Dacarbazine Pregnancy and Breastfeeding Warnings

Brand names: DTIC-Dome

Medically reviewed by Drugs.com. Last updated on Aug 16, 2023.

Dacarbazine Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: C

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.

This drug was mutagenic, teratogenic, and carcinogenic in animal studies at doses 10 times higher than recommended human doses. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Dacarbazine Breastfeeding Warnings

Use is contraindicated.

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

Comments:
-The effects in the nursing infant are unknown.
-Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.
-Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

Most experts consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy, especially alkylating agents such as this drug. It might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence; however, no data are available to determine an appropriate period to withhold breastfeeding.

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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