Important information about opsynvi

• OPSYNVI can cause serious birth defects if taken during pregnancy.¹
• Females must not be pregnant when they start taking OPSYNVI or become pregnant during treatment with OPSYNVI or for 1 month after stopping treatment with OPSYNVI.¹
• Females who are able to get pregnant must have a negative pregnancy test before beginning treatment with OPSYNVI, each month during treatment with OPSYNVI and 1 month after stopping OPSYNVI.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 2 acceptable forms of birth control during treatment with OPSYNVI, and for 1 month after stopping OPSYNVI 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 OPSYNVI.
• Females can only receive OPSYNVI 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 OPSYNVI, 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

• For patients who have not yet received any pulmonary arterial hypertension
  (PAH)-specific therapy or are transitioning from monotherapy with a drug belonging to the endothelin receptor antagonist (ERA) class¹:
  • The recommended starting dose of OPSYNVI is one 10 mg/20 mg tablet taken orally once daily with or without food for 1 week. If tolerated, the OPSYNVI dose will be increased to one 10 mg/40 mg tablet taken orally once daily with or without food as the maintenance dose.
• For patients transitioning from monotherapy with a drug belonging to the phosphodiesterase type-5 (PDE5) inhibitor class or combination therapy with drugs belonging to PDE5 inhibitor and ERA classes¹:
  • The recommended dose of OPSYNVI is one 10 mg/40 mg tablet taken orally once daily.

How should I take OPSYNVI?

• OPSYNVI will be mailed to you by a specialty pharmacy. Your healthcare provider will give you complete details.¹
• Take OPSYNVI exactly as your healthcare provider tells you to take it. Do not stop taking OPSYNVI unless your healthcare provider tells you.¹
• Take OPSYNVI with or without food.¹
• Do not cut, crush, or chew OPSYNVI tablets.¹
• If you take too much OPSYNVI, call your healthcare provider or go to the nearest hospital emergency room right away.¹
• If you miss a dose of OPSYNVI, 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 a 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 OPSYNVI.¹