Sotyktu · 4.3 Contraindications · 1

HOS-100027 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most commonly reported adverse reaction was upper respiratory infections (18.9% in plaque psoriasis studies and 15.1% in psoriatic arthritis studies). Overall, the safety profile observed in psoriatic arthritis patients treated with deucravacitinib was consistent with the safety profile observed in patients with plaque psoriasis. The longer-term safety profile of deucravacitinib was similar and consistent with previous experience. Tabulated list of adverse reactions Adverse reactions for deucravacitinib from clinical studies are listed (see Table 1) by MedDRA System Organ Class and are based on the following conventions: very common (≥ 1/10); 5 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 the available data). Table 1: List of adverse reactions System Organ Class Frequency Adverse reaction Infections and infestations Very common Upper respiratory infectionsa Common Herpes simplex infectionsb Uncommon Pneumonia Herpes zoster Bronchitis Gastrointestinal disorders Common Oral ulcersc Skin and subcutaneous tissue disorders Common Acneiform rashd Folliculitis Investigations Common Blood creatine phosphokinase increased a Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, pharyngitis, sinusitis, acute sinusitis, rhinitis, tonsillitis, peritonsillar abscess, laryngitis, tracheitis, pharyngotonsillitis, and rhinotracheitis. b Herpes simplex infections include oral herpes, herpes simplex, genital herpes, herpes ophthalmic, and herpes viral infection. c Oral ulcers include aphthous ulcer, mouth ulceration, tongue ulceration, and stomatitis. d Acneiform rash includes acne, dermatitis acneiform, rash, rosacea, pustule, rash pus

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HOS-100023 · 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 infections (e.g. active tuberculosis, see section 4.4).

HOS-100022 · has-indication-information · PDF-Seite 2

Plaque psoriasis SOTYKTU is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis SOTYKTU, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy (see section 5.1).

HOS-100025 · has-interaction-information · PDF-Seite 4

Clinical studies indicate that deucravacitinib does not have clinically relevant drug interactions upon coadministration with the following other medicinal products and therefore no dose adjustments are needed. 4 Effect of deucravacitinib on other medicinal products Deucravacitinib does not meaningfully impact plasma exposures of rosuvastatin (BCRP and OATP substrate), methotrexate (substrate of BCRP and renal transporters), mycophenolate mofetil (MMF) (CES1 and CES2 substrate), metformin (substrate of renal MATE2K-dependent and hepatic OCT1-dependent drug transport) or oral contraceptives (norethindrone acetate and ethinyl estradiol). Effect of other medicinal products on deucravacitinib Medicinal products that are inhibitors or inducers of CYP enzymes or transporters such as cyclosporine (dual P-gp/breast cancer resistance protein [BCRP] inhibitor), fluvoxamine (strong CYP 1A2 inhibitor), ritonavir (moderate CYP 1A2 inducer), diflunisal (UGT 1A9 inhibitor), pyrimethamine (OCT1 inhibitor), famotidine (H2 receptor antagonist) or rabeprazole (proton pump inhibitor) do not meaningfully affect plasma deucravacitinib exposures (see section 5.2).

HOS-100026 · has-pregnancy-information · PDF-Seite 5

Pregnancy There is a limited amount of data on the use of deucravacitinib in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of deucravacitinib during pregnancy. Breast-feeding Deucravacitinib and its metabolite (BMT-153261) are excreted in breast milk (see section 5.2). The estimated relative daily infant dose corresponds to 12% of the maternal dose. The effect of deucravacitinib on newborns/infants is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from deucravacitinib therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility The effect of deucravacitinib 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-100024 · has-warning-information · PDF-Seite 3

Infections Deucravacitinib may increase the risk of infections (see section 4.8). Treatment with deucravacitinib should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated (see section 4.3). Caution should be exercised when considering the use of deucravacitinib in patients with a chronic infection or a history of recurrent infection. Patients treated with deucravacitinib should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a clinically important infection or is not responding to standard therapy, the patient should be monitored carefully and deucravacitinib should not be given until the infection resolves. Pre-treatment evaluation for tuberculosis Prior to initiating treatment with deucravacitinib, patients should be evaluated for tuberculosis (TB) infection. Deucravacitinib should not be given to patients with active TB (see section 4.3). Treatment of latent TB should be initiated prior to administering deucravacitinib. Anti-TB therapy should be considered prior to initiation of deucravacitinib in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving deucravacitinib should be monitored for signs and symptoms of active TB. 3 Malignancies Malignancies, including lymphomas and non-melanoma skin cancer (NMSC), were observed in clinical studies with deucravacitinib. It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the adverse reactions of Janus Kinase (JAK) inhibition. In a large randomised active controlled study of a JAK inhibitor in rheumatoid arthritis (RA) patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma and NMSC, was observed with a JAK inhibitor compared to tumour necrosis factor (TNF) inhibitors. Limited clinical data are available to assess the potential relationship of exposure to deucravacitinib and the development of malignancies. Long-term safety evaluations are ongoing. The risks and benefits of deucravacitinib treatment should be considered prior to initiating patients. Major adverse cardiovascular events (MACE), deep venous thrombosis (DVT) and pulmonary embolism (PE) It is not known whether TYK2 inhibition may be associated

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