Oprelvekin (rHuIL-11)

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.

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.

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%

Composition

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

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