Mitomycin Pregnancy and Breastfeeding Warnings

Brand names: Jelmyto, Mutamycin

Medically reviewed by Drugs.com. Last updated on Jan 24, 2024.

Mitomycin Pregnancy Warnings

Use is not recommended.

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

Risk Summary: Safe use of this drug in pregnant women has not been established. Animal studies revealed teratogenicity. The effect on fertility has not been reported.

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 and genetic counseling should be provided.
-Female patients of a sexually mature age should take contraceptive measures during and up to 6 months after the end of therapy or refrain from sexual intercourse.
-This drug is genetically harmful; therefore, men should not father a child during therapy and up to 6 months after and to seek advice on the preservation of sperm before the start of therapy due to the possibility of irreversible infertility.

Animal studies have revealed evidence of teratogenicity, mutagenicity, and carcinogenicity. 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

Mitomycin 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.
-This drug is mutagenic, teratogenic, and carcinogenic; therefore, experts warn that breastfeeding should be discontinued during therapy.

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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