Ceritinib

The Basics

What is Ceritinib?

Used for the treatment of non-small cell lung cancer.

Brand names for Ceritinib

Zykadia

How Ceritinib is classified

Antineoplastic Agents, Enzyme Inhibitors, Protein Kinase Inhibitors, Signal Transduction Inhibitors, Tyrosine Kinase Inhibitors

Ceritinib During Pregnancy

Ceritinib pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Ceritinib while pregnant

Based on animal studies and its mechanism of action, ZYKADIA can cause fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY]. The limited available data on the use of ZYKADIA in pregnant women are insufficient to inform a risk. Administration of ceritinib to rats and rabbits during the period of organogenesis at maternal plasma exposures below the recommended human dose caused increases in skeletal anomalies in rats and rabbits (see Data). Advise a pregnant woman of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study in which pregnant rats were administered daily doses of ceritinib during organogenesis, dose-related skeletal anomalies were observed at doses as low as 50 mg/kg (less than 0.5-fold the human exposure by AUC at the recommended dose). Findings included delayed ossifications and skeletal variations. In pregnant rabbits administered ceritinib daily during organogenesis, dose-related skeletal anomalies, including incomplete ossification, were observed at doses equal to or greater than 2 mg/kg/day (approximately 0.015-fold the human exposure by AUC at the recommended dose). A low incidence of visceral anomalies, including absent or malpositioned gallbladder and retroesophageal subclavian cardiac artery, was observed at doses equal to or greater than 10 mg/kg/day (approximately 0.13-fold the human exposure by AUC at the recommended dose). Maternal toxicity and abortion occurred in rabbits at doses of 35 mg/kg or greater. In addition, embryolethality was observed in rabbits at a dose of 50 mg/kg.

Taking Ceritinib While Breastfeeding

What are recommendations for lactation if you're taking Ceritinib?

No information is available on the clinical use of ceritinib during breastfeeding. Because ceritinib is 97% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during ceritinib therapy and for 2 weeks after the final dose.

Maternal / infant drug levels

No information is available on the clinical use of ceritinib during breastfeeding. Because ceritinib is 97% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during ceritinib therapy and for 2 weeks after the final dose.

Possible effects of Ceritinib on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Ceritinib

None listed