The following premedications are recommended before LUNSUMIO infusion begins to reduce the risk of cytokine release syndrome (CRS) and infusion-related reactions.
Premedication to be administered to patients prior to LUNSUMIO infusion1 | ||||
---|---|---|---|---|
Treatment cycle | Patients requiring premedication | Premedication | Dosage | Administration |
Cycle 1 and Cycle 2 | All patients | Corticosteroid | Dexamethasone 20 mg IV or methylprednisolone 80 mg IV | Complete at least 1 hour prior to infusion |
Antihistamine | Diphenhydramine hydrochloride 50-100 mg or equivalent oral or IV antihistamine | At least 30 minutes prior to infusion | ||
Antipyretic | Oral acetaminophen (500-1000 mg) | At least 30 minutes prior to infusion | ||
Cycles 3+ | Patients who experienced any grade CRS with previous dose | Corticosteroid | Dexamethasone 20 mg IV or methylprednisolone 80 mg IV | Complete at least 1 hour prior to infusion |
Antihistamine | Diphenhydramine hydrochloride 50-100 mg or equivalent oral or IV antihistamine | At least 30 minutes prior to infusion | ||
Antipyretic | Oral acetaminophen (500-1000 mg) | At least 30 minutes prior to infusion |
Patients who experience CRS or other events that impair consciousness should be evaluated and advised not to drive and refrain from operating heavy or potentially dangerous machinery until events resolve. Patients who experience other clinically significant Grade 3 or 4 reactions should have treatment temporarily withheld until symptoms are resolved.1
Please see Dose Modifications for recommendations for grading and management of CRS.
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CRS=cytokine release syndrome; IRR=infusion-related reaction.
LUNSUMIO. Prescribing Information. Genentech, Inc.
LUNSUMIO. Prescribing Information. Genentech, Inc.
FDA grants Breakthrough Therapy Designation for Roche’s CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma. News release. July 14, 2020. Accessed December 17, 2021.
https://www.roche.com/investors/updates/inv-update-2020-07-14b.htm.
FDA grants Breakthrough Therapy Designation for Roche’s CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma. News release. July 14, 2020. Accessed December 17, 2021.
https://www.roche.com/investors/updates/inv-update-2020-07-14b.htm.
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. Published online July 5, 2022. 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. Published online July 5, 2022. doi:10.1016/S1470-2045(22)00335-7.
Data on file. Genentech, Inc; 2022.
Data on file. Genentech, Inc; 2022.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed May 12, 2023. 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.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed May 12, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
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.
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