Trodelvy

HOS-099299 · has-adverse-reaction-information · PDF-Seite 8

Summary of the safety profile Sacituzumab govitecan as monotherapy The most common adverse reactions reported in patients treated with sacituzumab govitecan were: neutropenia (67.3%), nausea (62.1%), diarrhoea (59.9%), fatigue (57.4%), alopecia (48.3%), anaemia (40.1%), constipation (36.7%), vomiting (31.3%), and decreased appetite (23.3%). The most common grade 3 or higher adverse reactions were neutropenia (48.6%), diarrhoea (10.0%), leukopenia (9.6%), anaemia (7.7%), fatigue (5.8%), febrile neutropenia (5.6%), and lymphopenia (3.1%). The most frequently reported serious adverse reactions in patients treated with sacituzumab govitecan were febrile neutropenia (4.5%), diarrhoea (3.7%), neutropenia (2.9%) and pneumonia (2.1%). Sacituzumab govitecan in combination with pembrolizumab Adverse reactions occurring in patients treated with sacituzumab govitecan in combination with pembrolizumab were generally similar to those observed with sacituzumab govitecan or pembrolizumab in breast cancer treatment. The most frequent adverse reactions in patients treated with sacituzumab govitecan in combination with pembrolizumab were diarrhoea (70.1%), nausea (67.9%), neutropenia (62.9%), fatigue (58.4%), alopecia (51.6%), constipation (40.7%), anaemia (36.7%) and vomiting (29.4%), and the most frequent grade 3 or higher adverse reactions were neutropenia (43.0%) and diarrhoea (10.0%). The combination of sacituzumab govitecan with pembrolizumab did not increase the frequency or severity of pembrolizumab-associated immune-mediated adverse reactions. When sacituzumab govitecan is administered in combination with pembrolizumab, refer to the SmPC for the respective combination therapy components prior to initiation of treatment. Adverse reactions known to occur with sacituzumab govitecan or combination therapy components given alone may 8 occur during treatment with these medicinal products in combination, even if these reactions were not reported in clinical studies with combination therapy. Tabulated list of adverse reactions The frequencies of adverse reactions are based on pooled data from four clinical studies involving 963 patients who received sacituzumab govitecan 10 mg/kg body weight for the treatment of metastatic TNBC and HR+/HER2- breast cancer. The median exposure to sacituzumab govitecan in this data set was 5.29 months. The safety of sacituzumab govitecan in combination with pembrolizumab has also

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HOS-099295 · has-contraindication-information · PDF-Seite 5

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

HOS-099294 · has-indication-information · PDF-Seite 2

Triple-Negative Breast Cancer Trodelvy is indicated: • in combination with pembrolizumab, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see sections 4.2 and 5.1). • as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1). • as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1) HR-Positive, HER2-Negative Breast Cancer Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting (see section 5.1). 2

HOS-099297 · has-interaction-information · PDF-Seite 7

No interaction studies have been performed. UGT1A1 inhibitors Concomitant administration of sacituzumab govitecan with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Sacituzumab govitecan should be used with caution in patients receiving UGT1A1 inhibitors (e.g. propofol, ketoconazole, EGFR tyrosine kinase inhibitors). UGT1A1 inducers Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Sacituzumab govitecan should be used with caution in patients receiving UGT1A1 inducers (e.g. carbamazepine, phenytoin, rifampicin, ritonavir, tipranavir). Based on the limited data available from patients who received UGT1A1 inhibitors (n=15) or inducers (n=7) while being treated with sacituzumab govitecan, free SN-38 exposures in these patients were comparable to those in patients who did not receive UGT1A1 inhibitor or inducer.

HOS-099298 · has-pregnancy-information · PDF-Seite 7

Women of childbearing potential/Contraception in males and females Women of childbearing potential have to use effective contraception during treatment and for 6 months after the last dose. Male patients with female partners of childbearing potential have to use effective contraception during treatment with sacituzumab govitecan and for 3 months after the last dose. Pregnancy There are no available data on the use of sacituzumab govitecan in pregnant women. However, based on its mechanism of action, sacituzumab govitecan can cause teratogenicity and/or embryo-foetal lethality when administered during pregnancy. Sacituzumab govitecan contains a genotoxic component, SN-38, and targets rapidly dividing cells. 7 Sacituzumab govitecan should not be used during pregnancy unless the clinical condition of the woman requires treatment with sacituzumab govitecan. The pregnancy status of women of childbearing potential should be verified prior to the initiation of sacituzumab govitecan. Women who become pregnant must immediately contact their doctor. Breast-feeding It is unknown whether sacituzumab govitecan or its metabolites are excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with sacituzumab govitecan and for 1 month after the last dose. Fertility Based on findings in animals, sacituzumab govitecan may impair fertility in females of reproductive potential (see section 5.3). No human data on the effect of sacituzumab govitecan on fertility are available.

HOS-099296 · has-warning-information · PDF-Seite 5

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. Neutropenia Sacituzumab govitecan can cause severe or life-threatening neutropenia (see section 4.8). Fatal infections in the setting of neutropenia have been observed in clinical studies with sacituzumab govitecan, primarily in the first two cycles of treatment. Primary prophylaxis with G-CSF should be considered starting in the first cycle of treatment in patients at increased risk of febrile neutropenia, e.g., older patients (in particular aged 65 years and older), patients with previous neutropenia, poor performance status, organ dysfunction (including renal, liver or cardiovascular dysfunction), or multiple comorbid conditions. Monitor ANC during treatment. Sacituzumab govitecan should not be administered if the ANC is below 1500/mm3 on Day 1 of any cycle or if the neutrophil count is below 1000/mm3 on Day 8 of any cycle. Sacituzumab govitecan should not be administered in case of neutropenic fever. Dose modifications may be required due to neutropenia or febrile neutropenia. Treat neutropenia with G-CSF and consider prophylaxis in subsequent cycles as clinically indicated (see sections 4.2 and 4.8). 5 Diarrhoea Sacituzumab govitecan can cause severe diarrhoea (see section 4.8). Diarrhoea in some cases was observed to have led to dehydration and subsequent acute kidney injury. Sacituzumab govitecan should not be administered in case of Grade 3-4 diarrhoea at the time of scheduled treatment and treatment should only be continued when resolved to ≤ Grade 1 (see section 4.2 and 4.8). At the onset of diarrhoea, and if no infectious cause can be identified, treatment with loperamide should be initiated. Additional supportive measures (e.g. fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment with sacituzumab govitecan (e.g. abdominal cramping, diarrhoea, salivation, etc.) can receive appropriate treatment (e.g. atropine) for subsequent treatments with sacituzumab govitecan. Hypersensitivity Sacituzumab govitecan can cause severe and life-threatening hypersensitivity (see section 4.8). Anaphylactic reactions have been observed in clinical studies with sacituzumab govitecan and the use of sacituzumab govitecan is contraindicated in p

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