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Janssen CarePath can:

  • Review your health plan benefits to help answer questions you may have about insurance coverage for OPSYNVI®
  • Identify options that may help make OPSYNVI® more affordable, if needed
  • Identify and coordinate with a specialty pharmacy to arrange shipment of your Janssen medication

OPSYNVI® (macitentan/tadalafil) Voucher Program

A free trial offer is available for eligible patients to help you become familiar with OPSYNVI®.

At the conclusion of the program, you and your healthcare provider decide whether to continue treatment. Subject to 1 (one) use per lifetime for the first supply of OPSYNVI®. Terms expire at the end of each calendar year and may change. This Voucher Program is open to patients who have commercial insurance, government coverage, or no insurance coverage; however, there is no guarantee of continuous accessibility after the program ends. Ask your doctor about the OPSYNVI® Voucher Program.

See full program requirements

Getting Started with OPSYNVI®

OPSYNVI® is delivered by a specialty pharmacy—it's not something that's kept in stock at your local retail pharmacy. The following is a typical process when starting out with OPSYNVI®, though your experience may vary.

  1. Prescription Prescription

    Your doctor selects OPSYNVI® as your new treatment.

    • Your healthcare team completes all the forms necessary to start you on the Janssen medicine. For OPSYNVI®, these forms include your prescription and, for females, enrollment in a program to make sure you use effective birth control during OPSYNVI® treatment and for 1 month after treatment discontinuation

    Macitentan-Containing Products REMS

    OPSYNVI® can cause serious birth defects if taken during pregnancy. If you are female, you must enroll in the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS) Program.

    The Macitentan-Containing Products REMS Program requires that, if you are able to get pregnant, you 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 your body. It also includes a monthly pregnancy test.

    If you are female, your healthcare team will enroll you in the Macitentan-Containing Products REMS Program at the start of your treatment.

  2. Insurance Verification Insurance verification

    The insurance company may ask your healthcare provider for additional information before they pay for your medicine.

    • A Janssen CarePath Care Coordinator can help with this process by gathering additional information from your healthcare team
  3. Delivery of Medicine Delivery of medicine

    OPSYNVI® is shipped to you by a specialty pharmacy.

    • A Janssen CarePath Care Coordinator will help you connect with a specialty pharmacy that delivers OPSYNVI® in your area
    • Each month, the specialty pharmacy will call you to confirm details of the delivery, make sure you've completed a pregnancy test if required, and arrange your refill
    • The shipment is usually quick, but the process leading up to your first delivery could take more than 2 weeks
    • Before shipping, the specialty pharmacy will call you to confirm some details, including the shipment date and verification that you've completed a pregnancy test (if required). Be sure to answer, or call the specialty pharmacy back if they leave a message

    Remember, the call from your specialty pharmacy may come from a phone number that you don't know. If you miss the call, it's important that you call back.

  4. Refills Refills

    Females who are able to get pregnant will need to complete required monthly testing and your doctor must verify your prescription. Once this is completed, the specialty pharmacy will ship your refill.

Your Janssen CarePath Care Coordinator may need additional information from you at the start of treatment

When you speak with a Care Coordinator, they may ask for additional information, including:

  • Details of your healthcare plan, including the name and contact information for the insurance company and your policy number
  • The name and contact information of your prescribing doctor (including the fax number)
  • Further details from your healthcare team, if your initial claim is denied

If you change insurance plans or healthcare providers, speak with your healthcare team and a Care Coordinator in a timely manner to make sure you can continue your treatment.

Contact a Care Coordinator with questions at 866-228-3546, Monday–Friday, 8:00 AM to 8:00 PM ET.

If your health plan does not approve OPSYNVI® treatment

Sometimes you may not be able to obtain the medication that your doctor has ordered for you. For example, your health plan might not cover the medication because it is not on the plan’s drug list (formulary) or the cost is higher than you think you should have to pay. In these situations, you and your doctor have the right to ask the health plan to explain its decision and to consider making the medication available to you as an exception to its policies.

Support Resources

  • Patient education and tools, including internet resources

Need Help? Call a Janssen CarePath Care Coordinator at 866-228-3546, Monday–Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support is available.

PAH Companion withMe

Everyone faces PAH differently. Once you and your doctor have decided that a Janssen PAH medication is right for you, you can join PAH Companion withMe*—a suite of patient support resources personalized just for you. You’ll receive one-on-one educational support to help with your prescribed Janssen PAH medication, plus customized tools and resources to help you take a more active role in your care.

When you participate in PAH Companion withMe, you’ll have access to:

  • My PAH Companion. One-on-one conversations with a trained, dedicated PAH Companion— someone who specializes in helping people living with PAH. Your PAH Companion will communicate with you via phone, email, or text.
  • My Resources. Educational resources to help with your prescribed Janssen PAH medication, tailored to your specific needs, questions, and interests.
  • My Tips. Ongoing support and education on living with PAH to help you partner with your healthcare team and engage with your support network.
  • Community. Connection to peer support groups, current PAH information and resources, and digital tools to help you track and monitor your health.

If you’re receiving a Janssen PAH medication, you can learn more about PAH Companion withMe by calling 866-300-1818, Monday–Friday, 8 AM to 9 PM ET.

PAH Companion withMe is limited to education about your Janssen PAH therapy, its administration, and/or PAH. It is not intended to provide medical advice, replace a treatment plan you receive from your healthcare team, or serve as a reason for you to start or stay on treatment.
*PAH Companion withMe is only for patients on certain Janssen PAH medications and requires a completed patient authorization form to enroll.

Visit PAHCompanion.com to learn more.

Connecting with others in your community

Resources are available online that can offer support and help you connect with others who are living with your condition. These include local support groups, fundraising walks, outreach programs, online communities, and volunteer opportunities. The websites below can help you learn more about your condition and connect with others.

OPSYNVI® Website
OPSYNVI.com
This website contains information about treatment with OPSYNVI®. On this website, you can also get helpful information about your condition.

Pulmonary Hypertension Association
phassociation.org
The Pulmonary Hypertension Association is dedicated to increasing awareness and advocacy by providing information about PAH to both physicians and patients.

Scleroderma Foundation
www.scleroderma.org
The Scleroderma Foundation offers a site for scleroderma patients, caregivers, and family members—dedicated to support, education, and research.

IMPORTANT SAFETY INFORMATION

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What is OPSYNVI® (macitentan and tadalafil)?

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.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about OPSYNVI® (macitentan and tadalafil)?

OPSYNVI® can cause serious birth defects if taken during pregnancy. 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®.

Females who are able to get pregnant must have a negative pregnancy test before beginning treatment, each month during treatment and for 1 month after stopping treatment with OPSYNVI®. Your doctor will decide when to do the pregnancy test.

  • Females who are able to get pregnant are females who:
    • have entered puberty, even if they have not started their menstrual period, and
    • have a uterus, and
    • have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed
  • Females who are not able to get pregnant are females who:
    • have not yet entered puberty, or
    • do not have a uterus, or
    • have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or
    • are infertile for other medical reasons and this infertility is permanent and cannot be reversed

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. If you have had a tubal sterilization, have a progesterone implant, or have an IUD (intrauterine device), these methods can be used without another form of birth control. Talk with your doctor 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 doctor or gynecologist to be sure that you choose another acceptable form of birth control. Also review the Medication Guide for acceptable birth control options.

Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your doctor may talk with you about using emergency birth control.

Tell your doctor right away if you miss a menstrual period or think you may be pregnant.

Females can only receive OPSYNVI® through a restricted program called the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS). If you are a female who can get pregnant, you must talk to your doctor, understand the benefits and risks of OPSYNVI®, and agree to all of the instructions in the Macitentan-Containing Products REMS. Males can receive OPSYNVI® without taking part in the Macitentan-Containing Products REMS.

Who should not take OPSYNVI® (macitentan and tadalafil)?

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 “What is the most important information I should know about OPSYNVI®?”)
  • are allergic to macitentan, tadalafil, or any of the ingredients in OPSYNVI®. Review the Medication Guide for a complete list of ingredients in OPSYNVI®
  • take any medicines called nitrates
  • take any medicines called guanylate cyclase (GC) stimulators

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

  • have liver problems
  • have low blood pressure
  • have low red blood cell levels (anemia)
  • have heart problems including heart attack or heart failure
  • have narrowing of the pulmonary veins (veins in your lungs). This is called pulmonary veno-occlusive disease (PVOD)
  • have any eye problems, including non-arteritic anterior ischemic optic neuropathy (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. OPSYNVI® can cause serious birth defects
  • 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 doctor 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 doctor. Especially tell your doctor 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 doctor 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 doctor or pharmacist when you get a new medicine.

What should I avoid while taking OPSYNVI®?

Do not have more than 4 alcohol-containing drinks in a short period of time during treatment with OPSYNVI®. Drinking too much alcohol can increase your chances of getting low blood pressure, increased heart rate, dizziness and headache.

What are the possible side effects of OPSYNVI®?

OPSYNVI® can cause serious side effects, including:

  • Serious birth defects. See “What is the most important information I should know about OPSYNVI®?”
  • Liver problems. OPSYNVI® can cause liver problems. Your doctor should do blood tests to check your liver before you start taking OPSYNVI®. Tell your doctor if you have any of the following symptoms of liver problems during treatment with OPSYNVI®:
  • nausea or vomiting
  • pain in the upper right stomach
  • tiredness
  • loss of appetite
  • yellowing of your skin or whites of your eyes
  • dark urine
  • fever
  • 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 doctor 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 doctor right away
  • Hearing problems. Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, can happen during treatment with OPSYNVI®. If you notice a sudden decrease or loss of hearing, contact your doctor right away
  • Fluid retention. Fluid retention can happen within weeks after starting OPSYNVI® and could lead to hospitalization. Tell your doctor right away if you have any unusual weight gain, trouble breathing, or swelling of your ankles or legs. Your doctor 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 doctor 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 OPSYNVI®. Painful erections (priapism) can cause permanent damage to the penis if not treated right away. Tell your doctor 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)
  • low red blood cell levels (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.

Please read full Prescribing Information, including Boxed Warning, and Medication Guide for OPSYNVI® and discuss any questions you have with your doctor.

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