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

OPSYNVI is a prescription medicine that contains 2 medicines called macitentan and tadalafil. OPSYNVI is used for long-term treatment of adults with pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.¹

How does OPSYNVI work?¹

Macitentan is an endothelin receptor antagonist (ERA) that helps in vasodilation which is the opening of blood vessels.

• In PAH, the local endothelin (ET) system is upregulated and involved in vascular (related to blood vessels) hypertrophy and organ damage.
• Macitentan stops the binding of ET-1 to its receptors (ETA and ETB).
• This helps lessen harmful effects such as vasoconstriction (narrowing of the blood vessels), fibrosis (thickening or stiffening of the body tissues), proliferation (rapid increase in the number of body cells), hypertrophy (rapid increase in the size of the body cells), and inflammation (a localized reaction of the body to an infection/irritation/injury that produces redness, warmth, swelling, and pain).
• Macitentan can improve your ability to exercise, improve some of your symptoms, and help slow down the progression of your disease. Macitentan can also lower your chance of being hospitalized for PAH.

Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor.

• PDE5 is an enzyme that is responsible for the breakdown of cyclic guanosine monophosphate (cGMP).
• In PAH, the cells lining the blood vessels release a reduced amount of nitric oxide which leads to a reduced concentration of cGMP in the pulmonary vascular (related to blood vessels in the lungs) smooth muscle.
• By inhibiting PDE5, tadalafil can increase the concentration of cGMP which leads to relaxation of the pulmonary vascular smooth muscle cells and opens the blood vessels.
• Tadalafil can improve your ability to exercise.

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