Prescribing information For Healthcare Professionals Only

Tremfya®

100 mg solution for injection in pre-filled syringe and pre-filled pen 

PRESCRIBING INFORMATION

ACTIVE INGREDIENT(S): guselkumab

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S): Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

DOSAGE & ADMINISTRATION: For use under guidance/supervision of physician experienced in diagnosis and treatment of plaque psoriasis. Subcutaneous injection. Avoid areas showing psoriasis. Adults: 100 mg at weeks 0 and 4, followed by maintenance dose every 8 weeks. Consider discontinuation if no response after 16 weeks of treatment. Children: No data available in children/adolescents <18 years. Elderly: No dose adjustment required, limited information in subjects aged ≥ 65 years. Renal & Hepatic impairment: Not studied.

CONTRAINDICATIONS: Serious hypersensitivity to active substance or excipients; clinically important, active infection.

SPECIAL WARNINGS & PRECAUTIONS: Infections: Potential to increase risk. If signs/symptoms of clinically important chronic/acute infection occur, monitor closely and discontinue Tremfya until resolved. Tuberculosis: Evaluate patients for TB pre-treatment; monitor for signs/symptoms of active TB during and after treatment. Consider anti-TB therapy prior to Tremfya if past history of latent/active TB and adequate treatment course not confirmed. Serious hypersensitivity reaction: If occurs, discontinue Tremfya immediately and initiate appropriate therapy. Immunisations: Consider completing all appropriate immunisations prior to Tremfya. Do not use live vaccines concurrently with Tremfya; no data available; before live vaccination, withhold Tremfya for at least 12 weeks and resume at least 2 weeks after vaccination.

SIDE EFFECTS: Very common: Upper respiratory infection. Common: Gastroenteritis, herpes simplex infections, tinea infections, headache, diarrhoea, urticaria, arthralgia, injection site erythema.

Refer to SmPC for other side effects.

PREGNANCY: Avoid use of Tremfya; no data. Women of childbearing potential should use effective contraception during and for at least 12 weeks after treatment.

LACTATION: Discontinue breast-feeding during treatment and up to 12 weeks after the last dose or discontinue Tremfya.

INTERACTIONS: No dose adjustment when co-administering with CYP450 substrates. Concomitant immunosuppressive therapy or phototherapy not evaluated.

Refer to SmPC for full details of interactions.

LEGAL CATEGORY: POM

PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS

Presentations Pack Sizes Marketing Authorisation Number(s) Basic NHS Costs
Pre-filled syringe X 1 EU/1/17/1234/001

£2250

Pre-filled pen X 1 EU/1/17/1234/002

£2250

MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK.

Prescribing information last revised: July 2018

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