Mosunetuzumab is a prescription medicine indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. It is available as injection for intravenous and subcutaneous use. MedsAcross supplies Mosunetuzumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
LUNSUMIO VELO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Source: US FDA prescribing information
Mosunetuzumab-axgb is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and some healthy B-lineage cells. In vitro, mosunetuzumab-axgb activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells.
Source: US FDA prescribing information
LUNSUMIO VELO and LUNSUMIO have different dosage and route of administration instructions. Administer LUNSUMIO VELO only as a subcutaneous injection. Premedicate to reduce risk of CRS. Recommended dosage for LUNSUMIO VELO for subcutaneous injection: Day of Treatment Cycle length = 21 days Subcutaneous Dose of LUNSUMIO VELO Cycle 1 Day 1 5 mg Day 8 45 mg Day 15 45 mg Cycles 2+ Day 1 45 mg See Full Prescribing Information for instructions on preparation and administration.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (cytokine release syndrome): Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO VELO. Initiate treatment with the LUNSUMIO VELO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO VELO until CRS resolves or permanently discontinue based on severity. Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome: Can cause serious and life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Monitor patients for signs and symptoms of neurologic toxicity during treatment, withhold or permanently discontinue based on severity. Infections: Can cause serious or fatal infections. Monitor patients for signs and symptoms of infection, including opportunistic infections, and treat as needed.
Source: US FDA prescribing information
The following adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome Infections Hemophagocytic Lymphohistiocytosis Cytopenias Tumor Flare The most common adverse reactions (≥ 20%) are injection site reactions, fatigue, rash, CRS, COVID-19 infection, musculoskeletal pain, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥ 15%) are decreased lymphocyte count, decreased neutrophil count, and increased uric acid.
Source: US FDA prescribing information
Effect of LUNSUMIO VELO on CYP450 Substrates LUNSUMIO VELO causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP450 substrates. Increased exposure of CYP450 substrates is more likely to occur after the first dose of LUNSUMIO VELO on Cycle 1 Day 1 and up to 14 days after the 45 mg dose on Cycle 1 Day 8 and during and after CRS. Monitor for toxicity or concentrations of drugs that are CYP450 substrates where minimal concentration changes may lead to serious adverse reactions. Consult the concomitant CYP450 substrate drug prescribing information for recommended dosage modification.
Source: US FDA prescribing information
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Mosunetuzumab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Lunsumio 1 mg/1 mL injectionIntravenous Cold chain | Genentech | US FDA | Available on request |
| Lunsumio 30 mg/30 mL injectionIntravenous Cold chain | Genentech | US FDA | Available on request |
| Lunsumio Velo 45 mg/1 mL injectionSubcutaneous Cold chain | Genentech | US FDA | Available on request |
| Lunsumio Velo 5 mg/0.5 mL injectionSubcutaneous Cold chain | Genentech | US FDA | Available on request |
2 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 4 presentations of Mosunetuzumab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Mosunetuzumab, including Lunsumio, Lunsumio Velo.
Yes. The US FDA first approved Mosunetuzumab on 22 December 2022, according to Drugs@FDA.
Yes. Mosunetuzumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Mosunetuzumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Mosunetuzumab is classified under ATC code L01FX25 (Mosunetuzumab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.