year of age, the initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, an initial dose of 0.75 μg / kg can be administered subcutaneously as a single injection once every two weeks. If the increase in hemoglobin is insufficient (less than 1 g / dl [0.6 mmol / l] in four weeks), the dose may be increased by approximately 25% . The dosage should not be increased more than once every four weeks .

If the increase in hemoglobin is greater than 2 g / dl (1.25 mmol / l) over a four-week period, reduce the dose by approximately 25% from the previous dose, depending on the level. increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.

The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then the hemoglobin level can be measured at larger intervals.

Correction of anemia in pediatric patients with a monthly administration frequency of Aranesp has not been studied.

Maintenance phase :

In children from 1 year of age, during the maintenance phase, Aranesp can continue to be administered as a single once-weekly injection or once every two weeks.

In patients younger than 6 years of age, higher doses may be needed to maintain target hemoglobin levels compared to patients 6 years of age and older. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered.

In patients 11 years of age and older who are not on dialysis, once the target hemoglobin level is reached by one dose every two weeks, Aranesp can be administered by subcutaneous injection once a month. using an initial dose equivalent to twice the dose used every two weeks.

Clinical data available in children have shown that patients receiving r-HuEPO two or three times a week can receive Aranesp once a week, and those receiving r-HuEPO once per week could benefit from administration of Aranesp once every two weeks. The initial weekly dose of Aranesp (μg / week) in pediatrics can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 240. The initial dose of Aranesp (μg / week) to be administered every two weeks in pediatrics can be calculated by dividing the total dose of r-HuEPO (UI / week) over two weeks by 240. Due to individual variability, the search for the optimal therapeutic dose should be performed for each patient.

The dose administered should be periodically evaluated to maintain the target hemoglobin level.

If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose.

If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) in 4 weeks, reduce the dose by approximately 25% depending on the importance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.

Patients starting dialysis during Aranesp therapy should be closely monitored for adequate control of their hemoglobin levels.

After each adjustment in dose or rate of administration, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.

When the route of administration is changed, the same dose should be used and hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired hemoglobin level.

Treatment of symptomatic anemia induced by chemotherapy in cancer patients

Aranesp should be administered subcutaneously to patients with anemia (eg, hemoglobin ≤ 10 g / dl (6.2 mmol / l)) to achieve a hemoglobin level not exceeding 12 g / dl (7.5 mmol / l). The symptoms and consequences of anemia may vary depending on age, sex and the overall clinical picture; It is necessary for a doctor to evaluate the disease and its evolution.

Due to intra-individual variability, point concentrations of hemoglobin can be observed below and above the desired values. The variability in hemoglobin levels should be controlled by adjusting the dose to the target hemoglobin level between 10 g / dl (6.2 mmol / l) and 12 g / dl (7.5 mmol / l). Maintaining a hemoglobin level greater than 12 g / dl (7.5 mmol / l) should be avoided; recommendations for dosage adjustment when the hemoglobin level exceeds 12 g / dl are detailed below.

The recommended starting dose is 500 pg (6.75 μg / kg body weight), administered once every three weeks, or 2.25 μg / kg body weight given once a week. If the clinical response (fatigue, hemoglobin level) is not satisfactory after nine weeks of treatment, continued treatment may be ineffective.

Aranesp treatment should be discontinued approximately four weeks after the end of chemotherapy.

Once the individual therapeutic goal is reached, the dose should be reduced by 25 to 50% to ensure that the appropriate minimum dose of Aranesp is used to maintain hemoglobin levels to control the symptoms of anemia. . The choice of a dose of 500 μg, 300 μg or 150 μg should be considered.

Patients should be closely monitored. If the hemoglobin level exceeds 12 g / dl (7.5 mmol / l), the dose should be reduced by approximately 25-50%. Aranesp treatment should be temporarily discontinued if the hemoglobin level exceeds 13 g / dl (8.1 mmol / l). Treatment will be resumed at approximately 25% lower than the previous dose when the hemoglobin level has dropped to 12 g / dl (7.5 mmol / l) or less.

If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) over a period of four weeks, the dose should be reduced by 25 to 50%.

Administration mode

Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled syringe

Aranesp is administered subcutaneously or intravenously as described under Dosage. Alternate injection sites and inject slowly to avoid discomfort at the injection site.

Aranesp is presented in a pre-filled syringe ready for injection.

Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled pen

Aranesp in pre-filled pen is intended for subcutaneous administration only.

Alternate injection sites to avoid discomfort at the injection site.

Aranesp is presented in pre-filled pen ready for injection.

Aranesp 25, 40, 60, 100, 200, 300 micrograms solution for injection in vial

Aranesp is administered subcutaneously or intravenously as described under Dosage.

Alternate injection sites and inject slowly to avoid discomfort at the injection site.

Aranesp is presented in a ready-to-use bottle.

For instructions on use, handling and disposal, see section Instructions for use, handling and disposal .

what is aranesp contraindications

CONTRA-INDICATED:

– Known hypersensitivity to darbepoetin alfa, to r-HuEPO or to any of the excipients.

– Poorly controlled arterial hypertension.

– Cases of erythroblastopenia due to neutralizing antibodies directed against erythropoietin have been reported with recombinant erythropoietins, including darbepoetin alfa. These neutralizing antibodies cross-react with other erythropoietins and a relay treatment with darbepoetin alfa should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed.

– Breast-feeding: as there is no clinical experience in women during breast-feeding, it is recommended not to administer Aranesp to women who are breast-feeding. When treatment with Aranesp is absolutely indicated, breast-feeding should be discontinued.

ADVISED AGAINST:

Pregnancy: No clinical data are available in pregnant women. Animal studies have not shown any deleterious effects on gestation, embryofoetal development, parturition or postnatal development.

Precautionary measures are required when prescribing in pregnant women.

Aranesp Side Effects

In addition to the desired effect, this medicine can cause side effects.

The main side effects are the following.

Sometimes (from 10 to 30 people in 100)

Increased blood pressure . You should only use this medicine if the blood pressure is good. If necessary, you can give blood pressure reducers to your doctor. Very rarely (in fewer than 1 in 100 people) suddenly a strongly increased blood pressure occurs. Warn your doctor with muscle twitches and sudden migraine-like headaches (vigorous throbbing unilateral headache).

Edema . You will notice this especially with swollen ankles and feet. Consult your doctor if you have a lot of problems with this.

Hypersensitivity to darbepoetin alfa. This can be seen, among other things, in unexplained fatigue, tightness in itching or hives, skin rash, skin redness, flu-like symptoms, fever, muscle pain, tightness or fainting. Stop using and consult your doctor. In very rare cases, a serious skin condition can develop with fever and blistering. The blisters mainly develop on the lips and on the mucous membranes of the mouth and genitals. Then immediately notify a doctor or go to the First Aid Service. You can not use this medicine in the future. Therefore tell the pharmacy that you are hypersensitive to darbepoetin alfa. The pharmacy team can then ensure that you do not get this remedy again.

Rarely (from 1 to 10 in 100 people)

Headache.

Pain at the injection site . This will pass after some time.

Formation of blood clots in the vessels (thrombosis), especially at the site of the injection needle. Do not use this medicine if you have an increased risk of thrombosis or if you have ever had a heart attack or stroke due to thrombosis. Your doctor may combine the treatment of darbepoietin with anticoagulants.

Stroke (cerebral infarction). You will notice this mainly by sudden complaints. These may be paralysis in the face (crooked mouth for example), confused speaking and thinking, paralysis of the arm or leg, loss of vision, and tingling. Tell a doctor immediately.

Very rare (affects less than 1 in 100 people)

Epileptic seizures . Then tell your doctor.

Too much potassium in the blood . This can be seen in an irregular heartbeat (often the first symptom), numbness or strange sensations in the arms and legs, lethargy, confusion and weakness. Consult your doctor for these symptoms.

If there are enough red blood cells in your blood and you still use darbepoietin alfa, it can happen that too many blood cells occur. This causes too much blood and increased blood pressure, especially if the number of red blood cells rises very quickly. That is why the doctor checks the blood regularly and keeps an eye on whether the increase does not go too fast. Consult your doctor if you suffer too much from any of the above mentioned side effects or if you experience other side effects that you are worried about.

Aranesp Interactions

The clinical results available to date have not shown any interaction between darbepoetin alfa and other substances.

However, there is a potential risk of drug interaction with substances with a high binding affinity for red blood cells such as ciclosporin and tacrolimus.

If Aranesp is administered concurrently with any of these treatments, their blood levels should be monitored and their dose adjusted according to the increase in hemoglobin.

Aranesp Warnings and Precautions

Overview

In order to improve the traceability of erythropoiesis stimulating agents (ESAs), the commercial name of the ESA administered should be clearly recorded in the patient’s chart.

Blood pressure should be monitored in all patients, especially during the initiation phase of Aranesp therapy. If blood pressure is difficult to control after appropriate measures are taken, hemoglobin levels can be reduced by decreasing the dosage or by spacing Aranesp injections (see Dosage and Method of Administration ). . Cases of severe hypertension, including hypertensive crises, hypertensive encephalopathy, and seizures have been observed in CKD patients treated with Aranesp.

To ensure effective erythropoiesis, martial status should be controlled in all patients, before and during treatment, iron supplementation may be required.

The lack of response to treatment with Aranesp should lead quickly to investigate the causes. A deficiency of iron, folic acid or vitamin B12 decreases the effectiveness of ESAs and must be corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminum intoxication, underlying hematological disease or myelofibrosis may also alter the erythropoietic response. The count of reticulocytes is an element of evaluation of the medullary activity. If usual causes of no response have been excluded, and if the patient has reticulopenia, bone marrow examination should be considered. If the bone marrow biopsy is compatible with PRCA, a search for

Pure red cell aplasia due to neutralizing antibodies to erythropoietin has been reported with ESAs, including Aranesp. This has mainly been reported in patients with chronic renal failure treated subcutaneously. These neutralizing antibodies cross-react with other epoetins and Aranesp relay therapy should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed (see section 4.8 ).

A paradoxical decrease in hemoglobin and the development of severe anemia associated with a low number of reticulocytes should prompt rapid discontinuation of epoetin and an anti-erythropoietin antibody test. Cases have been reported in patients with hepatitis C treated with interferon and ribavirin when epoetins are used concomitantly. Epoetins are not indicated for the treatment of anemia associated with hepatitis C.

The existence of a progressive liver pathology was an exclusion criterion for all studies with Aranesp. Therefore, no data are available in patients with hepatic impairment. Since the liver is considered the main route of elimination of darbepoetin alfa and r-HuEPO, Aranesp should be used with caution in patients with liver disease.

Aranesp should also be used with caution in patients with sickle cell anemia.

Misuse of Aranesp in healthy subjects may result in an excessive increase in hematocrit. This can be associated with life-threatening cardiovascular complications.

The protective cap of the pre-filled syringe or pre-filled pen contains natural rubber (a derivative of the latex) that can cause allergic reactions.

Aranesp should be used with caution in patients with epilepsy. Seizures have been reported in patients treated with Aranesp.

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie it is considered essentially “sodium-free”.

Chronic renal failure patients

In patients with chronic renal impairment, the hemoglobin level during the maintenance phase should not exceed the upper limit of the target hemoglobin level recommended under Dosage and Method of Administration . In clinical studies, an increase in the number of deaths, serious cardiovascular or cerebrovascular events, including stroke, and vascular thrombosis at the access point was observed when ESAs were administered in order to achieve Hemoglobin targets greater than 12g / dl (7.5 mmol / l).

Caution should be exercised with dose escalation of Aranesp in patients with chronic renal failure, as high cumulative doses of epoetin may be associated with an increased risk of mortality and serious cardiovascular and cerebrovascular events. In patients aynt a poor response to epoetins, other factors behind the poor response should be considered (see Dosage and Administration and Pharmacodynamic properties ).

Controlled clinical trials did not demonstrate any significant benefits attributable to epoetin administration when hemoglobin levels were increased beyond values ​​to control the symptoms of anemia and to avoid the use of transfusions. blood.

Iron supplementation is recommended for all patients with serum ferritin levels below 100 pg / l or transferrin saturation <20%.

Serum potassium should be monitored regularly during treatment with Aranesp. Potassium elevation has been reported in a few patients treated with Aranesp, although the causal link has not been established. If there is a high level or an increase in serum potassium, discontinuation of Aranesp should be considered until serum potassium is normalized.

Cancer patients

Effect on tumor growth

Epoetins are growth factors that essentially stimulate the production of red blood cells. Erythropoietin receptors would be expressed on the surface of different types of tumor cells. Like any growth factor, epoetins may stimulate growth of tumors. In several controlled studies in which epoetins have been administered, there has been no improvement in overall survival or decreased risk of tumor progression in patients with cancer-associated anemia.

In controlled clinical studies, the use of Aranesp and other ESAs has shown:

a shortening of time to tumor progression in patients with advanced head and neck cancer receiving radiotherapy when ESAs were administered to achieve target hemoglobin levels greater than 14 g / dl (8.7 mmol / l). ESAs are not indicated for use in this patient population.

a decrease in overall survival and an increase in the number of deaths at 4 months, attributed to disease progression, in patients with metastatic breast cancer receiving chemotherapy, when ESAs were administered for the purpose of target hemoglobin levels of between 12 and 14 g / dl (7.5-8.7 mmol / l).

an increased risk of death when ESAs were administered to achieve a target hemoglobin level of 12 g / dl (7.5 mmol / l) in patients with active malignancy who were not receiving chemotherapy, nor radiotherapy. ESAs are not indicated for use in this patient population.

In view of the above information, in certain clinical situations, blood transfusion should be the preferred treatment for anemia in cancer patients. The decision to administer recombinant epoetins should be based on a benefit-risk assessment taking into account the patient’s opinion in its specific clinical context. Factors to be considered in this assessment should include the type of tumor and its stage, the degree of anemia, life expectancy, the environment in which the patient is treated and the patient’s preference (see section 5.1 ). .

If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l) in patients with solid tumors or lymphoproliferative malignancies, strictly adhere to the dose adjustment described in section Dosage and method of administration , in order to minimize the possible risks of thromboembolic events. Platelet count and hemoglobin should also be monitored at regular intervals.

Drive and use machines

Aranesp has no or negligible influence on the ability to drive and use machines.

Aranesp and PREGNANCY / BREAST FEEDING

aranesp in pregnancy

There are no relevant and well-conducted studies regarding the use of Aranesp in pregnant women.

Animal studies have not shown deleterious effects on pregnancy, embryo-fetal development, parturition or postnatal development. No alteration of fertility was detected.

Caution is required when prescribing Aranesp in pregnant women.

Women whose pregnancies occur during treatment with Aranesp should be encouraged to enroll in the Amgen Pregnancy Surveillance Program. The contact details are in section 6 of the package leaflet.

aranesp in Breastfeeding

It is not known if Aranesp is excreted in breast milk. A risk for infants can not be ruled out.

The decision to discontinue breastfeeding or discontinue / abstain from treatment with Aranesp should be made with regard to the benefit of breastfeeding for the child and the benefit of treatment for the woman.

What should I do if I miss a dose?

If you inject yourself:

have you forgotten a dose and are you discovering it the same day? 

Use the dose as yet.

Do you discover it the next day? 

Consult your doctor.

 Never use a double dose.

What happens if I overdose from Aranesp ?

The maximum amount of Aranesp that can be safely administered at single or multiple doses has not been determined.

Aranesp treatment may result in polycythemia if the hemoglobin level is not closely monitored and the dose adjusted properly.

Cases of severe arterial hypertension have been observed after an overdose with Aranesp ( see Warnings and Precautions ).

In case of polycythemia, treatment with Aranesp should be temporarily interrupted ( see Dosage and Method of Administration ).

A bleeding can be performed in case of clinical need.

What is  Forms and Composition?

SC or IV solution for injection (clear, colorless) at 10 μg (25 μg / ml):   0.4 ml pre-filled syringe * with 27 G needle, unitary box. Injection solution SC or IV (clear, colorless) at 20 μg (40 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, unitary box.

SC or IV solution for injection (clear, colorless) at 30 μg (100 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, unitary box. SC or IV (clear, colorless) solution for injection at 40 μg (100 μg / ml):   0.4 ml secure * pre-filled syringe with 27 G needle, single unit.

Injection solution SC (clear, colorless) at 40 μg (100 μg / ml):   0.4 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.

Injection solution SC or IV (clear, colorless) at 50 μg (100 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, single box.

SC or IV solution for injection (clear, colorless) at 60 μg (200 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, unitary box.

Solution for injection SC (clear, colorless) at 60 μg (200 μg / ml):   0.3 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.

SC or IV injection solution (clear, colorless) at 80 μg (200 μg / ml):   0.4 ml secure * pre-filled syringe with 27G needle, single unit.

Injection solution SC (clear, colorless) at 80 μg (200 μg / ml):   0.4 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.

SC or IV solution for injection (clear, colorless) at 100 μg (200 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, single unit.

Solution for injection SC (clear, colorless) at 100 μg (200 μg / ml):   0.5 ml pre-filled * pen (SureClick) containing a 27 G needle syringe, unitary box.

SC or IV (clear, colorless) solution for injection at 130 μg (200 μg / ml):   0.65 ml pre-filled * safety syringe with 27 G needle, single unit.

SC or IV solution for injection (clear, colorless) at 150 μg (500 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, single box.

Solution for injection SC (clear, colorless) at 150 μg (500 μg / ml):   0.3 ml pre-filled * pen (SureClick) containing a 27 G needle syringe, unitary box.

SC or IV injection solution (clear, colorless) to 300 micrograms (500 micrograms / ml):   Pre-filled syringe * Secure 0.6 ml with 27 G needle, unitary box.

Solution for injection SC (clear, colorless) 300 μg (500 μg / ml):   * Prefilled pen * (SureClick) 0.6 ml containing a syringe with 27 G needle, unitary box.

Solution for injection SC or IV (clear, colorless) at 500 μg (500 μg / ml):   1 ml pre-filled syringe * with 27 G needle, unitary box.

Solution for injection SC (clear, colorless) 500 μg (500 μg / ml):   1 ml pre-filled *pen (SureClick) containing a 27 G needle syringe, unitary box.

*  The protective cap of the pre-filled syringe or pre-filled pen contains natural rubber (a derivative of the latex): see Warnings and Precautions for Use .

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.

The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

The post Aranesp Uses, Dosage, Side Effects, Precautions & Warnings appeared first on Drug Online.

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Aranesp Uses, Dosage, Side Effects, Precautions & Warnings

Drug Online

Therapeutic class: Cancerology and hematology Active ingredients: Darbepoetin alfa

Important to know about Aranesp ?

Darbepoetin alfa injections stimulate the body to produce red blood cells.

In case of severe anemia (as can occur in certain kidney diseases), in cancer chemotherapy and prior to surgery if the doctors expect a lot of blood loss.

It takes 2 to 6 weeks for the number of red blood cells to be up to standard.

You usually receive the injections once every 1, 2 or 3 weeks.

Side effects include: increased blood pressure and swollen ankles and feet. Do you suffer a lot from this? Consult your doctor.

Furthermore: hypersensitivity to this medication. You notice that among other things skin rash, itching, fever or tightness. Then warn a doctor.

A rare side effect is thrombosis (blood clot in a blood vessel). You notice thrombosis of sudden pain or swelling in your leg, or chest tightness or shortness of breath. Then immediately notify a doctor.

What is Aranesp used to treat and indication ?

Treatment of symptomatic anemia related to chronic renal insufficiency (CKD) in adults and children ( see Dosage and Method of Administration ).

Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy.

aranesp injection dosage

Treatment of symptomatic anemia in adults and children with chronic renal failure

The symptoms and consequences of anemia may vary depending on age, sex and the overall clinical picture; It is necessary for a doctor to evaluate the disease and its evolution. Aranesp can be administered subcutaneously or intravenously to increase hemoglobin to a maximum of 12 g / dl (7.5 mmol / l). The subcutaneous route is preferred in patients who are not hemodialysis, in order to preserve the peripheral veins.

Patients should be closely monitored to ensure that the minimum adequate dose of Aranesp is used to control the symptoms of anemia while maintaining hemoglobinemia less than or equal to 12 g / dL (7.5 mmol / L) . Caution is required when increasing doses of Aranesp in patients with chronic renal failure. Alternative explanations for poor response to treatment should be sought in patients treated with Aranesp who have an insufficient increase in hemoglobin (see Warnings and Precautions and Pharmacodynamic Properties section ).

Due to intra-individual variability, point concentrations of hemoglobin can be observed below and above the desired values. The variability of hemoglobin level should be controlled by adjusting the dosage, relative to the target hemoglobin level between 10 g / dl (6.2 mmol / l) and 12 g / dl (7.5 mmol / l) . Maintaining a hemoglobin level above 12 g / dl (7.5 mmol / l) should be avoided; recommendations for dosage adjustment when the hemoglobin level exceeds 12 g / dl (7.5 mmol / l) are detailed below. An increase of hemoglobin above 2 g / dl (1.25 mmol / l) over a period of 4 weeks should be avoided. If this occurs, the dosage should be adjusted.

Treatment with Aranesp is divided into two phases, corrective phase and maintenance phase. Treatment modalities are presented separately for adults and children.

Adults with chronic renal failure

Corrective phase :

The initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, the following initial doses may also be administered subcutaneously as a single injection: 0.75 μg / kg once every two weeks or 1.5 μg / kg once a month. If the increase in hemoglobin is insufficient (less than 1 g / dl [0.6 mmol / l] in four weeks), the dose may be increased by approximately 25%. The dosage should not be increased more than once every four weeks.

If the increase in hemoglobin is greater than 2 g / dl (1.25 mmol / l) over a four-week period, reduce the dose by approximately 25% from the previous dose, depending on the dose. importance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.

The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then the hemoglobin level can be measured at longer intervals.

Maintenance phase :

In dialysis patients, Aranesp can continue to be administered as a once weekly injection or once every two weeks. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered.

In non-dialysis patients, Aranesp can continue to be administered as a single injection once a week or once every two weeks or once a month. In patients treated with Aranesp once every two weeks, and after the target hemoglobin level has been reached, Aranesp can then be administered by subcutaneous injection once a month using an initial dose equivalent to twice the dose used every two weeks.

The dose administered should be evaluated to maintain the target hemoglobin level.

If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose.

If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) over a period of 4 weeks, reduce the dose by approximately 25% depending on the significance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.

After each dose or schedule adjustment, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.

When the route of administration is changed, the same dose should be used and the hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired level.

Clinical trials have shown that adult patients receiving r-HuEPO once, twice or three times a week may receive Aranesp once weekly or once every 2 weeks. The initial weekly dose of Aranesp (μg / week) can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 200. The initial dose of Aranesp administered every 2 weeks (μg / 2 weeks) can be calculated by dividing by 200 the total dose of r-HuEPO administered over a 2-week period. Due to individual variability, the search for the optimal therapeutic dose should be done for each patient. When replacing r-HuEPO with Aranesp, the rate of

Children with chronic renal failure

Treatment of children under 1 year of age has not been studied in randomized clinical trials.

Corrective phase :

In children from 1 year of age, the initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, an initial dose of 0.75 μg / kg can be administered subcutaneously as a single injection once every two weeks. If the increase in hemoglobin is insufficient (less than 1 g / dl [0.6 mmol / l] in four weeks), the dose may be increased by approximately 25% . The dosage should not be increased more than once every four weeks .

If the increase in hemoglobin is greater than 2 g / dl (1.25 mmol / l) over a four-week period, reduce the dose by approximately 25% from the previous dose, depending on the level. increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.

The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then the hemoglobin level can be measured at larger intervals.

Correction of anemia in pediatric patients with a monthly administration frequency of Aranesp has not been studied.

Maintenance phase :

In children from 1 year of age, during the maintenance phase, Aranesp can continue to be administered as a single once-weekly injection or once every two weeks.

In patients younger than 6 years of age, higher doses may be needed to maintain target hemoglobin levels compared to patients 6 years of age and older. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered.

In patients 11 years of age and older who are not on dialysis, once the target hemoglobin level is reached by one dose every two weeks, Aranesp can be administered by subcutaneous injection once a month. using an initial dose equivalent to twice the dose used every two weeks.

Clinical data available in children have shown that patients receiving r-HuEPO two or three times a week can receive Aranesp once a week, and those receiving r-HuEPO once per week could benefit from administration of Aranesp once every two weeks. The initial weekly dose of Aranesp (μg / week) in pediatrics can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 240. The initial dose of Aranesp (μg / week) to be administered every two weeks in pediatrics can be calculated by dividing the total dose of r-HuEPO (UI / week) over two weeks by 240. Due to individual variability, the search for the optimal therapeutic dose should be performed for each patient.

The dose administered should be periodically evaluated to maintain the target hemoglobin level.

If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose.

If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) in 4 weeks, reduce the dose by approximately 25% depending on the importance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.

Patients starting dialysis during Aranesp therapy should be closely monitored for adequate control of their hemoglobin levels.

After each adjustment in dose or rate of administration, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.

When the route of administration is changed, the same dose should be used and hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired hemoglobin level.

Treatment of symptomatic anemia induced by chemotherapy in cancer patients

Aranesp should be administered subcutaneously to patients with anemia (eg, hemoglobin ≤ 10 g / dl (6.2 mmol / l)) to achieve a hemoglobin level not exceeding 12 g / dl (7.5 mmol / l). The symptoms and consequences of anemia may vary depending on age, sex and the overall clinical picture; It is necessary for a doctor to evaluate the disease and its evolution.

Due to intra-individual variability, point concentrations of hemoglobin can be observed below and above the desired values. The variability in hemoglobin levels should be controlled by adjusting the dose to the target hemoglobin level between 10 g / dl (6.2 mmol / l) and 12 g / dl (7.5 mmol / l). Maintaining a hemoglobin level greater than 12 g / dl (7.5 mmol / l) should be avoided; recommendations for dosage adjustment when the hemoglobin level exceeds 12 g / dl are detailed below.

The recommended starting dose is 500 pg (6.75 μg / kg body weight), administered once every three weeks, or 2.25 μg / kg body weight given once a week. If the clinical response (fatigue, hemoglobin level) is not satisfactory after nine weeks of treatment, continued treatment may be ineffective.

Aranesp treatment should be discontinued approximately four weeks after the end of chemotherapy.

Once the individual therapeutic goal is reached, the dose should be reduced by 25 to 50% to ensure that the appropriate minimum dose of Aranesp is used to maintain hemoglobin levels to control the symptoms of anemia. . The choice of a dose of 500 μg, 300 μg or 150 μg should be considered.

Patients should be closely monitored. If the hemoglobin level exceeds 12 g / dl (7.5 mmol / l), the dose should be reduced by approximately 25-50%. Aranesp treatment should be temporarily discontinued if the hemoglobin level exceeds 13 g / dl (8.1 mmol / l). Treatment will be resumed at approximately 25% lower than the previous dose when the hemoglobin level has dropped to 12 g / dl (7.5 mmol / l) or less.

If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) over a period of four weeks, the dose should be reduced by 25 to 50%.

Administration mode

Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled syringe

Aranesp is administered subcutaneously or intravenously as described under Dosage. Alternate injection sites and inject slowly to avoid discomfort at the injection site.

Aranesp is presented in a pre-filled syringe ready for injection.

Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled pen

Aranesp in pre-filled pen is intended for subcutaneous administration only.

Alternate injection sites to avoid discomfort at the injection site.

Aranesp is presented in pre-filled pen ready for injection.

Aranesp 25, 40, 60, 100, 200, 300 micrograms solution for injection in vial

Aranesp is administered subcutaneously or intravenously as described under Dosage.

Alternate injection sites and inject slowly to avoid discomfort at the injection site.

Aranesp is presented in a ready-to-use bottle.

For instructions on use, handling and disposal, see section Instructions for use, handling and disposal .

what is aranesp contraindications

CONTRA-INDICATED:

– Known hypersensitivity to darbepoetin alfa, to r-HuEPO or to any of the excipients.

– Poorly controlled arterial hypertension.

– Cases of erythroblastopenia due to neutralizing antibodies directed against erythropoietin have been reported with recombinant erythropoietins, including darbepoetin alfa. These neutralizing antibodies cross-react with other erythropoietins and a relay treatment with darbepoetin alfa should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed.

– Breast-feeding: as there is no clinical experience in women during breast-feeding, it is recommended not to administer Aranesp to women who are breast-feeding. When treatment with Aranesp is absolutely indicated, breast-feeding should be discontinued.

ADVISED AGAINST:

Pregnancy: No clinical data are available in pregnant women. Animal studies have not shown any deleterious effects on gestation, embryofoetal development, parturition or postnatal development.

Precautionary measures are required when prescribing in pregnant women.

Aranesp Side Effects

In addition to the desired effect, this medicine can cause side effects.

The main side effects are the following.

Sometimes (from 10 to 30 people in 100)

Increased blood pressure . You should only use this medicine if the blood pressure is good. If necessary, you can give blood pressure reducers to your doctor. Very rarely (in fewer than 1 in 100 people) suddenly a strongly increased blood pressure occurs. Warn your doctor with muscle twitches and sudden migraine-like headaches (vigorous throbbing unilateral headache).

Edema . You will notice this especially with swollen ankles and feet. Consult your doctor if you have a lot of problems with this.

Hypersensitivity to darbepoetin alfa. This can be seen, among other things, in unexplained fatigue, tightness in itching or hives, skin rash, skin redness, flu-like symptoms, fever, muscle pain, tightness or fainting. Stop using and consult your doctor. In very rare cases, a serious skin condition can develop with fever and blistering. The blisters mainly develop on the lips and on the mucous membranes of the mouth and genitals. Then immediately notify a doctor or go to the First Aid Service. You can not use this medicine in the future. Therefore tell the pharmacy that you are hypersensitive to darbepoetin alfa. The pharmacy team can then ensure that you do not get this remedy again.

Rarely (from 1 to 10 in 100 people)

Headache.

Pain at the injection site . This will pass after some time.

Formation of blood clots in the vessels (thrombosis), especially at the site of the injection needle. Do not use this medicine if you have an increased risk of thrombosis or if you have ever had a heart attack or stroke due to thrombosis. Your doctor may combine the treatment of darbepoietin with anticoagulants.

Stroke (cerebral infarction). You will notice this mainly by sudden complaints. These may be paralysis in the face (crooked mouth for example), confused speaking and thinking, paralysis of the arm or leg, loss of vision, and tingling. Tell a doctor immediately.

Very rare (affects less than 1 in 100 people)

Epileptic seizures . Then tell your doctor.

Too much potassium in the blood . This can be seen in an irregular heartbeat (often the first symptom), numbness or strange sensations in the arms and legs, lethargy, confusion and weakness. Consult your doctor for these symptoms.

If there are enough red blood cells in your blood and you still use darbepoietin alfa, it can happen that too many blood cells occur. This causes too much blood and increased blood pressure, especially if the number of red blood cells rises very quickly. That is why the doctor checks the blood regularly and keeps an eye on whether the increase does not go too fast. Consult your doctor if you suffer too much from any of the above mentioned side effects or if you experience other side effects that you are worried about.

Aranesp Interactions

The clinical results available to date have not shown any interaction between darbepoetin alfa and other substances.

However, there is a potential risk of drug interaction with substances with a high binding affinity for red blood cells such as ciclosporin and tacrolimus.

If Aranesp is administered concurrently with any of these treatments, their blood levels should be monitored and their dose adjusted according to the increase in hemoglobin.

Aranesp Warnings and Precautions

Overview

In order to improve the traceability of erythropoiesis stimulating agents (ESAs), the commercial name of the ESA administered should be clearly recorded in the patient’s chart.

Blood pressure should be monitored in all patients, especially during the initiation phase of Aranesp therapy. If blood pressure is difficult to control after appropriate measures are taken, hemoglobin levels can be reduced by decreasing the dosage or by spacing Aranesp injections (see Dosage and Method of Administration ). . Cases of severe hypertension, including hypertensive crises, hypertensive encephalopathy, and seizures have been observed in CKD patients treated with Aranesp.

To ensure effective erythropoiesis, martial status should be controlled in all patients, before and during treatment, iron supplementation may be required.

The lack of response to treatment with Aranesp should lead quickly to investigate the causes. A deficiency of iron, folic acid or vitamin B12 decreases the effectiveness of ESAs and must be corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminum intoxication, underlying hematological disease or myelofibrosis may also alter the erythropoietic response. The count of reticulocytes is an element of evaluation of the medullary activity. If usual causes of no response have been excluded, and if the patient has reticulopenia, bone marrow examination should be considered. If the bone marrow biopsy is compatible with PRCA, a search for

Pure red cell aplasia due to neutralizing antibodies to erythropoietin has been reported with ESAs, including Aranesp. This has mainly been reported in patients with chronic renal failure treated subcutaneously. These neutralizing antibodies cross-react with other epoetins and Aranesp relay therapy should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed (see section 4.8 ).

A paradoxical decrease in hemoglobin and the development of severe anemia associated with a low number of reticulocytes should prompt rapid discontinuation of epoetin and an anti-erythropoietin antibody test. Cases have been reported in patients with hepatitis C treated with interferon and ribavirin when epoetins are used concomitantly. Epoetins are not indicated for the treatment of anemia associated with hepatitis C.

The existence of a progressive liver pathology was an exclusion criterion for all studies with Aranesp. Therefore, no data are available in patients with hepatic impairment. Since the liver is considered the main route of elimination of darbepoetin alfa and r-HuEPO, Aranesp should be used with caution in patients with liver disease.

Aranesp should also be used with caution in patients with sickle cell anemia.

Misuse of Aranesp in healthy subjects may result in an excessive increase in hematocrit. This can be associated with life-threatening cardiovascular complications.

The protective cap of the pre-filled syringe or pre-filled pen contains natural rubber (a derivative of the latex) that can cause allergic reactions.

Aranesp should be used with caution in patients with epilepsy. Seizures have been reported in patients treated with Aranesp.

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie it is considered essentially “sodium-free”.

Chronic renal failure patients

In patients with chronic renal impairment, the hemoglobin level during the maintenance phase should not exceed the upper limit of the target hemoglobin level recommended under Dosage and Method of Administration . In clinical studies, an increase in the number of deaths, serious cardiovascular or cerebrovascular events, including stroke, and vascular thrombosis at the access point was observed when ESAs were administered in order to achieve Hemoglobin targets greater than 12g / dl (7.5 mmol / l).

Caution should be exercised with dose escalation of Aranesp in patients with chronic renal failure, as high cumulative doses of epoetin may be associated with an increased risk of mortality and serious cardiovascular and cerebrovascular events. In patients aynt a poor response to epoetins, other factors behind the poor response should be considered (see Dosage and Administration and Pharmacodynamic properties ).

Controlled clinical trials did not demonstrate any significant benefits attributable to epoetin administration when hemoglobin levels were increased beyond values ​​to control the symptoms of anemia and to avoid the use of transfusions. blood.

Iron supplementation is recommended for all patients with serum ferritin levels below 100 pg / l or transferrin saturation <20%.

Serum potassium should be monitored regularly during treatment with Aranesp. Potassium elevation has been reported in a few patients treated with Aranesp, although the causal link has not been established. If there is a high level or an increase in serum potassium, discontinuation of Aranesp should be considered until serum potassium is normalized.

Cancer patients

Effect on tumor growth

Epoetins are growth factors that essentially stimulate the production of red blood cells. Erythropoietin receptors would be expressed on the surface of different types of tumor cells. Like any growth factor, epoetins may stimulate growth of tumors. In several controlled studies in which epoetins have been administered, there has been no improvement in overall survival or decreased risk of tumor progression in patients with cancer-associated anemia.

In controlled clinical studies, the use of Aranesp and other ESAs has shown:

a shortening of time to tumor progression in patients with advanced head and neck cancer receiving radiotherapy when ESAs were administered to achieve target hemoglobin levels greater than 14 g / dl (8.7 mmol / l). ESAs are not indicated for use in this patient population.

a decrease in overall survival and an increase in the number of deaths at 4 months, attributed to disease progression, in patients with metastatic breast cancer receiving chemotherapy, when ESAs were administered for the purpose of target hemoglobin levels of between 12 and 14 g / dl (7.5-8.7 mmol / l).

an increased risk of death when ESAs were administered to achieve a target hemoglobin level of 12 g / dl (7.5 mmol / l) in patients with active malignancy who were not receiving chemotherapy, nor radiotherapy. ESAs are not indicated for use in this patient population.

In view of the above information, in certain clinical situations, blood transfusion should be the preferred treatment for anemia in cancer patients. The decision to administer recombinant epoetins should be based on a benefit-risk assessment taking into account the patient’s opinion in its specific clinical context. Factors to be considered in this assessment should include the type of tumor and its stage, the degree of anemia, life expectancy, the environment in which the patient is treated and the patient’s preference (see section 5.1 ). .

If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l) in patients with solid tumors or lymphoproliferative malignancies, strictly adhere to the dose adjustment described in section Dosage and method of administration , in order to minimize the possible risks of thromboembolic events. Platelet count and hemoglobin should also be monitored at regular intervals.

Drive and use machines

Aranesp has no or negligible influence on the ability to drive and use machines.

Aranesp and PREGNANCY / BREAST FEEDING

aranesp in pregnancy

There are no relevant and well-conducted studies regarding the use of Aranesp in pregnant women.

Animal studies have not shown deleterious effects on pregnancy, embryo-fetal development, parturition or postnatal development. No alteration of fertility was detected.

Caution is required when prescribing Aranesp in pregnant women.

Women whose pregnancies occur during treatment with Aranesp should be encouraged to enroll in the Amgen Pregnancy Surveillance Program. The contact details are in section 6 of the package leaflet.

aranesp in Breastfeeding

It is not known if Aranesp is excreted in breast milk. A risk for infants can not be ruled out.

The decision to discontinue breastfeeding or discontinue / abstain from treatment with Aranesp should be made with regard to the benefit of breastfeeding for the child and the benefit of treatment for the woman.

What should I do if I miss a dose?

If you inject yourself:

have you forgotten a dose and are you discovering it the same day? 

Use the dose as yet.

Do you discover it the next day? 

Consult your doctor.

 Never use a double dose.

What happens if I overdose from Aranesp ?

The maximum amount of Aranesp that can be safely administered at single or multiple doses has not been determined.

Aranesp treatment may result in polycythemia if the hemoglobin level is not closely monitored and the dose adjusted properly.

Cases of severe arterial hypertension have been observed after an overdose with Aranesp ( see Warnings and Precautions ).

In case of polycythemia, treatment with Aranesp should be temporarily interrupted ( see Dosage and Method of Administration ).

A bleeding can be performed in case of clinical need.

What is  Forms and Composition?

SC or IV solution for injection (clear, colorless) at 10 μg (25 μg / ml):   0.4 ml pre-filled syringe * with 27 G needle, unitary box. Injection solution SC or IV (clear, colorless) at 20 μg (40 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, unitary box.

SC or IV solution for injection (clear, colorless) at 30 μg (100 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, unitary box. SC or IV (clear, colorless) solution for injection at 40 μg (100 μg / ml):   0.4 ml secure * pre-filled syringe with 27 G needle, single unit.

Injection solution SC (clear, colorless) at 40 μg (100 μg / ml):   0.4 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.

Injection solution SC or IV (clear, colorless) at 50 μg (100 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, single box.

SC or IV solution for injection (clear, colorless) at 60 μg (200 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, unitary box.

Solution for injection SC (clear, colorless) at 60 μg (200 μg / ml):   0.3 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.

SC or IV injection solution (clear, colorless) at 80 μg (200 μg / ml):   0.4 ml secure * pre-filled syringe with 27G needle, single unit.

Injection solution SC (clear, colorless) at 80 μg (200 μg / ml):   0.4 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.

SC or IV solution for injection (clear, colorless) at 100 μg (200 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, single unit.

Solution for injection SC (clear, colorless) at 100 μg (200 μg / ml):   0.5 ml pre-filled * pen (SureClick) containing a 27 G needle syringe, unitary box.

SC or IV (clear, colorless) solution for injection at 130 μg (200 μg / ml):   0.65 ml pre-filled * safety syringe with 27 G needle, single unit.

SC or IV solution for injection (clear, colorless) at 150 μg (500 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, single box.

Solution for injection SC (clear, colorless) at 150 μg (500 μg / ml):   0.3 ml pre-filled * pen (SureClick) containing a 27 G needle syringe, unitary box.

SC or IV injection solution (clear, colorless) to 300 micrograms (500 micrograms / ml):   Pre-filled syringe * Secure 0.6 ml with 27 G needle, unitary box.

Solution for injection SC (clear, colorless) 300 μg (500 μg / ml):   * Prefilled pen * (SureClick) 0.6 ml containing a syringe with 27 G needle, unitary box.

Solution for injection SC or IV (clear, colorless) at 500 μg (500 μg / ml):   1 ml pre-filled syringe * with 27 G needle, unitary box.

Solution for injection SC (clear, colorless) 500 μg (500 μg / ml):   1 ml pre-filled *pen (SureClick) containing a 27 G needle syringe, unitary box.

*  The protective cap of the pre-filled syringe or pre-filled pen contains natural rubber (a derivative of the latex): see Warnings and Precautions for Use .

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.

The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

The post Aranesp Uses, Dosage, Side Effects, Precautions & Warnings appeared first on Drug Online.

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