Bosentan (boe-SEN-tan)

Treats pulmonary arterial hypertension (PAH).

Brand Name(s):

Tracleer

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• The tablet for suspension can be taken whole or divided into half along the lines cut into its surface. Do not break it into quarters. You may dissolve it in a small amount of water to make a liquid mixture before taking it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the tablet for suspension that have been broken at room temperature in the opened blister container for up to 7 days.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with cyclosporine or glyburide.
• 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 affect how bosentan works. Tell your doctor if you are also using any of the following:
  • Amiodarone, diltiazem, sildenafil, tacrolimus
  • Blood thinner (including warfarin)
  • Medicine for HIV infection (including amprenavir, lopinavir/ritonavir, ritonavir)
  • Medicine for infection (including erythromycin, fluconazole, itraconazole, ketoconazole, rifampin)
  • Medicine to lower cholesterol (including atorvastatin, lovastatin, simvastatin)

Warnings While Using This Medicine:

• This medicine can cause very serious birth defects. Use 2 forms of effective birth control while you are taking this medicine, and for at least 1 month after you stop. For example, use 1 hormonal method (including birth control pills) and 1 barrier method (including condoms). If you miss a period or think you have become pregnant while you are taking 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 and for 1 month after treatment.
• Do not breastfeed while you are using this medicine.
• Tell your doctor if you have liver disease, heart disease, lung problems, or swelling in any part of your body.
• This medicine may cause the following problems:
  • Liver problems
  • Fluid retention, including pulmonary edema (fluid in the lungs)
• This medicine may decrease sperm production. Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, uneven, or pounding heartbeat
• Lightheadedness, dizziness, or fainting
• 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

If you notice these less serious side effects, talk with your doctor:

• Headache

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