Changes in the Neumega Package Insert to Include a Description of Ventricular Arrhythmic and Ophthalmologic Adverse Events

Neumega (Oprelvekin) was approved in November, 1997 for use in adults with nonmyeloid malignancies who are at high risk for severe thrombocytopenia due to myelosuppressive chemotherapy. Neumega is indicated for the prevention of severe thrombocytopenia and for the reduction in the proportion of patients requiring platelet transfusions.  Neumega is not indicated for use in children or in patients receiving myeloablative chemotherapy.

New adverse event information from post-marketing reports has been added to the Neumega prescription information.  The following statements have been added to the WARNINGS section:

“In the post-marketing setting, ventricular arrhythmias have been reported, generally occurring within two to seven days of initiation of treatment.”

“Changes in visual acuity and/or visual field defects ranging from blurred vision to blindness can occur in patients with papilledema taking Neumega.”

The post-marketing reports of the ADVERSE REACTIONS sections has been revised and reformatted to include reports of optic neuropathy and ventricular arrthymias.  In addition to incorporating the new adverse event information into product labeling, Wyeth Pharmaceuticals Inc. (Philadelphia, Pennsylvania) has committed to an evaluation of the effects of Neumega on the QT interval.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions, and contraindications is available at: www.fda.gov/cder/foi/label/2006/103694s5065lbl.pdf.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by phone at 1-800-FDA-1088; by facsimile 1-800-FDA-0178, by mail, or by using Form 3500 at https://www.accessdata.fda.gov/scripts/medwatch/.

For further information related to oncology drug approvals, regulatory information, and other oncology resources, please refer to the FDA “Oncology Tools” website at www.fda.gov/cder/cancer.

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