Generic Name: Bosentan

  • What is Tracleer?

    Tracleer is a medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the blood vessels between your heart and lungs, to diminish symptoms associated with exercise. Tracleer can improve your ability to exercise 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 Access Program (T.A.P.). Before you begin taking Tracleer, you must read and agree to all of the instructions in T.A.P.

    Tracleer can cause liver damage. Your doctor will perform a blood test before you start Tracleer and each month after that. These regular blood tests will help your doctor adjust or stop your treatment. Tell your doctor if you experience a fever, nausea, stomach area pain, unusual tiredness, vomiting, yellowing of your skin or the whites of your eyes.

    Tracleer can cause serious birth defects if you take it during pregnancy. You must not be pregnant when you start taking Tracleer or during Tracleer treatment. If you are able to get pregnant, you must have a negative pregnancy test before starting treatment and each month during Tracleer treatment.

    Talk to your doctor about birth control methods. You must use 2 reliable forms of birth control at the same time during Tracleer treatment. Do not have unprotected sex. Tell your doctor immediately if you miss a menstrual period or think you may be pregnant.

    Tell your doctor if you are already using a method of reliable birth control. Your doctor 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 allergic to it or any of its ingredients. Also, do not take Tracleer if you have a blood test that shows possible liver injury; if you take cyclosporine A (for psoriasis or rheumatoid arthritis) or antidiabetes medications (such as glyburide); or are pregnant, plan to become pregnant, or become pregnant during Tracleer treatment.

  • What should I tell my doctor before I take the first dose of Tracleer?

    Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Tracleer. Also, talk to your doctor about your complete medical history, especially if you have liver problems, or are pregnant, plan to become pregnant, or are breastfeeding.

  • What is the usual dosage?

    The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

    Adults: The recommended starting dose is 62.5 milligrams (mg) twice a day for 4 weeks, then 125 mg twice a day thereafter.

  • How should I take Tracleer?

    Take Tracleer exactly as prescribed by your doctor. Do not take extra doses or take more often without asking your doctor.

    Take 1 tablet in the morning and 1 tablet in the evening with or without food.

    Tracleer will be mailed to you by a specialty pharmacy. You will only receive a 30-day supply of Tracleer at one time.

  • What should I avoid while taking Tracleer?

    Do not miss your follow-up appointments with your doctor.

    Do not stop taking Tracleer unless your doctor tells you to. Suddenly stopping your treatment can cause your symptoms to get worse.

    Do not use Tracleer for a condition for which it was not prescribed. Do not give Tracleer to other people, even if they have the same symptoms that you have. It may harm them.

  • What are possible food and drug interactions associated with Tracleer?

    If Tracleer is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Tracleer with the following: amiodarone, amprenavir, cyclosporin A, digoxin, diltiazem, erythromycin, fluconazole, glyburide, hormonal birth control, itraconazole, ketoconazole, losartan, nimodipine, rifampin, ritonavir, sildenafil, simvastatin, tacrolimus, or warfarin.

  • What are the possible side effects of Tracleer?

    Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

    Side effects may include: anemia, fainting, flushing, headache, irregular heartbeat, joint pain, low blood pressure, lower sperm count (men), lung infections, sinusitis (inflammation of your sinuses), swelling of your ankles and legs

  • Can I receive Tracleer if I am pregnant or breastfeeding?

    Tracleer may cause harm to your unborn baby if you take it during pregnancy. Do not breastfeed while you are taking Tracleer. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

  • What should I do if I miss a dose of Tracleer?

    If you miss a dose of Tracleer, take it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular dosing schedule. Do not take two doses at once.

  • How should I store Tracleer?

    Store at room temperature.