PracticeUpdate: Oncology - Winter 2018

BREAK THE CYCLE With the first PBS listed CDK4/6 inhibitor - from 1 st July 1,2

As initial endocrine treatment for HR+/HER2– locally advanced (inoperable) or metastatic breast cancer, in combination with letrozole or anastrozole for men and postmenopausal women. 1,2

NOW PBS LISTED!

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

PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING. APPROVED PRODUCT INFORMATION IS AVAILABLE ONLINE AT WWW.NOVARTIS.COM.AU/PRODUCTS/HEALTHCARE- PROFESSIONALS.SHTML OR WWW.EBS.TGA.GOV.AU Kisqali ® (ribociclib): Indication: In combination with an aromatase inhibitor, for the treatment of men and postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer, as an initial endocrine therapy. Contraindications: QTcF>450ms; hypersensitivity to active substance, ingredients, soy products. Precautions: ECG, CBC, serum electrolytes, LFTs, and pregnancy status must be assessed prior to initiation of treatment. QT interval prolongation, hepatobiliary toxicity, neutropenia (including febrile). Monitoring during treatment – see full PI. Pregnancy (Category D), effective contraception, lactation, fertility. Interactions: Strong CYP3A inhibitors or inducers. Caution with narrow therapeutic index CYP3A substrates. Monitor for ADRs. Avoid co-administration with drugs that have a potential to prolong the QT interval. Avoid pomegranate, grapefruit. Adverse effects: Very common (≥10%): UTI, neutropenia, leukopenia, anaemia, lymphopenia, decreased appetite, headache, insomnia, dyspnoea, back pain, nausea, diarrhoea, vomiting, constipation, stomatitis, abdominal pain, alopecia, rash, pruritus, fatigue, peripheral oedema, asthenia, pyrexia, abnormal LFTs, leukocyte count decreased, neutrophil count decreased, haemoglobin decreased, lymphocyte count decreased, platelet count decreased, ALT increased, AST increased, creatinine increased, phosphorous decreased, potassium decreased. Common (1-10%): thrombocytopenia, febrile neutropenia, lacrimation increased, dry eye, hypocalcaemia, hypokalaemia, hypophosphataemia, syncope, epistaxis, dysgeusia, dyspepsia, hepatotoxicity, erythema, peripheral oedema, weight decreased, ECG QT prolonged, bilirubin increased. Dosage: Adults - Kisqali 600 mg taken orally, once daily for 21 consecutive days followed by 7 days off treatment, in repeating cycles of 28 days. Caution in severe renal impairment and/or moderate or severe hepatic impairment. Kisqali may require dose interruption, reduction, or discontinuation. Safety and efficacy not established in paediatrics, adolescents. Refer to full Kisqali PI and aromatase inhibitor PI. (kis120218m)

ABBREVIATIONS: CDK, cyclin dependent kinase; HR+, hormone receptor positive; HER-, human epidermal growth factor receptor negative. REFERENCES: 1. KISQALI Product Information. 2. Pharmaceutical Benefits Scheme. Available at: www.pbs.gov.au. Accessed July 2018.

Novartis Pharmaceuticals Australia Pty Limited ABN 18 004 244 160. 54 Waterloo Road, Macquarie Park NSW 2113. Ph (02) 9805 3555. ® Registered Trademark. Item No: AU-6243. Date of preparation July 2018. 3013RC.