Darbepoetin alfa

Generic name: Darbepoetin Alfa
Dosage form: injectable solution (10 mcg/0.4 mL; 100 mcg/0.5 mL; 100 mcg/mL; 150 mcg/0.3 mL; 200 mcg/0.4 mL; 200 mcg/mL; 25 mcg/0.42 mL; 25 mcg/mL; 300 mcg/0.6 mL; 300 mcg/mL; 40 mcg/0.4 mL; 40 mcg/mL; 500 mcg/mL; 60 mcg/0.3 mL; 60 mcg/mL)
Drug class: Recombinant human erythropoietins

Usage of Darbepoetin alfa

Darbepoetin alfa is a man-made form of a protein that helps your body produce red blood cells.

Darbepoetin alfa is used to treat anemia caused by chemotherapy or chronic kidney disease.

Darbepoetin alfa may also be used for purposes not listed in this medication guide.

Darbepoetin alfa side effects

Get emergency medical help if you have signs of an allergic Reaction (hives, wheezing, difficult breathing, severe dizziness or fainting, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Darbepoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use darbepoetin alfa. Seek emergency medical help if you have:

  • heart attack symptoms--chest pain or pressure, shortness of breath, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), confusion, sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--pain, swelling, warmth, redness, cold feeling, or pale appearance of an arm or leg; or
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

    • Darbepoetin alfa may cause serious side effects. Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • unusual weakness or tiredness;
  • a seizure (convulsions); or
  • shortness of breath (even with mild exertion), swelling, rapid weight gain.

    • Common side effects of darbepoetin alfa may include:

  • low blood pressure during dialysis;
  • cough, trouble breathing;
  • stomach pain; or
  • swelling in your arms or legs.

    • This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Darbepoetin alfa

    You should not use darbepoetin alfa if you are allergic to it, or if you have:

  • untreated or uncontrolled high blood pressure; or
  • if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using darbepoetin alfa or epoetin alfa.

    • Darbepoetin alfa may shorten remission time in some people with head and neck cancer who are also being treated with radiation. Darbepoetin alfa may also shorten survival time in certain people with breast cancer, non-small cell lung cancer, head and neck cancer, cervical cancer, or lymphoid cancer. Talk with your doctor about the risks and benefits of using this medicine.

    Tell your doctor if you have ever had:

  • heart disease, high blood pressure;
  • kidney disease (or if you are on dialysis);
  • a stroke, heart attack, or blood clot;
  • a seizure; or
  • a latex allergy.

    • Tell your doctor if you are pregnant or breastfeeding.

    Relate drugs

    How to use Darbepoetin alfa

    Usual Adult Dose for Anemia Associated with Chronic Renal Failure:

    Chronic Kidney Disease (CKD) Patients Not on Dialysis:Initial dose: 0.45 mcg/kg IV or suBCUTAneously once every 4 weeks as appropriateComments:-Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.CKD Patients on Dialysis:Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriateComments:-Initiate treatment when hemoglobin is less than 10 g/dL.-IV route is recommended for patients on hemodialysis.

    Usual Adult Dose for Anemia Associated with Chemotherapy:

    Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeksDuration of therapy: Until completion of chemotherapy courseComments:-Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned.-Use the lowest dose necessary to avoid RBC transfusions.Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.

    Usual Pediatric Dose for Anemia Associated with Chronic Renal Failure:

    Less than 18 Years:Initial dose:-Chronic Kidney Disease (CKD) Patients Not on Dialysis: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks-CKD Patients on Dialysis: 0.45 mcg/kg IV or subcutaneously once a weekComments: Initiate treatment when hemoglobin is less than 10 g/dL.

    Warnings

    darbepoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Seek emergency medical help if you have: chest pain, shortness of breath, sudden numbness or weakness, confusion, problems with vision or balance, trouble speaking or understanding, or pain or coldness in an arm or leg.

    Darbepoetin alfa may also shorten remission time or survival time in some people with certain types of cancer. Talk with your doctor about the risks and benefits of using darbepoetin alfa.

    What other drugs will affect Darbepoetin alfa

    Other drugs may affect darbepoetin alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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