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
  • 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.
• 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

Recommended dosage

• The recommended dosage of OPSUMIT is 10 mg once daily orally by mouth.¹
  • Doses higher than 10 mg once daily have not been studied in patients with pulmonary arterial hypertension (PAH) and are not recommended.

How should I take OPSUMIT?

• OPSUMIT will be mailed to you by specialty pharmacy. Your healthcare provider will give you complete details.¹
• Take OPSUMIT exactly as your healthcare provider tells you to take it. Do not stop taking OPSUMIT unless your healthcare provider tells you.¹
• You can take OPSUMIT with or without food.¹
• If you take too much OPSUMIT, call your healthcare provider or go to nearest hospital emergency room right away.¹
• If you miss a dose of OPSUMIT take it as soon as you remember that day.¹
  • Take the next dose at your regular time.
  • Do not take 2 doses at the same time to make up for the missed dose.

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