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Janssen CarePath Oral PAH Savings Program for TRACLEER®

Eligible patients using commercial or private insurance can save on out-of-pocket medication costs for TRACLEER®. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Eligible patients pay $5 per prescription fill with a $20,000 maximum program benefit per calendar year across all oral PAH therapies in the program. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. Offer not valid in CA or MA, or for MA residents (62.5 and 125 mg only). There is no income requirement.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners. If you are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please contact us at 866-228-3546.

See program requirements

Call a Janssen CarePath Care Coordinator at 866-228-3546 to enroll or for more information.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We can only refer you to foundations that support your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

For insured patients who are facing access and affordability challenges

Patient assistance is available if you have commercial, employer-sponsored, or government coverage that does not fully meet your needs. You may be eligible to receive your Janssen medication free of charge for up to one year. You must meet the eligibility and income requirements for the Janssen Patient Assistance Program. See terms and conditions at PatientAssistanceInfoPH.com or call 866-228-3546.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicare Savings Program

Many states have programs for people with limited income and resources that pay some or all of Medicare's premiums and may pay Medicare deductibles and co-insurance. Find out if your state has a program that can help you.

Visit this program site

Medicare Part D Extra Help — Low-Income Subsidy

Medicare patients who have limited income and resources may qualify for "extra help" to pay for prescription drugs. The Low-Income Subsidy (LIS) program from Medicare provides financial assistance for patients who may otherwise be unable to afford the costs associated with their Medicare Part D plan.

Those who are eligible for LIS may:

  • Receive assistance paying their monthly premium
  • Have a reduced or no deductible
  • Have reduced or no prescription co-insurance and co-payments
  • Have no gap in coverage

Visit this program site

Medicaid

Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We can only refer you to foundations that support your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

For insured patients who are facing access and affordability challenges

Patient assistance is available if you have commercial, employer-sponsored, or government coverage that does not fully meet your needs. You may be eligible to receive your Janssen medication free of charge for up to one year. You must meet the eligibility and income requirements for the Janssen Patient Assistance Program. See terms and conditions at PatientAssistanceInfoPH.com or call 866-228-3546.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicaid

Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We can only refer you to foundations that support your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. You may be eligible if you don't have insurance.

Want to see if you qualify? Get an application at JJPAF.org.

Questions? Call 833-919-3510 (toll free) / 308-920-4358 (direct dial), Monday through Friday, 8:00 AM to 8:00 PM ET.

Janssen CarePath Oral PAH Savings Program for TRACLEER®

Eligible patients using commercial or private insurance can save on out-of-pocket medication costs for TRACLEER®. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Eligible patients pay $5 per prescription fill with a $20,000 maximum program benefit per calendar year across all oral PAH therapies in the program. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. Offer not valid in CA or MA, or for MA residents (62.5 and 125 mg only). There is no income requirement.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners. If you are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please contact us at 866-228-3546.

See program requirements

Call a Janssen CarePath Care Coordinator at 866-228-3546 to enroll or for more information.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicare Savings Program

Many states have programs for people with limited income and resources that pay some or all of Medicare's premiums and may pay Medicare deductibles and co-insurance. Find out if your state has a program that can help you.

Visit this program site

Medicare Part D Extra Help — Low-Income Subsidy

Medicare patients who have limited income and resources may qualify for "extra help" to pay for prescription drugs. The Low-Income Subsidy (LIS) program from Medicare provides financial assistance for patients who may otherwise be unable to afford the costs associated with their Medicare Part D plan.

Those who are eligible for LIS may:

  • Receive assistance paying their monthly premium
  • Have a reduced or no deductible
  • Have reduced or no prescription co-insurance and co-payments
  • Have no gap in coverage

Visit this program site

Medicaid

Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We can only refer you to foundations that support your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

For insured patients who are facing access and affordability challenges

Patient assistance is available if you have commercial, employer-sponsored, or government coverage that does not fully meet your needs. You may be eligible to receive your Janssen medication free of charge for up to one year. You must meet the eligibility and income requirements for the Janssen Patient Assistance Program. See terms and conditions at PatientAssistanceInfoPH.com or call 866-228-3546.

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. You may be eligible if you don't have insurance.

Want to see if you qualify? Get an application at JJPAF.org.

Questions? Call 833-919-3510 (toll free) / 308-920-4358 (direct dial), Monday through Friday, 8:00 AM to 8:00 PM ET.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they may be able to help you.

Questions? 866-228-3546

Monday–Friday, 8:00 AM–8:00 PM ET

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IMPORTANT SAFETY INFORMATION
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WHAT IS TRACLEER®?

TRACLEER® is a prescription medicine used to treat people with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs.

TRACLEER® can improve your ability to exercise and can slow the worsening of your physical condition and symptoms.

TRACLEER® lowers high blood pressure in your lungs and lets your heart pump blood more efficiently.

TRACLEER® is only:

  • Prescribed by healthcare providers who are enrolled in the Bosentan REMS Program
  • Available to people who understand and agree to enroll in the Bosentan REMS Program

Important Safety Information

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT TRACLEER®?

TRACLEER® is only available through the Bosentan REMS Program. Before you begin taking TRACLEER®, you must read and agree to all of the instructions in the Bosentan REMS Program.

TRACLEER® can cause serious side effects including:

Liver Damage

  • Liver damage may not cause symptoms at first. Only a blood test can show if you have early liver damage. You must have your blood tested to check your liver function before you start TRACLEER® and each month after that. Your healthcare provider will order these tests. Regular blood tests are important because they will help your healthcare provider adjust or stop your treatment before there is permanent damage.
  • Tell your healthcare provider if you have had liver problems, including liver problems while taking other medicines. Call your healthcare provider right away if you have any of these symptoms of liver problems while taking TRACLEER®:
    • nausea
    • vomiting
    • fever
    • unusual tiredness
    • stomach area (abdominal) pain
    • yellowing of the skin or the whites of your eyes (jaundice)

Serious birth defects.

TRACLEER® can cause serious birth defects if taken during pregnancy. You must not be pregnant when you start taking TRACLEER® or during TRACLEER® treatment. Serious birth defects from TRACLEER® can happen early in pregnancy. Females who are able to get pregnant must have a negative pregnancy test before starting treatment with TRACLEER®, each month during treatment with TRACLEER®, and 1 month after stopping treatment with TRACLEER®.

  • Talk to your healthcare provider about your menstrual cycle. Your healthcare provider will decide when to do a pregnancy test and will order a pregnancy test for you depending on your menstrual cycle.
  • 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 two acceptable forms of birth control during treatment with TRACLEER®, and for one month after stopping TRACLEER® because the medicine may still be in the body.
    • If you have had a tubal sterilization or have an IUD (intrauterine device), these methods can be used alone and no other form of birth control is needed.
    • 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 TRACLEER®.
    • 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. 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.

If you are the parent or caregiver of a female child who started taking TRACLEER® before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your healthcare provider right away if you notice that she is developing breast buds or any pubic hair. Your healthcare provider should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.

Who should not take TRACLEER®?

Do not take TRACLEER® if you:

  • are pregnant, plan to become pregnant, or become pregnant during TRACLEER® treatment. TRACLEER® can cause serious birth defects. All females should read the birth defects section of “What is the most important information I should know about TRACLEER®?”
  • take one of these medicines:
    • cyclosporine A used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of heart, liver, and kidney transplants
    • glyburide used to treat diabetes
  • are allergic to bosentan or any of the ingredients in TRACLEER®. If you have a rash, hives or your lips swell after taking TRACLEER®, it may be a sign of an allergy. You should stop taking your TRACLEER® and talk to your healthcare provider.

What should I tell my healthcare provider before taking TRACLEER®?

TRACLEER® may not be right for you. Tell your healthcare provider about all your medical conditions, including if you:

  • have liver problems.
  • are breast-feeding or plan to breast feed. It is not known if TRACLEER® passes into your milk. You and your healthcare provider should decide if you will take TRACLEER® or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRACLEER® and other medicines may affect how each other works and cause side effects.

What are the possible side effects of TRACLEER®?

TRACLEER® can cause serious side effects, including:

  • Fluid retention and swelling of your ankles and legs. TRACLEER® can cause your body to hold too much water, and you may get swelling of your ankles and legs. Tell your healthcare provider if you have swelling of your ankles and legs that happens either with or without weight gain, or if you have more trouble with your breathing than normal. Your healthcare provider will look for the cause of this.
  • Lower Sperm Count. Some men who take TRACLEER® may have lower sperm counts. This may affect your ability to father a child. Tell your healthcare provider if fertility is a concern for you.
  • Low red blood cell levels (anemia). Your healthcare provider will do blood tests to check your red blood cells during treatment with TRACLEER®.

The most common side effects of TRACLEER® include:

  • respiratory tract infection
  • headache
  • fainting
  • flushing
  • low blood pressure
  • inflamed nose passages (sinusitis)
  • joint pain
  • irregular heart beats

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TRACLEER®. For more information, ask your doctor or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNINGS about liver injury and birth defects, and Medication Guide for TRACLEER® and discuss any questions you have with your doctor.

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