Darbepoetin alfa

What is Darbepoetin alfa?

• Darbepoetin alfa (Aranesp) is an erythropoiesis-stimulating agent (ESA) used to treat anemia caused by chronic kidney disease and some types of chemotherapy.

What are the uses of this medicine?

Darbepoetin alfa (Aranesp) used to treat anemia if it is caused by:

• Chronic kidney disease (you may or may not be on dialysis).
• Chemotherapy that will be used for at least two months after starting Aranesp.

Limitations of use: Aranesp has not been proven to improve the quality of life, fatigue, or well-being. Aranesp should not be used for the treatment of anemia:

• If you have cancer and you will not be receiving chemotherapy that may cause anemia.
• If you have a cancer that has a high chance of being cured.
• If your anemia caused by chemotherapy treatment can be managed by RBC transfusion.
• In place of emergency treatment for anemia (RBC transfusions).

How does this medicine work?

• People with anemia have a lower-than-normal number of RBCs.
• Aranesp works like the human protein called erythropoietin to help your body make more RBCs.
• Aranesp is used to reduce or avoid the need for RBC transfusions.
• Aranesp stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Have cancer and have not been counseled by your healthcare provider about treatment with Aranesp.
• Have high blood pressure that is not controlled (uncontrolled hypertension).
• Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with Aranesp or other erythropoietin protein medicines.
• Have had a serious allergic reaction to Aranesp.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Aranesp.
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• The medication was approved in September 2001, by the US Food and Drug Administration for treatment of anemia in patients with chronic kidney failure by intravenous or subcutaneous injection.
• In June 2001, it had been approved by the European Medicines Agency for this indication as well as the treatment of anemia in cancer patients undergoing chemotherapy.

How should this medicine be used?

Recommended dosage: Recommended starting dose for patients with Chronic kidney disease (CKD) on dialysis:

• 0.45 mcg/kg intravenously or subcutaneously weekly, or
• 0.75 mcg/kg intravenously or subcutaneously every 2 weeks
• Intravenous route is recommended for patients on hemodialysis

Recommended starting dose for patients with Chronic kidney disease (CKD) not on dialysis:

• 0.45 mcg/kg intravenously or subcutaneously at 4 week intervals

Recommended starting dose for pediatric patients with Chronic kidney disease (CKD):

• 0.45 mcg/kg intravenously or subcutaneously weekly
• patients with CKD not on dialysis may also be initiated at 0.75 mcg/kg every 2 weeks

Recommended starting dose for patients with cancer on chemotherapy:

• 2.25 mcg/kg subcutaneously weekly, or
• 500 mcg subcutaneously every 3 weeks

Administration:

• Take Aranesp exactly as your healthcare provider tells you to.
• Do not change the dose of Aranesp unless told to do so by your healthcare provider.
• Your healthcare provider will show you how much Aranesp to use, how to inject it, how often it should be injected, and how to safely throw away the used vials, syringes, and needles.
• If you miss a dose of Aranesp, call your healthcare provider right away and ask what to do.
• If you take more than the prescribed dose of Aranesp, call your healthcare provider right away.
• During treatment with Aranesp, continue to follow your healthcare provider’s instructions for diet and medicines.
• Have your blood pressure checked as instructed by your healthcare provider.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Single-dose vials
• Single-dose prefilled syringes

This medicine is available in fallowing brand namesː

• Aranesp

What side effects can this medication cause?

The most common side effects of this medicine include:

• shortness of breath
• cough
• low blood pressure during dialysis
• abdominal pain
• edema (swelling) of the arms or legs

Aranesp may cause serious side effects, including:

• Serious heart problems, such as heart attack or heart failure, and stroke
• Blood clots
• High blood pressure
• Seizures
• Antibodies to Aranesp
• Serious allergic reactions
• Severe skin reactions

What special precautions should I follow?

• Inform patients Of the increased risks of mortality, serious cardiovascular reactions, thromboembolic reactions, stroke, and tumor progression. Using Aranesp to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke.
• Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer.
• Aranesp is contraindicated in patients with uncontrolled hypertension. Control hypertension prior to initiating and during treatment with Aranesp.
• Aranesp increases the risk for seizures in patients with CKD. Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms.
• Cases of Pure Red Cell Aplasia (PRCA )and of severe anemia, with or without other cytopenias have been reported in patients treated with Aranesp. If severe anemia and low reticulocyte count develop during Aranesp treatment, withhold Aranesp and evaluate for PRCA.
• Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp. Discontinue Aranesp and manage reactions.
• Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including Aranesp).Discontinue Aranesp.

What to do in case of emergency/overdose?

Symptoms of overdosage may:

• cause hemoglobin levels above the desired level
• severe hypertension

Treatment of overdosage:

• Hemoglobin levels above the desired level, should be managed with discontinuation or reduction of Aranesp dosage and/or with phlebotomy.

Can this medicine be used in pregnancy?

• The limited available data on Aranesp use in pregnant women are insufficient to determine a drug-associated risk of major birth defects or miscarriage.
• Consider the benefits and risks of Aranesp for the mother and possible risks to the fetus when prescribing Aranesp to a pregnant woman.

Can this medicine be used in children?

• The safety and efficacy of Aranesp in pediatric patients with cancer have not been established.
• The safety and effectiveness of Aranesp in pediatric patients with Chronic kidney disease (CKD) receiving and not receiving dialysis have been established in the age groups 1 month to 16 years old.

What are the active and inactive ingredients in this medicine?

• Active ingredient: darbepoetin alfa
• Inactive ingredients: polysorbate 80, sodium chloride, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic monohydrate in Water for Injection, USP.

Who manufactures and distributes this medicine?

Manufactured by:

• Amgen Inc.
• One Amgen Center Drive
• Thousand Oaks, CA

What should I know about storage and disposal of this medication?

• Do not shake Aranesp.
• Store Aranesp in the carton it comes in to protect it from light.
• Store Aranesp in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze Aranesp. Do not use Aranesp that has been frozen.
• Throw away the Aranesp vial or prefilled syringe after one use. Do not re-use even if there is medicine left.

• Dailymed label info on Darbepoetin alfa
• FDA Darbepoetin alfa

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