Tracleer

Generic Name: bosentan (boe-SEN-tan)
Brand Name: Tracleer

Tracleer may cause serious liver problems. Liver function tests should be done before and during treatment with Tracleer to monitor for side effects. Be sure to keep all doctor and lab appointments. You should usually not take Tracleer if you have abnormal liver function tests. Contact your doctor immediately if you experience nausea, vomiting, fever, stomach pain, yellowing of the skin or eyes, dark urine, pale stools, or unusual tiredness.

Tracleer may cause serious birth defects if taken during pregnancy. Do not take Tracleer if you are pregnant or planning to become pregnant. You will need to have a negative pregnancy test before you start Tracleer, and monthly while you take it. You must also use 2 effective forms of birth control while you take Tracleer and for 1 month after you stop taking it. Talk with your doctor about the use of effective birth control while you take Tracleer.

Tracleer is only available through a special program called Tracleer Access Program. Talk to your doctor to be sure you are enrolled in this program and that you meet all of its requirements.


Tracleer is used for:

Treating high blood pressure in the lungs (pulmonary arterial hypertension) in certain patients.

Tracleer is an endothelin receptor antagonist. It works by blocking a certain substance in the lungs, which helps to decrease blood pressure in the lungs.

Do NOT use Tracleer if:

  • you are allergic to any ingredient in Tracleer
  • you are pregnant or may become pregnant
  • you have moderate to severe liver problems
  • you are taking bosutinib, cabazitaxel, cyclosporine, or glyburide

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Tracleer:

Some medical conditions may interact with Tracleer. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver problems, abnormal liver function tests, heart problems (eg, congestive heart failure), or blood problems (eg, anemia)
  • if you have fluid retention (eg, unusual swelling of the arms, hands, legs, or feet)
  • if you drink alcohol or take medicines that may harm the liver (eg, acetaminophen, methotrexate, isoniazid, certain medicines for HIV infection). Ask your doctor if you are unsure if any of your medicines might harm the liver

Some MEDICINES MAY INTERACT with Tracleer. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amiodarone, azole antifungals (eg, fluconazole, itraconazole, ketoconazole, voriconazole), cobicistat, cyclosporine, diltiazem, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), or tacrolimus because they may increase the risk of Tracleer's side effects
  • Glyburide or rifampin because the risk of liver problems may be increased
  • Anticoagulants (eg, warfarin), axitinib, bosutinib, cabazitaxel, HMG-CoA reductase inhibitors (statins) (eg, simvastatin), hormonal contraceptives (eg, oral, injected, patch, implanted birth control), or ulipristal because their effectiveness may be decreased by Tracleer

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tracleer may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tracleer:

Use Tracleer as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Tracleer comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tracleer refilled.
  • Take Tracleer by mouth with or without food.
  • Do not suddenly stop taking Tracleer without checking with your doctor. Your condition may become worse if Tracleer is suddenly stopped. If you need to stop Tracleer, your doctor may gradually lower your dose.
  • Take Tracleer on a regular schedule to get the most benefit from it. Taking Tracleer at the same times each day will help you to remember to take it.
  • Continue to take Tracleer even if you feel well. Do not miss any doses.
  • If you miss a dose of Tracleer, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tracleer.

Important safety information:

  • Tracleer may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Tracleer with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not take more than the recommended dose or change your dose of Tracleer without checking with your doctor.
  • Serious liver problems may occur while taking Tracleer. Contact your doctor right away if you develop symptoms of liver problems, such as nausea, vomiting, loss of appetite, fever, stomach pain, yellowing of the skin or eyes, dark urine, pale stools, itching, or unusual tiredness or achiness. Discuss any questions or concerns with your doctor.
  • Women who are able to become pregnant must have a negative pregnancy test before starting Tracleer. This test must occur during the first 5 days of a normal menstrual period and at least 11 days after the last unprotected sexual intercourse. Pregnancy tests must also be done each month during treatment with Tracleer.
  • Tracleer may decrease the effectiveness of hormonal birth control pills, injections, patches, and implants. Women who are able to become pregnant must use 2 effective forms of birth control while they take Tracleer and for 1 month after they stop taking it. Talk with your doctor about the use of effective birth control while you use Tracleer.
  • Tracleer may decrease sperm count in men, which could impair the ability to father a child. Contact your doctor with any questions or concerns.
  • Tell your doctor or dentist that you take Tracleer before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including liver function and complete blood cell counts, may be performed while you use Tracleer. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Tracleer should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Tracleer may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant or you miss your menstrual period, contact your doctor right away. It is not known if Tracleer is found in breast milk. Do not breast-feed while taking Tracleer.

Possible side effects of Tracleer:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Flushing; headache; nose or throat irritation; symptoms of respiratory tract infection (eg, cough, runny or stuffy nose, sneezing).

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; dizziness; fainting; fever, chills, or persistent sore throat; irregular heartbeat; joint pain; light-headedness; new or worsening swelling of the arms, hands, legs, or feet; shortness of breath; sudden, unexplained weight gain; symptoms of liver problems (eg, dark urine; pale stools; persistent loss of appetite; stomach pain; unusual nausea, vomiting, or tiredness; yellowing of the skin or eyes); unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; fainting; fast heartbeat; light-headedness; nausea; severe or persistent headache; vomiting.

Proper storage of Tracleer:

Store Tracleer at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tracleer out of the reach of children and away from pets.

General information:

  • If you have any questions about Tracleer, please talk with your doctor, pharmacist, or other health care provider.
  • Tracleer is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Tracleer or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tracleer. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tracleer. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Tracleer.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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