Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Regeneron Ireland DAC., One Warrington Place, Dublin 2, D02 HH27, Ireland
LYNOZYFIC 5 mg concentrate for solution for infusion.
LYNOZYFIC 200 mg concentrate for solution for infusion.
| Pharmaceutical Form |
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Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale yellow liquid that is essentially free from visible particulates, with a pH of 6.0, and osmolarity of approximately 358 mmol/L (2 mg/mL) and approximately 372 mmol/L (20 mg/mL). |
LYNOZYFIC 5 mg concentrate for solution for infusion:
Each vial contains 5 mg of linvoseltamab in 2.5 mL at a concentration of 2 mg/mL.
LYNOZYFIC 200 mg concentrate for solution for infusion:
Each vial contains 200 mg of linvoseltamab in 10 mL at a concentration of 20 mg/mL.
Linvoseltamab is a recombinant human immunoglobulin (Ig)G4-based bispecific antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture.
Excipient with known effect:
The 5 mg vial of linvoseltamab contains 2.5 mg of polysorbate 80 in each 2.5 mL vial which is equivalent to 1 mg/mL.
The 200 mg vial of linvoseltamab contains 10 mg of polysorbate 80 in each 10 mL vial which is equivalent to 1 mg/mL.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Linvoseltamab is a human IgG4-based bispecific antibody that binds to cluster of differentiation 3 (CD3), a T-cell antigen associated with the T-cell receptor complex, and B-cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. Simultaneous engagement of both arms of linvoseltamab results in formation of a synapse between the T-cell and the BCMA-expressing cell, resulting in T-cell activation and generation of polyclonal cytotoxic T-cell response, which result in redirected lysis of the targeted cells, including malignant multiple myeloma B-lineage cells. |
| List of Excipients |
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Histidine |
5 mg concentrate for solution for infusion:
2.5 mL of concentrate in a 5 mL Type 1 clear glass vial with a grey chlorobutyl stopper with coating and a 20 mm aluminium seal cap with a white flip-off button.
Pack of one vial.
200 mg concentrate for solution for infusion:
10 mL of concentrate in a 20 mL Type 1 clear glass vial with a grey chlorobutyl stopper with coating and a 20 mm aluminium seal cap with a blue flip-off button.
Pack of one vial.
Regeneron Ireland DAC., One Warrington Place, Dublin 2, D02 HH27, Ireland
EU/1/25/1917/001
EU/1/25/1917/002
| Drug | Countries | |
|---|---|---|
| LYNOZYFIC | Lithuania |
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