When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not use it if you had an allergic reaction to darbepoetin alfa, albumin, or polysorbate 80, or if you have high blood pressure that is not controlled.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin or through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Do not shake the vial or syringe. Do not use the medicine if it is discolored or has particles in it. Use a vial only once. Throw away any unused medicine in the vial or prefilled syringe.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect the medicine from direct light. Always store the medicine in the original carton until ready to use.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have a blood disorder, a history of blood clots or stroke, cancer, heart disease, high blood pressure, kidney disease, or epilepsy or a history of seizures. Tell your doctor if you had pure red cell aplasia caused by treatment with erythropoietin protein medicine. Also tell your doctor if you have an allergy to latex or if you are scheduled for any type of surgery.
• This medicine can cause the following problems:
  
  • Increased risk of heart attack, stroke, heart failure, and blood clots (may be life-threatening)
  • Seizures
  • High blood pressure
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• In some patients with cancer, this medicine can cause the cancer to grow faster, which can be life-threatening. Talk with your doctor about this risk.
• One form of darbepoetin alfa is made from donated human blood. There is a very small risk that it could contain a virus, although all medicines and donors are checked for viruses. Talk to your doctor if you have concerns.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Fast, slow, or uneven heartbeat
• Fever, sore throat
• Lightheadedness, dizziness, or fainting
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Pain or swelling in your lower leg (calf)
• Rapid weight gain, swelling in your hands, ankles, or feet
• Seizures
• Unusual tiredness, weakness, bleeding, or bruising

If you notice these less serious side effects, talk with your doctor:

• Cough
• Pain, redness, swelling, bleeding, or a lump under your skin where the shot or IV was given
• Stomach pain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088