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Sirolimus protein-bound Pregnancy and Breastfeeding Warnings

Brand names: Fyarro

Medically reviewed by Drugs.com. Last updated on Sep 21, 2022.

Sirolimus protein-bound Pregnancy Warnings

Level 2:
Studies in rats reported embryo/fetotoxic effects and maternal toxicity at subtherapeutic doses. Additionally, rabbit embryo-fetal development studies showed impaired ability to sustain a pregnancy at doses of 0.05 mg/kg (oral) and above. Maternal toxicity was also observed. 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.

Use should be avoided.

US FDA pregnancy category: Not assigned

Risk summary: Based on animal studies and its mechanism of action, this drug can cause fetal harm if administered during pregnancy.

Comments:
-This drug can cause fetal harm when administered to pregnant women.
-Verify pregnancy status of females of reproductive potential prior to treatment initiation.
-Females of reproductive potential should use effective contraception during treatment and for 12 weeks after the last dose.

See references

Sirolimus protein-bound Breastfeeding Warnings

Use is not recommended.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Due to the potential of adverse effects in breastfed infants, breastfeeding is not recommended during treatment and for 2 weeks after the last dose.

See references

References for pregnancy information

  1. Product Information. Fyarro (sirolimus protein-bound). Aadi Bioscience, Inc. 2022.

References for breastfeeding information

  1. Product Information. Fyarro (sirolimus protein-bound). Aadi Bioscience, Inc. 2022.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.