Fruquintinib Pregnancy and Breastfeeding Warnings

Brand names: Fruzaqla

Medically reviewed by Drugs.com. Last updated on Jan 26, 2024.

Fruquintinib Pregnancy Warnings

Use should be avoided.

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.

Comments:
-Pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Women of childbearing potential and males with female partners of childbearing potential should be advised to use effective contraception during treatment and for 2 weeks after the last dose.
-Pregnant patients should be apprised of the potential risk to a fetus.

Animal studies have revealed evidence of teratogenicity and embryofetal lethality. In pregnant rats administered this drug during organogenesis, developmental toxicities occurred at oral doses approximately 0.2 to 0.5 times the recommended clinical dose based on body surface area. 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

Fruquintinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

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

Comments:
-There is no data on the presence of this drug in human milk or its effects on a breastfed child or milk production.
-Women are advised not to breastfeed during treatment and for 2 weeks after the last dose due to the potential for serious adverse effects on the breastfed child.

See references

Further information

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

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