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        Indication

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 

Finished formulation	Store at 2-8℃ for 2 years
API (Concentrated solution)	Store at -70℃ for 7 months