- Aranesp® Full Product Information, including Medication Guide
- Prescribing Information, including Boxed WARNINGS
- Medication Guide—English
- Patient Instructions for Use—Single-Dose Vial
- Patient Instructions for Use—Single-Dose Prefilled Syringe (SingleJect®)
- Patient Instructions for Use—Single-Use Prefilled SureClick™ Autoinjector
- Letter to Healthcare Professionals (August 2008)
- Letter to Healthcare Professionals (April 2009)
- Letter to Healthcare Professionals (December 2009)
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Indication:
- Aranesp® is used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney failure in patients on dialysis and not on dialysis.
Important Safety Information:
Using Aranesp® can lead to death or other serious side effects.
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 ESA APPRISE Oncology Patient and Healthcare Professional (HCP) Acknowledgement Form to document that your healthcare provider discussed the risks of Aranesp® with you. When you sign this form, you are stating that you are aware of the risks associated with use of Aranesp®.
If you have breast, non-small cell lung, head and neck, lymphoid, or cervical cancer, your tumor may grow faster and you may die sooner when Aranesp® is used experimentally to try to raise your hemoglobin beyond the amount needed to avoid red blood cell transfusion, or if you are taking Aranesp® and not getting strong doses of chemotherapy. It is not known whether these risks exist when Aranesp® is given according to the FDA-approved directions for use.
- Your healthcare provider should prescribe the smallest dose of Aranesp® to lower the chance of getting red blood cell transfusions
- After you have finished your chemotherapy course, Aranesp® treatment should be stopped
- Aranesp® does not improve the symptoms of anemia (lower than normal number of red blood cells), quality of life, fatigue, or well-being for patients with cancer
All patients, including patients with cancer or chronic kidney failure:
You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with Aranesp® to a hemoglobin level above 12 g/dL. 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® and signed the ESA APPRISE Oncology Program Patient and Healthcare Professional (HCP) Acknowledgement Form before you begin to receive 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 allergies to any of the ingredients in Aranesp®.
- High blood pressure in patients with chronic kidney failure. 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 signs of anemia such as 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, 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.
While you are on Aranesp®, tell your healthcare provider if you are, or are planning to become, pregnant or breast-feed.
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 material that is like latex.
Common side effects of Aranesp® in patients with chronic kidney failure include: infection, high blood pressure, low blood pressure, and muscle spasm.
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.
