Rezafungin Pregnancy and Breastfeeding Warnings

Brand names: Rezzayo

Medically reviewed by Drugs.com. Last updated on Jul 20, 2023.

Rezafungin Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: There are no data available on use of this drug in pregnant women to inform a drug-associated risk.

Comments:
-Animal studies did not detect adverse embryofetal or post-natal outcomes.

In animal studies, doses 3 to 5 times the human recommended dose both in period of organogenesis and during post-natal development did not adversely affect offspring. Maternal toxicity was observed in some instances. Animal studies suggest this drug may impact the quality and quantity of sperm; however, results were variable. 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

Rezafungin Breastfeeding Warnings

Benefit should outweigh risk.
-According to some authorities, treatment with this drug is not a reason to discontinue breastfeeding.

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

Comments:
-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.
-The developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug and the potential for adverse effects in the breastfed infant.
-This drug is highly protein bound and has poor oral bioavailability therefore is less likely to be present in breast milk and absorbed by the infant in clinically significant amounts.

See references

Further information

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