Zykadia
(Ceritinib)Zykadia Prescribing Information
Warnings and Precautions, Gastrointestinal Adverse Reactions (5.1 Gastrointestinal Adverse Reactions Severe gastrointestinal adverse reactions occurred in patients treated with ZYKADIA 750 mg under fasted conditions [see Adverse Reactions (6.1)] . Diarrhea, nausea, vomiting, or abdominal pain occurred in 95% of 925 patients, including severe cases (Grade 3 or 4) in 14% of patients treated with ZYKADIA across clinical studies. Diarrhea, nausea, vomiting, or abdominal pain leading to dose interruptions or reductions occurred in 36% of patients and leading to treatment discontinuation occurred in 1.6% of patients.The incidence and severity of gastrointestinal adverse reactions were reduced for patients treated with ZYKADIA 450 mg with food in a dose optimization study (ASCEND-8). Diarrhea, nausea, vomiting, or abdominal pain occurred in 79% of 108 patients treated with ZYKADIA at the recommended dose of 450 mg with food. Of these, 53% were Grade 1 events and 24% were Grade 2 events. One patient (0.9%) experienced Grade 3 diarrhea, and one patient (0.9%) experienced Grade 3 vomiting. One patient (0.9%) required dose adjustment due to vomiting. Eleven (10%) patients had diarrhea, nausea, vomiting, or abdominal pain that required at least one dose interruption. Monitor and manage patients using standard of care, including antidiarrheals, antiemetics, or fluid replacement, as indicated. Withhold ZYKADIA if gastrointestinal adverse reaction is severe or intolerable and is not responsive to antiemetics or antidiarrheals. Upon improvement, resume ZYKADIA at a reduced dose [see Dosage and Administration (2.3)] . | 8/2021 |
ZYKADIA® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test
Recommended Dosage: 450 mg orally once daily with food. (
The recommended dosage of ZYKADIA is 450 mg orally once daily with food until disease progression or unacceptable toxicity
If a dose of ZYKADIA is missed, make up that dose unless the next dose is due within 12 hours.
If vomiting occurs during the course of treatment, do not administer an additional dose and continue with the next scheduled dose of ZYKADIA.
Capsules: 150 mg hard gelatin capsule with opaque blue cap and opaque white body containing a white to off-white powder. The opaque blue cap is marked in black ink with “LDK 150MG” and the opaque white body is marked in black ink with “NVR”.
Tablets: 150 mg film-coated tablet, light blue, round, biconvex with beveled edges, without score, debossed with “NVR” on one side and “ZY1” on the other side.
- Lactation: Advise not to breastfeed. ()8.000000000000000e+002LactationRisk Summary
There are no data regarding the presence of ceritinib or its metabolites in human milk, the effects of ceritinib on the breastfed child or its effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with ZYKADIA and for 2 weeks following completion of therapy.
- Severe Hepatic Impairment: For patients with severe hepatic impairment (Child-Pugh C), dose reduce ZYKADIA. ()8.6Hepatic Impairment
For patients with severe hepatic impairment (Child-Pugh C), reduce the dose of ZYKADIA
[see Dosage and Administration (2.5)]. No dose adjustment is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
None.