FACEPTOR

FACEPTOR

FACEPTOR

FACEPTOR

FACEPTOR

FACEPTOR

FACEPTOR

DESCRIPTION

FACEPTOR (Trastuzumab) is a recombinant DNA-derived humanized monoclonal antibody that selectively binds with high affinity in a cell-based assay (Kd = 5 nM) to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2.The antibody is an IgG1 kappa that contains human framework regions with the complementarity-determining regions of a murine antibody (4D5) that binds to HER2.
The humanized antibody against HER2 is produced by a mammalian cell (Chinese Hamster Ovary) [CHO] suspension culture in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.
TRASTUZUMAB is a sterile, white to pale yellow, preservative-free lyophilized powder for intravenous (IV) administration. The nominal content of each TRASTUZUMAB vial is 440 mg Trastuzumab, 9.9 mg L-histidine HCl, 6.4 mg L-histidine, 400 mg α,α-trehalose dihydrate, and 1.8 mg polysorbate 20, USP. Reconstitution with only 20 mL of the supplied Bacteriostatic Water for Injection (BWFI), USP, containing 1.1% benzyl alcohol as a preservative, yields a multi-dose solution containing 21 mg/mL Trastuzumab, at a pH of approximately 6.

INDICATION

FACEPTOR as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease. FACEPTOR in combination with paclitaxel is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy for their metastatic disease. FACEPTOR should only be used in patients whose tumors have HER2 protein overexpression. 

CONTRAINDICATION

Hypersensitivity or allergy to Trastuzumab (the active ingredient) or to any other excipient.

STORAGE, SHELF-LIFE AND PACKING UNITS

Storage: Store vials at 2 ºC – 8 ºC.  This medicine should not be used after the expiry date shown on the pack.
Packing Units:
Faceptor 150 mg single-dose vials: each pack contains 1 vial of Faceptor (150 mg trastuzumab).
Faceptor 440 mg multi-dose vials:  each pack contains 1 vial of Faceptor (440 mg trastuzumab) and one 20 mL vial of Bacteriostatic Water for Injection.

 

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