LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML [SIN17001P]

Product Info

LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML

[SIN17001P]

2.1 THERAPEUTIC INDICATION(S)
Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.

2.2 DOSAGE AND ADMINISTRATION
General
Lunsumio must only be administered as an intravenous infusion under the supervision of a qualified healthcare professional with appropriate medical support to manage severe reactions such as cytokine release syndrome and neurologic toxicity. (see Section 2.4 Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Do not administer as an IV push or bolus.

Prophylaxis and premedication
Lunsumio should be administered to well-hydrated patients. Table 1 provides details on recommended premedication for cytokine release syndrome and infusion related reactions.

The recommended dose of Lunsumio for each 21-day cycle is detailed in Table 2.

Duration of Treatment
Lunsumio 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 Lunsumio after 8 cycles, an additional 9 cycles of treatment (17 cycles total) should be administered, unless a patient experiences unacceptable toxicity or disease progression.

Delayed or Missed Doses
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, administer Lunsumio 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, administer Lunsumio at 1 mg on Day 1, 2 mg on Day 8, then resume the planned treatment schedule of 30 mg on Day 15.

Dose Modifications

Cytokine Release Syndrome

Identify cytokine release syndrome (CRS) based on clinical presentation (see section 2.4 Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Evaluate for and treat 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, manage according to the recommendations in Table 3.

Neurologic Toxicity Including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

Management recommendations for neurologic toxicity, including ICANS, is summarized in Table 4. At the first sign of neurologic toxicity, including ICANS, withhold Lunsumio for grade 2 and above and consider neurology evaluation. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care.

Dose modifications for other clinically significant adverse reactions
Patients who experience grade 3 or 4 reactions should have treatment temporarily withheld until symptoms are resolved.

2.2.1 Special Dosage Instructions
Pediatric use
The safety and efficacy of Lunsumio in children below 18 years of age have not been established.

Geriatric use
No dose adjustment of Lunsumio is required in patients ≥ 65 years of age (see section 2.5.5 Use in Special Populations, Geriatric Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal Impairment
No dose adjustment is required in patients with mild or moderate renal impairment. A recommended dose has not been determined for patients with CrCl <30 mL/min (see sections 2.5.6 Renal Impairment and 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic Impairment
No dose adjustment of Lunsumio is required for patients with mild hepatic impairment [total bilirubin greater than upper limit of normal (ULN) and ≤ 1.5x ULN or aspartate transaminase greater than ULN]. (see 2.5.7 Hepatic Impairment and 3.2.5 Pharmacokinetics in special populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). A recommended dose has not been determined for Lunsumio in patients with moderate or severe hepatic impairment.

2.3 CONTRAINDICATIONS
Lunsumio is contraindicated in patients with a known hypersensitivity to mosunetuzumab or any of the excipients.