Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: ADC Therapeutics (NL) B.V., Laarderhoogtweg 25, Amsterdam, Noord-Holland, 1101 EB, Netherlands
Zynlonta 10 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white lyophilised powder, which has a cake-like appearance. |
Each vial of powder for concentrate for solution for infusion contains 10 mg of loncastuximab tesirine.
After reconstitution, each mL contains 5 mg of loncastuximab tesirine.
Loncastuximab tesirine is a CD19-directed antibody and alkylating agent conjugate, consisting of a humanised IgG1 kappa monoclonal antibody, produced in Chinese Hamster Ovary cells by recombinant DNA technology, and conjugated to SG3199, a pyrrolobenzodiazepine (PBD) dimer cytotoxic alkylating agent, through a protease-cleavable valine-alanine linker. SG3199 attached to the linker is designated as SG3249, also known as tesirine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Loncastuximab tesirine |
Loncastuximab tesirine is an antibody-drug conjugate (ADC) targeting CD19. Upon binding to CD19, loncastuximab tesirine is internalised followed by release of SG3199 via proteolytic cleavage. The released SG3199 binds to the DNA minor groove and forms highly cytotoxic DNA interstrand crosslinks, subsequently inducing cell death. |
| List of Excipients |
|---|
|
L-histidine |
Vial (clear Type 1 glass) closed with a stopper (teflon coated rubber), with an aluminium seal with plastic flip-off cap containing 10 mg loncastuximab tesirine. Pack size of one vial.
ADC Therapeutics (NL) B.V., Laarderhoogtweg 25, Amsterdam, Noord-Holland, 1101 EB, Netherlands
EU/1/22/1695/001
| Drug | Countries | |
|---|---|---|
| ZYNLONTA | Austria, Estonia, Croatia, Ireland, Italy, Lithuania, Romania, United Kingdom, United States |
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