PRESCRIBING INFORMATION (PI)

SKYRIZI^® (risankizumab) subcutaneous injection in 150 mg solution for pre-filled pen (PEN) and 150 mg pre-filled syringe (PFS)

Refer to Summary of Product Characteristics (SmPC) before prescribing.

PRESENTATIONS: Each PEN and PFS contains 150 mg risankizumab in 1 mL solution.

INDICATIONS: For treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and alone or in combination with methotrexate (MTX) for 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).

DOSAGE AND ADMINISTRATION: Intended for use under guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis or psoriatic arthritis. Posology: The recommended dose is 150 mg administered as a subcutaneous injection at week 0, week 4, and every 12 weeks thereafter. Consider discontinuation of treatment in patients showing no response after 16 weeks of treatment. Some plaque psoriasis patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Special Populations: Elderly: No dose adjustment required. There is limited information including limited safety information in subjects aged ≥65 years. Renal or hepatic impairment: No dose adjustment required. No specific studies were conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of Skyrizi. Paediatric Population: The safety and efficacy of Skyrizi in children and adolescents less than 18 years has not been established. No data are available. Overweight patients: No dose adjustment is required.

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. Infections: Skyrizi may increase the risk of infections. In patients with a chronic infection or history of recurrent infections, or known risk factors for infection, Skyrizi should be used with caution. Treatment with Skyrizi should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.  Patients treated with Skyrizi 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 Skyrizi should not be administered until the infection resolves. Tuberculosis: Prior to initiating treatment with Skyrizi, patients should be evaluated for tuberculosis (TB) infection. Patients receiving Skyrizi should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating Skyrizi in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Immunisations: Prior to initiating therapy with Skyrizi 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 Skyrizi. Patients treated with Skyrizi should not receive live vaccines during treatment and for at least 21 weeks after treatment. Hypersensitivity: If a serious hypersensitivity reaction, including anaphylaxis, occurs, administration of Skyrizi should be discontinued immediately and appropriate therapy initiated.  Excipients with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per 150mg dose, that is to say essentially 'sodium-free'.

INTERACTIONS: Skyrizi is not expected to undergo metabolism by hepatic enzymes or renal elimination. Interactions between Skyrizi and inhibitors, inducers, or substrates of medicinal product metabolising enzymes are not expected, and no dose adjustment is needed. Concomitant immunosuppressive therapy or phototherapy: The safety and efficacy of Skyrizi in combination with immunosuppressants, including biologics or phototherapy have not been evaluated.

FERTILITY, PREGNANCY AND LACTATION: Women of Childbearing potential: Women of childbearing potential should use an effective method of contraception during treatment and for at least 21 weeks after treatment. Pregnancy: No or limited data available. It is preferable to avoid the use of Skyrizi during pregnancy as a precautionary measure.  Lactation:  It is unknown whether Skyrizi is excreted in human milk. A decision should be made whether to discontinue/abstain from Skyrizi therapy, taking into account the benefit of breast-feeding to the child and the benefit of Skyrizi therapy to the woman. Fertility: The effect of Skyrizi on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

ABILITY TO DRIVE AND USE MACHINES: Skyrizi has no or negligible influence on the ability to drive and use machines.

UNDESIRABLE EFFECTS:

See SmPC for more details on adverse reactions.

Very common (≥1/10): Upper respiratory infections.

Common (≥1/100 to <1/10): Tinea infections, headache, pruritus, rash, eczema, fatigue and injection site reactions.

Uncommon (≥1/1000 to <1/100): Folliculitis, urticaria.

Serious: Serious infections

MARKETING AUTHORISATION NUMBERS/PRESENTATIONS/ NHS LIST PRICE: Great Britain (GB) PLGB 41042/0045, Northern Ireland (NI) EU/1/19/1361/002, Skyrizi 150 mg solution for injection in PEN; GB PLGB 41042/0046, NI EU/1/19/1361/003, Skyrizi 150 mg solution for injection in PFS: £3326.09

LEGAL CLASSIFICATION: POM

MA HOLDER: Further information available from AbbVie Ltd, Maidenhead, SL6 4UB

DATE OF REVISION: July 2024

DOCUMENT NAME: RISN-UK-00020-C/PI-Skyrizi-008

UK-RISN-240454. Date of preparation: August 2024.