PracticeUpdate Dermatology May 2019

NOW PBS LISTED 1

SUPERIOR SKIN CLEARANCE SHOULD STAND THE TEST OF TIME 2-4† IN MODERATE-TO-SEVERE PLAQUE PSORIASIS † More patients achieved PASI 90 at Week 16 (73.3% vs 49.7%; p<0.001) and Week 48 (76.3% vs 47.9%; p<0.001) vs adalimumab 2-4

PBS Information: Authority Required. Refer to PBS Schedule for full authority information.

Please review Product Information before prescribing (available from http://www.janssen.com.au/Tremfya_PI) TREMFYA ® (guselkumab) MINIMUM PRODUCT INFORMATION. INDICATIONS: TREMFYA is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. CONTRAINDICATIONS: Serious hypersensitivity to guselkumab or any of the excipients. PRECAUTIONS: Infections: TREMFYA may increase risk of infections. Tuberculosis (TB): Evaluate for TB prior to initiating treatment. Do not administer to patients with active TB. Treat latent TB before administration. Consider anti-TB therapy in patients with suspected TB. Monitor patients for TB during and after treatment. *Hypersensitivity reactions: Serious hypersensitivity reactions have been reported in the postmarketing setting. Some cases occurred several days after treatment with guselkumab, including cases with urticaria and dyspnea. Immunisations: Live vaccines should not be used concurrently in patients treated with TREMFYA. Before live viral or live bacterial vaccination, treatment with TREMFYA should be withheld for at least 12 weeks from last dose and not resumed for at least 2 weeks after vaccination. See full PI. Use in Pregnancy – Category B1. INTERACTIONS: Live vaccines. No other meaningful interactions have been identified. see full PI. ADVERSE EFFECTS: Injection site reactions; diarrhoea; upper respiratory infections; gastroenteritis; herpes simplex infections; tinea infections; arthralgia; headache. DOSAGE AND ADMINISTRATION: Subcutaneous injection. 100 mg at week 0, week 4 and every 8 weeks thereafter. PRESENTATION: Pre-filled 1mL glass syringe in a passive needle-guard delivery system. STORAGE CONDITIONS: Store in a refrigerator (2°C – 8°C). Do not freeze. Do not shake. Protect from light. Date of preparation: 11 February 2019. *Please note changes to Product Information This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

PASI: Psoriasis Area and Severity Index. References: 1. Australian Government Department of Health. Available at: pbs.gov.au. 2. TREMFYA (guselkumab) Approved Product Information, 8 November 2018. 3. Blauvelt A et al. J Am Acad Dermatol 2017;76:405–17. 4. Griffiths CEM et al. J Drugs Dermatol 2018;17:826–32. ©Janssen-Cilag Pty Ltd 2019. Trademarks and brand names are the property of Johnson & Johnson, its affiliates or third party owners. Janssen-Cilag Pty Ltd, ABN 47 000 129 975. 1-5 Khartoum Road, Macquarie Park NSW 2113. Phone: 1800 226 334. CP-60496. JANS2575/EMBC. Date of preparation: February 2019.