Composition

Kadcyla 160 mg powder for concentrate for solution for infusion. One vial of powder for concentrate for solution for infusion contains 160 mg of Trastuzumab emtansine. After reconstitution, one vial of 8 mL solution contains 20 mg/mL of Trastuzumab emtansine. * Trastuzumab emtansine is an antibody-drug conjugate that contains trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture, covalently linked to DM1, a microtubule inhibitor, via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate)  

ATC Code

L01FD03  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

160 mg x 1's (in clear glass vial)  

Product Description

Powder for concentrate for solution for infusion. White to off-white lyophilized powder

Manufacturer Name

F. Hoffmann-La Roche Ltd

Manufacturer Country

SWITZERLAND  

Approval Date

2023-07-04  

Expiry Date

2028-05-30