Aranesp® (darbepoetin alfa) Indication
Aranesp® is 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 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®.
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
In place of emergency treatment for anemia (red blood cell transfusions)
Aranesp® has not been proven to improve quality of life, fatigue, or well-being.
IMPORTANT SAFETY INFORMATION
Aranesp® may cause serious side effects that can lead to death, including:
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 has received special training in order to prescribe Aranesp® and will talk with you in detail 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:
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 levels 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:
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 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 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 a serious allergic reaction, stop using Aranesp® and call your healthcare provider or get medical help right away.
Common side effects of Aranesp® include:
Shortness of breath
Low blood pressure during dialysis
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 US Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call
Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide.