PracticeUpdate Dermatology February 2019

NEW

First IL-23 inhibitor with 12-weekly dosing * and results that last † * First IL-23 inhibitor approved with 12 weekly dosing after initial doses at weeks 0 and 4 1 † Of 100mg responders at week 28, 94% and 78% maintained PASI 75 or 90 respectively out to week 52 1 NOW PBS LISTED

1 February 2019 for severe chronic plaque psoriasis 2

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

Please review Product Information before prescribing available from www.ebs.tga.gov.au or Sun Pharma by calling 1800 726 229 ILUMYA tildrakizumab (rch) 100 mg/1 mL solution for injection in pre-filled syringe. Indications: treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Contraindications: Hypersensitivity to the active substance or excipients. Clinically important active infections (e.g. active tuberculosis). Precautions: Infections: Chronic or a history of recurrent infections; monitor patients if a serious infection develops Active tuberculosis (TB); evaluate for TB prior to treatment. Consider anti-TB therapy in patients with history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor for TB during and after treatment. Hypersensitivity: Discontinue immediately if a serious reaction occurs and initiate appropriate therapy. Immunisations: Patients should not receive live vaccines during and for at least 17 weeks after treatment. Consider completion of immunisations prior to treatment initiation but if a live vaccine is received, wait at least 4 weeks prior to treatment initiation. Malignancy: Caution should be observed in patients with a history of malignancy or if this develops during therapy. Paediatric Use: not evaluated in under 18yr population. Interactions: Live vaccines. (See full PI). Pregnancy: (Category B1) Adverse effects: Common: diarrhoea, nausea, fatigue, injection site pain, nasopharyngitis, sinusitis, arthralgia, back pain and pain in extremity. Dosage and administration: subcutaneous injection (100mg) at weeks 0, 4 and every 12 weeks thereafter. See Consumer Medicines Information for instructions. Storage: store in refrigerator (2ºC-8ºC). Do not freeze. ILUMYA is stable for up to 30 days at 25ºC. Protect from light. Do not shake. Store in original container until ready for use. Date of preparation: August 2018 ▼ 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 https://www.tga.gov.au/reporting-problems References: 1. Approved Product Information 2. PBS. Schedule of Pharmaceutical Benefits - Effective 1 February 2019. Department of Health, Canberra. www.pbs.org.au. Sun Pharma ANZ Pty Ltd ABN 17 110 871 826, Macquarie Park NSW 2113. Ph: 1800 726 229. Fax: +61 2 8008 1639. Med Info and to report Adverse Events: adverse. events.aus@sunpharma.com or 1800 726 229. ILUMYA™ is a trade mark of Sun Pharma ANZ Pty Ltd. IL2019/02ELSpbs1. Date of preparation: February 2019.