Capivasertib Pregnancy and Breastfeeding Warnings

Brand names: Truqap

Medically reviewed by Drugs.com. Last updated on Feb 1, 2024.

Capivasertib Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: This drug should not be used 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 findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. There are no data available on the use of this drug in pregnant women to inform a drug-associated risk.

Comments:
-Verify the pregnancy status of females of reproductive potential prior to initiating treatment.
-Women of childbearing potential should be counseled to use effective contraception during treatment and for 1 month (4 weeks) after the last dose.
-Males with female partners of reproductive potential should be advised to use effective contraception during therapy and for 4 months (16 weeks) after the last dose.
-Pregnant women and females of childbearing potential should be apprised of the potential risk to a fetus if this drug is used during pregnancy.
-This drug is used in combination with fulvestrant; refer to the manufacturer product information for fulvestrant for additional pregnancy recommendations.

Animal studies have revealed evidence of reproductive toxicity. Oral administration of this drug at 150 mg/kg/day (0.7 times the human exposure based on AUC) to pregnant rats during the period of organogenesis resulted in embryofetal deaths (post-implantation loss), reduced fetal weights, and minor fetal visceral variations . In other animal studies, administration of this drug through gestation and lactation resulted in reduced litter and pup weights. Maternal toxicities occurred with administration of this drug and included reduced body weight gain and food consumption, and increased blood glucose. There are no controlled data in human pregnancy.

Effects on male fertility have been reported in animal studies, including tubular degeneration in the testes, and cellular debris and decreased spermatocytes in the epididymides. The effect on female fertility in animals has not been studied. There are no clinical data on human fertility.

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

Capivasertib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.
-There are no data on the presence of this drug or its metabolites in human milk, or the effects of this drug on milk production.
-This drug is used in combination with fulvestrant; refer to the manufacturer product information for fulvestrant additional lactation recommendations.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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