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Bleomycin Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Nov 24, 2022.

Bleomycin is also known as: Blenoxane, Bleo 15k

Bleomycin Pregnancy Warnings

Use should be avoided.

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

Risk Summary: This drug can cause fetal harm when administered to a pregnant woman. It has been shown to be abortifacient and teratogenic in animal studies. Administration of intraperitoneal doses of 1.5 mg/kg/day to animals (about 1.6 times the recommended human dose on a unit/m2 basis) on days 6 to 15 of gestation caused skeletal malformations, shortened innominate artery, and hydroureter.

-This drug can harm a developing fetus.
-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.
-The effects of this drug on fertility are not known.

Animal studies have revealed evidence of embryotoxicity and teratogenicity. 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

Bleomycin Breastfeeding Warnings

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence although no data are available to determine an appropriate period to withhold breastfeeding. 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.

Use is contraindicated.

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

-This drug can harm a nursing infant.

See references

References for pregnancy information

  1. American Medical Association, Division of Toxicology. Drug Evaluation Annual 1995. Chicago, IL: American Medical Association. 1995.
  2. Product Information. Blenoxane (bleomycin). Bristol-Myers Squibb. 2001.
  3. Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. Baltimore, MD: Williams & Wilkins. 1998.

References for breastfeeding information

  1. Committee on Drugs, 1992 to 1993. The transfer of drugs and other chemicals into human milk. Pediatrics. 1994;93:137-50.
  2. Product Information. Blenoxane (bleomycin). Bristol-Myers Squibb. 2001.

Further information

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