Selpercatinib Pregnancy and Breastfeeding Warnings

Brand names: Retevmo

Medically reviewed by Drugs.com. Last updated on May 23, 2023.

Selpercatinib Pregnancy Warnings

Animal studies have revealed evidence of embryolethality and malformations at doses resulting in exposures less than or equal to the human exposure. 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.

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. There are no available data on its use in pregnant women to inform a drug-associated risk.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-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 female patients of reproductive potential to use effective contraception during therapy and for 1 week after the final dose.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for 1 week.
-This drug may impair fertility in females and males of reproductive potential.

See references

Selpercatinib Breastfeeding Warnings

Use should be avoided.

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

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

Medical Disclaimer