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LUNSUMIO (mosunetuzumab-axgb) is 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Important Safety Information
BOXED WARNING: Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity.
Warnings and Precautions
- Neurologic Toxicity: Can cause serious 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
- Cytopenias: Monitor complete blood cell counts during treatment
- Tumor Flare: Can cause serious tumor flare reactions. Monitor patients at risk for complications of tumor flare
- Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception
Most Common Adverse Reactions
The most common adverse reactions (≥20%) are CRS, fatigue, rash, pyrexia, and headache.
The most common Grade 3 to 4 laboratory abnormalities (≥10%) are decreased lymphocyte count, decreased phosphate, increased glucose, decreased neutrophil count, increased uric acid, decreased white blood cell count, decreased hemoglobin, and decreased platelets.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
Please see the LUNSUMIO full Prescribing Information for additional Important Safety Information, including BOXED WARNING.