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ADCETRIS Powder for concentrate for solution (2019)

Active ingredients: Brentuximab vedotin

Product Name and Form

ADCETRIS 50 mg powder for concentrate for solution for infusion.

Pharmaceutical form

Powder for concentrate for solution for infusion.

White to off-white cake or powder.

Qualitative and Quantitative Composition

Each vial contains 50 mg of brentuximab vedotin.

After reconstitution (see section 6.6), each mL contains 5 mg of brentuximab vedotin.

ADCETRIS is an antibody-drug conjugate composed of a CD30-directed monoclonal antibody (recombinant chimeric immunoglobulin G1 [IgG1], produced by recombinant DNA technology in Chinese Hamster ovary cells) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE).

Excipient with known effect: Each vial contains approximately 13.2 mg of sodium.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Brentuximab vedotin

Brentuximab vedotin is an antibody drug conjugate (ADC) that delivers an antineoplastic agent that results in apoptotic cell death selectively in CD30-expressing tumour cells. Nonclinical data suggest that the biological activity of brentuximab vedotin results from a multi-step process. Binding of the ADC to CD30 on the cell surface initiates internalisation of the ADC-CD30 complex, which then traffics to the lysosomal compartment. Within the cell, a single defined active species, MMAE, is released via proteolytic cleavage. Binding of MMAE to tubulin disrupts the microtubule network within the cell, induces cell cycle arrest and results in apoptotic death of the CD30-expressing tumour cell.

List of excipients

Citric acid monohydrate (for pH-adjustment)
Sodium citrate dihydrate (for pH-adjustment)
α,α-Trehalose dihydrate
Polysorbate 80

Pack sizes and Marketing

Type I glass vial with a butyl rubber stopper and an aluminium/plastic flip-off seal, containing 50 mg powder.

Pack of 1 vial.

Marketing authorization holder
Authorization dates

Takeda Pharma A/S, Dybendal Alle 10, 2630, Taastrup, Denmark

Date of first authorisation: 25 October 2012

Marketing authorization number:

EU/1/12/794/001