Repotrectinib Use in Special Populations

Repotrectinib Use in Special Populations

Based on literature reports of human congenital mutations leading to altered tropomyosin receptor tyrosine kinase signaling, animal study results, and the mechanism of action of repotrectinib, this drug may cause fetal harm when administered to pregnant women. The tropomyosin receptor tyrosine kinase signaling pathway plays an important role in embryonic development, and inhibition of this pathway by the drug may result in embryo-fetal developmental abnormalities. Therefore, all female patients of childbearing potential should be informed of the potential risk to the fetus. Pregnancy status should be confirmed in females of reproductive potential prior to starting treatment.

Contraceptive Advice for Women Taking Repotrectinib

Because repotrectinib may render certain hormonal contraceptives ineffective, females of childbearing potential are advised to use effective non-hormonal contraception during treatment and for 2 months after the final dose. The efficacy of hormonal contraceptives (e.g., oral contraceptives, contraceptive patches, vaginal rings, implants) may be reduced due to drug-drug interactions, leading to unintended pregnancy. Patients should discuss non-hormonal contraceptive options with their physician, such as intrauterine devices (non-hormonal), copper IUDs, barrier methods (condoms, diaphragms), etc.

Contraceptive Advice for Male Patients Taking Repotrectinib

For male patients with female partners of childbearing potential, effective contraception should be used during treatment with repotrectinib and for 4 months after the final dose. This is because the drug may pose a potential risk to the fetus through effects on sperm production or transfer via seminal fluid. Effective contraceptive measures include barrier methods such as condoms. Physicians should thoroughly explain this requirement to male patients and emphasize the importance of adhering to contraception throughout the treatment period and for 4 months after the last dose to minimize potential harm to the fetus.