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Dactinomycin Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on May 3, 2023.

Dactinomycin is also known as: Cosmegen

Dactinomycin Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity and teratogenicity at doses lower than the recommended human dose. 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

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.

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

Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise females of reproductive potential to use effective contraception during therapy and for at least 6 months after.
-Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during therapy and for 3 months after.
-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.

See references

Dactinomycin Breastfeeding Warnings

No information is available on the use of this drug during breastfeeding. Most experts consider breastfeeding contraindicated during maternal antineoplastic therapy.

Use is not recommended.

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

-The effects in the nursing infant are unknown.
-The manufacturer recommends that breastfeeding be discontinued during therapy and for at least 14 days after.

See references

References for pregnancy information

  1. Product Information. Cosmegen (dactinomycin). Merck & Co., Inc. 2001.

References for breastfeeding information

  1. Product Information. Cosmegen (dactinomycin). Merck & Co., Inc. 2001.
  2. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.

Further information

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