Darbepoetin Alfa, Injection

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KEY POINTS

• This medicine is given by injections (shots) to treat low red blood cell counts.
• A high level of hemoglobin in your blood may increase the chance of heart attack, stroke, heart failure, blood clots, and death. If you have cancer, your tumor may grow faster. Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: erythropoiesis stimulating factor

Generic and brand names: darbepoetin alfa, injection; Aranesp

What is this medicine used for?

This medicine is given by injections (shots) to treat low red blood cell counts (anemia). It is given to people who have long-term kidney disease or who have certain types of cancer and are receiving chemotherapy.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before receiving this medicine, tell your healthcare provider if you have:

• An allergy to any medicine or to latex
• A history of seizures
• A history of blood clots, stroke, or heart attack
• An infection
• Blood disorders such as sickle cell anemia or porphyria
• Bone marrow problems
• Folic acid deficiency or vitamin B12 deficiency
• Heart or blood vessel disease
• High blood pressure

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

You may receive this medicine weekly in one of two forms: as an IV or a subcutaneous injection (shot just under the skin). The length of treatment will depend on your response to the medicine. Follow your healthcare provider's instructions exactly. If your healthcare provider is giving you the shots, keep all your appointments.

Sometimes you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know when to take the medicine and how much medicine you should take. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

What if I miss a dose?

If you miss a dose, contact your healthcare provider and ask what to do.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222

Symptoms of an acute overdose may include: chest pain, shortness of breath, irregular or fast heartbeat, sudden headache, unusual tiredness or weakness, sudden weakness or numbness, problems with walking, speech, or vision; sudden confusion; pain or swelling in leg or arms, seizures.

What should I watch out for?

This is a very strong medicine. Only healthcare providers who have received special training should prescribe it. Before you can begin to receive this medicine, you must sign a special form to document that your healthcare provider discussed the risks of this medicine with you. Make sure you understand what the risks and benefits of treatment are.

You need blood tests regularly while you are receiving this medicine. A high level of hemoglobin in your blood may increase the chance of heart attack, stroke, heart failure, blood clots, and death. If you have cancer, your tumor may grow faster. Talk with your provider about this.

You need to have lab tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Seizures are a possible side effect of treatment with this medicine. Do not drive or operate machinery until you know how the medicine affects you.

Follow your healthcare provider's instructions about diet and taking iron or vitamin supplements.

This medicine may change your blood pressure. Have your blood pressure checked often and report any changes to your healthcare provider.

If you are on dialysis, your dialysis access may become blocked. Talk with your healthcare provider about this.

A form of this medicine is made from human tissue. It is tested for viruses such as hepatitis and HIV. The risk of getting an infection from this medicine is very low, but it is still possible. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine. If you take this medicine before surgery, this medicine may increase your chance of a blood clot. Your healthcare provider may give you a medicine that reduces the chance of blood clots forming.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; tightness in your chest; swelling of your lips, tongue, or throat; trouble breathing); seizures; sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Chest pain; confusion; fainting; fast or irregular heartbeat; redness, pain, or swelling in arms or legs; seizures; severe confusion; severe shortness of breath or coughing; unusual tiredness.

Other: Cough, diarrhea, fever, headache, loss of appetite, muscle or joint pain, nausea, sore mouth, trouble sleeping, vomiting, weight loss.

What products might interact with this medicine?

No significant drug interactions have been reported. Tell your provider about any other medicines you take that affect the blood, such as epoetin (Procrit) or warfarin (Coumadin).

Do not drink alcohol while receiving this medicine without your healthcare provider’s approval.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in its original container in the refrigerator. Do not let it freeze. Do not shake the vials. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.