Treats a lung condition called pulmonary arterial hypertension (high blood pressure in the arteries of the lungs).
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
You should not use this medicine if you have had an allergic reaction to bosentan, or if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®), or glyburide (Diabeta®, Glynase®, Micronase®). You should not use this medicine if you are pregnant or planning to become pregnant during your treatment.
How to Use This Medicine
- Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. If you take more medicine than you are supposed to, call your doctor right away.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
- You may take this medicine with or without food.
- This medicine is available only under a special restricted distribution program called the Tracleer® Access Program (T.A.P.).
If a dose is missed:
- If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
How to Store and Dispose of This Medicine
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure you tell your doctor about all other medicines you are using. This is especially important if you are a woman taking birth control pills while you are using bosentan. Some medicines can cause birth control pills not to work as well to prevent pregnancy, and you should not take bosentan if you get pregnant.
- Make sure your doctor knows if you are also using amiodarone (Cordarone®), amprenavir (Agenerase®), diltiazem (Cardizem®, Dilacor®, Tiazac®), erythromycin (E-Mycin®, Eryc®, Ery-Tab®), lopinavir/ritonavir (Kaletra®), rifampicin (Rifadin®, Rimactane®), ritonavir (Norvir®) sildenafil (Viagra®), or tacrolimus (Prograf®). Tell your doctor if you are using medicine to treat a fungus infection (such as fluconazole, itraconazole, ketoconazole, voriconazole, Diflucan®, Nizoral®, Sporanox®, or Vfend®), medicine to lower cholesterol or triglycerides (such as atorvastatin, lovastatin, simvastatin, Lescol®, Lipitor®, Pravachol®, or Zocor®), or a blood thinner (such as warfarin, Coumadin®).
Warnings While Using This Medicine
Using this medicine while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant while you are using this medicine (even if the medicine is temporarily stopped), and for at least one month after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap. If a woman has had a tubal ligation, she does not need to use a second form of birth control. If you think you have become pregnant while using this medicine, tell your doctor right away.
- You must have a negative pregnancy test before you will be allowed to take this medicine. You will also be required to have a pregnancy test every month during your treatment. If you miss a period while you are using this medicine, tell your doctor right away.
- Make sure your doctor knows if you have liver disease, heart disease, or lung problems.
- Do not breastfeed while you are using this medicine.
- Stop using this medicine and call your doctor right away if you start to have nausea, vomiting, fever, dark-colored urine or pale stools, loss of appetite, pain in your upper stomach, or yellow eyes or skin. These could be signs of liver injury.
- This medicine may cause fluid retention. Check with your doctor right away if you are gaining weight rapidly; have swelling in your hands, ankles, feet, or all over the body; or if you have trouble with breathing while you are using this medicine.
- This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
- Pulmonary edema may occur while using this medicine. Stop using this medicine and check with your doctor right away if you have chest pain; difficult, fast, noisy breathing, sometimes with wheezing; blue lips and fingernails; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; or shortness of breath.
- Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
- Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check your liver function before you start this medicine and each month after that.
Possible Side Effects While Using This Medicine
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Chest pain or shortness of breath.
- Dark-colored urine or pale stools.
- Fast, uneven, or pounding heartbeat.
- Lightheadedness, dizziness, or fainting.
- Nausea, vomiting, loss of appetite, or pain in your upper stomach.
- Rapid weight gain.
- Swelling in your hands, ankles, lower legs, or feet.
- Unusual bleeding, bruising, or weakness.
- Warmth or redness in your face, neck, arms, or upper chest.
- Yellowing of your skin or the whites of your eyes.
If you notice these less serious side effects, talk with your doctor:
- Muscle or joint pain.
- Rash or itching skin.
- Sore throat or stuffy nose.
- Unusual tiredness.
- Upset stomach.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
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