"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"...
(darbepoetin alfa) Injection, for Intravenous or Subcutaneous Use
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, Aranesp dose, or dosing strategy that does not increase these risks.
- Use the lowest Aranesp 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 3, 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 Aranesp 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].
Aranesp (darbepoetin alfa) is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Aranesp is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons.
Aranesp is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).
What are the possible side effects of darbepoetin alfa (Aranesp, Aranesp Albumin Free, Aranesp SureClick)?
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 light-headed or unusually weak or tired. These may be signs that your body has stopped responding to darbepoetin alfa.
Darbepoetin 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 darbepoetin alfa. Seek emergency medical help if you...
What are the precautions when taking darbepoetin alfa (Aranesp)?
Before using darbepoetin 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 (e.g., epoetin alfa); or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients (such as polysorbate, latex), 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, blood disorders (e.g., sickle cell anemia, white blood cell or platelet problems, bone marrow problems), bleeding/clotting problems, blood vessel problems (e.g., stroke), heart problems (e.g., angina, heart failure), seizure disorder, a certain...
Last reviewed on RxList: 1/27/2014
This monograph has been modified to include the generic and brand name in many instances.
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