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Ceritinib Pregnancy and Breastfeeding Warnings

Ceritinib is also known as: Zykadia

Ceritinib Pregnancy Warnings

May cause fetal harm. US FDA pregnancy category: D Comments: Advise females of reproductive potential to use effective contraception during treatment and for at least 2 weeks following completion of therapy.

Animal studies during organogenesis at levels less than the recommended human dose showed increased skeletal anomalies including incomplete ossification and skeletal variations; low incidence of visceral anomalies, including absent or malpositioned gallbladder and retroesophageal subclavian cardiac artery were also seen. Maternal toxicity and abortion occurred in rabbits at doses of 35 mg/kg or higher; embryolethality was observed at a dose of 50 mg/kg. There is no controlled data in human pregnancy. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Ceritinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: Potential for serious adverse effects in infants.

See references

References for pregnancy information

  1. "Product Information. Zykadia (ceritinib)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. "Product Information. Zykadia (ceritinib)." Novartis Pharmaceuticals, East Hanover, NJ.

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