Trabectedin Pregnancy and Breastfeeding Warnings

Brand names: Yondelis

Medically reviewed by Drugs.com. Last updated on Mar 15, 2024.

Trabectedin Pregnancy Warnings

Use should be avoided.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action this drug may cause serious birth defects when administered to a pregnant woman.

Comments:
-Verify the pregnancy status of females of reproductive potential prior to initiating treatment.
-Female patients 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.
-Male partners 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.

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.

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

Trabectedin Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.
-According to some authorities: Use is contraindicated during treatment and for 3 months thereafter.

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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