Elrexfio

HOS-100263 · has-adverse-reaction-information · PDF-Seite 11

Summary of the safety profile The most frequent adverse reactions are CRS (57.9%), anaemia (54.1%), neutropenia (45.9%), fatigue (44.8%), upper respiratory tract infection (43.2%), injection site reaction (38.3%), diarrhoea (42.1%), pneumonia (38.3%), thrombocytopenia (36.6%), lymphopenia (30.1%), decreased appetite (27.3%), 11 pyrexia (29.0%), rash (27.9%), arthralgia (26.8%), hypokalaemia (23.5%), nausea (21.9%), dry skin (21.9%) and dyspnoea (20.8%). Serious adverse reactions are pneumonia (31.7%), sepsis (15.8%), CRS (12.6%), anaemia (5.5%), upper respiratory tract infection (5.5%), urinary tract infection (3.8%), febrile neutropenia (3.3%), diarrhoea (2.7%), dyspnoea (2.7%) and pyrexia (2.2%). 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]). The median duration of treatment was 4.1 (range: 0.03 to 35.9) 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. Adverse reactions in multiple myeloma patients treated with ELREXFIO in MagnetisMM-3 at the recommended dose System organ class Adverse reaction Frequency N=183 (All grades) Any grade Grade 3 (%) or 4 (%) Infections and infestations Pneumoniaa Very common 38.3 25.7 Sepsisb Very common 18.6 13.1 Upper respiratory tract Very common 43.2 6.0 infection Urin

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HOS-100259 · has-contraindication-information · PDF-Seite 9

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100258 · has-indication-information · PDF-Seite 2

ELREXFIO is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

HOS-100261 · has-interaction-information · PDF-Seite 10

No interaction studies have been performed with ELREXFIO. 10 The initial release of cytokines associated with the start of ELREXFIO may suppress cytochrome P450 (CYP) enzymes. The highest risk of interaction is expected to occur during and up to 14 days after the step-up dosing as well as during and up to 14 days after CRS. During this time period, toxicity or medicinal product concentrations should be monitored in patients who are receiving concomitant sensitive CYP substrates with a narrow therapeutic index (e.g., cyclosporine, phenytoin, sirolimus, and warfarin). The dose of the concomitant medicinal product should be adjusted as needed.

HOS-100262 · has-pregnancy-information · PDF-Seite 11

Women of child-bearing potential/Contraception The pregnancy status of women of child-bearing potential should be verified prior to initiating treatment with ELREXFIO. Women of child-bearing potential should use effective contraception during treatment with ELREXFIO and for 6 months after the last dose. Pregnancy There are no human or animal data to assess the risk of elranatamab use during pregnancy. Human immunoglobulin (IgG) is known to cross the placenta after the first trimester of pregnancy. Based on the mechanism of action, elranatamab may cause foetal harm when administered to a pregnant woman and therefore ELREXFIO is not recommended for use during pregnancy. ELREXFIO is associated with hypogammaglobulinaemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with ELREXFIO should be considered. Breast-feeding It is not known whether elranatamab is excreted in human or animal milk, affects breastfed infants or affects milk production. Human IgGs are known to be excreted in breast milk. A risk to the breastfed child cannot be excluded and therefore breast-feeding is not recommended during treatment with ELREXFIO and for 6 months after the last dose. Fertility There are no data on the effect of elranatamab on human fertility. Effects of elranatamab on male and female fertility have not been evaluated in animal studies.

HOS-100260 · has-warning-information · PDF-Seite 9

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. Clinical signs and symptoms of CRS may include, but are not limited to, fever, hypoxia, chills, hypotension, tachycardia, headache, and elevated liver enzymes (see section 4.8). 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. Pre-treatment medicinal products should be administered prior to the first three doses to reduce risk of CRS (see section 4.2). 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. CRS should be managed according to the recommendations in section 4.2, and further management should be considered per local institutional guidelines. Supportive therapy for CRS (including but not limited to anti-pyretic agents, intravenous fluid support, vasopressors, IL-6 or IL-6 receptor inhibitors, supplemental oxygen, etc.) 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. Neurologic toxicities, including ICANS Serious or life-threatening neurologic toxicities, including ICANS, may occur following treatment with ELREXFIO (see section 4.8). Patients should be monitored for signs and symptoms (e.g., 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. 9 At the first sign of neurologic toxicity, including ICANS, ELREXFIO should be withheld and neurology evaluation should be considered. General management for neurologic toxicity (e.g., ICANS) is summarised in Table 3 (see section 4.2). Due to the potential for ICANS, patients should be advised not to drive or operate heavy or potential dangerous machinery during the step-up dosing schedule and for 48 hours after

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