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: