Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
ELAHERE 5 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
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Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless solution. |
1 mL of concentrate for solution for infusion contains 5 mg of mirvetuximab soravtansine. One vial contains 100 mg mirvetuximab soravtansine in 20 mL.
Mirvetuximab soravtansine is a FRα-directed antibody-drug conjugate (ADC). The ADC consists of an anti-FRα monoclonal antibody of IgG1 subtype produced using recombinant DNA technology in Chinese Hamster Ovary cells and attached via a cleavable linker (butanoic acid, 4-(2-pyridinyldithio)-2-sulfo-1-(2,5-dioxo-1-pyrrolidinyl) ester) to a maytansinoid DM4, an anti-tubulin agent. Mirvetuximab soravtansine contains an average of 3.4 DM4 payload molecules bound to the anti-FRα antibody.
Excipients with known effect:
This medicinal product contains 2.11 mg of polysorbate 20 in each vial.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mirvetuximab soravtansine |
Mirvetuximab soravtansine is an antibody-drug conjugate. The antibody is an engineered IgG1 directed against folate receptor alpha (FRα). The function of the antibody portion is to bind to FRα expressed on the surface of ovarian cancer cells. DM4 is a microtubule inhibitor attached to the antibody via a cleavable linker. Upon binding to FRα, mirvetuximab soravtansine is internalised followed by intracellular release of DM4 via proteolytic cleavage. DM4 disrupts the microtubule network within the cell, resulting in cell cycle arrest and apoptotic cell death. |
| List of Excipients |
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Glacial acetic acid (E260) |
Type I glass vial with a butyl rubber stopper and an aluminum seal with a royal blue polypropylene flip cap, containing 20 mL concentrate for solution.
Pack size of 1 vial.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
EU/1/24/1866/001
| Drug | Countries | |
|---|---|---|
| ELAHERE | France, Lithuania, United States |
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