100 mg solution for injection in pre-filled penPRESCRIBING 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: some cases occurred several days after treatment and included urticaria and dyspnoea. 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. Other side effects: hypersensitivity, rash.
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 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: February 2019