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Ribociclib Pregnancy and Breastfeeding Warnings

Ribociclib is also known as: Kisqali

Ribociclib Pregnancy Warnings

Based on findings in animals and its mechanism of action, this drug may cause fetal harm; safety has not been established. US FDA pregnancy category: Not assigned. Comments: -Advise pregnant women of the potential risk to a fetus, and advise women of reproductive potential to use effective contraception (methods that result in less than 1% pregnancy rates) during treatment and for at least 3 weeks after the last dose. -Obtain a pregnancy test for females of reproductive potential prior to treatment initiation. -This drug may impair fertility in males of reproductive potential based on data from animal studies.

See references

Ribociclib Breastfeeding Warnings

Lactating women should not breastfeed during treatment and for at least 3 weeks after the last dose. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -This drug and its metabolites readily pass into the milk of lactating animals. -The effects in the nursing infant and on milk production are unknown.

In lactating animals administered a single 50 mg/kg dose, exposure to this drug was 3.56-fold higher in milk compared to maternal plasma.

See references

References for pregnancy information

  1. "Product Information. Kisqali (ribociclib)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. "Product Information. Kisqali (ribociclib)." Novartis Pharmaceuticals, East Hanover, NJ.

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