Ribociclib Pregnancy and Breastfeeding Warnings
Brand names: Kisqali
Ribociclib Pregnancy Warnings
Use is not recommended during pregnancy or in patients of childbearing potential not using contraception.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned
Risk summary: Based on animal data and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman; no data are available on the use of this drug in pregnant women to inform a drug-related risk.
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.
-Pregnancy status should be verified in patients of childbearing potential before starting this drug.
-Patients of childbearing potential should be advised to use highly effective contraception (methods that result in less than 1% pregnancy rates) during therapy and for at least 21 days after the last dose.
Animal studies have revealed evidence of fetal harm, including teratogenicity and postimplantation loss. In rats administered 300 mg/kg/day (maternal systemic exposures [AUC] about 0.6 times the exposure in patients at the highest recommended dose [600 mg/day]) during organogenesis, reduced maternal body weight gain and fetal skeletal changes related to reduced fetal weights were observed; no significant effects on embryofetal viability or fetal morphology were seen at 50 or 300 mg/kg/day. In rabbits administered 30 mg/kg/day (maternal systemic exposures about 1.5 times the exposure in patients at the highest recommended dose) or greater during organogenesis, adverse effects on embryofetal development (including increased incidences of fetal abnormalities [malformations and external/visceral/skeletal variants]) and fetal growth (lower fetal weights) were observed; no increased incidence of embryofetal mortality was seen. No maternal toxicity was observed at 30 mg/kg/day. There are no controlled data in human pregnancy.
Based on animal data, this drug may impair fertility in males of reproductive potential.
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.
Ribociclib Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug and for at least 21 days after the last dose.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions in breastfed infants from this drug.
Because protein binding of this drug is 70%, clinically significant amounts may be excreted into breast milk.
See also
References for pregnancy information
- (2024) "Product Information. Kisqali (ribociclib)." Novartis Pharmaceuticals, SUPPL-18
- (2024) "Product Information. Kisqali (ribociclib)." Novartis Pharmaceuticals Pty Ltd
- (2024) "Product Information. Kisqali (ribociclib)." Novartis Pharmaceuticals UK Ltd
References for breastfeeding information
- Bethesda (MD): National Institute of Child Health and Human Development (US) (2024) Ribociclib - Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK500944/
- (2024) "Product Information. Kisqali (ribociclib)." Novartis Pharmaceuticals, SUPPL-18
- (2024) "Product Information. Kisqali (ribociclib)." Novartis Pharmaceuticals Pty Ltd
- (2024) "Product Information. Kisqali (ribociclib)." Novartis Pharmaceuticals UK Ltd
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.