Ilumetri · 4.6 Fertility, pregnancy and lactation · 1

HOS-098399 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most common adverse reactions are upper respiratory tract infections (12.6%), headache (4.0%), diarrhoea (1.6%), gastroenteritis (1.5%), back pain (1.5%), nausea (1.3%) and injection site pain (1.3%). Tabulated list of adverse reactions Adverse reactions from clinical studies (Table 1) are listed by MedDRA system organ class (SOC) and frequency, using the following convention: 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 (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 5 Table 1. List of adverse reactions MedDRA System organ Preferred term Frequency category class Infections and infestations Upper respiratory tract infectionsa Very common Nervous system disorders Headache Common Gastrointestinal disorders Gastroenteritis Common Diarrhoea Common Nausea Common General disorders and Back pain Common administration site conditions Injection site pain Common aIncluding nasopharyngitis. Long-term Safety The safety profile of tildrakizumab observed during the long-term extensions periods of reSURFACE 1 and reSURFACE 2 was consistent with that of the double-blind periods. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

HOS-098395 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important active infection, e.g. active tuberculosis (see section 4.4). 3

HOS-098394 · has-indication-information · PDF-Seite 2

Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. 2

HOS-098397 · has-interaction-information · PDF-Seite 4

Vaccines No data are available on the response to live or inactivated vaccines. Live vaccines should not be given concurrently with tildrakizumab (see section 4.4). Interactions with cytochrome P450 Concomitant medicinal products affecting tildrakizumab pharmacokinetics are not expected since it is cleared from the body by general protein catabolism processes with no contribution of cytochrome P450 (CYP450) enzymes, and it is not eliminated by renal or hepatic pathways. Furthermore, tildrakizumab does not impact the pharmacokinetics of concomitant medicinal products metabolised by CYP450 enzymes either through direct or indirect mechanisms (see section 5.2). 4 Interactions with other immunosuppressive agents or phototherapy The safety and efficacy of tildrakizumab in combination with other immunosupressive agents, including biologics, or phototherapy has not been evaluated.

HOS-098398 · has-pregnancy-information · PDF-Seite 5

Women of childbearing potential Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment. Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tildrakizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Ilumetri during pregnancy. Breast-feeding It is unknown whether tildrakizumab is excreted in human milk. Available toxicological data in cynomolgus monkey have shown negligible levels of Ilumetri in milk on postnatal day 28 (see section 5.3). In humans, during the first few days after birth antibodies may be transferred to the newborns through milk. In this short period, a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ilumetri therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility The effect of Ilumetri on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).

HOS-098396 · 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. Infections Tildrakizumab has the potential to increase the risk of infection (see section 4.8). Caution should be exercised when considering the use of tildrakizumab in patients with a chronic infection or a history of recurrent or recent serious infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of a clinically relevant chronic or acute infection occur. If a patient develops a serious infection, the patient should be closely monitored and tildrakizumab should not be administered until the infection resolves (see section 4.3). Pre-treatment evaluation for tuberculosis Prior to initiating treatment, patients should be evaluated for tuberculosis (TB) infection. Patients receiving tildrakizumab should be closely monitored for signs and symptoms of active TB during and after treatment. Anti-TB therapy should be considered prior to initiating treatment in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Hypersensitivity If a serious hypersensivity reaction occurs, administration of tildrakizumab should be discontinued immediately and appropriate therapy initiated (see section 4.3). Vaccinations Prior to initiating treatment with tildrakizumab, consider completion of all appropriate immunisations according to current immunisation guidelines. If a patient has received live viral or bacterial vaccination it is recommended to wait at least 4 weeks prior to starting treatment with tildrakizumab. Patients treated with tildrakizumab should not receive live vaccines during treatment and for at least 17 weeks after treatment (see section 4.5). Excipients This medicine contains 0.5 mg of polysorbate 80 (E 433) in each pre-filled syringe or pre-filled pen of 100 mg and 1 mg of polysorbate 80 (E 433) in each pre-filled syringe or pre-filled pen of 200 mg, which is equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions.