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Coverage:

-Chemotherapy-induced thrombocytopenia

Oprelvekin (Neumega) has not been approved for primary prophylaxis. All other indications are considered experimental and investigational.

Discussion:

Oprelvekin (Neumega) is a recombinant version of human interleukin-11 (IL-11). IL-11 belongs to a family of human growth factors, which includes granulocyte colony-stimulating factor (G-CSF), human growth hormone, and other growth factors. Oprelvekin functions similarly to endogenous interleukin (IL)-11 and stimulates platelet production.

This product is used clinically to prevent severe chemotherapy-induced thrombocytopenia and to reduce the need for platelet transfusions following myelosuppressive chemotherapy for nonmyeloid malignancies.

Oprelvekin (Neumega) dosing-

For the prevention of severe chemotherapy-induced thrombocytopenia and to reduce the need for platelet transfusions following myelosuppressive chemotherapy in patients with non-myeloid malignancies who are at high risk of severe thrombocytopenia:

NOTE: Oprelvekin has been designated an orphan drug by the FDA for this indication.

Subcutaneous dosage:

Adults and adolescents: The recommended dose is 50 mcg/kg SC once daily. Dosing should be initiated 6—24 hours after the completion of chemotherapy and continued until the post-nadir platelet count is >= 50,000/mm. Platelet counts should be monitored periodically to assess the optimal duration of therapy. In controlled clinical trials, doses were administered for 10—21 days. Dosing beyond 21 days per treatment course is not recommended. Oprelvekin has not been evaluated in patients receiving regimens longer than 5 days duration or with agents associated with delayed myelosuppression (e.g., nitrosoureas, mitomycin C). Treatment should be discontinued at least 2 days before the start of the next planned cycle of chemotherapy.

Children and infants 8 months to 11 years: The manufacturer recommends that oprelvekin use in children, especially those < 12 years of age, be restricted to controlled clinical trials with closely monitored safety assessments . In a phase I, single arm, dose escalation study, 43 pediatric patients were treated with oprelvekin at doses ranging from 25—125 mcg/kg/day SC following ICE chemotherapy. All patients required platelet transfusions and the lack of a comparator arm made the study design inadequate to assess efficacy. The projected effective dose in children (based on comparable AUC observed for the effective dose in healthy adults) appears to exceed the maximum tolerated pediatric dose of 50 mcg/kg/day. The most commonly reported adverse events include edema, papilledema, shortness of breath, chills, cough and diarrhea. Severe allergic reactions have also been reported.

Oprelvekin (Neumega) is pregnancy category C.

References:

Cantor SB, Elting LS, Hudson DV Jr, Rubenstein EB.. Pharmacoeconomic analysis of oprelvekin (recombinant human interleukin-11) for secondary prophylaxis of thrombocytopenia in solid tumor patients receiving chemotherapy.
Cancer. 2003 Jun 15;97(12):3099-106.

Rust DM, Wood LS, Battiato LA., Oprelvekin: an alternative treatment for thrombocytopenia.
Clin J Oncol Nurs. 1999 Apr;3(2):57-62.

Isaacs C, Robert NJ, Bailey FA, Schuster MW, Overmoyer B, Graham M, Cai B, Beach KJ, Loewy JW, Kaye JA., Randomized placebo-controlled study of recombinant human interleukin-11 to prevent chemotherapy-induced thrombocytopenia in patients with breast cancer receiving dose-intensive cyclophosphamide and doxorubicin.
J Clin Oncol. 1997 Nov;15(11):3368-77.