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Macitentan Pregnancy and Breastfeeding Warnings

Macitentan is also known as: Opsumit

Medically reviewed on March 15, 2018

Macitentan Pregnancy Warnings

Reproductive toxicity has been reported in animal studies. There are no controlled data in human pregnancy.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated.

AU TGA pregnancy category: X
US FDA pregnancy category: X

Comments:
-Females: Women of childbearing potential must have a negative pregnancy test prior to starting treatment and monthly pregnancy tests during treatment; adequate methods of contraception must be used during and after treatment with this drug.
-Males: This drug, like other endothelin receptor antagonists, may have an adverse effect on spermatogenesis.

See references

Macitentan Breastfeeding Warnings

AU: Breastfeeding is not recommended during use of this drug.
UK: Use is contraindicated.
US: A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Opsumit (macitentan)." Actelion Pharmaceuticals US Inc, South San Francisco, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Opsumit (macitentan)." Actelion Pharmaceuticals US Inc, South San Francisco, CA.

Further information

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

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