Recommended LUNSUMIO™ dose and schedule (21-day treatment cycles)1 | |||
---|---|---|---|
Day of Treatment | Dose | Rate of Infusion | |
Cycle 1 | Day 1 | 1 mg | Administer over a minimum of 4 hours. |
Day 8 | 2 mg | ||
Day 15 | 60 mg | ||
Cycle 2 | Day 1 | 60 mg | Administer over 2 hours if infusions from Cycle 1 were well tolerated. |
Cycles 3+ | Day 1 | 30 mg |
Recommendations for restarting therapy with LUNSUMIO after dose delay | ||
---|---|---|
Last Dose Administered | Time Since the Last Dose Administered | Action for Next Dose(s) |
1 mg Cycle 1 Day 1 |
1 to 2 weeks | Administer 2 mg (Cycle 1 Day 8), then resume the planned treatment schedule. |
>2 weeks | Repeat 1 mg (Cycle 1 Day 1), then administer 2 mg (Cycle 1 Day 8) and resume the planned treatment schedule. | |
2 mg Cycle 1 Day 8 |
1 to 2 weeks | Administer 60 mg (Cycle 1 Day 15), then resume the planned treatment schedule. |
>2 weeks to <6 weeks | Repeat 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule. | |
≥6 weeks | Repeat 1 mg (Cycle 1 Day 1) and 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule. | |
60 mg Cycle 1 Day 15 |
1 week to <6 weeks | Administer 60 mg (Cycle 2 Day 1), then resume the planned treatment schedule. |
≥6 weeks | Repeat 1 mg (Cycle 2 Day 1) and 2 mg (Cycle 2 Day 8), then administer 60 mg (Cycle 2 Day 15), followed by 30 mg (Cycle 3 Day 1) and then resume the planned treatment schedule. | |
60 mg Cycle 2 Day 1 |
3 weeks to <6 weeks | Administer 30 mg (Cycle 3 Day 1), then resume the planned treatment schedule. |
≥6 weeks | Repeat 1 mg (Cycle 3 Day 1) and 2 mg (Cycle 3 Day 8), then administer 30 mg (Cycle 3 Day 15)*, followed by 30 mg (Cycle 4 Day 1) and then resume the planned treatment schedule. | |
30 mg Cycle 3 onwards |
3 weeks to <6 weeks | Administer 30 mg, then resume the planned treatment schedule. |
≥6 weeks | Repeat 1 mg on Day 1 and 2 mg on Day 8 during the next cycle, then administer 30 mg on Day 15*, followed by 30 mg on Day 1 of subsequent cycles. |
*For the Day 1, Day 8, and Day 15 doses in the next cycle, administer premedication as per the Recommended Premedications table for all patients.
LUNSUMIO can be administered outpatient
Hospitalization may be needed to manage select AEs, should be considered for subsequent infusions following a Grade 2 CRS event, and is recommended for subsequent infusions following a Grade 3 CRS event.
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AE=adverse event; CRS=cytokine release syndrome.
LUNSUMIO. Prescribing Information. Genentech, Inc.
LUNSUMIO. Prescribing Information. Genentech, Inc.
FDA grants Breakthrough Therapy Designation for Roche’s CD20xCD3 bispecific cancer immunotherapy lunsumioetuzumab 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 lunsumioetuzumab 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.
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