You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
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).
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
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.