SKYRIZI

Skyrizi 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 Crohn’s disease The recommended dose is 600 mg administered by intravenous infusion at Week 0, Week 4, and Week 8, followed by 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter.

Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit by Week 24. 2 of the Skyrizi 600 mg concentrate for solution for infusion Summary of Product Characteristics. Ulcerative colitis The recommended induction dose is 1 200 mg administered by intravenous (IV) infusion at Week 0, Week 4, and Week 8.

Starting at Week 12 and every 8 weeks thereafter, the recommended maintenance dose is based on individual patient presentation: • A dose of 180 mg administered by subcutaneous injection is recommended for patients with adequate improvement in disease activity after induction • A dose of 360 mg administered by subcutaneous injection is recommended for patients with inadequate improvement in disease activity after induction Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit by Week 24.

2 of the Skyrizi 600 mg concentrate for solution for infusion Summary of Product Characteristics. 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 Skyrizi. 2). Paediatric population The safety and efficacy of Skyrizi for the treatment of Crohn’s disease in children and adolescents younger than 16 years of age have not yet been established.

The safety and efficacy of Skyrizi in children aged 0-17 years for the treatment of ulcerative colitis have not yet been established. 2 but no recommendation on posology can be made. 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 damaged. Patients may self-inject Skyrizi after training in subcutaneous injection technique with the pre-filled syringe.

Patients should be instructed to read section 7 ‘Instructions for use’ provided in the package leaflet before administration. One pre-filled syringe should be injected to administer the 180 mg maintenance dose. Two pre-filled syringes should be injected to administer the 360 mg maintenance dose.

The two injections should be administered at different anatomic locations.

2% in ulcerative colitis). 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); and very rare (< 1/10 000).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 5 events per 100 subject-years. The majority of cases were non-serious and mild to moderate in severity and did not lead to discontinuation of risankizumab.

4). Crohn’s disease The adverse drug reaction profile observed in patients with Crohn’s disease treated with risankizumab was consistent with the adverse drug reaction profile observed in patients across indications. No new adverse reactions were identified in risankizumab Crohn’s disease studies.

Infections The majority of infections were non-serious and mild to moderate in severity and did not lead to discontinuation of risankizumab. 7 events per 100 subject-years in placebo. 4). 0 events per 100 subject-years in subjects who received placebo after risankizumab induction.

4). Ulcerative colitis Overall, the safety profile observed in patients with ulcerative colitis treated with risankizumab was consistent with the safety profile observed in patients across indications. 2 events per 100 subject-years in placebo.

4). 6 events per 100 subject-years in subjects who received placebo after risankizumab induction. 4). Immunogenicity As with all therapeutic proteins, there is the potential for immunogenicity with risankizumab. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.

4% (2/58) and 0% (0/58) of evaluated subjects, respectively. 2% (2/91) for the 360 mg SC dose, of evaluated subjects, respectively. Antibodies to risankizumab including neutralizing […]

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.

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. 48 mg of polysorbate 20 in each 360 mg dose. Polysorbates may cause allergic reactions.

Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 180 mg dose and 360 mg dose, that is to say essentially ‘sodium-free’.

1. g. 4).