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LUNSUMIO is a brand name for Mosunetuzumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology Prophylaxis and premedication Lunsumio 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 Lunsumio infusion Patients requiring premedication Premedication Administration Intravenous corticosteroids: dexamethasone 20 mg or methylprednisolone 80 mg Complete at least 1 hour prior to Lunsumio infusion Anti-histamine: 50-100 mg diphenhydramine hydrochloride or equivalent oral or intravenous anti-histamine Cycles 1 and 2: all patients Cycles 3 and beyond: patients who experienced any grade CRS with previous dose Anti-pyretic: 500-1000 mg paracetamol At least 30 minutes prior to Lunsumio infusion The recommended dose of Lunsumio for each 21 day-cycle is detailed in Table 2.
Table 2 Dose of Lunsumio for patients with relapsed or refractory follicular lymphoma Day of treatment Dose of Lunsumio Rate of infusion Day 1 1 mg Day 8 2 mg Cycle 1 Day 15 60 mg Infusions of Lunsumio in Cycle 1 should be administered over a minimum of 4 hours.
Cycle 2 Day 1 60 mg Cycles 3 and Day 1 30 mg If the infusions were well-tolerated in Cycle 1, subsequent infusions of Lunsumio may be administered beyond over 2 hours. 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 dose 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, Lunsumio 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, Lunsumio 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.
Summary of safety profile The adverse reactions (ARs) described in this section were identified from the pivotal clinical trial GO29781 in patients treated at the recommended dose (n=218). 5%). The median number of cycles of Lunsumio received was 8 (range 1 -17), 37% of patients received 8 cycles, and 15% received more than 8 cycles up to 17 cycles.
The most common adverse reactions (≥ 20%) observed were cytokine release syndrome, neutropenia, pyrexia, hypophosphatemia and headache. The most common serious adverse reactions (≥ 2%) observed included cytokine release syndrome (CRS) (21% by ASTCT grading system), pyrexia (5%), and pneumonia (3%).
1%) discontinued Lunsumio due to an adverse event. 9%]). Tabulated list of adverse reactions The adverse reactions are listed below by MedDRA system organ class (SOC) and categories of frequency. Frequency categories are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 5% of patients treated with Lunsumio. The one patient with the grade 4 event was a patient with FL in the leukemic phase who also experienced concurrent TLS.
CRS of any grade occurred in 15% of patients after the Cycle 1, Day 1 dose; 5% after the Cycle 1, Day 8 dose; 33% after the Cycle 1, Day 15 dose, 5% occurred in patients after the Cycle 2 and 1% in Cycles 3 and beyond. 1-391 hours), and Cycle 2 Day 1 was 46 hours (range: 12-82 hours).
CRS resolved in all patients, and the median duration of CRS events was 3 days (range 1-29 days). Of the 86 patients that experienced CRS, the most common signs and symptoms of CRS included pyrexia (98%), chills (36%), hypotension (35%), tachycardia (24%), hypoxia (22%) and headache (16%).
Traceability In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded. 8). Signs and symptoms included pyrexia, chills, hypotension, tachycardia, hypoxia, and headache.
Infusion related reactions may be clinically indistinguishable from manifestations of CRS. CRS events occurred predominantly in cycle 1 and were mainly associated with Day 1 and Day 15 dose administrations. Patients should be premedicated with corticosteroids, antipyretics and antihistamines at least through cycle 2.
Patients must receive adequate hydration prior to the administration of Lunsumio. Patients should be monitored for signs or symptoms of CRS. Patients should be counselled to seek immediate medical attention should signs or symptoms of CRS occur at any time.
Physicians should institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. 2). Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, has been reported in patients receiving Lunsumio. HLH is a life-threatening syndrome characterized by fever, hepatomegaly and cytopenias.
HLH should be considered when the presentation of CRS is atypical or prolonged. 2). For suspected HLH, Lunsumio must be interrupted and treatment for HLH initiated. 8). Febrile neutropenia was observed in patients after receiving Lunsumio infusion.
Lunsumio should not be administered in the presence of active infections. , chronic, active Epstein-Barr Virus), with underlying conditions that may predispose to infections or who have had significant prior immunosuppressive treatment.
Patients should be administered prophylactic antibacterial, antiviral and/or antifungal medicinal products, as appropriate. Patients should be monitored for signs and symptoms of infection, before and after Lunsumio administration, and treated appropriately.
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g. 4). 4). 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 in Table 3.
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Tocilizumab and/or corticosteroids were used to manage a CRS event in 16% of patients: 6% received tocilizumab alone, 6% received corticosteroids alone, and 4% received both tocilizumab and corticosteroids. Among the 10% of patients who received tocilizumab (with or without a corticosteroid), 86% received only one dose of tocilizumab, with no more than two doses of tocilizumab administered for a single CRS event.
In patients experiencing Grade 2 CRS, 48% of patients were treated with symptomatic management without corticosteroids or tocilizumab, 18% received tocilizumab alone, 21% received corticosteroids alone, and 12% received both corticosteroids and tocilizumab.
Patients with grade 3 or grade 4 CRS received tocilizumab, corticosteroids, vasopressors and/or oxygen supplementation. Three percent of patients experienced hypotension and/or hypoxia without fever following Lunsumio administration; 2% of patients received tocilizumab and/or corticosteroids in the absence of fever.
Hospitalizations due to CRS occurred in 21% of patients and the median duration of hospitalization was 5 days (range 0-30 days). Neutropenia Neutropenia of any grade occurred in 28% of patients, including 24% Grade 3-4 events. The median time to onset […]
In the event of febrile neutropenia, patients should be evaluated for infection and managed with antibiotics, fluids and other supportive care, according to local guidelines. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) ICANS have occurred in patients receiving Lunsumio, including serious and life threatening reactions.
The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Manifestations of ICANS reported in clinical trials included confusional state, lethargy, encephalopathy, depressed level of consciousness, and memory impairment.
The majority of cases occurred during Cycle 1. Patients should be monitored for signs and symptoms of ICANS following Lunsumio administration. Patients must be counselled to seek immediate medical attention should signs or symptoms occur at any time (see Patient card below).
7). At the first signs or symptoms of ICANS, manage according to the ICANS guidance provided in Table 4. Treatment with Lunsumio should be withheld or discontinued permanently as recommended. 8). Manifestations included new or worsening pleural effusions, localised pain and swelling at the sites of lymphoma lesions and tumour inflammation.
Consistent with the mechanism of action of Lunsumio, tumour flare is likely due to the influx of T-cells into tumour sites following Lunsumio administration. There are no specific risk factors for tumour flare that have been identified, however, there is a heightened risk of compromise and morbidity due to mass effect secondary to tumour flare in patients with bulky tumours located in close proximity to airways and/or a vital organ.
Patients treated with Lunsumio should be monitored and evaluated for tumour flare at critical anatomical sites. 8). Patients must have adequate hydration prior to the administration of Lunsumio. g allopurinol, rasburicase), as appropriate.
Patients should be monitored for signs or symptoms of TLS, especially patients with high tumour burden or rapidly proliferative tumours, and patients with reduced renal function. Patients should be monitored for blood chemistries and abnormalities should be managed promptly.
Immunisation Live and/or live-attenuated vaccines should not be given concurrently with Lunsumio. Studies have not been conducted in patients who recently received live vaccines. Patient card The prescriber must discuss the risks of Lunsumio therapy with the patient.
The patient should be provided with the patient card and instructed to carry it at all times. The patient card describes the common signs and symptoms of CRS and ICANS, including instructions on when a patient should seek medical attention.