[Posted 06/24/2011] ISSUE: FDA notified healthcare professionals that new, modified recommendations for more conservative dosing of Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic kidney disease (CKD) have been approved to improve the safe use of these drugs. FDA has made these recommendations because of data showing increased risks of cardiovascular events with ESAs in this patient population. The new dosing recommendations are based on clinical trials showing that using ESAs to target a hemoglobin level of greater than 11 g/dL in patients with CKD provides no additional benefit than lower target levels, and increases the risk of experiencing serious adverse cardiovascular events, such as heart attack or stroke.
BACKGROUND: ESAs treat certain types of anemia by stimulating the bone marrow to produce red blood cells and by decreasing the need for blood transfusions. The manufacturer has revised the Boxed Warning, Warnings and Precautions, and Dosage and Administration sections of the labels for the ESAs to include this new information.
RECOMMENDATION: Healthcare professionals should weigh the possible benefits of using ESAs to decrease the need for red blood cell transfusions in CKD patients against the increased risks for serious cardiovascular events, and should inform their patients of the current understanding of potential risks and benefits. Therapy should be individualized to the patient and the lowest possible ESA dose given to reduce the need for transfusions. See the Drug Safety Communication for additional information including a table of key trials and other supporting references. Treatment with ESAs in CKD was discussed at the Drug Safety and Risk Management Advisory Committee, held October 18, 2010. For summary minutes of that Advisory Committee, see the following link: [Web]. For more information visit the FDA website at: [Web] and [Web].
REMS:
FDA approved a REMS for epoetin alfa to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of epoetin alfa and consists of the following: medication guide, elements to assure safe use, communication plan, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
What is this medicine?
EPOETIN ALFA (e POE e tin AL fa) helps your body make more red blood cells. This medicine is used to treat anemia caused by chronic kidney failure, cancer chemotherapy, or HIV-therapy. It may also be used before surgery if you have anemia.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
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. 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 drug may be prescribed 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 or shake. Throw away any unused portion if using a single-dose vial. Multi-dose vials can be kept in the refrigerator for up to 21 days after the initial dose. Throw away unused medicine.
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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