Practice Update | Onology

Now PBS listed 1

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

SERIOUS ADVERSE EVENTS The following severe adverse events have been seen. Monitor closely and consider early dose reduction. See referenced () sections for details and appropriate management. • QT interval prolongation (see Pharmacokinetics, Precautions, Adverse Effects, Dosage & Administration).

• Interstitial Lung Disease/Pneumonitis, including fatal cases (see Precautions, Adverse Effects, Dosage & Administration). • Hepatotoxicity, including drug-induced liver injury (Pharmacokinetics, Precautions, Adverse Effects, Dosage & Administration).

• Gastrointestinal toxicity (Precautions, Adverse Effects, Dosage & Administration). ZYKADIA has not been studied in patients with moderate and severe hepatic impairment. ZYKADIA must be taken while fasting — any food consumption within a 2 hour period before or after administration increases systemic exposure up to 2-fold increasing the risk of toxicities, and also potentially exceeds the maximum dose tested, and the risks are unknown (see Pharmacokinetics, Dosage and Administration). ZYKADIA should only be prescribed and supervised by a qualified physician experienced in the use of anticancer agents. Please review Zykadia ® (ceritinib) product information before prescribing.

Approved product information is available on request or online at www.novartis.com.au/products/healthcare-professionals.shtml