"The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfiel"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
DARBEPOETIN ALFA - INJECTION
COMMON BRAND NAME(S): Aranesp
WARNING: Discuss the risks and benefits of use for darbepoetin alfa with your doctor, as this medication may rarely cause very serious (possibly fatal) side effects, including blood clots. It will be very important to keep all laboratory test appointments, as your doctor will need to carefully check your red blood cell tests (hemoglobin). The lowest effective dose of this medication should be used.
When used to treat anemia related to cancer, this medication may also increase the risk of death and/or cause your tumor to grow faster. Therefore, your doctor should have special training in order to prescribe this medication and be able to discuss with you the risks and benefits of this medication. This medication should be stopped after completing a treatment course of chemotherapy as directed by your doctor.
USES: This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic renal failure) and people receiving chemotherapy for some types of cancer (non-myeloid cancers). Darbepoetin alfa helps to reverse anemia. It also helps to reduce the need for blood transfusions. It works by signaling the bone marrow to make more red blood cells. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia.
HOW TO USE: Read the Medication Guide and Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions in the product package. If you have any questions, ask your doctor or pharmacist.
This medication is given as an injection under the skin or into a vein as directed by your doctor. Hemodialysis patients should receive this medication by injection into a vein.
Do not shake this medication and do not mix it with other drugs or IV solutions. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If you are injecting this medication under the skin, change the location of the injection site every time to avoid problem areas under the skin.
Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.
The dosage is based on your medical condition, weight, and response to treatment. Blood tests should be performed frequently to check how well this medication is working and to determine the correct dose for you. Consult your doctor for more details.
Do not increase your dose or use this medication more often than directed. Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week as directed.
It may take 2 to 6 weeks before your red blood cell count increases. Tell your doctor if your symptoms do not improve or if they worsen.
Additional Aranesp Information
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