Oprelvekin (rHuIL-11)
l Description
Oprelvekin is a human interleukin 11, produced by recombinant DNA technology by 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.
l Indications
rHuIL-11 is indicated for severe thrombocytopenia with degree III and IV induced by chemotherapy to solid tumor and to non-marrow leukemia. Solid tumor and non-marrow leukemia patient who have thrombocyropenia degree III/IV with platelet counts ﹤5×109/L in the previous chemotherapy course, should be administered with rHuIL-11 before next chemotherapy course to reduce the bleeding caused by thrombocytopenia and dependence for platelet transfusions. It could be administered together with rHuG-CSF to treat patients with leucopenia.
l Pharmaceutical Particulars
Sterile, white and preservative-free lyophilized powder to be reconstituted with a diluent (Sterile Water for Injection) for injection, presented in vials.
Dosage: 1mg/vial, 1.5mg/vial, 2mg/vial, 3mg/vial and 5mg/vial
Reference: Internal Requirement
Specific activity: ≥8.0×106U/mg
Purity (HPLC, SDS-PAGE): ≥98%
l Composition
Active ingredients: Oprelvekin (rHuIL-11)
Inactive ingredients: Glycine, Dibasic Sodium Phosphate and Monobasic Sodium Phosphate.
l Shelf life and storage conditions
| Drug product | Storage at 2-8℃ for 2 years |
| Drug Substance (Concentrated solution) | Storage at -70℃ for 7 months |
