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Important Information
you should know about Aranesp®.

Important Safety Information

Using Aranesp® can lead to death or other serious side effects.

For patients with cancer:

Your healthcare provider has received special training through the ESA APPRISE Oncology Program in order to prescribe Aranesp®. Before you can begin to receive Aranesp®, you must sign the patient-healthcare provider acknowledgment form. When you sign this form, you are stating that your healthcare provider talked with you about the risks of taking Aranesp®.

These risks include that your tumor may grow faster and you may die sooner if you choose to take Aranesp®.

For all patients who take Aranesp®, including patients with cancer or chronic kidney disease:

  • Your healthcare provider should prescribe the smallest dose of Aranesp® that is needed to reduce your chance of getting red blood cell transfusions.
  • You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with Aranesp® to reach a normal or near-normal hemoglobin level. If your hemoglobin level stays too high or goes up too quickly, this may also lead to these serious problems. Serious health problems may happen even if you take Aranesp® and do not have an increase in your hemoglobin level. Your doctor should monitor your hemoglobin regularly.
  • You may get blood clots at any time while taking Aranesp®. If you are going to have surgery, talk to your healthcare provider about whether you will need a blood thinner to lessen the chance of blood clots during or following surgery. Call your healthcare provider or get medical help right away if you have symptoms of blood clots such as:
    • Chest pain
    • Trouble breathing or shortness of breath
    • Pain or swelling in your legs
    • Arm or leg feels cool or appears pale
    • Sudden confusion or trouble with speech
    • Sudden numbness or weakness in your face, arm, or leg
    • Sudden trouble seeing
    • Sudden dizziness or trouble with walking or balance
    • Loss of consciousness (fainting)
    • Your hemodialysis vascular access stops working

You should not take Aranesp® if you:

  • Have cancer and have not been counseled by your healthcare provider regarding the risks of Aranesp® or if you have not signed the patient-healthcare provider acknowledgment form before you start Aranesp® treatment.
  • Have high blood pressure that is not controlled (uncontrolled hypertension).
  • Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with Aranesp® or other erythropoietin protein medicines.
  • Have had a serious allergic reaction to Aranesp®.

Aranesp® may cause other serious side effects:

  • High blood pressure. High blood pressure is a common side effect of Aranesp® in patients with chronic kidney disease. Your blood pressure may go up or be difficult to control with medicine while taking Aranesp®. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often.
  • Seizures. Seizures have occurred in patients taking Aranesp®. If you have a seizure, get medical help right away.
  • Antibodies to Aranesp®. Your body may make antibodies to Aranesp® that can block or lessen your body’s ability to make red blood cells and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting.
  • Serious allergic reactions. Serious allergic reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness and fainting due to a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have such a reaction, stop using Aranesp® and get medical help right away.

Tell your healthcare provider if you are pregnant or breastfeeding, or are planning to become pregnant or breastfeed.

If you know you are allergic to latex, talk to your healthcare provider before using Aranesp® because the needle cover on the prefilled syringe contains latex.

Common side effects of Aranesp® include:

  • Shortness of breath
  • Cough
  • Low blood pressure during dialysis
  • Abdominal pain
  • Edema (swelling) of the arms or legs

These are not all of the possible side effects of Aranesp®. Tell your healthcare provider about any side effects that bother you or do not go away.

You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.