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For Healthcare Professionals Only

TREMFYA® 100 mg solution for injection 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 NUMBERS & BASIC NHS COSTS:

PRESENTATIONS PACK SIZE MARKETING AUTHORISATION NUMBERS BASIC NHS COST
Pre-filled syringe X 1 EU/1/17/1234/001 £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: November 2017.

Adverse events should be reported. ▼ This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com.