Oprelvekin (rHuIL-11)

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Description

Oprelvekin is a recombinant human interleukin 11, produced by recombinant DNA technology using E.coli. It has a molecular weight of approximately 19.0kD, non-glycosylated. The polypeptide is 177 amino acids and differs from the 178 amino acid length of native IL-11 only in lacking the amino-terminal protein residue, this alteration has not resulted in measurable differences in bioactivity either in vitro?or?in vivo.

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Indications

Oprelvekin is indicated for severe thrombocytopenia with degree III and IV induced by chemotherapy to solid tumor and to non-marrow leukemia. It could be administered together with rHuG-CSF to treat patients with leucopenia.

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Pharmaceutical Particulars

Sterile and white lyophilized powder to be reconstituted with a diluent (Sterile Water for Injection) for injection, presented in vials.

• Strength: 3mg/vial and 5mg/vial
• Reference: Internal Standard
• Specific activity: ≥8.0×10⁶U/mg
• Purity (HPLC, SDS-PAGE): ≥98%

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Composition

• Active Ingredients: Oprelvekin (rHuIL-11)
• Inactive Ingredients: Glycine, Disodium Phosphate and Sodium Dihydrogen Phosphate.

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Shelf life and storage conditions

• Drug Product: Storage at 2-8°C for 30 months
• Drug Substance (Concentrated solution): Storage at?or?below -65°C for 12 months