Inavolisib Pregnancy and Breastfeeding Warnings

Brand names: Itovebi

Medically reviewed by Drugs.com. Last updated on Jan 28, 2025.

Inavolisib 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. There are no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Verify pregnancy status in females of reproductive potential before starting therapy.
-Counsel women of childbearing potential to use effective non-hormonal contraception during treatment and for 1 week after the last dose.
-Advise male patients with female partners of reproductive potential to use effective contraception during treatment with and for 1 week after the last dose.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential harm to the fetus.
-Male and female fertility may be compromised by use of this drug.
-This drug is given in combination with palbociclib and fulvestrant; refer to the manufacturer product information for agents given in combination with this drug for relevant pregnancy-related information.

Animal studies have revealed evidence of embryofetal death and teratogenicity. Administration of this drug to pregnant animals during the period of organogenesis resulted in malformations, adverse developmental outcomes, including embryo-fetal mortality, structural abnormalities, and alterations to growth at maternal exposures approximately equivalent to the human exposure at the recommended dose based on AUC. 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.

See references

Inavolisib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for at least 1 week after the last dose.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

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

See references

Further information

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