Ibrexafungerp Pregnancy and Breastfeeding Warnings

Brand names: Brexafemme

Medically reviewed by Drugs.com. Last updated on Jan 11, 2023.

Ibrexafungerp Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category: Not assigned

Risk summary: Based on animal data, this drug may cause fetal harm when administered to a pregnant patient.

Comments:
-A pregnancy exposure registry is available.
-For patients of childbearing potential:
---Verify that the patient is not pregnant before starting treatment with this drug; pregnancy status should be reassessed before each dose when this drug is used monthly for 6 months for reduction in the incidence of recurrent vulvovaginal candidiasis.
---For treatment of vulvovaginal candidiasis, patients should be advised to use effective contraception during treatment with this drug and for 4 days after the last dose.
---For reduction in the incidence of recurrent vulvovaginal candidiasis, patients should be advised to use effective contraception throughout the 6-month treatment period with this drug and for 4 days after the last dose.

Animal studies have revealed evidence of fetal malformations; after administration via oral gavage to pregnant rabbits during organogenesis (at dose exposures greater or equal to about 5 times the human exposure at the recommended human dose [RHD] based on AUC comparison), fetal malformations (including absent forelimb[s], absent hindpaw, absent ear pinna, and thoracogastroschisis) were observed. In rabbits, fetal malformations (including absent ear pinna, craniorachischisis, thoracogastroschisis, trunk kyphosis, absent forelimbs, absent forepaws, and absent hindpaw) occurred at about 5 times the RHD (based on AUC comparison) in a single fetus, while malformations (including absent hindpaw and anencephaly) occurred with an increased litter incidence at about 13 times the RHD (based on AUC comparison) and other malformations occurred in single fetuses and litters (absent ear pinna, thoracogastroschisis, absent forelimb, absent thyroid gland); no changes in embryofetal survival or fetal body weights were seen at any dose and no fetal malformations were observed at about 2 times the RHD (based on AUC comparison). After administration via oral gavage to pregnant rats during organogenesis (at dose exposures up to about 5 times the human exposure at the RHD based on AUC comparison), no fetal malformations, changes in embryofetal survival, or changes in fetal body weights occurred. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy safety study has been established. If this drug is inadvertently administered during pregnancy or if pregnancy is detected within 4 days after administration, pregnant women exposed to this drug and health care providers are encouraged to report pregnancies by calling 1-888-982-7299.

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

Ibrexafungerp Breastfeeding Warnings

If this drug is required by the mother of an older infant, it is not a reason to discontinue breastfeeding; however, until more data are available, an alternate agent may be preferred, particularly while breastfeeding newborn or preterm infants.

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

Comments:
-No information is available on the use of this drug during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-This drug is highly protein bound; amounts in milk are likely to be very low.

See references

Further information

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