Topleucon (Molgramostim; GM-CSF)

Molgramostim (rHuGM-CSF)

Description

Molgramostim is a recombinant human granulocyte macrophage colony stimulating factor (rHuGM-CSF), produced by recombinant DNA technology using E.coli. It is a 127 amino acid protein, non-glycosylated, and has a molecular weight of approximately 14.5kD.

Indications

1. In patients receiving myelosuppressive therapy cancer chemotherapy to reduce the severity of neutropenia, thereby reducing the risk of infection and allowing better adherence to the chemotherapeutic regimen;

2. In patients undergoing autologous or syngeneic bone marrow transplantation to accelerate myeloid recovery (Molgramostim does not improve overall survival or increase time to relapse);

Pharmaceutical particulars

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

• Strength: 100μg, 300μg and 400μg
• Reference: Current EP/CP
• Specific activity: ≥1.0×10⁷IU/mg
• Purity (HPLC, SDS-PAGE): ≥98%

Composition

• Active Ingredients: Molgramostim (rHuGM-CSF)
• Inactive Ingredients: Mannitol, Macrogol 4000, Human Albumin, Disodium Phosphate and Monobasic Potassium Phosphate.

Shelf life and storage conditions

• Drug Product: Storage at 2-8°C for 36 months
• Drug Substance (Concentrated solution): Storage at or below -65°C for 12 months