darbepoetin alfa

	What is the most important information I should know about darbepoetin alfa?
	What is darbepoetin alfa?
	What should I discuss with my healthcare provider before using darbepoetin alfa?
	How should I use darbepoetin alfa?
	What happens if I miss a dose?
	What happens if I overdose?
	What should I avoid while using darbepoetin alfa?
	What are the possible side effects of darbepoetin alfa?
	What other drugs will affect darbepoetin alfa?
	Where can I get more information?
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This medicine 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 symptoms of heart or circulation problems, such as chest pain or heavy feeling, pain spreading to the arm or shoulder, shortness of breath, slurred speech, or problems with vision or balance.

Do not use darbepoetin alfa if you have high blood pressure (hypertension) that is not controlled by diet and/or medication.

Before using darbepoetin alfa, tell your doctor if you have heart disease, congestive heart failure, high blood pressure, kidney disease, a blood cell or clotting disorder, cancer, epilepsy or another seizure disorder, or a history of stroke, heart attack, or blood clots.

To be sure this medication is helping your body produce red blood cells, your blood will need to be tested on a regular basis. You may also need to check your blood pressure during treatment. Do not miss any scheduled appointments.

Contact your doctor if you feel weak, 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.

Some women using darbepoetin alfa have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

Darbepoetin alfa is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Darbepoetin alfa is a man-made form of a protein that helps your body produce red blood cells. The amount of this protein in your body 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 (a lack of red blood cells in the body).

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

Do not use this medication if you are allergic to darbepoetin alfa, epoetin alfa (Epogen or Procrit), or if you have:

• untreated or uncontrolled high blood pressure;
• an allergy to animal products; or
• an allergy to albumin.

If you have any of these other conditions you may need a dose adjustment or special tests to safely use this medication:

• heart disease, congestive heart failure, or 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; or
• epilepsy or another seizure disorder.

Darbepoetin alfa is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether darbepoetin is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether darbepoetin alfa passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Some women using darbepoetin alfa have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need to use birth control while you are using darbepoetin 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.

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Darbepoetin alfa is given as an injection under the skin or into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. With your medication you will receive patient instructions.

You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your darbepoetin alfa dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use each disposable needle and syringe only one time. Throw away used needles and syringes in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Store darbepoetin alfa in the refrigerator and do not allow it to freeze.

To be sure this medication is helping your body produce red blood cells, your blood will need to be tested on a regular basis. You may also need to check your blood pressure during treatment. Do not miss any scheduled appointments.

Contact your doctor if you miss a dose of darbepoetin alfa.

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include headache, dizziness, itching (especially after bathing), fullness in your upper stomach, redness of the face, shortness of breath, and vision problems.

Darbepoetin alfa can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Contact your doctor if you feel weak, 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.

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 symptoms of heart or circulation problems, such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• feeling short of breath, even with mild exertion;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance; or
• pain or swelling in one or both legs.

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

Stop using darbepoetin alfa and call your doctor at once if you have any of these serious side effects:

• feeling short of breath, even with mild exertion;
• swelling of your ankles or feet;
• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
• feeling light-headed, fainting; or
• seizure (black-out or convulsions).

Less serious side effects may include:

• dizziness, mild headache;
• fever, sore throat, body aches, flu symptoms;
• joint or muscle pain;
• nausea, vomiting, diarrhea, stomach pain, constipation; or
• bruising, swelling, warmth, redness, oozing, or bleeding where the IV needle is placed.

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. You may report side effects to FDA at 1-800-FDA-1088.

There may be other drugs that can interact with darbepoetin alfa. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Your pharmacist can provide more information about darbepoetin alfa.