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|Darbepoetin Alfa

Darbepoetin Alfa (Polysorbate 80)

Darbepoetin Alfa (Polysorbate 80) is used for:

Treating anemia in patients with chronic kidney failure or certain types of cancers. It may also be used for other conditions as determined by your doctor.

Darbepoetin Alfa (Polysorbate 80) is similar to the natural protein human erythropoietin. It works by stimulating the bone marrow to produce more red blood cells. An increased number of red blood cells may reduce symptoms of anemia.

Do NOT use Darbepoetin Alfa (Polysorbate 80) if:

• you are allergic to any ingredient in Darbepoetin Alfa (Polysorbate 80) or similar medicines (eg, erythropoietin)
• you are allergic to products made from mammalian cells
• you have uncontrolled or severe high blood pressure, or you have certain red blood cell problems (eg, certain types of aplasia)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Darbepoetin Alfa (Polysorbate 80) :

Some medical conditions may interact with Darbepoetin Alfa (Polysorbate 80) . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a vitamin B or folic acid deficiency
• if you have a blood disease (eg, sickle cell anemia, porphyria, hemolytic anemia, thalassemia)
• if you have high blood pressure, heart problems (eg, congestive heart failure), blood in your stools, seizures, recent infection or injury, cancer, certain bone problems (eg, osteofibrosis cystica), or inflammatory conditions (eg, bowel disease, or rheumatoid arthritis)

Some MEDICINES MAY INTERACT with Darbepoetin Alfa (Polysorbate 80) . Tell your health care provider if you are taking any other medicines.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Darbepoetin Alfa (Polysorbate 80) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Darbepoetin Alfa (Polysorbate 80) :

Use Darbepoetin Alfa (Polysorbate 80) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Darbepoetin Alfa (Polysorbate 80) comes with an additional patient leaflet. Read it carefully and reread it each time you get Darbepoetin Alfa (Polysorbate 80) refilled.
• Darbepoetin Alfa (Polysorbate 80) is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Darbepoetin Alfa (Polysorbate 80) at home, carefully follow the injection procedures taught to you by your health care provider.
• If Darbepoetin Alfa (Polysorbate 80) contains particles or is discolored or cloudy, or if the vial is cracked or damaged in any way, do not use it.
• Do not shake Darbepoetin Alfa (Polysorbate 80) .
• Do not dilute or mix Darbepoetin Alfa (Polysorbate 80) with any other solutions or medicines.
• Discard any unused portion of medicine left in the vial or syringe.
• Use only disposable syringes and needles. Use the syringes and needles only once and dispose of them in a puncture-proof container as instructed by your health care provider.
• Choose a new site each time you inject Darbepoetin Alfa (Polysorbate 80) . Do not inject into an area that is tender, red, bruised, hard, swollen, or has scars or stretch marks.
• If you miss a dose of Darbepoetin Alfa (Polysorbate 80) , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Darbepoetin Alfa (Polysorbate 80) .

Important safety information:

• Darbepoetin Alfa (Polysorbate 80) may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Darbepoetin Alfa (Polysorbate 80) . Using Darbepoetin Alfa (Polysorbate 80) alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• It is important to keep your blood pressure under control during treatment with Darbepoetin Alfa (Polysorbate 80) . Do not stop taking any of your blood pressure medicines without checking with your doctor. Closely follow your doctor"s instructions for diet and blood pressure monitoring.
• It may take 2 to 6 weeks for Darbepoetin Alfa (Polysorbate 80) to work. If your symptoms do not improve or they become worse, check with your doctor.
• LAB TESTS, including blood pressure, blood cell counts, kidney function, blood electrolyte levels, and blood iron levels, will be performed to monitor your progress. Be sure to keep all doctor and lab appointments.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risk of using Darbepoetin Alfa (Polysorbate 80) during pregnancy. It is unknown if Darbepoetin Alfa (Polysorbate 80) is excreted in breast milk. If you are or will be breast-feeding while using Darbepoetin Alfa (Polysorbate 80) , discuss with your doctor the risks to your baby.

Possible side effects of Darbepoetin Alfa (Polysorbate 80) :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; cough; diarrhea; dizziness; headache; muscle, joint, back, or stomach pain; nausea or vomiting; pain, swelling, irritation, redness, or bruising at the injection site; unusual tiredness or weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or vision changes; chest pain; confusion; fast or irregular heartbeat; fainting; flu-like symptoms (fever, chills, sore throat); one-sided weakness; redness, tenderness, or swelling of the calf; seizures; severe headache, dizziness, vomiting, stomach pain, or diarrhea; severe or persistent tiredness or weakness; slurred speech; sudden pain or numbness of an arm or leg; sudden shortness of breath; swelling of the arms or legs.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Darbepoetin Alfa (Polysorbate 80) in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Do not use past the expiration date on the vial or prefilled syringe. When traveling, transport Darbepoetin Alfa (Polysorbate 80) in the original carton in a cool carrier with a coolant, such as blue ice. To avoid freezing, be sure the medicine does not touch the coolant. Once you arrive, place the medicine in the refrigerator as soon as possible. Keep Darbepoetin Alfa (Polysorbate 80) out of the reach of children and away from pets.

General information:

• If you have any questions about Darbepoetin Alfa (Polysorbate 80) , please talk with your doctor, pharmacist, or other health care provider.
• Darbepoetin Alfa (Polysorbate 80) is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about this medicine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.