Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
BLENREP 100 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Powder for concentrate for solution for infusion (powder for concentrate). Lyophilised white to yellow powder. |
One vial of powder contains 100 mg of belantamab mafodotin.
After reconstitution, the solution contains 50 mg belantamab mafodotin per mL.
Belantamab mafodotin is an antibody-drug conjugate that contains belantamab, an afucosylated humanised monoclonal IgG1k antibody specific for B cell maturation antigen (BCMA), produced using recombinant DNA technology in a mammalian cell line (Chinese Hamster Ovary) that is conjugated with maleimidocaproyl monomethyl auristatin F (mcMMAF).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Belantamab mafodotin |
Belantamab mafodotin is a humanised IgG1Îș monoclonal antibody conjugated with a cytotoxic agent, maleimidocaproyl monomethyl auristatin F (mcMMAF). Belantamab mafodotin binds to cell surface BCMA and is rapidly internalised. Apoptosis induced by belantamab mafodotin is accompanied by markers of immunogenic cell death, which may contribute to an adaptive immune response to tumour cells. |
| List of Excipients |
|---|
|
Sodium citrate |
Type 1 glass vial sealed with bromobutyl rubber stopper and aluminium overseal with a plastic removable cap containing 100 mg powder.
Pack size: 1 vial.
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
EU/1/20/1474/001
Date of first authorisation: 25 August 2020
| Drug | Countries | |
|---|---|---|
| BLENREP | Austria, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Poland, United Kingdom, United States |
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