Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Lunsumio 5 mg solution for injection.
Lunsumio 45 mg solution for injection.
| Pharmaceutical Form |
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Solution for injection. Clear, colourless to slightly brownish-yellow, preservative free liquid and pH 5.8. Osmolality of the 5 mg mosunetuzumab is 260-360 mOsm/kg and osmolality of the 45 mg mosunetuzumab is 275-375 mOsm/kg. |
Lunsumio 5 mg solution for injection:
Each vial contains 5 mg of mosunetuzumab in 0.5 mL at a concentration of 10 mg/mL.
Lunsumio 45 mg solution for injection:
Each vial contains 45 mg of mosunetuzumab in 1 mL at a concentration of 45 mg/mL.
Mosunetuzumab is a full-length, humanised anti-CD20/CD3 immunoglobulin (Ig)G1 isotype that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipient with known effect:
Each 5 mg vial contains 0.3 mg of polysorbate 20.
Each 45 mg vial contains 0.6 mg of polysorbate 20.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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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 |
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L-histidine |
5 mg solution for injection:
Type I glass-vial with a fluororesin-laminated rubber stopper and an aluminium seal with a plastic brown flip-off cap containing 5 mg of solution for injection.
Pack of one vial.
45 mg solution for injection:
Type I glass-vial with a fluororesin-laminated rubber stopper and an aluminium seal with a plastic lavender flip-off cap containing 45 mg of solution for injection.
Pack of one vial.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/22/1649/003
EU/1/22/1649/004
Date of first authorisation: 3 June 2022
Date of latest renewal: 14 April 2025
| Drug | Countries | |
|---|---|---|
| LUNSUMIO | Austria, Cyprus, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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