Aranesp is a man-made form of a protein that helps your body produce red blood cells. This protein 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.

Aranesp is used to treat anemia caused by chemotherapy or chronic kidney disease.

Aranesp can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Seek emergency medical help if you have: chest pain, shortness of breath, sudden numbness or weakness, confusion, problems with vision or balance, trouble speaking or understanding, or pain or coldness in an arm or leg.

Aranesp may also shorten remission time or survival time in some people with certain types of cancer. Talk with your doctor about the risks and benefits of using darbepoetin alfa.

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

You should not use this medicine if you have uncontrolled high blood pressure, or if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using darbepoetin alfa or epoetin alfa (Epogen or Procrit).

To be sure Aranesp is helping your condition, your blood may need to be tested often. Your blood pressure will also need to be checked. Visit your doctor regularly.

Contact your doctor if you feel light-headed or unusually weak or tired. These may be signs that your body has stopped responding to Aranesp.

Before taking this medicine

You should not use Aranesp if you are allergic to darbepoetin alfa, or if you have:

• untreated or uncontrolled high blood pressure; or

• if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using Aranesp or epoetin alfa.

Aranesp 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 the risks and benefits of using this medicine.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;

• kidney disease (or if you are on dialysis);

• a stroke, heart attack, or blood clot;

• a seizure; or

• a latex allergy.

Tell your doctor if you are pregnant or breastfeeding.

Use Aranesp exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Aranesp is given every 1 to 4 weeks, depending on the condition you are treating. You may also need to take blood pressure medication. Follow your doctor's instructions very carefully.

Aranesp is injected under the skin, or given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. You must know how to properly measure a full or partial dose of this medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Do not shake the medicine. Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your injections may be delayed based on the results of these tests.

Call your doctor if you feel weak, tired, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to Aranesp.

If you need surgery, tell the surgeon ahead of time that you are using this medicine.

Store in the refrigerator and protect from light. Do not freeze Aranesp, and throw away the medicine if it has become frozen.

Each vial (bottle) or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose of Aranesp for Anemia Associated with Chronic Renal Failure:

Chronic Kidney Disease (CKD) Patients Not on Dialysis:
Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate

Comments:
-Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.

CKD Patients on Dialysis:
Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate

Comments:
-Initiate treatment when hemoglobin is less than 10 g/dL.
-IV route is recommended for patients on hemodialysis.

Usual Adult Dose of Aranesp for Anemia Associated with Chemotherapy:

Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks

Duration of therapy: Until completion of chemotherapy course

Comments:
-Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned.
-Use the lowest dose necessary to avoid RBC transfusions.

Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.

Usual Pediatric Dose of Aranesp for Anemia Associated with Chronic Renal Failure:

Less than 18 Years:
Initial dose:
-Chronic Kidney Disease (CKD) Patients Not on Dialysis: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks
-CKD Patients on Dialysis: 0.45 mcg/kg IV or subcutaneously once a week

Comments: Initiate treatment when hemoglobin is less than 10 g/dL.

You should not use Aranesp if you are allergic to darbepoetin alfa, or if you have:

• untreated or uncontrolled high blood pressure; or

• if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using Aranesp or epoetin alfa.

Aranesp 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 the risks and benefits of using this medicine.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;

• kidney disease (or if you are on dialysis);

• a stroke, heart attack, or blood clot;

• a seizure; or

• a latex allergy.

Tell your doctor if you are pregnant or breastfeeding.

Call your doctor for instructions if you miss a dose of Aranesp.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Aranesp (hives, wheezing, difficult breathing, severe dizziness or fainting, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

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 Aranesp. Seek emergency medical help if you have:

• heart attack symptoms - chest pain or pressure, shortness of breath, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), confusion, sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot - pain, swelling, warmth, redness, cold feeling, or pale appearance of an arm or leg; or

• increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• unusual weakness or tiredness;

• a seizure (convulsions); or

• shortness of breath (even with mild exertion), swelling, rapid weight gain.

Common Aranesp side effects may include:

• low blood pressure during dialysis;

• cough, trouble breathing;

• stomach pain; or

• swelling in your arms or legs.

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.

Other drugs may interact with Aranesp, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.