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darbepoetin alfa

Pronunciation

Generic Name: darbepoetin alfa (DAR be POE e tin AL fa)
Brand Name: Aranesp, Aranesp SureClick, Aranesp Albumin Free, Aranesp SingleJect

What is darbepoetin alfa?

Darbepoetin alfa is a man-made form of a protein that helps your body produce red blood cells. This protein may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

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

Darbepoetin alfa is available to cancer patients only under a special program called APPRISE. You must be registered in the program and understand the risks and benefits of taking this medicine.

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

What is the most important information I should know about darbepoetin alfa?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. 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.

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You should not use this medicine if you have 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 (Epogen or Procrit).

What should I discuss with my healthcare provider before using darbepoetin alfa?

You should not use this medicine if you are allergic to darbepoetin alfa or epoetin alfa (Epogen or Procrit), 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 your individual risk.

To make sure darbepoetin alfa is safe for you, tell your doctor if you have:

  • heart disease, congestive heart failure, high blood pressure;

  • kidney disease (or if you are on dialysis);

  • a history of stroke, heart attack, or blood clots;

  • a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;

  • cancer;

  • a seizure disorder; or

  • if you are allergic to latex.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether darbepoetin alfa passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use darbepoetin alfa?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Darbepoetin alfa is injected under the skin, or into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Darbepoetin alfa is given every 1 to 4 weeks, depending on the condition you are treating. Follow your doctor's dosing instructions very carefully.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your injections may be delayed based on the results of these tests.

If you need surgery, tell the surgeon ahead of time that you are using darbepoetin alfa. You may need to stop using the medicine for a short time.

You may need to take blood pressure medication while you are using darbepoetin alfa. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Store in the refrigerator and protect from light. Do not freeze darbepoetin alfa, and throw away the medication if it has become frozen.

Do not shake the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Each single-use vial (bottle) or prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of darbepoetin alfa.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using darbepoetin alfa?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Darbepoetin alfa side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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, pain spreading to your jaw or shoulder, nausea, sweating;

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs; or

  • dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats.

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 may include:

  • high blood pressure;

  • cough, trouble breathing;

  • stomach pain; or

  • swelling in your hands or feet.

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.

See also: Side effects (in more detail)

Darbepoetin alfa dosing information

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 appropriate

Comments:
-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 appropriate

Comments:
-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 weeks

Duration of therapy: Until completion of chemotherapy course

Comments:
-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 week

Comments: Initiate treatment when hemoglobin is less than 10 g/dL.

What other drugs will affect darbepoetin alfa?

Other drugs may interact with darbepoetin alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about darbepoetin alfa.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 8.01. Revision Date: 2015-11-09, 4:47:59 PM.

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