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
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
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