Bimzelx · 4.1 Therapeutic indications · 1

HOS-099493 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most frequently reported adverse reactions were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS respectively). Tabulated list of adverse reactions Adverse reactions from clinical studies and post-marketing reports (Table 1) are classified by MedDRA System Organ Class 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), not known (cannot be estimated from the available data). A total of 5862 patients have been treated with bimekizumab in blinded and open-label clinical studies in plaque psoriasis (PSO), psoriatic arthritis (PsA), axial spondyloarthritis (nr-axSpA and AS) and 6 hidradenitis suppurativa (HS) representing 11468.6 patient-years of exposure. Of these, over 4660 patients were exposed to bimekizumab for at least one year. Overall, the safety profile of bimekizumab is consistent across all indications. Table 1: List of adverse reactions System Organ Class Frequency Adverse reaction Infections and infestations Very common Upper respiratory tract infections Common Oral candidiasis, Tinea infections, Ear infections, Herpes simplex infections, Oropharyngeal candidiasis, Gastroenteritis, Folliculitis, Vulvovaginal mycotic infection (including vulvovaginal candidiasis) Uncommon Mucosal and cutaneous candidiasis (including oesophageal candidiasis), Conjunctivitis Blood and lymphatic system Uncommon

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HOS-099489 · has-contraindication-information · PDF-Seite 4

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-099488 · has-indication-information · PDF-Seite 2

Plaque psoriasis Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Bimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) 2 Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non- steroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. Hidradenitis suppurativa (HS) Bimzelx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy (see section 5.1).

HOS-099491 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. There is no direct evidence for the role of IL-17A or IL-17F in the expression of CYP450 enzymes. The formation of some CYP450 enzymes is suppressed by increased levels of cytokines during chronic inflammation. Thus, anti-inflammatory treatments, such as with the IL-17A and IL-17F inhibitor bimekizumab, may result in normalisation of CYP450 levels with accompanying lower exposure of CYP450-metabolised medicinal products. Therefore, a clinically relevant effect on CYP450 substrates with a narrow therapeutic index, in which the dose is individually adjusted (e.g. 5 warfarin) cannot be excluded. On initiation of bimekizumab therapy in patients being treated with these types of medicinal products, therapeutic monitoring should be considered. Population pharmacokinetic (PK) data analyses indicated that concomitant administration of conventional disease modifying antirheumatic drugs (cDMARDs) including methotrexate or prior exposure to biologics have no clinically relevant impact on the clearance of bimekizumab. Live vaccines should not be given concurrently with bimekizumab (see section 4.4).

HOS-099492 · has-pregnancy-information · PDF-Seite 6

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 is a limited amount of data on the use of bimekizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Bimzelx during pregnancy. Breast-feeding It is unknown whether bimekizumab is excreted in human milk. A risk to the newborn/infant cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Bimzelx therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility The effect of bimekizumab 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-099490 · 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 Bimekizumab may increase the risk of infections such as upper respiratory tract infections and oral candidiasis (see section 4.8). Caution should be exercised when considering the use of bimekizumab in patients with a chronic infection or a history of recurrent infection. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated (see section 4.3). Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms 4 suggestive of an infection occur. If a patient develops an infection, the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves. Pre-treatment evaluation for tuberculosis (TB) Prior to initiating treatment with bimekizumab, patients should be evaluated for TB infection. Bimekizumab should not be given in patients with active TB (see section 4.3). Patients receiving bimekizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating bimekizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Inflammatory bowel disease Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab (see section 4.8). Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated. Hypersensitivity Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated. Vaccinations Prior to initiating therapy with bimekizumab, completion of all age-appropriate immunisations according to current immunisation guidelines should be considered. Live vaccines should not be given in patients tre

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