Tracleer (Bosentan)

(boe sen' tan)

For female patients: Do not take bosentan if you are pregnant or plan to become pregnant. Bosentan may harm the fetus. If you are sexually active and able to become pregnant, you should not begin taking bosentan until a pregnancy test has shown that you are not pregnant. You must use a reliable method of birth control and be tested for pregnancy every month during your treatment. Hormonal contraceptives (birth control pills, patches, rings, shots, implants, and intrauterine devices) may not work well when used with bosentan and should not be used as your only method of birth control. Talk to your doctor about birth control methods that will work for you. Call your doctor immediately if you miss a period or think that you may be pregnant while you are taking bosentan. For male and female patients: Bosentan may cause liver damage. Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately: upset stomach, vomiting, fever, stomach pain, yellowing of the skin or eyes, or extreme tiredness. Keep all appointments with your doctor and the laboratory. Your doctor will order a blood test to be sure your liver is working normally before you start taking bosentan and every month during your treatment. Bosentan may damage the liver without causing symptoms. Regular blood tests are the only way to find liver damage before it becomes permanent and severe. Bosentan is not available at retail pharmacies. Your medication will be mailed to you from a central pharmacy. This program is required to be sure that all patients who receive the medication are tested for liver damage and pregnancy. Ask your doctor if you have any questions about how you will receive your medication. Talk to your doctor about the risks of taking bosentan.

Bosentan is used to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs). Bosentan may improve the ability to exercise and slow the worsening of symptoms in patients with PAH. Bosentan is in a class of medications called endothelin receptor antagonists. It works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have PAH.

Bosentan comes as a tablet to take by mouth. It is usually taken with or without food twice a day in the morning and evening. To help you remember to take bosentan, take it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take bosentan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Your doctor will probably start you on a low dose of bosentan and increase your dose after 4 weeks. Bosentan controls the symptoms of PAH but does not cure it. It may take 1 to 2 months or longer before you feel the full benefit of bosentan. Continue to take bosentan even if you feel well. Do not stop taking bosentan without talking to your doctor. If you suddenly stop taking bosentan, your symptoms may get worse. Your doctor may decrease your dose gradually.

Before taking bosentan,
• tell your doctor and pharmacist if you are allergic to bosentan, any other medications, or corn.
• do not take cyclosporine (Sandimmune, Neoral) or glyburide (DiaBeta, Glynase, Micronase, others) while taking bosentan.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin; cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor); gemfibrozil (Lopid); hormonal contraceptives (birth control pills patches, rings, shots, implants, and intrauterine devices); ketoconazole (Nizoral); and medications for diabetes. Many other medications may also interact with bosentan, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had anemia (condition in which red blood cells do not bring enough oxygen to the organs) or heart disease.

Talk to your doctor about drinking grapefruit juice while taking this medication.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Bosentan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• flushing
• runny nose, sore throat, and other cold symptoms
• heartburn

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• hives
• rash
• itching
• difficulty breathing or swallowing
• fever
• swollen lymph nodes
• tiredness
• unexplained weight loss
• swelling of the arms, hands, feet, ankles, or lower legs
• sudden weight gain
• fast, pounding, or irregular heartbeat
• fainting
• dizziness
• blurred vision
• pale skin
• confusion
• shortness of breath
• weakness

Male laboratory animals who were given medications similar to bosentan developed problems with their testicles and produced fewer sperm (male reproductive cells) than normal. It is not known if bosentan will damage the testicles or decrease the number of sperm produced in men. Talk to your doctor about the risks of taking bosentan if you would like to have children in the future. Bosentan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Do not let anyone else take your medication. Ask your doctor any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.