Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Increased Mortality, Serious Cardiovascular Events, Thromboembolic Events, Stroke, and Increased Risk of Tumor Progression or Recurrence
Increased risk of death, serious cardiovascular events, and stroke reported in patients with chronic renal failure (CRF) receiving therapy with darbepoetin alfa or other erythropoiesis-stimulating agents (ESAs) targeted to hemoglobin concentrations ≥13 g/dL in clinical studies. (See Increased Mortality and Cardiovascular and Thromboembolic Events under Cautions.)
Individualize dosing of ESAs in CRF patients to achieve and maintain hemoglobin concentrations within 10–12 g/dL.
ESA therapy shortened overall survival and/or increased risk of tumor progression or recurrence in some studies in patients with breast, non-small cell lung, head and neck, lymphoid, or cervical cancers. (See Increased Mortality and/or Tumor Progression under Cautions.)
To decrease these risks and risk of serious cardiovascular and thromboembolic events in anemic patients with cancer, titrate ESA dosage to lowest hemoglobin concentration sufficient to avoid RBC transfusion.
Darbepoetin alfa may be prescribed and/or dispensed to cancer patients only by clinicians and institutions enrolled in the ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) Oncology program. (See Risk Management Plan under Dosage and Administration.)
Use ESAs in cancer patients only for treatment of anemia caused by concomitant myelosuppressive chemotherapy.
ESAs not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure of the underlying malignancy.
Discontinue ESAs following completion of a course of chemotherapy.
This medicine is for injection into a vein or under the skin. It is usually given by a health care professional in a hospital or clinic setting.
If you get this medicine at home, you will be taught how to prepare and give this medicine. Do not shake the solution before you withdraw a dose. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be used in children as young as 1 year for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your prescriber or health care professional for regular checks on your progress and for the needed blood tests and blood pressure measurements. It is especially important for the doctor to make sure your hemoglobin level is in the desired range, to limit the risk of potential side effects and to give you the best benefit. Keep all appointments for any recommended tests. Check your blood pressure as directed. Ask your doctor what your blood pressure should be and when you should contact him or her.
As your body makes more red blood cells, you may need to take iron, folic acid, or vitamin B supplements. Ask your doctor or health care provider which products are right for you. If you have kidney disease continue dietary restrictions, even though this medication can make you feel better. Talk with your doctor or health care professional about the foods you eat and the vitamins that you take.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
redness, stinging, or swelling at site where injected
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Do not shake. Throw away any unused portion if using a single-dose vial. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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