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 (see WARNINGS, Increased Toxicity Following Myeloablative Therapy). The safety and effectiveness of Neumega have not been established in pediatric patients.

The recommended dose of Neumega in adults without severe renal impairment is 50 mg/kg given once daily. Neumega should be administered subcutaneously as a single injection in either the abdomen, thigh, or hip (or upper arm if not self-injecting). A safe and effective dose has not been established in children (see PRECAUTIONS, Pediatric Use).

The recommended dose of Neumega in adults with severe renal impairment (creatinine clearance <30 mL/min) is 25 mg/kg. An estimate of the patient's creatinine clearance (CLcr) in mL/min is required. CLcr in mL/min may be estimated from a spot serum creatinine (mg/dL) determination using the following formula:

Dosing should be initiated six to 24 hours after the completion of chemotherapy. Platelet counts should be monitored periodically to assess the optimal duration of therapy. Dosing should be continued until the post-nadir platelet count is ≥50,000/mL. In controlled clinical trials, doses were administered in courses of 10 to 21 days. Dosing beyond 21 days per treatment course is not recommended.

Treatment with Neumega should be discontinued at least two days before starting the next planned cycle of chemotherapy.

1. Neumega is a sterile, white, preservative-free, lyophilized powder for subcutaneous injection upon reconstitution. Reconstitute the Neumega 5 mg vial using the 1.0 mL of Sterile Water for Injection, USP (without preservative) contained in the pre-filled syringe included in the kit The reconstituted Neumega solution is clear, colorless, isotonic, with a pH of 7.0, and contains 5 mg/mL of Neumega. Any unused portion of the reconstituted Neumega solution should be discarded.

2. During reconstitution, the Sterile Water for Injection, USP should be directed at the side of the vial and the contents gently swirled. Excessive or vigorous agitation should be avoided.

3. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter is present or the solution is discolored, the vial should not be used.

4. Administer Neumega within 3 hours following reconstitution. Reconstituted Neumega may be refrigerated [2°C to 8°C (36°F to 46°F)] or maintained at room temperature [up to 25°C (77°F)]. Do not freeze or shake the reconstituted solution.

Neumega is supplied as a sterile, white, preservative-free, lyophilized powder in vials containing 5 mg oprelvekin. Neumega is available in boxes containing one single-dose Neumega vial and one pre-filled syringe containing 1 mL Sterile Water for Injection, USP. - NDC 58394-004-08

The kit containing the vial of lyophilized Neumega and pre-filled diluent syringe should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect Neumega powder from light. Do not freeze.

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