"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"...
ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
- In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
- No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
- Use the lowest Epogen dose sufficient to reduce the need for red blood cell (RBC) transfusions [see WARNINGS AND PRECAUTIONS].
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers [see Table 2, WARNINGS AND PRECAUTIONS].
- Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Epogen to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance [see WARNINGS AND PRECAUTIONS].
- To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see DOSAGE AND ADMINISTRATION].
- Use ESAs only for anemia from myelosuppressive chemotherapy [see INDICATIONS AND USAGE].
- ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see INDICATIONS AND USAGE].
- Discontinue following the completion of a chemotherapy course [see DOSAGE AND ADMINISTRATION].
Epogen (epoetin alfa) is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin.
Epogen is formulated as a sterile, colorless liquid in vials in multiple formulations. Single-dose vials, formulated with an isotonic sodium chloride/sodium citrate-buffered solution, are supplied in multiple strengths. Each 1 mL vial contains 2000, 3000, 4000, or 10,000 Units of epoetin alfa, Albumin (Human) (2.5 mg), citric acid (0.06 mg), sodium chloride (5.9 mg), and sodium citrate (5.8 mg) in Water for Injection, USP (pH 6.9 ± 0.3). Single-dose 1 mL vials formulated with an isotonic sodium chloride/sodium phosphate buffer contain 40,000 Units of epoetin alfa albumin (human) (2.5 mg),citric acid (0.0068 mg), sodium chloride (5.8 mg), sodium citrate (0.7 mg), sodium phosphate dibasic anhydrate (1.8 mg), and sodium phosphate monobasic monohydrate (1.2 mg) in Water for Injection, USP (pH 6.9 ± 0.3). Multidose, 2 mL vials contain 10,000 Units epoetin alfa, albumin (human) (2.5 mg), benzyl alcohol (1%), sodium chloride (8.2 mg), and sodium citrate (1.3 mg) per 1 mL Water for Injection, USP (pH 6.1 ± 0.3). Multidose 1 mL vials contain 20,000 Units epoetin alfa, albumin (human) (2.5 mg), benzyl alcohol (1%), sodium chloride (8.2 mg), citric acid (0.11 mg), and sodium citrate (1.3 mg), per 1 mL in Water for Injection, USP (pH 6.1 ± 0.3).
What are the possible side effects of epoetin alfa (Epogen, Procrit)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Contact your doctor if you feel weak, lightheaded, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.
Epoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use epoetin alfa. Seek emergency medical help if you have symptoms of...
What are the precautions when taking epoetin alfa (Epogen)?
See also Side Effects section.
Before using epoetin alfa, tell your doctor or pharmacist if you are allergic to it; or to other drugs that cause more red blood cells to be made (such as darbepoetin alfa); or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, other blood disorders (such as sickle cell anemia, white blood cell or platelet problems, bone marrow problems), seizure disorder, a certain metabolic disorder (porphyria), certain vitamin deficiencies (folic acid, vitamin...
Last reviewed on RxList: 6/20/2012
This monograph has been modified to include the generic and brand name in many instances.
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