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.

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.

Comments:
-There are no data available on the use of this drug in pregnant women to inform a drug-associated risk.
-The pregnancy status of females of reproductive potential should be verified prior to initiating treatment.
-Pregnant women and females of childbearing potential should be apprised of the potential risk to a fetus.
-Women of childbearing potential should be counseled to use effective contraception during treatment and for 1 month after the last dose.
-Males with female partners of reproductive potential should be counseled to use effective contraception during treatment and for 4 months after the last dose.
-This drug is used in combination with fulvestrant; refer to the manufacturer product information for fulvestrant for pregnancy, contraception, and infertility information.

Animal studies have revealed evidence of embryofetal deaths (post-implantation loss), reduced fetal weights, and minor fetal visceral variations when this drug was orally administered at a dose of 150 mg/kg/day (0.7 times the human exposure based on AUC) to pregnant rats during the period of organogenesis. Additionally, reduced litter and pup weights were observed in other animal studies at the same dose exposure. 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.

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.

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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 for lactation information.

In a pre- and post-natal assessment, this drug was detected in the plasma of suckling rat pups on lactation day 7 and 8 after administration to maternal rats during the lactation period. The plasma concentrations in rat pups were up to 0.6% of the concentration in maternal plasma (of rats in the 150 mg/kg/day group).

See references

Further information

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