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Tipiracil / trifluridine Pregnancy and Breastfeeding Warnings

Tipiracil / trifluridine is also known as: Lonsurf

Tipiracil / trifluridine Pregnancy Warnings

Animal studies revealed evidence of embryofetal lethality and structural anomalies with the trifluridine (FTD) dose of 150 mg/kg, approximately 0.92 times the FTD exposure at the clinical dose of 35 mg/m2 twice daily. Structural anomalies observed were cleft palate, skeletal anomalies, alterations in great vessels, kinked tail, ectrodactyly, and anasarca. Male and female fertility in animals was not affected; however, dose-related increases in the corpus luteum count and implanted embryo count were observed. 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.

This drug can cause fetal harm, based on animal studies and its mechanism of action. US FDA pregnancy category: Not Assigned Comments: -Women of reproductive potential should be advised to use effective contraception during treatment due to the potential risk to the fetus. -Males with female partners of reproductive potential should be advised to use condoms during treatment and for at least 3 months after the final dose because of the genotoxicity potential.

See references

Tipiracil / trifluridine Breastfeeding Warnings

Animal studies reveal levels of trifluridine (FTD)-derived radioactivity were as high as approximately 50% of the exposure in maternal plasma 1 hour after dosing with this drug and were approximately the same as those in maternal plasma for up to 12 hours following dosing. Exposure to tipiracil (TPI)-derived radioactivity was higher in milk than in maternal plasma beginning 2 hours after dosing and continuing for at least 12 hours following administration of this drug.

Breastfeeding is not recommended during use of this drug and for one day following the final dose. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Lonsurf (tipiracil-trifluridine)." Taiho Oncology, Inc., Princeton, NJ.

References for breastfeeding information

  1. "Product Information. Lonsurf (tipiracil-trifluridine)." Taiho Oncology, Inc., Princeton, NJ.

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