Skyrizi

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 Skyrizi is indicated. Posology The recommended dose is 150 mg administered as a subcutaneous injection at week 0, week 4, and every 12 weeks thereafter (either as two 75 mg pre-filled syringe injections or one 150 mg pre-filled pen or pre-filled syringe injection).

Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Some plaque psoriasis patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.

Missed dose If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time. 2). There is limited information in subjects aged ≥ 65 years. Renal or hepatic impairment No specific studies were conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of risankizumab.

2). Paediatric population The safety and efficacy of risankizumab in children and adolescents aged 5 to less than 18 years have not been established. No data are available. There is no relevant use of risankizumab in children aged below 6 years for the indication of moderate to severe plaque psoriasis or in children aged below 5 years for the indication of psoriatic arthritis.

2). Method of administration Skyrizi is administered by subcutaneous injection. The injection should be administered in the thigh or abdomen. Patients should not inject into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.

Patients may self-inject Skyrizi after training in subcutaneous injection technique. Patients should be instructed to read the ‘Instructions for use’ provided in the package leaflet before administration. Administration of Skyrizi in the upper, outer arm may only be performed by a healthcare professional or caregiver.

Skyrizi 75 mg solution for injection in pre-filled syringe Two pre-filled syringes should be injected for the full 150 mg dose. The two injections should be administered at different anatomic locations.

0% in psoriasis). Tabulated list of adverse reactions Adverse reactions for risankizumab from clinical studies (Table 1) are listed by MedDRA system organ class and are based on 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 the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 0 events per 100 subject-years from the psoriatic arthritis clinical studies, including long-term exposure to risankizumab. The majority of cases were non-serious and mild to moderate in severity and did not lead to discontinuation of risankizumab.

4). Immunogenicity For subjects treated with risankizumab at the recommended clinical dose for up to 52 weeks in psoriasis clinical trials, treatment-emergent anti-drug antibodies and neutralising antibodies were detected in 24% (263/1 079) and 14% (150/1 079) of evaluated subjects, respectively.

For subjects exposed to long term treatment of risankizumab in the extension study, the immunogenicity profile observed up to 204 weeks of treatment was consistent compared to the first 52 weeks of treatment. For most subjects with psoriasis, antibodies to risankizumab including neutralising antibodies were not associated with changes in clinical response or safety.

Among the few subjects (approximately 1%; 7/1 000 at week 16 and 6/598 at week 52) with high antibody titres (>128), clinical response appeared to be reduced. 3%). The injection site reactions were all mild to moderate in severity, none were serious, and none led to discontinuation of risankizumab.

1% (79/652) and 0% (0/652) of evaluated subjects, respectively. Antibodies to risankizumab were not associated with changes in clinical response or safety for psoriatic arthritis. Psoriatic arthritis Overall, the safety profile observed in patients with psoriatic arthritis treated with risankizumab was consistent with the safety profile observed in patients with plaque psoriasis.

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 Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution.

Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.

If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves. Tuberculosis Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection.

Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

5 Immunisations Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab.

2). 8). If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated. 2 mg of polysorbate 20 in each 150 mg dose. Polysorbates may cause allergic reactions.

1. g. 4).