Zykadia® (ceritinib) – New formulation approval • On March 18, 2019, the FDA approved ’ Zykadia (ceritinib) tablets, for the treatment of adults with metastatic non-small cell whose tumors are anaplastic 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.

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