IMPORTANT INFORMATION ABOUT OPSUMIT

• OPSUMIT can cause serious birth defects if taken during pregnancy.¹
• Females must not be pregnant when they start taking OPSUMIT or become pregnant during treatment with OPSUMIT.¹
• Females who are able to get pregnant must have a negative pregnancy test before beginning treatment, each month during treatment, and 1 month after stopping 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 must use two acceptable forms of birth control during treatment with OPSUMIT, and for one month after stopping OPSUMIT because the medicine may still be in the body.¹
  • Females who are able to get pregnant are females who:
    • have entered puberty, even if they have not started their menstrual period
    • have a uterus
    • have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
  • Females who are not able to get pregnant are females who:
    • have not yet entered puberty
    • do not have a uterus
    • have gone through menopause
    • are infertile for other medical reasons and this infertility is permanent and cannot be reversed
  • If you have had a tubal sterilization, have a progesterone implant, or have an IUD (intrauterine device), these methods can be used alone and no other form of birth control is needed.
  • 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.
  • If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another acceptable form of birth control.
• Females can only receive OPSUMIT through a restricted program called the
  Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS).¹
  • If you are a female who can get pregnant, you must talk to your healthcare provider, understand the benefits and risks of OPSUMIT, and agree to all of the instructions in the Macitentan-Containing Products REMS Program.
• 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.

Summary

How does OPSUMIT Work?¹

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 MEDICATION GUIDE for OPSUMIT.¹