Darbepoetin Alfa (Polysorbate 80) (dar-be-POE-e-tin AL-fa (POL-ee-SOR-bate))Brand Name:
Clinical studies have shown Aranesp to increase the risk of serious side effects (eg, blood clots, stroke, heart attack, heart failure) and death in some cases. It has also been shown to shorten overall survival and/or increase the risk of tumor growth or recurrence in patients with certain types of cancer. Talk with your doctor about the risks and benefits of using Aranesp . Do not use more than the recommended dose without checking with your doctor.
Aranesp is used for:
Treating anemia in patients with chronic kidney failure or certain types of cancers. It may also be used for other conditions as determined by your doctor.
Aranesp is similar to the natural protein human erythropoietin. It works by stimulating the bone marrow to produce more red blood cells. An increased number of red blood cells may reduce symptoms of anemia.
Do NOT use Aranesp if:
- you are allergic to any ingredient in Aranesp or similar medicines (eg, erythropoietin)
- you are allergic to products made from mammalian cells
- you have uncontrolled or severe high blood pressure, or you have certain red blood cell problems (eg, certain types of aplasia)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Aranesp :
Some medical conditions may interact with Aranesp . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a vitamin B or folic acid deficiency
- if you have a blood disease (eg, sickle cell anemia, porphyria, hemolytic anemia, thalassemia)
- if you have high blood pressure, heart problems (eg, congestive heart failure), blood in your stools, seizures, recent infection or injury, cancer, certain bone problems (eg, osteofibrosis cystica), or inflammatory conditions (eg, bowel disease, rheumatoid arthritis)
Some MEDICINES MAY INTERACT with Aranesp . Tell your health care provider if you are taking any other medicines.
Ask your health care provider if Aranesp may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Aranesp :
Use Aranesp as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Aranesp comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Aranesp refilled.
- Aranesp is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Aranesp at home, a health care provider will teach you how to use it. Be sure you understand how to use Aranesp . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Aranesp if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Do not shake Aranesp .
- Do not dilute or mix Aranesp with any other solutions or medicines.
- Discard any unused portion of medicine left in the vial or syringe.
- Use only disposable syringes and needles. Use the syringes and needles only once and dispose of them in a puncture-proof container as instructed by your health care provider.
- Choose a new site each time you inject Aranesp . Do not inject into an area that is tender, red, bruised, hard, swollen, or has scars or stretch marks.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Aranesp , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Aranesp .
Important safety information:
- Aranesp may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Aranesp with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- It is important to keep your blood pressure under control during treatment with Aranesp . Do not stop taking any of your blood pressure medicines without checking with your doctor. Closely follow your doctor's instructions for diet and blood pressure monitoring.
- It may take 2 to 6 weeks for Aranesp to work. If your symptoms do not improve or they become worse, check with your doctor.
- Lab tests, including blood pressure, blood cell counts, kidney function, blood electrolyte levels, and blood iron levels, will be performed while you use Aranesp . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Aranesp should be used with extreme caution in CHILDREN with chronic kidney failure younger than 1 year old or CHILDREN with cancer; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aranesp while you are pregnant. It is not known if Aranesp is found in breast milk. If you are or will be breast-feeding while you use Aranesp , check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Aranesp :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; cough; diarrhea; dizziness; headache; muscle, joint, back, or stomach pain; nausea or vomiting; pain, swelling, irritation, redness, or bruising at the injection site; unusual tiredness or weakness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or vision changes; chest pain; confusion; fainting; fast or irregular heartbeat; flu-like symptoms (fever, chills, sore throat); one-sided weakness; pale skin color; seizures; redness, tenderness, or swelling of the calf; severe diarrhea, dizziness, headache, stomach pain, or vomiting; severe or persistent tiredness or weakness; slurred speech; sudden pain or numbness of an arm or leg; sudden shortness of breath; sudden trouble walking or loss of balance; swelling of the arms or legs; vision or speech problems; weight gain.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Aranesp :
Store Aranesp in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Do not use past the expiration date on the vial or prefilled syringe. When traveling, transport Aranesp in the original carton in a cool carrier with a coolant, such as blue ice. To avoid freezing, be sure the medicine does not touch the coolant. Once you arrive, place the medicine in the refrigerator as soon as possible. Keep Aranesp out of the reach of children and away from pets.
- If you have any questions about Aranesp , please talk with your doctor, pharmacist, or other health care provider.
- Aranesp is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Aranesp . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Aranesp Prescribing Information (FDA)
- Aranesp Advanced Consumer (Micromedex) - Includes Dosage Information
- Aranesp Consumer Overview
- Darbepoetin Alfa Professional Patient Advice (Wolters Kluwer)