J&J Medical Connect
OPSUMIT®

(macitentan)

This information is intended for US patients and caregivers to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended to promote the use of our products, nor to provide medical advice.

Can I Breastfeed While Taking OPSUMIT?

Last Updated: 04/15/2025

IMPORTANT INFORMATION ABOUT OPSUMIT

  • OPSUMIT can cause serious birth defects if taken during pregnancy.1
  • Females should not be pregnant when they start taking OPSUMIT or become pregnant during treatment with OPSUMIT.1
  • Females who are able to get pregnant should have a negative pregnancy test before beginning treatment with OPSUMIT.1
    • Talk to your healthcare provider about your menstrual cycle. Your healthcare provider will decide when to do the pregnancy test and will order a pregnancy test for you depending on your menstrual cycle.
  • Females who are able to get pregnant should use effective birth control before starting treatment with OPSUMIT, during treatment, and for 1 month after stopping OPSUMIT because the medicine may still be in the body.1
    • Talk with your healthcare provider or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable birth control that you may use to prevent pregnancy during treatment with OPSUMIT.
  • Do not have unprotected sex.1
    • Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your healthcare provider may talk with you about using emergency birth control.
  • Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant.1 

summary

What should I avoid while taking OPSUMIT?

  • It is not known if OPSUMIT passes into your breastmilk. You should not breastfeed if you take OPSUMIT.1
    • Talk to your healthcare provider about the best way to feed your baby if you take OPSUMIT.

additional information

This information is provided ONLY in response to your request and is not intended as medical advice, to promote the use of our product, or suggest using it in any manner other than as described in the PRESCRIBING INFORMATION. All decisions regarding your medical treatment should be made with your healthcare professional(s). Please contact your healthcare professional(s) to discuss the information in this response.

Please refer to the attached full PRESCRIBING INFORMATION and the PATIENT MEDICATION GUIDE for OPSUMIT.1

 

References

1 OPSUMIT (macitentan) [Prescribing Information]. Titusville, NJ: Actelion Pharmaceuticals US, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/OPSUMIT-pi.pdf