PROPRIETARY NAME
Recombinant Human Interleukin 11For Injection

BRAND NAME
XIN MEI GE

COMPOSITION
Xinmeige is formulated in single-use vials containing 4 mg of oprelvekin (specific activity approximately 8 x 106 Units/mg) as a sterile, lyophilized powder with 23 mg Glycine, 1.6 mg Dibasic Sodium Phosphate Heptahydrate, and 0.55 mg Monobasic Sodium Phosphate Monohydrate.
 
WARNING
Allergic Reactions Including Anaphylaxis
Xinmeige has caused allergic or hypersensitivity reactions, including anaphylaxis.
Administration of Xinmeige should be permanently discontinued in any patient who develops an allergic or hypersensitivity reaction.

IDENTIFICATION OF THE MEDICINE
Xinmeige is a sterile, white, preservative-free, lyophilized powder for subcutaneous injection upon reconstitution. The reconstituted Xinmeige solution is clear, colorless, and contains 4 mg/mL of Xinmeige.

CLINICAL PHARMACOLOGY
Interleukin eleven (IL-11) is a thrombopoietic growth factor that directly stimulates the proliferation of hematopoietic stem cells and megakaryocyte progenitor cells and induces megakaryocyte maturation resulting in increased platelet production. Platelets produced in response to Xinmeige were morphologically and functionally normal and possessed a normal life span.

INDICATIONS
Xinmeige is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia.