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.
• 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 should I store OPSYNVI?

• Store OPSYNVI tablets at room temperature between 68°F to 77°F (20°C to 25°C).¹
• Store OPSYNVI in the package that it comes in to protect from moisture.¹
• OPSYNVI contains a desiccant to help keep the tablets dry. Do not discard or eat the desiccant.¹
• OPSYNVI bottles have a child-resistant cap.¹
• Keep OPSYNVI and all medicines out of the reach of children.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 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