ABBREVIATED PRESCRIBING INFORMATION:

SKYRIZI^® (risankizumab) 600 mg concentrate for solution for infusion; Skyrizi 360 mg solution for injection in cartridge; Skyrizi 180 mg solution for injection in cartridge.

Please refer to the Summary of Product Characteristics (SmPC) before prescribing. PRESENTATION: Each vial contains 600 mg risankizumab in 10 mL solution. Each cartridge contains 360 mg risankizumab in 2.4 mL solution or 180 mg of risankizumab in 1.2 mL solution. INDICATION: Crohn’s disease (CD): For the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. Ulcerative colitis (UC): For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

DOSAGE AND ADMINISTRATION: Intended for use under guidance and supervision of a physician experienced in diagnosis and treatment of conditions for which Skyrizi is indicated. Dosage: CD: 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. UC: Recommended induction dose is 1 200 mg administered by intravenous infusion at week 0, week 4, and week 8. Starting at week 12 and every 8 weeks thereafter, the recommended maintenance dose administered by subcutaneous injection is based on individual patient presentation: a dose of 180 mg for patients with adequate improvement in disease activity after induction; a dose of 360 mg for patients with inadequate improvement in disease activity after induction. CD and UC: Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit by week 24. Special Populations: Elderly: No dose adjustment required. Limited information aged in patients ≥65 years. Renal or hepatic impairment: No dose adjustment considered necessary. Paediatric Population: No data; safety and efficacy not yet established. Overweight patients: No dose adjustment required. Method of administration: Refer to SmPC. Skyrizi concentrate for solution for infusion: intravenous infusion only; 600 mg dose should be administered over at least one hour, and the 1 200 mg dose over at least two hours. Skyrizi 360 mg and 180mg solution for injection in cartridge: administer by subcutaneous injection in the thigh or abdomen; patients may self-inject after training in subcutaneous injection technique with the on-body injector.

CONTRAINDICATIONS: Hypersensitivity to any of the active substances or excipients. Clinically important active infections (e.g. active tuberculosis).

SPECIAL WARNINGS AND PRECAUTIONS: See SmPC for full details. 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 infections. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Instruct patients 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: Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment. Monitor 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: Completion of all appropriate immunisations should be considered prior to initiating therapy. 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. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment. Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of risankizumab. If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated. Excipients with known effect: Contains less than 1 mmol sodium (23 mg) per vial/cartridge, that is to say essentially ‘sodium free’. Contains polysorbate 20; polysorbates may cause allergic reactions (see SmPCs for quantity in each dose).

INTERACTIONS: The safety and efficacy of risankizumab in combination with immunosuppressants, including biologics, have not been evaluated.

FERTILITY, PREGNANCY AND LACTATION: Women of childbearing potential: An effective method of contraception during treatment and for at least 21 weeks after treatment should be used. Pregnancy: Limited data available. It is preferable to avoid the use of risankizumab during pregnancy as a precautionary measure. Breast-feeding: It is unknown whether risankizumab is excreted in breast milk. A decision should be made whether to discontinue/abstain from risankizumab therapy, taking into account the benefit of breast-feeding to the child and the benefit of risankizumab therapy to the woman. Fertility: The effect of risankizumab on human fertility has not been evaluated.

UNDESIRABLE EFFECTS: Very common (≥1/10): Upper respiratory infections. Common (≥1/100 to <1/10): Tinea infections, headache, pruritus, rash, eczema, fatigue, injection site reactions. Refer to Section 4.8 of the SmPC for details of other side effects, and for further information.

Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; website: www.hpra.ie.

LEGAL CLASSIFICATION: POM (S1A).

MARKETING AUTHORISATION HOLDER: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany.

MARKETING AUTHORISATION NUMBERS: Skyrizi 600 mg concentrate for solution for infusion: EU/1/19/1361/004; Skyrizi 360 mg solution for injection in cartridge: EU/1/19/1361/005; Skyrizi 180 mg solution for injection in cartridge: EU/1/19/1361/007.

Further information is available on request from: AbbVie Limited, 14 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.

DATE OF REVISION: June 2025 PI/1361/CDUC/005