Important Safety Information

For people with cancer:

• In patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers: Your tumor may grow faster and you may die sooner if you choose to take Aranesp^®.
• Your healthcare provider will talk with you about these risks.

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

• Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with Aranesp^® to increase red blood cells (RBCs) to near the same level found in healthy people.
• Blood clots. Blood clots may happen at any time while taking Aranesp^®. If you are receiving Aranesp^® for any reason and are going to have surgery, talk with your healthcare provider about whether you need to take 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 any of these symptoms:
  • Chest pain
  • Trouble breathing or shortness of breath
  • Pain or swelling in your legs
  • A cool or pale arm or leg
  • Sudden confusion, trouble speaking, or trouble understanding others' speech
  • Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body
  • Sudden trouble seeing
  • Sudden trouble walking, dizziness, loss of balance or coordination
  • Loss of consciousness (fainting)
  • Hemodialysis vascular access stops working

If you decide to take Aranesp^®, your healthcare provider should prescribe the smallest dose that is necessary to reduce your chance of needing RBC transfusions.

If your hemoglobin level stays too high or goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take Aranesp^®, even if you do not have an increase in your hemoglobin level.

Do not take Aranesp^® if you:

• Have cancer and have not been counseled by your healthcare provider about treatment with Aranesp^®.
• 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 medicines.
• Have had a serious allergic reaction to Aranesp^®.

Before taking Aranesp^®, tell your doctor if you: have heart disease; have high blood pressure; have had a seizure or stroke; or if you are pregnant or breastfeeding, or plan 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.

Aranesp^® may cause other serious side effects, including:

• High blood pressure. High blood pressure is a common side effect of Aranesp^® in people with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medication 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. If you have seizures while taking Aranesp^®, get medical help right away and tell your healthcare provider.
• Antibodies to Aranesp^®. Your body may make antibodies to Aranesp^® that can block or lessen your body’s ability to make RBCs and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking Aranesp^®.
• Serious allergic reactions. Serious allergic reactions can cause a skin rash, itching, 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 a serious allergic reaction, stop using Aranesp^® and call your healthcare provider or get medical help right away.
• Severe skin reactions. Signs and symptoms of severe skin reactions with Aranesp^® may include: skin rash with itching, blisters, skin sores, peeling or areas of skin coming off. If you have any signs or symptoms of a severe skin reaction, stop using Aranesp^® and call your healthcare provider or get medical help right away.

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 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 US Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indications

Aranesp^® is a prescription medicine used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease in patients on dialysis and not on dialysis.

Aranesp^® is a prescription medicine used to treat a lower than normal number of red blood cells (anemia) caused by chemotherapy that will be used for at least two months after starting Aranesp^®.

Limitations of Use

Aranesp^® has not been proven to improve quality of life, fatigue, or well-being.

Aranesp^® should not be used for the treatment of anemia:

• If you have cancer and you will not be receiving chemotherapy that may cause anemia for at least 2 more months
• If you have a cancer that has a high chance of being cured
• If your anemia caused by chemotherapy treatment can be managed by RBC transfusion.
• In place of emergency treatment for anemia (red blood cell transfusions)

Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide.