"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
Allergic Reactions Including Anaphylaxis
Neumega (oprelvekin) has caused allergic or hypersensitivity reactions, including anaphylaxis. Administration of Neumega (oprelvekin) should be permanently discontinued in any patient who develops an allergic or hypersensitivity reaction (see WARNINGS, CONTRAINDICATIONS, ADVERSE REACTIONS and ADVERSE REACTIONS, Immunogenicity).
Interleukin eleven (IL-11) is a thrombopoietic growth factor that directly stimulates the proliferation of hematopoietic stem cells and megakaryocyte progenitor cells and induces megakaryocyte maturation resulting in increased platelet production. IL-11 is a member of a family of human growth factors which includes human growth hormone, granulocyte colonystimulating factor (G-CSF), and other growth factors.
Oprelvekin, the active ingredient in Neumega (oprelvekin) , is produced in Escherichia coli (E. coli) by recombinant DNA technology. The protein has a molecular mass of approximately 19,000 daltons, and is non-glycosylated. The polypeptide is 177 amino acids in length and differs from the 178 amino acid length of native IL-11 only in lacking the amino-terminal proline residue. This alteration has not resulted in measurable differences in bioactivity either in vitro or in vivo.
Neumega (oprelvekin) is formulated in single-use vials containing 5 mg of oprelvekin (specific activity approximately 8 x 106 Units/mg) as a sterile, lyophilized powder with 23 mg Glycine, USP, 1.6 mg Dibasic Sodium Phosphate Heptahydrate, USP, and 0.55 mg Monobasic Sodium Phosphate Monohydrate, USP. When reconstituted with 1 mL of Sterile Water for Injection, USP, the resulting solution has a pH of 7.0 and a concentration of 5 mg/mL.
What are the possible side effects of oprelvekin (Neumega)?
Stop using oprelvekin and get emergency medical help if you have any of these signs of an allergic reaction: fever, rash, shortness of breath, chest pain, wheezing, confusion, fainting, hives, or swelling of your face, lips, tongue, or throat. Once you have had an allergic reaction to oprelvekin, you must never use it again.
Stop using oprelvekin and call your doctor at once if you have any of these serious side effects:
- feeling short of breath, even with mild exertion;
- swelling, rapid weight gain;
- chest pain, fast or uneven...
What are the precautions when taking oprelvekin (Neumega)?
Before using oprelvekin, tell your doctor or pharmacist if you are allergic to it; 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: kidney disease, heart/blood vessel disease (e.g., congestive heart failure, irregular heartbeat, stroke), unusual fluid retention (e.g., swelling of the ankles/feet, ascites, pleural effusion), eye problems (e.g., papilledema), brain/spinal cord tumors, high blood pressure (hypertension).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can...
Last reviewed on RxList: 10/21/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Neumega Information
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