Selpercatinib Pregnancy and Breastfeeding Warnings

Brand names: Retevmo

Medically reviewed by Drugs.com. Last updated on Jul 2, 2024.

Selpercatinib Pregnancy Warnings

Safety has not been established.
-According to some authorities: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. Use is not recommended in women of childbearing potential not using contraception.

AU TGA pregnancy category: D
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. There are no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Verify pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise women patients of childbearing potential to use effective contraception during treatment with and for 1 week after the last dose.
-Counsel males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose.
-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
-Female and male fertility may be compromised by this drug; men and women should seek advice on fertility preservation before treatment.

Animal studies have revealed evidence of embryolethality and malformations. Administration of this drug to pregnant animals during the period of organogenesis resulted in early resorptions, malformations, and decreased fetal body weights at maternal exposures approximately equal to the human exposure at the clinical dose of 160 mg twice daily based on AUC. There are no controlled data in human pregnancy.

Based on animal studies, treatment may impair fertility in both males and females; however, no data are available in humans.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Selpercatinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for at least 1 week after the last dose.

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

Comments:
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.
-Because this drug is highly protein bound, the amount in milk is expected to be low.

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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