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Trabectedin Pregnancy and Breastfeeding Warnings

Trabectedin is also known as: Yondelis

Trabectedin Pregnancy Warnings

Animal studies at relevant doses have not been conducted; however, placental transfer of this drug was demonstrated in pregnant rats. Both cytotoxic and mutagenic, this drug is likely to affect the reproductive capacity and may cause irreversible infertility in males and females. It also may damage spermatozoa, resulting in possible genetic and fetal abnormalities. 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 is not recommended unless clearly needed as this drug may cause fetal harm and irreversible infertility. US FDA pregnancy category: Not Assigned Comments: -Women of reproductive potential should use effective contraception during treatment and for 2 to 3 months after the last dose, and immediately inform their treating physician if a pregnancy occurs. -Men with female partners of reproductive potential should use effective contraception during treatment and for at least 5 months after the last dose. -If this drug is used at the end of pregnancy, potential adverse reactions in the newborns should be carefully monitored. -Patients should consider seeking genetic counseling if pregnancy occurs during treatment and advice on conservation of ovules or sperm if they wish to have children after therapy.

See references

Trabectedin Breastfeeding Warnings

UK: Use is contraindicated during treatment and for 3 months thereafter. US: Breastfeeding is not recommended during use of this drug. Excreted into human milk: Unknown Excreted into animal milk: Unknown Comments: The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Yondelis (trabectedin)." Janssen Pharmaceuticals, Titusville, NJ.

References for breastfeeding information

  1. "Product Information. Yondelis (trabectedin)." Janssen Pharmaceuticals, Titusville, NJ.

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