NEUMEGA® (oprelvekin)
Product Overview
NEUMEGA® (oprelvekin)
Indications and Usage
- NEUMEGA is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. NEUMEGA is not indicated following myeloablative chemotherapy. The safety and effectiveness of NEUMEGA have not been established in pediatric patients.
Important Safety Information
Allergic Reactions Including Anaphylaxis
NEUMEGA has caused allergic or hypersensitivity reactions, including anaphylaxis. Administration of NEUMEGA should be permanently discontinued in any patient who develops an allergic or hypersensitivity reaction (see WARNINGS, CONTRAINDICATIONS, ADVERSE REACTIONS and ADVERSE REACTIONS, Immunogenicity).
NEUMEGA has caused allergic or hypersensitivity reactions, including anaphylaxis. Administration of NEUMEGA should be permanently discontinued in any patient who develops an allergic or hypersensitivity reaction (see WARNINGS, CONTRAINDICATIONS, ADVERSE REACTIONS and ADVERSE REACTIONS, Immunogenicity).
- Serious adverse reactions have been associated with NEUMEGA administration, including allergic or hypersensitivity reactions and anaphylaxis. NEUMEGA is known to cause serious fluid retention that can result in peripheral edema, dyspnea, pulmonary edema, capillary leak syndrome, atrial arrhythmias (some with strokes), dilutional anemia, and exacerbation of pre-existing pericardial or pleural effusions.
- Neumega should be used with caution in patients with congestive heart failure (CHF), at risk of developing CHF, or with a history of heart failure. Other more common adverse events include mild to moderate fluid retention, tachycardia, conjunctival redness, and papilledema. Changes in visual acuity and/or visual field defects ranging from blurred vision to blindness can occur in patients with papilledema taking NEUMEGA.
- In post-marketing surveillance, ventricular arrhythmias have been reported.
- Dose adjustments are recommended for patients with severe renal impairment.
- In randomized studies, most adverse events were reversible within several days following discontinuation of NEUMEGA.
Please see full Prescribing Information.
241135-01