Active Ingredient: Mosunetuzumab
Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
1 - 60 mg
From 1 To 60 mg once every 7 day(s) for 168 day(s)
1 mg
30 mg
Mosunetuzumab should be administered to well-hydrated patients.
Table 1 provides details on recommended premedication for CRS and infusion related reactions.
Table 1. Premedication to be administered to patients prior to mosunetuzumab infusion:
| Patients requiring premedication | Premedication | Administration |
|---|---|---|
| Cycles 1 and 2: all patients Cycles 3 and beyond: patients who experienced any grade CRS with previous dose | Intravenous corticosteroids: dexamethasone 20 mg or methylprednisolone 80 mg | Complete at least 1 hour prior to mosunetuzumab infusion |
| Anti-histamine: 50-100 mg diphenhydramine hydrochloride or equivalent oral or intravenous anti-histamine | At least 30 minutes prior to mosunetuzumab infusion | |
| Anti-pyretic: 500-1000 mg paracetamol |
The recommended dose of mosunetuzumab for each 21 day-cycle is detailed in Table 2.
Table 2. Dose of mosunetuzumab for patients with relapsed or refractory follicular lymphoma:
| Day of treatment | Dose of mosunetuzumab | Rate of infusion | |
|---|---|---|---|
| Cycle 1 | Day 1 | 1 mg | Infusions of mosunetuzumab in Cycle 1 should be administered over a minimum of 4 hours. |
| Day 8 | 2 mg | ||
| Day 15 | 60 mg | ||
| Cycle 2 | Day 1 | 60 mg | If the infusions were well-tolerated in Cycle 1, subsequent infusions of mosunetuzumab may be administered over 2 hours. |
| Cycles 3 and beyond | Day 1 | 30 mg | |
Mosunetuzumab should be administered for 8 cycles, unless a patient experiences unacceptable toxicity or disease progression.
For patients who achieve a complete response, no further treatment beyond 8 cycles is required. For patients who achieve a partial response or have stable disease in response to treatment with mosunetuzumab after 8 cycles, an additional 9 cycles of treatment (17 cycles total) should be administered, unless a patient experiences unacceptable toxicity or disease progression.
If any dose in cycle 1 is delayed for >7 days, the previous tolerated dose should be repeated prior to resuming the planned treatment schedule.
If a dose interruption occurs between Cycles 1 and 2 that results in a treatment-free interval of ≥6 weeks, mosunetuzumab should be administered at 1 mg on Day 1, 2 mg on Day 8, then resume the planned Cycle 2 treatment of 60 mg on Day 15.
If a dose interruption occurs that results in a treatment-free interval of ≥6 weeks between any Cycles in Cycle 3 onwards, mosunetuzumab should be administered at 1 mg on Day 1, 2 mg on Day 8, then resume the planned treatment schedule of 30 mg on Day 15.
Patients who experience grade 3 or 4 reactions (e.g. serious infection, tumour flare, tumour lysis syndrome) should have treatment temporarily withheld until symptoms are resolved.
CRS should be identified based on clinical presentation. Patients should be evaluated and treated for, other causes of fever, hypoxia, and hypotension, such as infections/sepsis. Infusion related reactions (IRR) may be clinically indistinguishable from manifestations of CRS. If CRS or IRR is suspected, patients should be managed according to the recommendations.
Mosunetuzumab must be diluted using aseptic technique under the supervision of a healthcare professional. It should be administered as an intravenous infusion through a dedicated infusion line. Do not use an inline filter to administer mosunetuzumab. Drip chamber filters can be used to administer mosunetuzumab.
The first cycle of mosunetuzumab should be administered over a minimum of 4 hours as intravenous infusion. If the infusions are well-tolerated in cycle 1, the subsequent cycles may be administered over a 2-hours infusion.
Mosunetuzumab must not be administered as intravenous push or bolus.
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