*What is Tracleer® (bosentan)?
Tracleer is a prescription medicine indicated for patients with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs, (WHO Group 1). 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.1
- 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.1-3
Studies showing Tracleer is effective included mainly patients with NYHA 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 Access Program (T.A.P.®)
- available to people who understand and agree to enroll in T.A.P.
It is not known if Tracleer is safe and works in children below 12 years of age.
What is the most important information I should know about Tracleer?
Tracleer is only available through T.A.P. Before you begin taking Tracleer, you must read and agree to all of the instructions in T.A.P. 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 T.A.P., by calling 1-866-228-3546. Adverse events can also be reported directly via this number.
- 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 professional if you have had liver problems, including liver problems while taking other medicines. Call your healthcare professional right away if you have any of these symptoms of liver problems while taking Tracleer: nausea, vomiting, fever, unusual tiredness, stomach area (abdominal) pain, or 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 and each month during Tracleer treatment.
- Talk with your healthcare professional or gynecologist (a doctor who specializes in female reproduction) to find out about how to prevent pregnancy. Do not have unprotected sex. Tell your healthcare professional right away if you miss a menstrual period or think you may be pregnant.
- Females who are able to get pregnant must use two forms of birth control (contraception) during Tracleer treatment because there is a possibility of birth defects.
- Birth control pills, shots, patches, and implants should not be used alone because they are not reliable when you are taking Tracleer. You must choose and use two reliable forms of birth control at the same time.
- If you have had a tubal sterilization or have an IUD, these methods can be used alone. Otherwise, you should use two forms of birth control.
Talk with your healthcare professional about which 2 methods of reliable birth control you should use. Your healthcare professional may recommend that you use a different method of birth control to help lower your risk of problems with your pulmonary arterial hypertension.
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:
- Do not take Tracleer with cyclosporine A, a medication used for psoriasis and rheumatoid arthritis, and to prevent rejection of heart or kidney transplants. Using cyclosporine A with Tracleer may increase your chance of side effects.
- Do not take Tracleer with glyburide. Glyburide is used to treat diabetes and when used with Tracleer it may increase your chance of liver injury.
- Are allergic to 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 professional.
What are the possible side effects of Tracleer?
Tracleer can cause serious side effects, including:
- See "What is the most important information I should know about Tracleer?"
- 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 are: respiratory tract infection, headache, fainting, flushing, low blood pressure, inflamed nose passages (sinusitis), joint pain and irregular heartbeats.
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.
Please see full Prescribing Information, including BOXED WARNING about liver injury and birth defects, and Medication Guide.