DrugindexOnline^{2nd edition}

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

Bosentan may cause serious liver problems. Liver function tests should be done before and during treatment with Bosentan to monitor for side effects. Be sure to keep all doctor and lab appointments. You should usually not take Bosentan 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. Bosentan may cause major birth defects if taken during pregnancy. Do not take Bosentan if you are pregnant or planning to become pregnant. You will need to have a pregnancy test before you start to take Bosentan , and monthly while you take it. Bosentan may interfere with the effectiveness of hormone birth control, including oral, patch, injectable, and implantable forms. Talk with your doctor about using reliable methods of birth control while you are taking Bosentan .

Bosentan is used for:

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

Bosentan 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 Bosentan if:

• you are allergic to any ingredient in Bosentan
• you are pregnant
• you have abnormal liver function tests
• you are taking cyclosporine or glyburide

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

Before using Bosentan :

Some medical conditions may interact with Bosentan . 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 taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver problems, heart problems (eg, congestive heart failure), or blood problems (eg, anemia)
• if you are taking warfarin

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

• Amiodarone, azole antifungals (eg, ketoconazole), cyclosporine, fluconazole, ritonavir, or tacrolimus because they may increase the risk of Bosentan 's side effects
• Glyburide or rifampin because the risk of liver problems may be increased
• Hormonal contraceptives (eg, oral, injected, patch, implanted birth control), HMG-CoA reductase inhibitors (eg, simvastatin), or medicines for diabetes because their effectiveness may be decreased by Bosentan

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bosentan 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 Bosentan :

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

• Bosentan comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Bosentan refilled.
• Take Bosentan by mouth with or without food.
• Take Bosentan on a regular schedule to get the most benefit from it. Taking Bosentan at the same times each day will help you to remember to take it.
• Continue to take Bosentan even if you feel well. Do not miss any doses.
• If you miss a dose of Bosentan , 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 Bosentan .

Important safety information:

• Dizziness or lightheadedness may occur while you are using Bosentan . These effects may be worse if you take it with alcohol or certain medicines. Use Bosentan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not stop taking Bosentan without checking with your doctor. Some conditions may become worse when the medicine is suddenly stopped.
• Women who are able to become pregnant must have a pregnancy test before starting Bosentan . 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 Bosentan .
• Bosentan decrease the effectiveness of hormonal birth control pills, injections, patches, and implants. Use at least 2 reliable forms of birth control while you are taking Bosentan . Talk with your doctor or pharmacist for more information.
• Lab tests, including liver function tests and complete blood cell counts, may be performed while you use Bosentan . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Bosentan 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: Bosentan may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Bosentan while you are pregnant. It is not known if Bosentan is found in breast milk. Do not breast-feed while taking Bosentan .

Possible side effects of Bosentan :

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; stomach upset; tiredness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; coughing up blood; dark urine; dizziness; fainting; fever; irregular heartbeat; lightheadedness; nausea; pale stools; severe or persistent stomach pain; shortness of breath; sudden weight gain; swelling of the ankles or legs; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include dizziness; fainting; fast heartbeat; lightheadedness.

Proper storage of Bosentan :

Store Bosentan at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bosentan out of the reach of children and away from pets.

General information:

• If you have any questions about Bosentan , please talk with your doctor, pharmacist, or other health care provider.
• Bosentan 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.

This information is a summary only. It does not contain all information about Bosentan . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.