PracticeUpdate Conference Series World Congress of Dermatology 2019

92% of patients treated with ODOMZO ® experience tumour shrinkage * *92% of locally advanced basal cell carcinoma (BCC) (N=48/52) and metastatic BCC (N=11/12) patients experienced tumour shrinkage as assessed by central review 1

Not a real patient

A Hedgehog inhibitor indicated for adults with metastatic basal cell carcinoma (BCC) or locally advanced BCC who are not amenable to curative surgery or radiation therapy 1

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Please review Product Information before prescribing available from www.ebs.tga.gov.au ODOMZO sonidegib diphosphate 200mg hard capsule blister pack. Indications: locally advanced BCC not amenable to curative surgery or radiation therapy and metastatic BCC in adults. Contraindications: Pregnant or breast-feeding woman and women of child-bearing potential. Clinically significant precautions: Muscle related adverse events: Check CK levels prior to initiation and as clinically indicated thereafter. If clinically notable elevation, assess renal function. Closely monitor patients for muscle related symptoms when used in combination with certain medications (e.g. CYP3A inhibitors, chloroquine, hydroxychloroquine, fibric acid derivatives, penicillamine, zidovudine, niacin, HMG-CoA reductase inhibitors) and patients with neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) due to an increased risk of muscle toxicity. Effects on fertility: Male and female fertility may be compromised. Fertility preservation strategies should be discussed prior to initiation. Women of child-bearing potential: Verify pregnancy status within 7 days prior to initiation and monthly during treatment. Use two methods of contraception, including one highly effective method and a barrier method. Contraception must be continued for 20 months after ending treatment. Pregnancy (Category X): May cause embryo-foetal death or severe birth defects. Must not be administered to women who are, or planning to become, pregnant. Women should not become pregnant for at least 20 months following their last dose. Breast-feeding: women must not breast feed while taking Odomzo or for at least 20 months after ending treatment. Sexually active males: Men should not father a child or donate semen and for at least 6 months after ending treatment. A condom with spermicide (if available), regardless of the vasectomy status should be used during intercourse and for 6 months after ending treatment. Blood donation: Patients should not to donate blood while taking Odomzo and for at least 20 months after ending treatment. Advice to handler: Do not open capsules due to risk of teratogenicity. Clinically significant interactions: Strong CYP3A inhibitors e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole and nefazodone. Strong CYP3A inducers, e.g. carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin and St John’s Wort (Hypericum perforatum). Substrates of breast cancer resistance protein (BCRP) transporter. Medications known to increase the risk of muscle related toxicity. Adverse effects: Very common: muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhoea, weight decreased, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, pruritus, amenorrhea. Common: dehydration, dyspepsia, constipation, gastroesophageal reflux disorder, rash, abnormal hair growth, myopathy (muscular fatigue and muscular weakness). Laboratory abnormalities: Very common: hemoglobin decreased, lymphocyte count decreased, amylase increased, blood glucose increased, lipase increased, serum CK increase, serum creatinine increased, ALT increased, AST increased. Dosage and method of use: Adults: 200 mg swallowed whole once daily on an empty stomach, at least 1 hour before, or two hours after a meal. Temporary dose interruption and/or dose reduction may be required for CK elevations and muscle related adverse events or other adverse reactions. Date prepared: April 2018. References: 1. Approved Product Information, 19 April 2018. 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. ODO2019/05els1. Date of preparation: May 2019.