Prescription medicine
Mosunetuzumab Brand names: Lunsumio
Mosunetuzumab (Lunsumio) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the mosunetuzumab FDA label on DailyMed (effective June 29, 2026); every mosunetuzumab label on DailyMed.
Highlights of the record
FDA label of June 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 [see Dosage and Administration (2.1 and 2.4) and Warnings and Precautions (5.1) ]. WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning. 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.
Used for
From the label: indications and usageLUNSUMIO 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.
Forms and strengths
- 1 mg/ml
- 5 mg/.5ml
- 30 mg/30ml
- 45 mg/ml
Concentrate; injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 916 through July 30, 2026
What is mosunetuzumab used for?
From the label: indications and usageLUNSUMIO 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). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO VELO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. […]
Conditions named in the indications of mosunetuzumab's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Lunsumio Velo), Genentech, Inc., effective June 29, 2026 (SPL set 6a2b6dc2-48bd-4da7-a611-bc6bae2893c8), via openFDA; the full label on DailyMed
What does the patient leaflet for mosunetuzumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about LUNSUMIO VELO?LUNSUMIO VELO can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO VELO, and can also be severe or life-threatening. Get medical help right away if you develop any signs or symptoms of CRS at any time, including: fever of 100.4°F (38°C) or higher chills low blood pressure fast or irregular heartbeat tiredness or weakness difficulty breathing headache confusion feeling anxious dizziness or light-headedness nausea vomiting Due to the risk of CRS, you will receive LUNSUMIO VELO on a "step-up dosing schedule". The step-up dosing schedule is when you receive smaller "step-up" doses before receiving higher doses of LUNSUMIO VELO during your first cycle of treatment. If your dose of LUNSUMIO VELO is delayed for any reason, you may need to repeat the "step-up dosing schedule." You may receive medicines to help reduce your risk of CRS before your dose. See " How will I receive LUNSUMIO VELO? " for more information about how you will receive LUNSUMIO VELO. Your healthcare provider will check you for CRS during treatment with LUNSUMIO VELO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with LUNSUMIO VELO if you have severe side effects. See " What are the possible side effects of LUNSUMIO VELO? " for more information about side effects.
From the patient leaflet: What should I avoid while receiving LUNSUMIO VELO?Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems. See " What is the most important information I should know about LUNSUMIO VELO? " and " What are the possible side effects of LUNSUMIO VELO? " for more information about signs and symptoms of CRS and neurologic problems.
Source: FDA drug label (Lunsumio Velo), Genentech, Inc., effective June 29, 2026 (SPL set 6a2b6dc2-48bd-4da7-a611-bc6bae2893c8), via openFDA; the full label on DailyMed
Is there a generic for mosunetuzumab (Lunsumio)?
No generic mosunetuzumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for mosunetuzumab?
The FDA Adverse Event Reporting System holds 916 reports that list mosunetuzumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 140 are coded as a death and 415 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as mosunetuzumab?
36 other medicines are given the same way (intravenous) and in the same FDA class as mosunetuzumab or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Mosunetuzumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other