How Does OPSYNVI Work?

Important information about opsynvi

• OPSYNVI can cause serious birth defects if taken during pregnancy.¹
• Females should not be pregnant when they start taking OPSYNVI or become pregnant during treatment with OPSYNVI.¹
• Females who are able to get pregnant should have a negative pregnancy test before beginning treatment with 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 should use effective birth control before starting treatment with OPSYNVI, during treatment, 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.
  • 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.
• 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.¹ 

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 (ET) receptor blocker that helps in relaxation of blood vessels.

• ETs are small proteins that attach to their receptors and make blood vessels tighter to help keep your blood pressure normal. 
• In PAH, the lung blood vessels have more ET in them. This makes the blood vessels get smaller and raises blood pressure. 
• When there is more ET, the walls of the blood vessels get thicker. This makes the vessels narrow or blocked, so less blood can flow through, and organs can be hurt. 
• This helps reduce problems like 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 advancement 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 the chemical molecule cyclic guanosine monophosphate (cGMP).
• In PAH, the cells in the blood vessels make less nitric oxide. This causes less cGMP in smooth muscle of the lungs.
• Tadalafil stops PDE5 from working, so more cGMP stays in the body. This helps relax the muscles in the blood vessels in the lungs and makes it easier for blood to flow.
• 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