Elrexfio

Treatment should be initiated and supervised by physicians experienced in the treatment of multiple myeloma. 4). Prior to initiating treatment, complete blood count should be performed. 6). 3 Posology Recommended dosing schedule The recommended doses are step-up doses of 12 mg on day 1 and 32 mg on day 4, followed by a full treatment dose of 76 mg weekly from week 2 to week 24 (see Table 1).

For patients who have received at least 24 weeks of treatment and have achieved a response, the dosing interval should transition to an every two-week schedule. For patients who have received at least 24 weeks of treatment at the every two week schedule and have maintained the response, the dose interval should transition to an every four week schedule.

ELREXFIO should be administered according to the step-up dosing schedule in Table 1 to reduce the incidence and severity of CRS and ICANS. 4). Table 1. ELREXFIO dosing schedule Dosing schedule Week/day Dose Step-up dosinga,b Week 1: day 1 Step-up dose 1 12 mg Week 1: day 4 Step-up dose 2 32 mg Weekly dosinga,c,d Week 2-24: day 1 Full treatment dose 76 mg once weekly Every 2 weeks dosingd,e Week 25-48: day 1 Full treatment dose 76 mg once every two weeks Every 4 weeks dosingd,f,g Week 49 onward: day 1 Full treatment dose 76 mg once every four weeks a.

Pre-treatment medicinal products should be administered prior to the first three doses of ELREXFIO. b. A minimum of 2 days should be maintained between step-up dose 1 (12 mg) and step-up dose 2 (32 mg). c. A minimum of 3 days should be maintained between step-up dose 2 (32 mg) and the first full treatment (76 mg) dose.

d. A minimum of 6 days should be maintained between doses. e. For patients who have achieved a response. f. For patients who have received at least 24 weeks of treatment at the every two week schedule. g. For patients who maintained the response.

Note:

See Table 5 for recommendations on restarting ELREXFIO after dose delays. 4). Dose modifications based on toxicity Dose reductions of ELREXFIO are not recommended. 4). See Tables 2 and 3 for recommended actions for adverse reactions of CRS and ICANS, respectively.

See Table 4 for recommended actions for other adverse reactions. 4). Patients should be evaluated and treated for other causes of fever, hypoxia, and hypotension. ) should be administered as appropriate. Laboratory testing to monitor for disseminated intravascular coagulation (DIC), haematology parameters, as well as pulmonary, cardiac, renal, and hepatic function should be considered.

8%). 2%). Tabulated list of adverse reactions Table 6 summarises adverse reactions reported in patients who received ELREXFIO at the recommended dosing regimen (N=183 including 64 patients with prior BCMA-directed antibody drug conjugate [ADC] or chimeric antigen receptor [CAR] T cell therapy [supportive Cohort B]).

9) months. The safety data of ELREXFIO was also evaluated in the all-treated population (N=265) with no additional adverse reactions identified. Adverse reactions are listed according to the MedDRA system organ classification and by 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 (frequency cannot be estimated from the available data).

Within each frequency grouping, where relevant, adverse reactions are presented in order of decreasing seriousness. Table 6. 1 13 Table 6. 8

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Cytokine release syndrome (CRS) CRS, including life-threatening or fatal reactions, may occur in patients receiving ELREXFIO.

8). Therapy should be initiated according to the step-up dosing schedule to reduce risk of CRS and patients should be monitored following administration of ELREXFIO accordingly. 2). Patients should be counselled to seek urgent medical attention should signs or symptoms of CRS occur.

At the first sign of CRS, ELREXFIO should be withheld and patients should be immediately evaluated for hospitalisation. 2, and further management should be considered per local institutional guidelines. ) should be administered as appropriate.

Laboratory testing to monitor for disseminated intravascular coagulation (DIC), haematology parameters, as well as pulmonary, cardiac, renal, and hepatic function should be considered. 8). , decrease level of consciousness, seizures and/or motor weakness) of neurologic toxicities during treatment.

Patients should be counselled to seek urgent medical attention should signs or symptoms of neurologic toxicity occur. 10 At the first sign of neurologic toxicity, including ICANS, ELREXFIO should be withheld and neurology evaluation should be considered.

2). 7). 8). New or reactivated viral infections occurred during therapy with ELREXFIO, including cytomegalovirus infection/reactivation. Progressive multifocal leukoencephalopathy (PML), which can be fatal, has also occurred during therapy with ELREXFIO.

Treatment should not be initiated in patients with active infections. Patients should be monitored for signs and symptoms of infection prior to and during treatment with ELREXFIO and treated appropriately. 2). , prevention of herpes zoster reactivation) should be administered according to local institutional guidelines.

1.