Zykadia® (ceritinib) – New formulation approval • On March 18, 2019, the FDA approved Novartis’ Zykadia (ceritinib) tablets, for the treatment of adults with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase- positive as detected by an FDA-approved test. — Zykadia is also available as capsules for the same indication. • The approval of Zykadia tablets was based on studies conducted with Zykadia capsules. • Warnings and precautions of Zykadia include gastrointestinal adverse reactions, hepatotoxicity, interstitial lung disease/pneumonitis, QT interval prolongation, hyperglycemia, bradycardia, pancreatitis, and embryo-fetal toxicity. • The most common adverse reactions (≥ 25%) with the use of Zykadia 450 mg with food were diarrhea, nausea, abdominal pain vomiting, and fatigue; and with Zykadia 750 mg under fasted conditions were diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and weight loss. • The recommended dose of Zykadia tablets or capsules is 450 mg orally once daily with food until disease progression or unacceptable toxicity. • Novartis’ launch plans for Zykadia tablets are pending. Zykadia tablets will be available in a strength of 150 mg. optumrx.com OptumRx® specializes in the delivery, clinical management and affordability of prescription medications and consumer health products. We are an Optum® company — a leading provider of integrated health services. Learn more at optum.com. All Optum® trademarks and logos are owned by Optum, Inc. All other brand or product names are trademarks or registered marks of their respective owners. This document contains information that is considered proprietary to OptumRx and should not be reproduced without the express written consent of OptumRx. RxNews® is published by the OptumRx Clinical Services Department. ©2019 Optum, Inc. All rights reserved. .