OPSYNVI^® Resources
and FAQs

Pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) is a serious and progressive disease causing high blood pressure in the arteries between the heart and lungs that may lead to right heart failure over time.

PAH treatments address imbalances in naturally occurring substances that affect the health of the blood vessels in the lungs, such as endothelin, nitric oxide, and prostacyclin. Targeting these three foundational pathways aims to restore balance to manage PAH.

There are three foundational pathways targeted by PAH treatments. These treatments aim to help correct imbalances in the endothelin, nitric oxide, and/or prostacyclin pathways.

PAH is a progressive disease, which means it worsens over time, sometimes without clear indications of symptom worsening. However, effective medical interventions and treatment can improve the manageability of PAH symptoms and clinical outcomes. Ongoing care is often essential for maintaining optimal control.

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.

It is not known if OPSYNVI^® is safe and effective in children.

OPSYNVI^® contains two active ingredients: macitentan and tadalafil. OPSYNVI^® contains a number of inactive ingredients, which do not have a therapeutic effect but are still necessary for the medication.

Please see the OPSYNVI^® Medication Guide for a full list of ingredients.

The study included patients taking OPSYNVI^® (n=108) once daily, taking macitentan alone (n=35) and taking tadalifil alone (n=44) once daily.

If you are taking other PAH medications, speak to your doctor for advice.

Whether you are starting a PAH medication for the first time, or transitioning from another PAH-specific medication (like an ERA, PDE5 inhibitor, or a combination of the two), your doctor will advise you on how to start OPSYNVI^®. To determine the correct starting dose, your doctor will take into account your medical history, any current PAH-specific medications you may be taking, as well as other medications you are taking, including prescription medications for other conditions, over-the-counter medications, vitamins, or supplements.

Do not take OPSYNVI^® if you:

• are pregnant, plan to become pregnant, or become pregnant during treatment with OPSYNVI^®. OPSYNVI^® can cause serious birth defects. See Important Safety Information below
• are allergic to macitentan, tadalafil, or any of the ingredients in OPSYNVI^®
• take any medicines called nitrates
• take any medicines called guanylate cyclase (GC) stimulators

OPSYNVI^® can cause serious side effects, including:

• Serious birth defects. See Important Safety Information below
• Liver problems. OPSYNVI^® can cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking OPSYNVI^®. Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with OPSYNVI^®

  • nausea or vomiting

  • yellowing of your skin or whites of your eyes

  • pain in the upper right stomach

  • dark urine

  • tiredness

  • fever

  • loss of appetite

  • itching

• Decreased blood pressure (hypotension). OPSYNVI^® can cause low blood pressure that lasts for a short time
• Low red blood cell levels (anemia) can occur with OPSYNVI^® treatment, usually during the first weeks after starting therapy. Your healthcare provider will do blood tests to check your red blood cells before starting and as needed during treatment with OPSYNVI^®
• Vision loss. OPSYNVI^® can cause decreased eyesight or permanent loss of vision in 1 or both eyes, which could be a sign of NAION. There is an increased risk of NAION in people who have already had NAION in 1 eye. If you notice a sudden decrease or loss of vision in 1 or both eyes, contact your healthcare provider right away
• Hearing problems. Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, can happen during treatment with OPSNYVI^®. If you notice a sudden decrease or loss of hearing, contact your healthcare provider right away
• Fluid retention. Fluid retention can happen within weeks after starting OPSYNVI^® and could lead to hospitalization. Tell your healthcare provider right away if you have any unusual weight gain, trouble breathing, or swelling of your ankles or legs. Your healthcare provider will look for the cause of any fluid retention and may stop treatment with OPSYNVI^®
• Decreased sperm count. OPSYNVI^® can cause decreased sperm counts in males and may affect the ability to father a child. Tell your healthcare provider if being able to have children is important to you
• Prolonged erection. Erections that last more than 4 hours, with or without pain, can happen during treatment with OPSNYVI^®. Painful erections (priapism) can cause permanent damage to the penis if not treated right away. Tell your healthcare provider right away if you have an erection that lasts longer than 4 hours, with or without pain

The most common side effects of OPSYNVI^® include:

• too much fluid in your body (fluid retention) and swelling caused by too much fluid (edema)
• anemia
• headache, including migraine headache

These are not all the possible side effects of OPSYNVI^®.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking OPSYNVI^®, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
• have low blood pressure
• have anemia
• have heart problems including heart attack or heart failure
• have pulmonary veno-occlusive disease (PVOD)
• have any eye problems, including NAION or an inherited eye disorder called retinitis pigmentosa
• have hearing problems such as ringing in the ears, dizziness, or loss of hearing
• have a deformed penis shape or Peyronie’s disease or have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia. These conditions increase your risk of getting a prolonged erection
• have kidney problems or get dialysis
• are pregnant or plan to become pregnant during OPSYNVI^® treatment. OPSNYVI^® can cause serious birth defects. See Important Safety Information below
• are breastfeeding or plan to breast feed. It is not known if OPSYNVI^® passes into your breastmilk. Do not breastfeed during treatment with OPSYNVI^®

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking OPSYNVI^® with other medicines may affect the way OPSYNVI^® and the other medicines work, and may increase your risk of side effects. Do not start any new medicine until you check with your healthcare provider.

Especially tell your healthcare provider if you take:

• nitrate medicines
• HIV medicines
• antifungal medicines
• antiseizure medicines
• medicines used to treat infection
• erectile dysfunction medicines
• blood pressure medicines
• medicines used to treat PAH or heart problems

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list and show it to your healthcare provider or pharmacist when you get a new medicine.

OPSYNVI^® will be mailed to you by a specialty pharmacy. Your healthcare provider will give you complete details.

• Take OPSYNVI^® exactly as your healthcare provider tells you to take it. Do not stop taking OPSYNVI^® unless your healthcare provider tells you
• Take OPSYNVI^® with or without food
• Do not cut, crush, or chew OPSYNVI^® tablets
• If you take too much OPSYNVI^®, call your healthcare provider or go to the nearest hospital emergency room right away
• If you miss a dose of OPSYNVI^®, take it as soon as you remember that day. Take the next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose

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

Once you and your healthcare provider have decided that a Janssen medication is right for you, Janssen CarePath will help you find the resources you may need to get started and stay on track.

We will give you information on your insurance coverage, potential out-of-pocket costs, and treatment support, and identify options that may help make your treatment more affordable.

Visit JanssenCarePath.com/OPSYNVI.

If you have questions, call a Janssen CarePath Care Coordinator at 866-228-3546, Monday–Friday, 8:00 AM–8:00 PM ET. Multilingual phone support is available.