IMPORTANT WARNING:  

Why is this medication prescribed?  

Darbepoetin alfa is used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (a condition where over a period of time there is a decrease in kidney function that is not reversible). Darbepoetin alfa is also used to treat anemia in people receiving chemotherapy (medications used to treat cancer).Darbepoetin alfa is in a class of medications called erythropoiesis-stimulating agents (ESAs). It works by causing the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.

How should this medicine be used?  

Darbepoetin alfa comes as a solution (liquid) to inject subcutaneously (just under the skin) or intravenously (into a vein). It is usually injected once a week every 1 to 3 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use darbepoetin alfa exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor may start you on the lowest possible dose of darbepoetin alfa and gradually increase or decrease your dose, not more than once every month. Your doctor may also tell you to stop using darbepoetin alfa for a time. Follow these instructions carefully. If your doctor tells you to stop using darbepoetin alfa, do not begin using it again until your doctor tells you that you should. It is likely that your doctor will restart your treatment with a lower dose of darbepoetin alfa than you were using.

Darbepoetin alfa is used to reduce the need for red blood cell transfusions. Darbepoetin alfa controls anemia but does not cure it. It may take 2 to 6 weeks or longer before you feel the full benefit of darbepoetin alfa Continue to use darbepoetin alfa even if you feel well. Do not stop using darbepoetin alfa without talking to your doctor.

Darbepoetin alfa injections are usually given by a doctor or nurse. Your doctor may decide that you can inject darbepoetin alfa yourself, or that you may have a friend or relative give the injections.Your doctor will train the person who will be injecting the medication and will test him to be sure he can give the injection correctly. Be sure that you and the person who will be giving the injections know the correct dose, how to give the medication, and how often to give the medication. Be sure that you and the person who will be giving the injections read the manufacturer's information for the patient that comes with darbepoetin alfa before you use it for the first time at home.

Darbepoetin alfa comes in prefilled syringes and also in vials to use with disposable syringes. Use vials and prefilled or disposable syringes only once. Do not put a needle through the rubber stopper of a vial more than once. Throw away a vial, syringe, or prefilled syringe after one use, even if it is not empty. Throw away used syringes in a puncture-resistant container, out of the reach of children.Do not throw a filled container into the household trash or recycling.Talk to your doctor or pharmacist about how to throw away the puncture-resistant container. There may be special state and local laws for throwing away used needles and syringes.

If you are using vials of darbepoetin alfa, you will need to use disposable syringes to inject your medication. Your doctor or pharmacist will tell you what type of syringe you should use. Do not use any other type of syringe because you may not get the right amount of medication.

Always inject darbepoetin alfa solution in its own syringe; never mix it with any other medication.

If you are injecting darbepoetin alfa subcutaneously, you can inject it just under the skin anywhere on these parts of your body: the outer area of your upper arms, your stomach except for the two-inch area around your navel (belly button), the front of your middle thighs, and the upper outer areas of your buttocks.

Choose a new spot each time you inject darbepoetin alfa. Do not inject darbepoetin alfa into a spot that is tender, red, bruised, hard, lumpy, or swollen.

Carefully read the manufacturer's instructions that describe how to prepare and inject a dose of darbepoetin alpha. Be sure to ask your pharmacist or doctor if you have any questions about how to prepare or inject this medication.

Other uses for this medicine  

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What storage conditions are needed for this medicine?  

Keep this medication in the carton it came in, tightly closed, and out of reach of children. Once a vial or prefilled syringe has been taken out of its carton, keep it covered to protect it from room light until the dose is given. Store darbepoetin alfa in the refrigerator, but do not freeze it. Throw away any medication that has been frozen or is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

When traveling, pack darbepoetin alfa in its original carton in an insulated container with a coolant such as blue ice. To avoid freezing, make sure the darbepoetin alfa vial or prefilled syringe does not touch the coolant. Once you arrive, place darbepoetin alfa in a refrigerator as soon as possible.

In case of emergency/overdose  

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• unusual tiredness, weakness, or lack of energy
• shortness of breath
• cough that won't go away, or coughing up blood
• wheezing
• dizziness or lightheadedness
• swelling around the mouth or eyes
• blue-grey coloring or darkening around mouth or nails
• fast or irregular heartbeat
• sweating
• seizure
• fainting or loss of consciousness
• chest pain, squeezing pressure, or tightness
• discomfort or pain in the arms, shoulder, neck, jaw, or back
• nausea
• vomiting
• sudden weakness or numbness of an arm or leg (especially on one side of the body) or face
• sudden confusion
• sudden trouble speaking or understanding speech
• sudden trouble seeing in one or both eyes
• sudden trouble walking, or loss of balance or coordination
• sudden severe headache
• pain, tenderness, redness, warmth, and/or swelling in the legs
• swelling of the hands, feet, or ankles
• increased blood pressure
• blood clot in hemodialysis access port

What other information should I know?  

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using darbepoetin alfa.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

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