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Exemestane Pregnancy and Breastfeeding Warnings

Exemestane is also known as: Aromasin

Medically reviewed by Drugs.com. Last updated on Nov 16, 2020.

Exemestane Pregnancy Warnings

Use is not recommended.
-According to some authorities: Use is contraindicated.

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

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

Comments:
-Verify the pregnancy status of females of reproductive potential within seven days prior to treatment.
-Female patients of reproductive potential should be advised to use effective contraception during therapy and for at least 1 month after the last dose.
-Female and male fertility may be compromised by this drug.
-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 hazard to the fetus and the potential risk for pregnancy loss.

Animal studies have revealed this drug to be embryotoxic, fetotoxic, and abortifacient. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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

Exemestane Breastfeeding Warnings

Use should be avoided.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Female patients should not to breastfeed during treatment and for at least 1 month after the last dose.
-The effects in the nursing infant or milk production are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Aromasin (exemestane)" Pharmacia & Upjohn, Kalamazoo, MI.

References for breastfeeding information

  1. "Product Information. Aromasin (exemestane)" Pharmacia & Upjohn, Kalamazoo, MI.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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