DESCRIPTION
RAPTIVA™ (efalizumab) is an immunosuppressive recombinant humanized IgG1 kappa isotype monoclonal antibody that binds to human CD11a (1). Efalizumab has a molecular weight of approximately 150 kilodaltons and is produced in a Chinese hamster ovary mammalian cell expression system in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.
RAPTIVA is supplied as a sterile, white to off-white, lyophilized powder in single-use glass vials for subcutaneous (SC) injection. Reconstitution of the single-use vial with 1.3 mL of the supplied sterile water for injection (non-USP) yields approximately 1.5 mL of solution to deliver 125 mg per 1.25 mL (100 mg/mL) of RAPTIVA. The sterile water for injection supplied does not comply with USP requirement for pH. After reconstitution, RAPTIVA is a clear to pale yellow solution with a pH of approximately 6.2. Each single-use vial of RAPTIVA contains 150 mg of efalizumab, 123.2 mg of sucrose, 6.8 mg of L-histidine hydrochloride monohydrate, 4.3 mg of L-histidine and 3 mg of polysorbate 20 and is designed to deliver 125 mg of efalizumab in 1.25 mL.
|
