Bimzelx

This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which it is indicated. Posology Plaque psoriasis The recommended dose for adult patients with plaque psoriasis is 320 mg (given as 2 subcutaneous injections of 160 mg or 1 subcutaneous injection of 320 mg) at week 0, 4, 8, 12, 16 and every 8 weeks thereafter.

Psoriatic arthritis The recommended dose for adult patients with active psoriatic arthritis is 160 mg (given as 1 subcutaneous injection of 160 mg) every 4 weeks. For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, the recommended dose is the same as for plaque psoriasis [320 mg (given as 2 subcutaneous injections of 160 mg or 1 subcutaneous injection of 320 mg) at week 0, 4, 8, 12, 16 and every 8 weeks thereafter].

After 16 weeks, regular assessment of efficacy is recommended and if a sufficient clinical response in joints cannot be maintained, a switch to 160 mg every 4 weeks can be considered. Axial spondyloarthritis (nr-axSpA and AS) The recommended dose for adult patients with axial spondyloarthritis is 160 mg (given as 1 subcutaneous injection of 160 mg) every 4 weeks.

Hidradenitis suppurativa The recommended dose for adult patients with hidradenitis suppurativa is 320 mg (given as 2 subcutaneous injections of 160 mg or 1 subcutaneous injection of 320 mg) every 2 weeks up to week 16 and every 4 weeks thereafter.

For above indications, consideration should be given to discontinuing treatment in patients who have shown no improvement by 16 weeks of treatment. 1). 2). Renal or hepatic impairment Bimekizumab has not been studied in these patient populations.

2). Paediatric population The safety and efficacy of bimekizumab in children and adolescents below the age of 18 years have not yet been established. No data are available. Method of administration This medicinal product is administered by subcutaneous injection.

A 320 mg dose can be given as 2 subcutaneous injections of 160 mg or 1 subcutaneous injection of 320 mg. Suitable areas for injection include thigh, abdomen and upper arm. Injection sites should be rotated and injections should not be given into psoriasis plaques or areas where the skin is tender, bruised, erythematous, or indurated.

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).

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 disorders Uncommon Neutropenia Nervous system disorders Common Headache Gastrointestinal disorders Uncommon Inflammatory bowel disease Skin and subcutaneous tissue disorders Common Rash, dermatitis and eczema, Acne General disorders and administration site conditions Common Injection site reactionsa, Fatigue a) Includes: injection site erythema, reaction, oedema, pain, swelling, haematoma.

5% of patients treated with placebo. 3% of patients treated with bimekizumab and 0% treated with placebo. The majority of infections consisted of non-serious mild to moderate upper respiratory tract infections such as nasopharyngitis.

2% respectively compared to 0% for placebo-treated patients). More than 98% of cases were non-serious, mild or moderate in severity, and did not require treatment discontinuation. 0% in patients ≥70 kg). 4 per 100 patient-years). 4). 3% respectively in axSpA compared to 0% with placebo.

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. 8). Caution should be exercised when considering the use of bimekizumab in patients with a chronic infection or a history of recurrent infection.

3). Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms 5 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. 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. 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 treated with bimekizumab.

1. g. 4).