TRACLEER® (bosentan) Patient Resources

The following resources are designed to help you as you start treatment with TRACLEER®. You will also find common questions and answers about Janssen CarePath and TRACLEER®.

Learn more about TRACLEER®

More information is available at Tracleer.com.

Remember, your healthcare team should always be your first point of contact when you have questions about your health and treatment.

Frequently Asked Questions (FAQs)

Janssen CarePath is a program that provides you with support and resources, including shipment verification, benefits verification, and coordination with your specialty pharmacy.

Janssen provides a wide range of support and resources through Janssen CarePath. If you choose to enroll, your Janssen CarePath Care Coordinator will call you to:

The assistance of Janssen CarePath and our Care Coordinators is available at no cost to patients taking TRACLEER®.

Enroll today. Call a Janssen CarePath Care Coordinator at 866-228-3546, Monday-Friday, 8 AM to 8 PM ET.

Multilingual phone support is available.

Your Janssen CarePath Care Coordinator may be able to help. Call 866-228-3546, Monday-Friday, 8 AM to 8 PM ET to speak with a Care Coordinator.

Multilingual phone support is available.

To learn about the basic steps of getting a Janssen medicine,
download and review Steps to Getting Your Medicine.

A specialty pharmacy is a pharmacy that can ship certain medicines directly to your home. Janssen PAH medicines are available by mail from a specialty pharmacy.

Learn about Working With a Specialty Pharmacy.

When your prescription is submitted to a specialty pharmacy, you will receive a call to:

  • Coordinate with your healthcare provider and insurance company to find out if you have coverage for your medicine and explore financial assistance options
  • Arrange delivery of your medicine

Each month, you will get a call from your specialty pharmacy to:

  • Confirm your order
  • Arrange delivery of your medicine
  • Confirm any required testing

Once your medicine is shipped:

  • It will be delivered to your home, unless you have made other arrangements, such as your doctor's office
  • Someone will need to be at home to sign for the package. Your specialty pharmacy will confirm this when they call to arrange the delivery

Your insurance provider will need to gather information about your condition and your treatment before covering TRACLEER®. Sometimes, all their questions are answered at the time of prescription, but they may also need more information from your healthcare team, including:

  • Diagnostic test results, such as the numbers from your right heart catheterization (RHC)
  • Additional test results, including acute vasoreactivity testing or 6-minute walk distance (6MWD)
  • Details on past treatments you and your healthcare team have tried
  • Information missing from your prescription forms

TRACLEER® can cause serious side effects, including liver damage and birth defects. When starting TRACLEER®, you must enroll in the Bosentan Risk Evaluation and Mitigation Strategy (REMS) Program.

Your healthcare team will enroll you at the start of treatment.

To learn more about the Bosentan REMS Program, visit BosentanREMSProgram.com.

There are several programs that may help you pay for TRACLEER®. For information on these programs, call a Janssen CarePath Care Coordinator at 866-228-3546, Monday-Friday, 8 AM to 8 PM ET.

Commercially insured

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 the health insurance plan, savings may apply toward co-pay, coinsurance 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.
See full eligibility requirements.

Government insured or no insurance

If you use a government-funded healthcare program to pay for TRACLEER® or have no insurance coverage and need help paying for your medication:

Janssen CarePath can provide information about other resources that may be able to help with your out-of-pocket medication costs for TRACLEER®.

Call a Janssen CarePath Care Coordinator at 866-228-3546 for more information about affordability programs and independent foundations that may have funding available.

Independent co-pay assistance foundations have their own rules for eligibility. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation.

There are independent patient advocacy organizations that can provide you with additional support and information:

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

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

see more

What is TRACLEER® (bosentan)?

TRACLEER® is a prescription medicine indicated for patients with certain types of pulmonary arterial hypertension (PAH, WHO Group 1), which is high blood pressure in the vessels of the lungs. TRACLEER® can improve your ability to exercise as measured by 6-minute walk test and can slow the worsening of your physical condition and symptoms.

  • In two different studies, TRACLEER® improved 6-minute walk distance by 35 and 76 meters. These studies focused on patients with WHO Functional Class III-IV.

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. Because of potential liver damage and in an effort to make the chance of fetal exposure to TRACLEER® as small as possible, TRACLEER® may be prescribed only through the Bosentan REMS Program.

Liver damage:

  • Liver damage may not cause symptoms at first. Only a blood test can show if you have early liver damage. So you must have your blood tested to check your liver function before you start TRACLEER® and each month after that. Your healthcare professional will order these tests. Regular blood tests are important because they will help your healthcare professional adjust or stop your treatment before there is permanent damage.

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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. Because of potential liver damage and in an effort to make the chance of fetal exposure to TRACLEER® as small as possible, TRACLEER® may be prescribed only through the Bosentan REMS Program.

Liver damage:

  • Liver damage may not cause symptoms at first. Only a blood test can show if you have early liver damage. So you must have your blood tested to check your liver function before you start TRACLEER® and each month after that. Your healthcare professional will order these tests. Regular blood tests are important because they will help your healthcare professional adjust or stop your treatment before there is permanent damage.
  • TRACLEER® can cause serious liver damage, including in rare cases liver failure. Even in situations with regular liver testing, rare cases of unexplained liver cirrhosis (scar tissue in the liver) have developed in patients with other medical conditions and taking other medications in addition to TRACLEER® for over 12 months.
  • 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
    • stomach area (abdominal) pain
    • fever
    • unusual tiredness
    • 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 are the possible side effects of TRACLEER®?

TRACLEER® can cause serious side effects, including:

  • Fluid retention and swelling of 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 professional 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 professional 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 professional if fertility is a concern for you.
  • Low red blood cell levels (anemia). Your healthcare professional 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 doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or by calling Actelion at 866-228-3546.


Please read the full Prescribing Information, including BOXED WARNING about liver injury and birth defects, and Medication Guide for TRACLEER®.

cp-113986

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. Because of potential liver damage and in an effort to make the chance of fetal exposure to TRACLEER® as small as possible, TRACLEER® may be prescribed only through the Bosentan REMS Program.

Liver damage:

  • Liver damage may not cause symptoms at first. Only a blood test can show if you have early liver damage. So you must have your blood tested to check your liver function before you start TRACLEER® and each month after that. Your healthcare professional will order these tests. Regular blood tests are important because they will help your healthcare professional adjust or stop your treatment before there is permanent damage.
  • TRACLEER® can cause serious liver damage, including in rare cases liver failure. Even in situations with regular liver testing, rare cases of unexplained liver cirrhosis (scar tissue in the liver) have developed in patients with other medical conditions and taking other medications in addition to TRACLEER® for over 12 months.
  • 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
    • stomach area (abdominal) pain
    • fever
    • unusual tiredness
    • 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 are the possible side effects of TRACLEER®?

TRACLEER® can cause serious side effects, including:

  • Fluid retention and swelling of 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 professional 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 professional 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 professional if fertility is a concern for you.
  • Low red blood cell levels (anemia). Your healthcare professional 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 doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or by calling Actelion at 866-228-3546.

Please read the full Prescribing Information, including BOXED WARNING about liver injury and birth defects, and Medication Guide for TRACLEER®.

cp-113986


What is TRACLEER® (bosentan)?

+

TRACLEER® is a prescription medicine indicated for patients with certain types of pulmonary arterial hypertension (PAH, WHO Group 1), which is high blood pressure in the vessels of the lungs. TRACLEER® can improve your ability to exercise as measured by 6-minute walk test and can slow the worsening of your physical condition and symptoms.

  • In two different studies, TRACLEER® improved 6-minute walk distance by 35 and 76 meters. These studies focused on patients with WHO Functional Class III-IV.
  • Clinical worsening was defined as any one of the following: a need to go to the hospital for PAH, stopping treatment because of worsening of PAH, a need for intravenous (IV) treatment (epoprostenol), or death.

Studies showing TRACLEER® is effective in adults included mainly patients with WHO Functional Class II-IV PAH. In these patients, PAH was caused by: unidentified or hereditary factors (60%); connective tissue disease (21%); being born with a hole in the heart between the left and right sides (18%).

TRACLEER® is also indicated in pediatric patients 3 years and older with PAH caused by unidentified or hereditary factors to improve a certain kind of blood flow to the heart called peripheral vascular resistance (PVR). Studies showing TRACLEER® is effective in pediatric patients included mainly patients with WHO Functional Class II-III.

TRACLEER® is only:

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