Ribociclib Pregnancy and Breastfeeding Warnings

Brand names: Kisqali

Medically reviewed by Drugs.com. Last updated on Aug 21, 2023.

Ribociclib Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Advise women of reproductive potential to use effective contraception (methods that result in less than 1% pregnancy rates) during therapy and for at least 3 weeks after the last dose.
-Obtain a pregnancy test for females of reproductive potential prior to therapy initiation.
-This drug may impair fertility in males of reproductive potential based on data from animal studies.

Animal studies have revealed evidence of embryotoxicity and teratogenicity. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Ribociclib Breastfeeding Warnings

Use is not recommended.

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.
-Lactating women should not breastfeed during therapy and for at least 3 weeks after the last dose.

Because it is 70% bound to proteins, clinically important amounts of the drug might pass into breastmilk. 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

Further information

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