Thiotepa Pregnancy and Breastfeeding Warnings

Brand names: Tepadina, Tepylute, Thioplex

Medically reviewed by Drugs.com. Last updated on Aug 4, 2025.

Thiotepa Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated.

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

Risk summary: Based on the mechanism of action and findings in animals, this drug can cause fetal harm when administered to a pregnant woman. Insufficient data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Adequate methods of contraception should be encouraged.
-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 embryolethality, mutagenicity, and teratogenicity. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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

Thiotepa Breastfeeding Warnings

Use is contraindicated.

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

Comments:
-This drug can harm a nursing infant.
-Breastfeeding should be discontinued during therapy and for 3 months after.

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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