Mosunetuzumab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 15, 2026🚩 Report this page

Mosunetuzumab

Other Monoclonal Antibodies and Antibody Drug Conjugates

Sold as Lunsumio · LUNSUMIO SC

GB MHRAEU EMACA Health Canada

Drug class: Other Monoclonal Antibodies and Antibody Drug Conjugates
Availability: See label
Routes: Intravenous, Subcutaneous
Markets covered: 3
Products on record: 8

L01FXOther Monoclonal Antibodies and Antibody Drug Conjugates

Overview

Mosunetuzumab is an active pharmaceutical ingredient in the Other Monoclonal Antibodies and Antibody Drug Conjugates group (L01FX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	4	May 15, 2026
EU European Union	EMA	1	February 16, 2026
CA Canada	Health Canada	3	May 15, 2026

GBUnited Kingdom· MHRA

4 products

Uses

GBOfficial regulatory label· revised May 15, 2026[1]

Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised February 16, 2026[2]

Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

How to take

CACanada· Health Canada

3 products

3 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (2)

Sources & citations

[1]MHRA (UK) · PLGB000310934 · revised May 15, 2026
[2]European Medicines Agency · EMEA/H/C/005680 · revised February 16, 2026
[3]Health Canada (DPD) · 02565226 · revised May 15, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

4). Posology Prophylaxis and premedication Lunsumio should be administered to well-hydrated patients. Table 1 provides details on recommended premedication for CRS and infusion related reactions. Table 1 Premedication to be administered to patients prior to Lunsumio infusion Patients requiring premedication Premedication Administration Intravenous corticosteroids: dexamethasone 20 mg or methylprednisolone 80 mg Complete at least 1 hour prior to Lunsumio infusion Anti-histamine: 50-100 mg diphenhydramine hydrochloride or equivalent oral or intravenous anti-histamine Cycles 1 and 2: all patients Cycles 3 and beyond: patients who experienced any grade CRS with previous dose Anti-pyretic: 500-1000 mg paracetamol At least 30 minutes prior to Lunsumio infusion The recommended dose of Lunsumio for each 21 day-cycle is detailed in Table 2.
Table 2 Dose of Lunsumio for patients with relapsed or refractory follicular lymphoma Day of treatment Dose of Lunsumio Rate of infusion Day 1 1 mg Day 8 2 mg Cycle 1 Day 15 60 mg Infusions of Lunsumio in Cycle 1 should be administered over a minimum of 4 hours.
Cycle 2 Day 1 60 mg Cycles 3 and Day 1 30 mg If the infusions were well-tolerated in Cycle 1, subsequent infusions of Lunsumio may be administered beyond over 2 hours. Duration of treatment Lunsumio should be administered for 8 cycles, unless a patient experiences unacceptable toxicity or disease progression.
For patients who achieve a complete response, no further treatment beyond 8 cycles is required. For patients who achieve a partial response or have stable disease in response to treatment with Lunsumio after 8 cycles, an additional 9 cycles of treatment (17 cycles total) should be administered, unless a patient experiences unacceptable toxicity or disease progression.
Delayed or missed dose If any dose in cycle 1 is delayed for > 7 days, the previous tolerated dose should be repeated prior to resuming the planned treatment schedule. If a dose interruption occurs between Cycles 1 and 2 that results in a treatment-free interval of ≥ 6 weeks, Lunsumio should be administered at 1 mg on Day 1, 2 mg on Day 8, then resume the planned Cycle 2 treatment of 60 mg on Day 15.
If a dose interruption occurs that results in a treatment-free interval of ≥ 6 weeks between any Cycles in Cycle 3 onwards, Lunsumio should be administered at 1 mg on Day 1, 2 mg on Day 8, then resume the planned treatment schedule of 30 mg on Day 15.
g. 4). 4). Patients should be evaluated and treated for, other causes of fever, hypoxia, and hypotension, such as infections/sepsis. Infusion related reactions (IRR) may be clinically indistinguishable from manifestations of CRS. If CRS or IRR is suspected, patients should be managed according to the recommendations in Table 3.
, CPAP, […]

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 15, 2026[1]

Summary of safety profile The adverse reactions (ARs) described in this section were identified from the pivotal clinical trial GO29781 in patients treated at the recommended dose (n=218). 5%). The median number of cycles of Lunsumio received was 8 (range 1 -17), 37% of patients received 8 cycles, and 15% received more than 8 cycles up to 17 cycles.
The most common adverse reactions (≥ 20%) observed were cytokine release syndrome, neutropenia, pyrexia, hypophosphatemia and headache. The most common serious adverse reactions (≥ 2%) observed included cytokine release syndrome (CRS) (21% by ASTCT grading system), pyrexia (5%), and pneumonia (3%).
1%) discontinued Lunsumio due to an adverse event. 9%]). Tabulated list of adverse reactions The adverse reactions are listed below by MedDRA system organ class (SOC) and categories of frequency. Frequency categories are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 5% of patients treated with Lunsumio. The one patient with the grade 4 event was a patient with FL in the leukemic phase who also experienced concurrent TLS.
CRS of any grade occurred in 15% of patients after the Cycle 1, Day 1 dose; 5% after the Cycle 1, Day 8 dose; 33% after the Cycle 1, Day 15 dose, 5% occurred in patients after the Cycle 2 and 1% in Cycles 3 and beyond. 1-391 hours), and Cycle 2 Day 1 was 46 hours (range: 12-82 hours).
CRS resolved in all patients, and the median duration of CRS events was 3 days (range 1-29 days). Of the 86 patients that experienced CRS, the most common signs and symptoms of CRS included pyrexia (98%), chills (36%), hypotension (35%), tachycardia (24%), hypoxia (22%) and headache (16%).
Tocilizumab and/or corticosteroids were used to manage a CRS event in 16% of patients: 6% received tocilizumab alone, 6% received corticosteroids alone, and 4% received both tocilizumab and corticosteroids. Among the 10% of patients who received tocilizumab (with or without a corticosteroid), 86% received only one dose of tocilizumab, with no more than two doses of tocilizumab administered for a single CRS event.
In patients experiencing Grade 2 CRS, 48% of patients were treated with symptomatic management without corticosteroids or tocilizumab, 18% received tocilizumab alone, 21% received corticosteroids alone, and 12% received both corticosteroids and tocilizumab.
Patients with grade 3 or grade 4 CRS received tocilizumab, corticosteroids, vasopressors and/or oxygen supplementation. Three percent of patients experienced hypotension and/or hypoxia without fever following Lunsumio administration; 2% of patients received tocilizumab and/or corticosteroids in the absence of fever.
Hospitalizations due to CRS occurred in 21% of patients and the median duration of hospitalization was 5 days (range 0-30 days). Neutropenia Neutropenia of any grade occurred in 28% of patients, including 24% Grade 3-4 events. The median time to onset […]

GBOfficial regulatory label· Warnings and precautions· revised May 15, 2026[1]

Traceability In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded. 8). Signs and symptoms included pyrexia, chills, hypotension, tachycardia, hypoxia, and headache.
Infusion related reactions may be clinically indistinguishable from manifestations of CRS. CRS events occurred predominantly in cycle 1 and were mainly associated with Day 1 and Day 15 dose administrations. Patients should be premedicated with corticosteroids, antipyretics and antihistamines at least through cycle 2.
Patients must receive adequate hydration prior to the administration of Lunsumio. Patients should be monitored for signs or symptoms of CRS. Patients should be counselled to seek immediate medical attention should signs or symptoms of CRS occur at any time.
Physicians should institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. 2). Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, has been reported in patients receiving Lunsumio. HLH is a life-threatening syndrome characterized by fever, hepatomegaly and cytopenias.
HLH should be considered when the presentation of CRS is atypical or prolonged. 2). For suspected HLH, Lunsumio must be interrupted and treatment for HLH initiated. 8). Febrile neutropenia was observed in patients after receiving Lunsumio infusion.
Lunsumio should not be administered in the presence of active infections. , chronic, active Epstein-Barr Virus), with underlying conditions that may predispose to infections or who have had significant prior immunosuppressive treatment.
Patients should be administered prophylactic antibacterial, antiviral and/or antifungal medicinal products, as appropriate. Patients should be monitored for signs and symptoms of infection, before and after Lunsumio administration, and treated appropriately.
In the event of febrile neutropenia, patients should be evaluated for infection and managed with antibiotics, fluids and other supportive care, according to local guidelines. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) ICANS have occurred in patients receiving Lunsumio, including serious and life threatening reactions.

This is not medical advice. Consult a qualified healthcare professional.

4). It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous fixed dose) is being administered to the patient, as prescribed. Lunsumio intravenous formulation is not intended for subcutaneous administration and should be administered via intravenous infusion only.
3 Posology Prophylaxis and premedication Lunsumio should be administered to well-hydrated patients. Table 1 provides details on recommended premedication for CRS and infusion related reactions. Table 1 Premedication to be administered to patients prior to Lunsumio infusion Patients requiring premedication Premedication Administration Cycles 1 and 2: all patients Cycles 3 and beyond: patients who experienced any grade CRS with previous dose Intravenous corticosteroids: dexamethasone 20 mg (preferred) or methylprednisolone 80 mg Complete at least 1 hour prior to Lunsumio infusion Anti-histamine: 50-100 mg diphenhydramine hydrochloride or equivalent oral or intravenous anti-histamine At least 30 minutes prior to Lunsumio infusion Anti-pyretic: 500-1000 mg paracetamol The recommended dose of Lunsumio for each 21 day-cycle is detailed in Table 2.
Day 8 2 mg Day 15 60 mg Cycle 2 Day 1 60 mg If the infusions were well-tolerated in Cycle 1, subsequent infusions of Lunsumio may be administered over 2 hours. Cycles 3 and beyond Day 1 30 mg Duration of treatment Lunsumio should be administered for 8 cycles, unless a patient experiences unacceptable toxicity or disease progression.
For patients who achieve a complete response, no further treatment beyond 8 cycles is required. For patients who achieve a partial response or have stable disease in response to treatment with Lunsumio after 8 cycles, an additional 9 cycles of treatment (17 cycles total) should be administered, unless a patient experiences unacceptable toxicity or disease progression.
Delayed or missed dose Table 3:
Recommendations for restarting therapy with Lunsumio intravenous infusion after dose delay Last dose administered Time since the last dose administered Action for next dose(s) 1 mg Cycle 1 Day 1 1 to 2 weeks Administer 2 mg (Cycle 1 Day 8), then resume the planned treatment schedule.
Greater than 2 weeks Repeat 1 mg (Cycle 1 Day 1), then administer 2 mg (Cycle 1 Day 8) and resume the planned treatment schedule. 4 Last dose administered Time since the last dose administered Action for next dose(s) 2 mg Cycle 1 Day 8 1 to 2 weeks Administer 60 mg (Cycle 1 Day 15), then resume the planned treatment schedule.
Greater than 2 weeks to less than 6 weeks Repeat 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule. Greater than or equal to 6 weeks Repeat 1 mg (Cycle 1 Day 1) and 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule.
60 mg Cycle 1 Day 15 1 week to less than 6 weeks Administer 60 mg (Cycle 2 Day 1), then resume the planned treatment schedule. Greater than or equal to 6 weeks Repeat 1 mg (Cycle 2 Day 1) and 2 mg (Cycle 2 Day 8), then administer 60 mg (Cycle 2 Day 15), followed by 30 mg (Cycle 3 Day 1) and then resume the planned treatment schedule.
60 mg Cycle 2 Day 1 3 weeks to less than 6 weeks Administer 30 mg (Cycle 3 Day 1), then resume the planned treatment schedule. Greater than or equal to 6 weeks Repeat 1 mg (Cycle 3 Day 1) and 2 mg (Cycle 3 Day 8), then administer 30 mg (Cycle 3 Day 15)*, followed by 30 mg (Cycle 4 Day 1) and then resume the planned treatment schedule.
30 mg Cycle 3 onwards 3 weeks to less than 6 weeks Administer 30 mg, then resume the planned treatment schedule. Greater than or equal to 6 weeks Repeat 1 mg on Day 1 and 2 mg on Day 8 during the next cycle, then administer 30 mg on Day 15*, followed by 30 mg on Day 1 of subsequent cycles.
*For the Day 1, Day 8, and Day 15 doses in the next cycle, administer premedication as per Table 1 for all patients Note that all references to Cycle and Day are to the nominal Cycle and Day. g. 4). 4). Patients should be evaluated and treated for, other causes of fever, hypoxia, and hypotension, such as infections/sepsis.
Infusion related reactions (IRR) may be clinically indistinguishable from manifestations of CRS. If CRS or IRR is suspected, patients should be managed according to the recommendations in Table 4. Table 4 CRS grading1 and management CRS grade CRS management2 Next scheduled infusion of Lunsumio Grade 1 Fever ≥ 38ºC If CRS occurs during infusion:  The infusion should be interrupted and symptoms treated  The infusion should be re-started at the same rate once the symptoms resolve The symptoms should be resolved for at least 72 hours prior to next infusion The patient should be monitored more frequently 5  If symptoms recur with re-administration, the current infusion should be discontinued If CRS occurs post-infusion:  The symptoms should be treated If CRS lasts > 48 hours after symptomatic management:  Dexamethasone3 and/or tocilizumab4,5 should be considered Grade 2 Fever ≥ 38ºC and/or hypotension not requiring vasopressors and/or hypoxia requiring low-flow […]