Composition

Kadcyla 100 mg powder for concentrate for solution for infusion. One vial of powder for concentrate for solution for infusion contains 100 mg of Trastuzumab emtansine*. After reconstitution one vial of 5 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

100 mg x 1's (in 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

2023-06-06  

Expiry Date

2028-05-30