Imdylltra · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-100924 · has-adverse-reaction-information · PDF-Seite 13

Summary of the safety profile The safety of IMDYLLTRA was evaluated in 473 patients with small cell lung cancer (SCLC) who received the tarlatamab target dose of 10 mg as monotherapy in clinical trials. The most common adverse reactions are: CRS (56.7%), decreased appetite (36.4%), pyrexia (31.9%), dysgeusia (31.3%), constipation (30.4%), anaemia (30.0%), fatigue (29.8%), nausea (24.9%), asthenia (19.0%), neutropenia (16.9%), hyponatraemia (16.7%), headache (16.3%), lymphopenia (15.6%). The most common serious adverse reactions are CRS (19.7%) and pyrexia (4.7%). Tabulated list of adverse reactions Adverse reactions reported in clinical trials are listed by system organ class and by frequency. The frequencies of adverse reactions is based on pooled data from one phase 1, one phase 2, and one phase 3 clinical trials with 473 patients. The median duration of exposure was 18.0 weeks (range: 0.1 to 175.1 weeks). 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, adverse reactions are presented in order of decreasing seriousness. Table 8. Adverse reactions MedDRA system Adverse reaction All grades Grade ≥ 3 organ class Blood and lymphatic Anaemia Very common Common system disorders Neutropeniaa, c Very common Common Lymphopeniab Very common Very common Thrombocytopenia Common Uncommon Leukopenia Common Uncommon Gastrointestinal Constipation Very common Uncommon disorders Nausea Very common Uncommon Vomiting Very common Uncommon Diarrhoea Very common Uncommon 13 MedDRA system Adverse reaction All grades Grade ≥ 3 organ class General

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HOS-100920 · has-contraindication-information · PDF-Seite 10

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

HOS-100919 · has-indication-information · PDF-Seite 2

IMDYLLTRA is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.

HOS-100922 · has-interaction-information · PDF-Seite 12

No interaction studies have been performed. Initiation of tarlatamab treatment causes transient release of cytokines that may suppress CYP450 enzymes and may result in increased exposures of concomitant CYP substrates. Patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, should be monitored for known adverse events. The dose of the concomitant medicinal product should be adjusted as needed.

HOS-100923 · has-pregnancy-information · PDF-Seite 12

Women of child bearing potential/contraception Women of child bearing potential have to use effective contraception during and for 2 months after treatment with tarlatamab. Pregnancy There are no available data from the use of tarlatamab in pregnant women. A reproductive toxicity study conducted in mice using the murine surrogate molecule muS757 showed transplacental transport of muS757 (see section 5.3). Based on its mechanism of action and potential development of adverse reactions (like CRS) following tarlatamab exposure, tarlatamab may cause foetal harm when administered to a pregnant woman (see section 5.1). Tarlatamab is not recommended during pregnancy and in women of child bearing potential not using contraception. Pregnancy status for females of child-bearing potential should be verified prior to starting treatment with tarlatamab. Breast-feeding It is unknown whether tarlatamab is secreted in human milk. Because many medicinal products, including antibodies, can be secreted in human milk, a risk to the newborns/infants cannot be 12 excluded. Breast-feeding should be discontinued during treatment with tarlatamab and for at least 2 months after the last dose. Fertility There are no clinical trials to evaluate the effect of tarlatamab on fertility.

HOS-100921 · has-warning-information · PDF-Seite 10

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 10 Cytokine release syndrome (CRS) Administration of tarlatamab has been associated with CRS, including life-threatening or fatal events, see section 4.8. CRS may be associated with symptoms including pyrexia, hypotension, hypoxia, fatigue, tachycardia, headache, chills, nausea, and vomiting. Patients and caregivers should be advised of the potential for CRS onset after discharge and instructed to seek immediate medical attention if any signs or symptoms occur. Tarlatamab should be administered in a healthcare facility equipped to monitor and manage CRS. It should be ensured that patients are euvolemic prior to initiating the infusions. Patients should be closely monitored for signs and symptoms of CRS during the initiation of tarlatamab treatment. To mitigate the risk of CRS, it is important to initiate tarlatamab at the recommended starting dose in table 1. CRS should be managed according to the recommendations in table 4. Immune effector cell-associated neurotoxicity syndrome (ICANS) Administration of tarlatamab has been associated with ICANS, including life-threatening or fatal events, see section 4.8. ICANS can occur up to several weeks following administration of tarlatamab. Adverse reactions that may be associated with ICANS include headache, encephalopathy, confusion, delirium, seizure, ataxia, neurotoxicity, and tremor. Patients should be closely monitored for signs and symptoms of ICANS during tarlatamab treatment. Patients and caregivers should be advised of the potential for ICANS onset after discharge and instructed to seek immediate medical attention if any signs or symptoms occur. ICANS should be managed according to the recommendations in table 5. Neutropenia Administration of tarlatamab has been associated with neutropenia, see section 4.8. Patients should be closely monitored for signs and symptoms of neutropenia during tarlatamab treatment. Neutropenia should be managed according to the recommendations in table 6. Infections Serious infections, including life-threatening and fatal infections, have been reported in patients treated with tarlatamab. The most frequent infections include pneumonia, urinary tract infection, COVID-19, upper respiratory tract infection, respiratory tract infection, candida infec

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