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.
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 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 may also be used for purposes not listed in this medication guide.
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 ever had:
- heart disease, high blood pressure;
- kidney disease (or if you are on dialysis);
- a stroke, heart attack, or blood clot;
- a seizure disorder; or
- a latex allergy.
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 affect the nursing baby. Tell your doctor if you are breast-feeding.
How should I use darbepoetin alfa?
Follow all directions on your prescription label. Your doctor may occasionally change your dose. 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. You must also know how to properly measure a full or partial dose of this medicine.
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.
Call your doctor if you feel weak, tired, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to darbepoetin alfa.
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 it away after one use, even if there is still medicine left inside.
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.
What are the possible side effects of darbepoetin alfa?
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:
- a light-headed feeling, like you might pass out;
-
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.
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:
- 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.
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 your doctor about all your current medicines 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.
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