Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, withhold LUNSUMIO® [IV] or LUNSUMIO VELO™ until CRS resolves, and manage according to the recommendations in these tables and per current practice guidelines. Administer supportive therapy for CRS, which may include intensive care for severe or life-threatening CRS.
*Based on ASTCT 2019 grading for CRS.
†If CRS is refractory to management, consider other causes including hemophagocytic lymphohistiocytosis.
‡Premedication may mask fever; therefore, if clinical presentation is consistent with CRS, follow these management guidelines.
§Refer to Restarting LUNSUMIO VELO or LUNSUMIO [IV] after dose delays.
‖Refer to Recommended Premedications for additional information on premedication.
¶Low-flow oxygen defined as oxygen delivered at <6 L/minute; high-flow oxygen defined as oxygen delivered at ≥6 L/minute.
| Recommendations for management of neurologic toxicity (including ICANS) for LUNSUMIO [IV] or LUNSUMIO VELO | ||
|---|---|---|
| Adverse reaction | Severity#** | Actions |
| Neurologic Toxicity# (including ICANS**) | Grade 1 |
|
| Grade 2 |
|
|
| Grade 3 |
|
|
| Grade 4 |
|
|
Recommended dosage modifications for LUNSUMIO [IV] or LUNSUMIO VELO due to other adverse reactions
For infections#
For neutropenia#
For other adverse reactions#
#Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
**Based on ASTCT 2019 grading for ICANS.
††See recommendations on Restarting Treatment After Dose Delays.
Learn about a fixed-duration dosing schedule of treatment
Interested in learning more about LUNSUMIO [IV] or LUNSUMIO VELO?
ASTCT=American Society for Transplantation and Cellular Therapy; AR=adverse reaction; BiPAP=bilevel positive airway pressure; CPAP=continuous positive airway pressure; CRS=cytokine release syndrome; CTCAE=Common Terminology Criteria for Adverse Events; ICANS=immune effector cell-associated neurotoxicity syndrome; IV=intravenous; NCI=National Cancer Institute.
LUNSUMIO VELO. Prescribing Information. Genentech, Inc.
LUNSUMIO VELO. Prescribing Information. Genentech, Inc.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-cell Lymphomas V.1.2026. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed December 22, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-cell Lymphomas V.1.2026. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed December 22, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.
Rivas-Delgado A, Magnano L, Moreno-Velazquez M, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2019;184(5):753-759. doi:10.1111/bjh.15708.
Rivas-Delgado A, Magnano L, Moreno-Velazquez M, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2019;184(5):753-759. doi:10.1111/bjh.15708.
LUNSUMIO. Prescribing Information. Genentech, Inc.
LUNSUMIO. Prescribing Information. Genentech, Inc.
Sun LL, Ellerman D, Mathieu M, et al. Anti-CD20/CD3 T cell-dependent bispecific antibody for the treatment of B cell malignancies. Sci Transl Med. 2015;7(287):287ra70. doi:10.1126/scitranslmed.aaa4802.
Sun LL, Ellerman D, Mathieu M, et al. Anti-CD20/CD3 T cell-dependent bispecific antibody for the treatment of B cell malignancies. Sci Transl Med. 2015;7(287):287ra70. doi:10.1126/scitranslmed.aaa4802.
Ferl GZ, Reyes A, Sun LL, et al. A preclinical population pharmacokinetic model for anti-CD20/CD3 T-cell-dependent bispecific antibodies. Clin Transl Sci. 2018;11(3):296-304. doi:10.1111/cts.12535.
Ferl GZ, Reyes A, Sun LL, et al. A preclinical population pharmacokinetic model for anti-CD20/CD3 T-cell-dependent bispecific antibodies. Clin Transl Sci. 2018;11(3):296-304. doi:10.1111/cts.12535.
Budde LE, Sehn LH, Matasar M, et al. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. 2022;23(8):1055-1065. doi:10.1016/S1470-2045(22)00335-7.
Budde LE, Sehn LH, Matasar M, et al. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. 2022;23(8):1055-1065. doi:10.1016/S1470-2045(22)00335-7.
BLA Multi-disciplinary Review and Evaluation {BLA 761263, Lunsumio (Mosunetuzumab)}. US Food and Drug Administration. January 2020. Accessed March 14, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761263Orig1s000MultidisciplineR.pdf.
BLA Multi-disciplinary Review and Evaluation {BLA 761263, Lunsumio (Mosunetuzumab)}. US Food and Drug Administration. January 2020. Accessed March 14, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761263Orig1s000MultidisciplineR.pdf.
Shadman M, Bartlett NL, Matasar M, et al. Mosunetuzumab continues to demonstrate clinically meaningful outcomes in patients with relapsed and/or refractory follicular lymphoma after ≥2 prior therapies including those with a history of POD24: 4-year follow-up of a pivotal Phase II study. Presented at: The 66th American Society of Hematology Annual Meeting. December 7-10, 2024. P4407.
Shadman M, Bartlett NL, Matasar M, et al. Mosunetuzumab continues to demonstrate clinically meaningful outcomes in patients with relapsed and/or refractory follicular lymphoma after ≥2 prior therapies including those with a history of POD24: 4-year follow-up of a pivotal Phase II study. Presented at: The 66th American Society of Hematology Annual Meeting. December 7-10, 2024. P4407.
Bartlett NL, Sehn LH, Assouline S, et al. Presented at: The 66th American Society of Hematology Annual Meeting. December 7-10, 2024. P1645.
Bartlett NL, Sehn LH, Assouline S, et al. Presented at: The 66th American Society of Hematology Annual Meeting. December 7-10, 2024. P1645.
Data on file. Genentech, Inc.
Data on file. Genentech, Inc.
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