Zykadia Generic Name & Formulations
Ceritinib 150mg; tabs.
In adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Zykadia Dosage and Administration
Take with food. 450mg once daily until disease progression or unacceptable toxicity. Discontinue if 150mg once daily with food not tolerated. Severe hepatic impairment or if concomitant use of strong CYP3A4 inhibitors unavoidable: reduce ceritinib dose by ⅓. Dose modifications: see full labeling.
Zykadia Boxed Warnings
Monitor for severe or intolerable GI toxicity; if occurs, withhold until improved; resume at reduced dose. Monitor ALT/AST and total bilirubin once monthly, and more frequently if elevated transaminases develop; withhold then reduce dose, or permanently discontinue based on severity. Congenital long QT syndrome; avoid. Patients with CHF, bradyarrhythmias, electrolyte abnormalities, or those who are taking drugs known to prolong the QTc interval; monitor ECG, electrolytes periodically. Permanently discontinue if QTc prolongation in combination with Torsade de pointes or polymorphic ventricular tachycardia or serious arrhythmia develop. Monitor HR and BP regularly; fasting serum glucose, lipase, amylase prior to initiation and periodically thereafter. Monitor for pulmonary symptoms as clinically indicated. Permanently discontinue if treatment-related interstitial lung disease (ILD)/pneumonitis, uncontrolled hyperglycemia, or life-threatening bradycardia occur. Severe hepatic impairment. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners; use condoms) after completion. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after completion).
See Adults. Potentiated by strong CYP3A4 inhibitors (eg, ritonavir, macrolides, ketoconazole, nefazodone), grapefruit juice; avoid. Avoid concomitant strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, St. John’s Wort). Avoid concomitant sensitive CYP3A substrates (eg, midazolam) or CYP2C9 substrates with narrow therapeutic indices (eg, warfarin); if unavoidable, consider dose reduction of these substrates. Avoid concomitant drugs known to prolong the QTc interval or other drugs known to cause bradycardia (eg, beta-blockers, non-dihydropyridine CCBs, clonidine, digoxin).
Zykadia Adverse Reactions
Diarrhea, nausea, fatigue, vomiting, abdominal pain, decreased appetite, weight loss; hepatotoxicity, ILD/pneumonitis, QT prolongation, hyperglycemia, bradycardia, pancreatitis.
Zykadia Clinical Trials
Zykadia Patient Counseling