• Leukemias, lymphomas, and other hematologic cancers

Lunsumio Generic Name & Formulations

General Description

Mosunetuzumab-axgb 1mg/mL; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Bispecific CD20-directed CD3 T-cell engager.

How Supplied

Single-dose vial (1mL, 30mL)—1 


Generic Availability


Mechanism of Action

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.

Lunsumio Indications


In adults with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.

Lunsumio Dosage and Administration


Premedicate with corticosteroid, antihistamine, and antipyretic before each dose in Cycle 1 and Cycle 2 for all patients, and those who experienced any grade CRS with the previous dose in Cycles 3+. Give by IV infusion over a minimum of 4hrs for Cycle 1; if infusions are well-tolerated, give over 2hrs for Cycle 2 and thereafter. Treat for 8 cycles unless unacceptable toxicity or disease progression occurs. If complete response is achieved after 8 cycles, no further treatment is required; if partial response or stable disease is achieved after 8 cycles, give an additional 9 cycles (17 cycles total) unless unacceptable toxicity or disease progression occurs. Cycle 1: Give 1mg on Day 1, 2mg on Day 8, and 60mg on Day 15; Cycle 2: Give 60mg on Day 1; Cycle 3 and thereafter: Give 30mg on Day 1. Recommendations for restarting therapy after dose delay, dose modifications for adverse reactions: see full labeling.


Not established.

Lunsumio Contraindications

Not Applicable

Lunsumio Boxed Warnings

Boxed Warning

Cytokine release syndrome (CRS).

Lunsumio Warnings/Precautions


Must be administered by a qualified healthcare professional. Have appropriate medical support available. Risk for CRS. Initiate Lunsumio therapy with step-up dosing schedule and premedicate to reduce the risk for CRS. Ensure adequate hydration and monitor after administration. Monitor for neurologic toxicity (including ICANS), infections prior to and during treatment. Evaluate immediately if CRS (may need hospitalization) or neurologic toxicity (including ICANS) occurs; manage according to guidelines, and provide supportive care; withhold or discontinue based on severity (see full labeling). Active infections: do not initiate. History of recurring or chronic infections (eg, chronic, active Epstein-Barr Virus), underlying conditions that may predispose to infections or those with significant prior immunosuppressive treatment: use cautiously; give antimicrobial prophylaxis as appropriate. Obtain CBCs during treatment. If cytopenias occur, consider prophylactic granulocyte colony-stimulating factor as needed. Bulky tumors or disease (in close proximity to airways or a vital organ): monitor closely during initial therapy. Monitor for signs/symptoms of compression or obstruction due to mass effect secondary to tumor flare; treat if occurs. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after the last dose).

Lunsumio Pharmacokinetics


Half-life: 16.1 days.

Lunsumio Interactions


May potentiate CYP450 substrates (particularly after the 1st dose on Cycle 1 Day 1 and up to 14 days after the 2nd dose on Cycle 2 Day 1, and during and after CRS). Monitor for toxicity or concentrations of these CYP450 substrates; adjust dose as needed. 

Lunsumio Adverse Reactions

Adverse Reactions

Cytokine release syndrome, fatigue, rash, pyrexia, headache, Grade 3/4 lab abnormalities (decreased lymphocyte count, decreased phosphate, increased glucose, decreased neutrophil count, increased uric acid, decreased WBC, decreased hemoglobin, decreased platelets); infections, cytopenias, renal insufficiency, tumor flare.

Lunsumio Clinical Trials

See Literature

Lunsumio Note

Not Applicable

Lunsumio Patient Counseling

See Literature