Quizartinib Pregnancy and Breastfeeding Warnings

Brand names: Vanflyta

Medically reviewed by Drugs.com. Last updated on Nov 28, 2023.

Quizartinib Pregnancy Warnings

Safety has not been established during pregnancy; use should be avoided.

US FDA pregnancy category: Not assigned

Risk summary: Based on its mechanism of action and findings from animal studies, this drug may cause fetal harm when administered to a pregnant woman.

Comments:
-Verify pregnancy status of females of reproductive potential within 7 days before treatment initiation.
-Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months after last dose.
-Advise male patients with female sexual partners to use effective contraception during treatment and for at least 4 months after last dose.
-This drug may impair fertility in females and males of reproductive potential.
-There are no data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of adverse developmental outcomes during the period of organogenesis, including structural abnormalities and alterations to growth at maternal exposures 3 times the maximum recommended human dose (MRHD). Adverse findings in female reproductive systems were observed, including ovarian cysts, vaginal mucosal modifications, and atrophy of the uterus, ovary, and vagina at exposures 0.2 times the MRHD. In male animals, adverse reproductive findings included testicle seminiferous tubular degeneration, failure of sperm release, germ cell depletion, and oligospermia/aspermia at exposures 0.4 times the MRHD. The majority of these reproductive findings were reversible in males and females. 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

Quizartinib Breastfeeding Warnings

Use is not recommended.

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

Comments:
-Advise lactating women not to breastfeed during treatment with this drug and for one month after last dose due to the potential for serious adverse reactions in the breastfed child.
-There is no information on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production.

See references

Further information

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