Repotrectinib Pregnancy and Breastfeeding Warnings

Brand names: Augtyro

Medically reviewed by Drugs.com. Last updated on Feb 6, 2024.

Repotrectinib Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on its mechanism of action, literature reports, and findings in animal models, this drug can cause embryofetal harm when administered during pregnancy. No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Pregnancy status of patients of childbearing potential should be verified before starting this drug.
-Females of reproductive potential should use effective nonhormonal contraception during treatment and for 2 months after the last dose, as this drug can render some hormonal contraceptives ineffective.
-Based on genotoxicity findings, males with female partners of reproductive potential should use effective contraception during treatment and for 4 months 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.

Animal studies have revealed evidence of fetal harm and teratogenicity. After once daily oral dosing in pregnant rats during organogenesis, maternal effects of increased body weight and skin abrasions or ulcerations were observed at doses of 6 mg/kg or greater. Fetal malformations were observed at doses of 12 mg/kg or greater (about 0.3 times the recommended dose of 160 mg twice daily based on body surface area). There are no controlled data in human pregnancy.

Published reports of individuals with congenital mutations in tropomyosin receptor kinase (TRK) pathway proteins suggest that decreases in TRK-mediated signaling are correlated with obesity, developmental delays, cognitive impairment, insensitivity to pain, and anhidrosis.

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

Repotrectinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 10 days after the last dose.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant or on milk production are unknown; there is the potential for serious adverse reactions.
-Because this drug is highly bound to plasma proteins, the amount in milk is likely to be low and oral bioavailability is less than 50%; however, the half-life is about 50 hours in adults.

See references

Further information

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