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:
For:
Regimen A, for cycle 1 :
Intravenous, 1 milligrams mosunetuzumab, one dose, over the duration of 7 days. Afterwards, intravenous, 2 milligrams mosunetuzumab, one dose, over the duration of 7 days. Afterwards, intravenous, 60 milligrams mosunetuzumab, one dose, over the duration of 7 days.
Regimen A, for cycle 2 :
Intravenous, 60 milligrams mosunetuzumab, one dose, over the duration of 21 days.
Regimen A, from cycle 3 until cycle 8 :
Intravenous, 30 milligrams mosunetuzumab, once every 21 days.
Regimen B, for cycle 1 :
Intravenous, 1 milligrams mosunetuzumab, one dose, over the duration of 7 days. Afterwards, intravenous, 2 milligrams mosunetuzumab, one dose, over the duration of 7 days. Afterwards, intravenous, 60 milligrams mosunetuzumab, one dose, over the duration of 7 days.
Regimen B, for cycle 2 :
Intravenous, 60 milligrams mosunetuzumab, one dose, over the duration of 21 days.
Regimen B, from cycle 3 until cycle 8 :
Intravenous, 30 milligrams mosunetuzumab, once every 21 days.
Regimen B, from cycle 9 until cycle 17 and in the case that there is poor response to treatment :
Intravenous, 30 milligrams mosunetuzumab, once every 21 days.
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 (preferred) 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.
Table 3. Recommendations for restarting therapy with mosunetuzumab intravenous infusion 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. |
| Greater than 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. |
| Greater than 2 weeks to less than 6 weeks | Repeat 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule. | |
| Greater than or equal to 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 less than 6 weeks | Administer 60 mg (Cycle 2 Day 1), then resume the planned treatment schedule. |
| Greater than or equal to 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 less than 6 weeks | Administer 30 mg (Cycle 3 Day 1), then resume the planned treatment schedule. |
| Greater than or equal to 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 less than 6 weeks | Administer 30 mg, then resume the planned treatment schedule. |
| Greater than or equal to 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 Table 1 for all patients
Note that all references to Cycle and Day are to the nominal Cycle and Day.
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.
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.
For:
Regimen A, for cycle 1 :
Subcutaneous, 5 milligrams mosunetuzumab, one dose, over the duration of 7 days. Afterwards, subcutaneous, 45 milligrams mosunetuzumab, one dose, over the duration of 7 days. Afterwards, subcutaneous, 45 milligrams mosunetuzumab, one dose, over the duration of 7 days.
Regimen A, from cycle 2 until cycle 8 :
Subcutaneous, 45 milligrams mosunetuzumab, once every 21 days.
Regimen B, for cycle 1 :
Subcutaneous, 5 milligrams mosunetuzumab, one dose, over the duration of 7 days. Afterwards, subcutaneous, 45 milligrams mosunetuzumab, one dose, over the duration of 7 days. Afterwards, subcutaneous, 45 milligrams mosunetuzumab, one dose, over the duration of 7 days.
Regimen B, from cycle 2 until cycle 8 :
Subcutaneous, 45 milligrams mosunetuzumab, once every 21 days.
Regimen B, from cycle 9 until cycle 17 and in the case that there is poor response to treatment :
Subcutaneous, 45 milligrams mosunetuzumab, once every 21 days.
Mosunetuzumab subcutaneous injection should be administered to well-hydrated patients.
Table 1 provides details on recommended premedication for CRS.
Table 1. Premedication to be administered to patients prior to mosunetuzumab subcutaneous injection:
| Patients requiring premedication | Premedication |
| Cycles 1 all patients Cycles 2+: patients who experienced any grade CRS with the previous dose | Intravenous or oral corticosteroids: dexamethasone 20 mg (preferred) or methylprednisolone 80 mg |
| Anti-histaminea: 50-100 mg diphenhydramine hydrochloride or equivalent oral or intravenous anti-histamine | |
| Anti-pyretica: 500-1000 mg paracetamol |
a Anti-histamines and anti-pyretics are optional in cycle 1 and beyond
The recommended dose of mosunetuzumab subcutaneous injection for each 21 day-cycle is detailed in Table 2.
Table 2. Dose of mosunetuzumab subcutaneous injection for patients with relapsed or refractory follicular lymphoma:
| Day of treatment | Dose of mosunetuzumab | |
| Cycle 1 | Day 1 | 5 mg |
| Day 8 | 45 mg | |
| Day 15 | 45 mg | |
| Cycle 2 and beyond | Day 1 | 45 mg |
Mosunetuzumab subcutaneous injection 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 subcutaneous injection after 8 cycles, an additional 9 cycles of treatment (17 cycles total) should be administered, unless a patient experiences unacceptable toxicity or disease progression.
Table 3. Recommendations for restarting therapy with mosunetuzumab subcutaneous injection after dose delay:
| Last dose administered | Time since the last dose administered | Action for next dose(s) |
| 5 mg Cycle 1 Day 1 | 1 week to 2 weeks | Administer 45 mg (Cycle 1 Day 8)*, then resume the planned treatment schedule |
| >2 weeks | Repeat 5 mg (Cycle 1 Day 1)*, then administer 45 mg (Cycle 1 Day 8)* and resume the planned treatment schedule | |
| 45 mg Cycle 1 Day 8 | 1 week to less than 6 weeks | Administer 45 mg (Cycle 1 Day 15)*, then resume the planned treatment schedule |
| ≥6 weeks | Repeat 5 mg*, then administer 45 mg (Cycle 1 Day 15)* 7 days later and resume the planned treatment schedule | |
| 45 mg Cycle 1 Day 15 | 1 week to less than 6 weeks | Administer 45 mg (Cycle 2 Day 1), then resume the planned treatment schedule |
| ≥6 weeks | Repeat 5 mg (Cycle 2 Day 1)*, then administer 45 mg (Cycle 2 Day 8)* followed by 45 mg on Day 1 of subsequent cycles | |
| 45 mg Cycle 2 and beyond | 3 weeks to less than 6 weeks | Administer 45 mg, then resume the planned treatment schedule |
| ≥6 weeks | Repeat 5 mg* on Day 1 during the next cycle, then administer 45 mg* on Day 8, followed by 45 mg on Day 1 of subsequent cycles |
* Administer premedication as per Cycle 1
Note that all references to Cycle and Day are to the nominal Cycle and Day.
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.
The injection should be administered subcutaneously into the tissue of the abdomen or thigh, changing the site of injection with each dose and never into areas where the skin has tattoos, moles or scars or areas where the skin is red, bruised, tender, hard, or not intact.
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