Pexidartinib Pregnancy and Breastfeeding Warnings

Brand names: Turalio

Medically reviewed by Drugs.com. Last updated on Oct 29, 2024.

Pexidartinib 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 may cause embryofetal harm when administered to a pregnant woman. The available human data do not establish the presence or absence of major birth defects or miscarriage.

Comments:
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Advise females of reproductive potential to use effective non-hormonal contraception during therapy and for 1 month after the final dose. This drug may render hormonal contraceptives ineffective.
-Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 1 week after.
-This drug may impair both male and female fertility.

Animal studies in rats and rabbits have revealed evidence of embryotoxicity and teratogenicity such as increased post-implantation loss, fetal malformations including absence of or malposition of kidney or ureter, rib abnormalities, skeletal variations of accessory skull bones, localized fetal edema, abnormalities of the reproductive tract, and developmental variations including decreased skeletal ossification. These studies gave doses approximately equal to the human exposure at the recommended dose. 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

Pexidartinib Breastfeeding Warnings

Safety has not been established and use should be avoided.

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

Comments:
-The effects in the nursing infant are unknown.
-Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during therapy and for at least 1 week after.

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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