Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Lunsumio 1 mg concentrate for solution for infusion.
Lunsumio 30 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Clear, colourless liquid, pH 5.8 and osmolality of 240-333 mOsm/kg. |
Lunsumio 1 mg concentrate for solution for infusion: Each vial contains 1 mg of mosunetuzumab in 1 mL at a concentration of 1 mg/mL.
Lunsumio 30 mg concentrate for solution for infusion: Each vial contains 30 mg of mosunetuzumab in 30 mL at a concentration of 1 mg/mL.
Mosunetuzumab is a full-length, humanized anti-CD20/CD3 immunoglobulin (Ig)G1 isotype that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mosunetuzumab |
Mosunetuzumab is an anti-CD20/CD3 T-cell engaging bispecific antibody targeting CD20-expressing B-cells. It is a conditional agonist; targeted B-cell killing is observed only upon simultaneous binding to CD20 on B-cells and CD3 on T-cells. Engagement of both arms of mosunetuzumab results in the formation of an immunologic synapse between a target B cell and a cytotoxic T cell leading to T-cell activation. Subsequent directed release of perforin and granzymes from T-cell activation through the immunologic synapsis induce B-cell lysis leading to cell death. |
| List of Excipients |
|---|
|
L-histidine |
1 mg concentrate for solution for infusion:
Type I glass-vial with a butyl rubber stopper and an aluminium seal with a plastic dark grey flip-off cap containing 1 mg of concentrate for solution for infusion.
Pack of one vial.
30 mg concentrate for solution for infusion:
Type I glass-vial with a butyl rubber stopper and an aluminium seal with a plastic light blue flip-off cap containing 30 mg of concentrate for solution for infusion.
Pack of one vial.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/22/1649/001
EU/1/22/1649/002
| Drug | Countries | |
|---|---|---|
| LUNSUMIO | Austria, Cyprus, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
