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(boe sen' tan)For male and female patients: Bosentan may cause liver damage. Tell your doctor if you have or have ever had liver disease. 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. Keep all appointments with your doctor and the laboratory. Bosentan may damage the liver before causing symptoms. Regular blood tests are the only way to find liver damage before it becomes permanent and severe. If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, fever, stomach pain, yellowing of the skin or eyes, or extreme tiredness. Your doctor may reduce your dose, or temporarily or permanently stop your treatment with bosentan if you experience side effects or have abnormal lab results. For female patients: Do not take bosentan if you are pregnant or plan to become pregnant. Bosentan may harm the fetus. If you are able to become pregnant, you will need to take a pregnancy test before starting treatment, every month during treatment, and for 1 month after your treatment to show that you are not pregnant. Your doctor will order the pregnancy tests for you. You must use a reliable method of birth control during your treatment and for 1 month after 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. In most cases you will be required to use two forms of birth control. Call your doctor immediately if you have unprotected sex, think your birth control failed, miss a period or think that you may be pregnant while you are taking bosentan. Do not wait until your next appointment to discuss this with your doctor. If you are a parent or guardian of a female patient who had not yet reached puberty, check your child regularly to see if she is developing any signs of puberty (breast buds, pubic hair) and let her doctor know about any changes. Because of the risks of liver damage and birth defects, bosentan is only available through a restricted program called the Tracleer Risk Evaluation and Mitigation Strategy Program (Tracleer REMS). In order to receive bosentan you and your doctor must be registered with Tracleer REMS, and follow the programs requirements such as once a month liver function and pregnancy testing. Your doctor will register you in the program. Bosentan is only available at certain pharmacies that are registered with Tracleer REMS. Ask your doctor or pharmacist if you have any questions about how you can fill your prescription. Talk to your doctor about the risks of taking bosentan.
Before taking bosentan,
- tell your doctor and pharmacist if you are allergic to bosentan, any other medications, or any of the ingredients in bosentan tablets or dispersible tablets.
- do not take cyclosporine (Gengraf, Neoral, Sandimmune) or glyburide (DiaBeta, Glynase) 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: amiodarone (Nexterone, Pacerone); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet), lovastatin (Altoprev), and simvastatin (Flolopid, Zocor, in Vytorin); diltiazem (Cardizem, Cartia, Diltzac, others); erythromycin (E.E.S., Eryc, PCE); fluconazole (Diflucan); gemfibrozil (Lopid); itraconazole (Onmel, Sporanox); ketoconazole ; rifampin (Rifadin, Rimactane, in Rifater, Rifamate); ritonavir (Norvir, in Kaletra, Viekira Pak, Technivie); voriconazole (Vfend); and warfarin (Coumadin, Jantoven). 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 heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body).
- tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor will probably tell you not to breastfeed while taking bosentan.
- if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the dispersible tablets are sweetened with aspartame, a source of phenylalanine.
- runny nose, sore throat, and other cold symptoms
- joint pain
- hives; rash; itching; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, and eyes; hoarseness; fever; swollen lymph nodes; tiredness
- swelling of the feet, ankles, or lower legs, sudden weight gain, more trouble with breathing than normal
- new or worsening shortness of breath; new or worsening cough with or without blood; chest pain; fast, pounding, or irregular heartbeat
- dizziness; pale skin; shortness of breath; weakness; fast, pounding, or irregular heartbeat