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Getting Started on TRACLEER® (bosentan)

TRACLEER is usually delivered by a specialty pharmacy—it’s not something that’s kept in stock at your local pharmacy. The following is a typical process when starting out with TRACLEER, but your experience may vary.

  1. Prescription

    Your doctor selects TRACLEER as your new treatment.

    • Your healthcare team completes all the forms necessary to start you on the Actelion medicine. For TRACLEER, this includes enrollment in the REMS program to monitor liver function and to make sure that females who are able to get pregnant use effective birth control during treatment and for 1 month after treatment discontinuation
  2. Insurance verification

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

    • An Actelion Pathways® Case Manager can help with this process by gathering additional information from your healthcare team
  3. Delivery of medicine

    TRACLEER is shipped to you by a specialty pharmacy.

    • The shipment is usually quick, but the process leading up to your first delivery could take up to 2 weeks or more
    • Before shipping, the specialty pharmacy will call you to confirm some details, including the shipment date and verification that you’ve completed a monthly liver function test and a pregnancy test (females only). Be sure to answer, or call the specialty pharmacy back if they leave a message
  4. Refills

    You will need to complete required monthly testing and your doctor will verify your prescription. Then the specialty pharmacy will ship your refill.

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.

Once you start taking TRACLEER, be sure to contact your healthcare provider if you have any questions.

TRACLEER REMS enrollment

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

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

Next: Learn about financial support resources in Finding Support and Financial Assistance

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 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%).

In patients with Functional Class II symptoms, TRACLEER slowed the worsening of PAH, however, it did not show meaningful improvement in walk distance. If you are a patient with Functional Class II symptoms, your healthcare professional will consider whether the potential benefits of TRACLEER outweigh the risk of liver damage, which may prevent future use of TRACLEER as your disease progresses.

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.