Teizeild

HOS-099765 · has-adverse-reaction-information · PDF-Seite 7

Summary of safety profile The most frequently reported adverse reactions were lymphopenia (75%), leukopenia (58%), neutropenia (37%), and rash (36%). The most frequent serious adverse reaction was cytokine release syndrome (0.9%). Other serious adverse reactions included alanine aminotransferase increased (0.2%), aspartate aminotransferase increased (0.2%), lymphopenia (0.2%), neutropenia (0.2%), and infection (0.2%). Tabulated list of adverse reactions The adverse reactions occurring in patients in the pooled safety analysis of clinical studies and post- marketing setting are shown in Table 1 per MedDRA System Organ Class presented by frequency categories: 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), not known: (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 1. Adverse reactions Frequency System organ class Very common Common Uncommon Not known Epstein-Barr Infections and infestations Infections1 virus reactivation Lymphopenia, Thrombocytopenia, Blood and lymphatic Leukopenia, Eosinophilia system disorders Neutropenia, Haemoglobin decreased Cytokine Immune system disorders release Hypersensitivity1 syndrome Nervous system disorders Headache Diarrhoea, Gastrointestinal disorders Vomiting, Nausea Abdominal pain Alanine aminotrans

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HOS-099761 · has-contraindication-information · PDF-Seite 4

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

HOS-099760 · has-indication-information · PDF-Seite 2

Teizeild is indicated to delay the onset of stage 3 type 1 diabetes (T1D) in adult and paediatric patients 8 years of age and older with stage 2 T1D.

HOS-099763 · has-interaction-information · PDF-Seite 6

No drug interaction studies have been performed. Teizeild should be administered with caution in patients with concomitant medicinal products that are associated with significant liver abnormalities, cytopenias and other immune modulators. Cytokine release syndrome accompanied by a slight and transient increase in IL-6 concentrations may occur with Teizeild. Teizeild is not expected to have any relevant cytochrome P450 mediated drug-drug interactions. Teizeild may interfere with the immune response to vaccination (see section 4.4).

HOS-099764 · has-pregnancy-information · PDF-Seite 6

Women of childbearing potential Women of childbearing potential have to use effective contraception during treatment with teplizumab and for 30 days after the last dose of treatment. Teizeild is not recommended in women of childbearing potential not using contraception. Pregnancy There are no available data from the use of teplizumab in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Teizeild is not recommended during pregnancy. Breast-feeding It is unknown whether teplizumab is excreted in human milk. Toxicological data in animals suggest excretion of teplizumab in milk of lactating mice (see section 5.3). A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Teizeild and for 30 days after the last dose of treatment. Fertility There are no clinical data available for teplizumab on the effects on fertility. Fertility and reproductive performance were unaffected in female and male mice treated with a surrogate anti-mouse CD3 antibody (see section 5.3).

HOS-099762 · has-warning-information · PDF-Seite 4

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. Cytokine release syndrome Cytokine release syndrome (CRS) has been observed in clinical studies in patients treated with teplizumab during the treatment period and through 28 days after the last administration (see section 4.8). CRS symptoms included fever, nausea, fatigue, headache, myalgia, arthralgia, increased ALT, increased AST, and increased total bilirubin. These symptoms typically occurred during the first 5 days of treatment (see section 4.8). To mitigate CRS: • antipyretics, antihistamines and/or antiemetics should be administered prior to treatment (see section 4.2). • liver enzymes and bilirubin should be monitored during treatment, more frequently within the first week. Treatment should be discontinued in patients who develop elevated ALT or AST more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN. • Symptoms of CRS should be treated with antipyretics, antihistamines and/or antiemetics. If severe CRS develops, temporarily pausing dosing for 1-2 days should be considered (and the remaining doses to complete the full 14-day course should be administered on consecutive days). If CRS does not improve or if CRS recurs despite the pause, discontinuing treatment may be warranted. Serious infections Bacterial and viral infections have occurred in patients treated with Teizeild, including gastroenteritis, cellulitis, pneumonia, abscess, sepsis (see section 4.8). Use of Teizeild is not recommended in patients with active serious infection or chronic infection other than localised skin infections. Patients should 4 be monitored for signs and symptoms of infection during and after treatment. If serious infection develops, appropriate treatment should be provided and Teizeild should be discontinued. Lymphopenia In clinical studies, 75% of patients treated with Teizeild developed lymphopenia. For most patients who experienced lymphopenia, lymphocyte levels began to recover after the fifth day of treatment and returned to pre-treatment values within two weeks after treatment completion and without dose interruption (see section 4.8). White blood cell counts should be monitored during the treatment period. If prolonged severe lymphopen

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