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Prescribing Information (PI)

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

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

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

INDICATION: 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. Dosage: 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. Renal or hepatic impairment: No dose adjustment required. Paediatric Population: No data available.

CONTRAINDICATIONS: Hypersensitivity to any of the active substances or excipients. Clinically important active infections.

SPECIAL WARNINGS AND PRECAUTIONS: See SmPC for full details. 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 should be evaluated for tuberculosis infection prior to initiating treatment. 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. 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 Skyrizi. Patients treated with Skyrizi should not receive live vaccines during treatment and for at least 21 weeks after treatment. Skyrizi 150 mg solution for injection contains less than 1 mmol sodium (23 mg) per PEN or PFS.  INTERACTIONS: The safety and efficacy of Skyrizi in combination with immunosuppressants, including biologics or phototherapy have not been evaluated.

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 Skyrizi during pregnancy as a precautionary measure. Lactation:  It is not known whether Skyrizi is excreted in breast milk. Skyrizi may be used during breast-feeding if clinically needed. Fertility: The effect of Skyrizi on human fertility has not been evaluated.

ADVERSE REACTIONS: See SmPC for full details on adverse reactions. Very common adverse reactions (≥1/10): Upper respiratory infections. Common adverse reactions (≥1/100 to <1/10): Tinea infections, headache, pruritus, fatigue and injection site reactions.

LEGAL CLASSIFICATION: POM

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

FURTHER INFORMATION: available from AbbVie Ltd, Maidenhead, SL6 4UB

DATE OF REVISION: January 2022

PI-Skyrizi-004

Adverse events should be reported. Reporting forms and information can be found at
https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play
or Apple App Stores. Adverse events should also be reported to AbbVie on GBPV@abbvie.com

UK-RISN-220027. Date of preparation: February 2022.