Treatment with ZYKADIA may cause GI Adverse Reactions, Hepatic and Embryo-fetal Toxicities, Interstitial Lung Disease/Pneumonitis, QTc Interval Prolongation, Hyperglycemia, Bradycardia, Pancreatiti...
FDA-APPROVED ONCE-DAILY DOSING—450 mg WITH FOOD1*†
FDA, US Food and Drug Administration.
*Approval based on a dose optimization study (ASCEND-8), in which ZYKADIA 450 mg once daily with food was compared with 750 mg once daily under fasted conditions in both previously treated and untreated patients with ALK+ metastatic NSCLC. There was no clinically meaningful difference in the systemic steady-state exposure of ZYKADIA for the 450-mg once-daily with food arm compared with the 750-mg once-daily fasted arm.
†Food=approximately 100 to 500 calories and 1.5 to 15 grams of fat.
RECOMMENDATIONS FOR DOSE ADJUSTMENTS WITH ZYKADIA
REDUCE DOSE AS NECESSARY TO MANAGE ADVERSE REACTIONS1
Refer to the full Prescribing Information for potential risks associated with ZYKADIA and recommendations for managing adverse reactions.
Please click here for Important Prescribing Information Letter
FDA-APPROVED RECOMMENDED DOSE: 450 mg ONCE DAILY WITH FOOD*
ZYKADIA STARTING DOSE BASED ON ASCEND-8 DOSE OPTIMIZATION STUDY
In ASCEND-8, a dose optimization study, ZYKADIA 450 mg once daily with food (n=89) was compared with 750 mg once daily under fasted conditions (n=90) in both previously treated and untreated patients with ALK+ metastatic NSCLC. The primary pharmacokinetic analysis investigated the steady-state pharmacokinetics and safety of ZYKADIA. The overall safety and exposure profile of ZYKADIA 450 mg once daily with food was consistent with ZYKADIA 750 mg once daily fasted, except for a reduction in the incidence and severity of GI adverse reactions, while achieving comparable steady-state exposure.1
COMPARABLE STEADY-STATE PHARMACOKINETICS
NO CLINICALLY MEANINGFUL DIFFERENCE IN THE SYSTEMIC STEADY-STATE EXPOSURE OF ZYKADIA (AUC) FOR THE 450-mg ONCE-DAILY WITH FOOD ARM (n=36) COMPARED WITH THE 750-mg ONCE-DAILY FASTED ARM (n=31)1,2
AUC, area under the curve.
*Food=approximately 100 to 500 calories and 1.5 to 15 grams of fat.
References: 1. Zykadia [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2017. 2. Data on file. Clinical Study Report. Novartis Pharmaceuticals Corp; 2017.
ZYKADIA® (ceritinib) capsules is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
IMPORTANT SAFETY INFORMATION for ZYKADIA® (ceritinib) capsules
Gastrointestinal Adverse Reactions
Interstitial Lung Disease/Pneumonitis
QTc Interval Prolongation
Effect of Other Drugs on Ceritinib
Effect of Ceritinib on Other Drugs