Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark, medinfoEMEA@takeda.com
ADCETRIS 50 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Powder for concentrate for solution for infusion. White to off-white cake or powder. |
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.
| Active Ingredient |
|---|
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Brentuximab vedotin is an ADC that delivers an antineoplastic agent that results in apoptotic cell death selectively in CD30-expressing tumour cells. Because of the CD30-targeted mechanism of action brentuximab vedotin is able to overcome chemo-resistance as CD30 is consistently expressed in patients who are refractory to multi-agent chemotherapy, irrespective of prior transplant status. |
| List of Excipients |
|---|
|
Citric acid monohydrate (for pH-adjustment) |
Type I glass vial with a butyl rubber stopper and an aluminium/plastic flip-off seal, containing 50 mg powder.
Pack of 1 vial.
Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark, medinfoEMEA@takeda.com
EU/1/12/794/001
Date of first authorisation: 25 October 2012
Date of latest renewal: 16 September 2021
| Drug | Countries | |
|---|---|---|
| ADCETRIS | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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