Contact a Case Manager for assistance

at 1-866-ACTELION
(1-866-228-3546).

Mon-Fri, 8 am-8 pm ET.

Support and Financial Assistance for TRACLEER® (bosentan)

If you have insurance coverage when TRACLEER is first prescribed, your healthcare team will submit your information to get your prescription paid for by your insurance plan. Sometimes, your insurance plan needs additional information. Alternatively, if you do not have insurance but need assistance to meet out-of-pocket costs, there may be financial assistance options available. In both cases, an Actelion Pathways® Case Manager can help with the process.

Connecting with financial assistance

There are several programs that can help you pay for TRACLEER.

Commercially insured
If you receive insurance through your employer or purchase it privately
Actelion Oral PAH Therapy Co-Pay Program* A savings program that lets eligible patients pay $5 per prescription fill per product. Contact an Actelion Pathways Case Manager for more information. Call 1-866-ACTELION (1-866-228-3546) Mon-Fri, 8 am-8 pm ET.*
Government insured
If you receive your medication through Medicare or other government-funded plans
Independent foundations There may be support available from independent third-party patient support foundations. An Actelion Pathways Case Manager can provide general information about resources.
Uninsured or underinsured
If you are uninsured or the cost of your medicine is covered by insurance, but you are unable to afford the out-of-pocket costs
Patient Assistance Program (PAP) A yearly program that helps you receive medicine at no cost. Contact an Actelion Pathways Case Manager to learn more.
Bridge Program (temporary patient assistance program) Offers 90 days of free drug coverage for patients when coverage is not immediately available (e.g., waiting for coverage to start, waiting for approval of prior authorization appeal, etc). Contact an Actelion Pathways Case Manager to learn more.

*Applies to patients who have provided consent to services offered by Actelion Pathways. The Actelion Oral PAH Therapy Co-Pay Program is only available for residents of the US and Puerto Rico who are 18 or older and have commercial health insurance with co-pay/co-insurance exceeding $5 per prescription fill per product. Patients ineligible for the Actelion Oral PAH Therapy Co-Pay Program include those enrolled in Medicare, Medicaid, VA/DoD (Tricare), the Indian Health Service, or any other federal- or state-funded healthcare program, or where prohibited by law. The Actelion Oral PAH Therapy Co-Pay Program is not prescription drug coverage or insurance. Actelion reserves the right to terminate or modify this program at any time or without notice. Other terms and conditions apply.

Additional support resources

The following organizations offer education and support to patients. Visit their websites for PAH information, news, and ideas about how to get involved with the PAH community.

Type of assistance Details Next steps
Education and advocacy The Pulmonary Hypertension Association is dedicated to increasing awareness and advocacy by providing information about PAH to both physicians and patients. Visit Pulmonary Hypertension Association online
Support and education The Scleroderma Foundation offers a site for scleroderma patients, caregivers, and family members—dedicated to support, education, and research. Visit Scleroderma Foundation online

Your Case Manager may need additional information from you at the start of treatment

When you speak with a Case Manager, they may ask for additional information including:

  • Details of your insurance 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)
  • If your initial claim is denied, your Case Manager may also need additional information from your healthcare team

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


Next: Find out about how your medicine can be delivered directly to your home in Working With a Specialty Pharmacy

What is the most important information I should know about TRACLEER?

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

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.

What is the most important information I should know about TRACLEER?

TRACLEER is only available through the Tracleer REMS Program. Before you begin taking TRACLEER, you must read and agree to all of the instructions in the Tracleer 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 Tracleer 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.
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.
  • 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 to improve the blood flow through the lungs, also known as pulmonary vascular resistance (PVR), which is expected to improve their ability to exercise. Studies showing TRACLEER is effective in pediatric patients included patients with WHO Functional Class II-III PAH and whose PAH was caused by unidentified or hereditary factors or being born with a heart condition.

TRACLEER is only:

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

  • 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 1-866-228-3546.

Please see full Prescribing Information, including BOXED WARNING about liver injury and birth defects, and Medication Guide.