Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: 7. MARKETING AUTHORISATION HOLDER, Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
TECVAYLI 10 mg/mL solution for injection.
TECVAYLI 90 mg/mL solution for injection.
| Pharmaceutical Form |
|---|
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Solution for injection (injection). The solution is colourless to light yellow, with a pH of 5.2 and osmolarity of approximately 296 mOsm/L (10 mg/mL solution for injection), and approximately 357 mOsm/L (90 mg/mL solution for injection). |
TECVAYLI 10 mg/mL solution for injection: One 3 mL vial contains 30 mg of teclistamab (10 mg/mL).
TECVAYLI 90 mg/mL solution for injection: One 1.7 mL vial contains 153 mg of teclistamab (90 mg/mL).
Teclistamab is a humanised immunoglobulin G4-proline, alanine, alanine (IgG4-PAA) bispecific antibody directed against the B cell maturation antigen (BCMA) and CD3 receptors, produced in a mammalian cell line (Chinese hamster ovary [CHO]) using recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Teclistamab |
Teclistamab is a full-size, IgG4-PAA bispecific antibody that targets the CD3 receptor expressed on the surface of T cells 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. With its dual binding sites, teclistamab is able to draw CD3+ T cells in close proximity to BCMA+ cells, resulting in T cell activation and subsequent lysis and death of BCMA+ cells, which is mediated by secreted perforin and various granzymes stored in the secretory vesicles of cytotoxic T cells. |
| List of Excipients |
|---|
|
EDTA disodium salt dihydrate |
3 mL solution for injection in a Type 1 glass vial with an elastomeric closure, and aluminium seal with a flip-off button containing 30 mg of teclistamab (10 mg/mL). Pack size of 1 vial.
1.7 mL solution for injection in a Type 1 glass vial with an elastomeric closure, and aluminium seal with a flip-off button containing 153 mg of teclistamab (90 mg/mL). Pack size of 1 vial.
7. MARKETING AUTHORISATION HOLDER, Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/22/1675/001 (10 mg/ml)
EU/1/22/1675/002 (90 mg/ml)
| Drug | Countries | |
|---|---|---|
| TECVAYLI | Austria, Estonia, Finland, France, Croatia, Italy, Lithuania, United States |
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