Bosentan, Oral

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KEY POINTS

• This medicine is taken by mouth to treat pulmonary arterial hypertension. Take it exactly as directed.
• This medicine is likely to cause birth defects. You must NOT be pregnant before or while taking this medicine or for 1 month after stopping this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious liver problems or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antihypertensive

Generic and brand names: bosentan, oral; Tracleer

What is this medicine used for?

This medicine is taken by mouth to treat pulmonary arterial hypertension (high blood pressure in the blood vessels between the heart and lungs).

This medicine may cause severe birth defects and liver problems. You must be enrolled in a special program before you can receive this medicine. This medicine will be mailed to you from a special central pharmacy. It is not available through local pharmacies. Talk with your healthcare provider about this.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Blood disorders (such as anemia)
• Heart failure
• Liver disease

You should not take this medicine if you also are taking cyclosporine (Gengraf, Neoral, Sandimmune) or glyburide (Glynase). Tell your healthcare provider about all the medicines you are taking.

Females of childbearing age: This medicine has been reported to cause birth defects. You must NOT be pregnant before or while taking this medicine. Read the information that comes in the medicine package. You must meet certain conditions and sign a consent form. You need to have a negative pregnancy test before starting treatment and each month during treatment with this medicine. You must use 2 effective forms birth control while you are taking this medicine and for a month after stopping this medicine. Hormone-based forms of birth control may not be reliable and should not be used alone when taking this medicine. If you have an IUD (intrauterine device), no other form of birth control is needed. Talk with your healthcare provider about what forms of birth control are right for you. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

Males: This medicine may make you sterile (unable to have children). If you plan to have children someday, talk with your healthcare provider before you start treatment.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check with your healthcare provider before using this medicine in children under age 12.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Your dose may be adjusted after 4 weeks. Do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually. Take the medicine at the same time each day to help you remember to take it.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Take this medicine with a full glass of water.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: headache, nausea, vomiting, fast heartbeat, fainting, sweating, blurred vision, dizziness.

What should I watch out for?

This medicine may cause serious liver problems. If you develop nausea, vomiting, a fever, stomach pain, unexplained loss of appetite, itching, yellowing of your eyes or skin, light-colored bowel movements, dark urine, or severe tiredness or weakness, contact your healthcare provider right away. These may be signs of a liver problem. You need to have tests before you start treatment and monthly during treatment to see how this medicine affects your liver. Keep all appointments.

Avoid alcohol while taking this medicine. Alcohol may increase the risk of liver problems.

Swelling all over the body (fluid retention) can happen within weeks after starting this medicine. Tell your healthcare provider right away if you have any unusual weight gain, tiredness, or increased trouble breathing. These may be symptoms of a serious health problem.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Nausea; vomiting; fever; stomach pain; yellowing of your eyes or skin; dark-colored urine; light-colored bowel movements; irregular or fast heartbeat; chest pain; severe dizziness or fainting; unusual tiredness or weakness; trouble breathing; unusual bruising or bleeding; unexplained swelling of hands, legs, feet or ankles.

Other: Headache, flushing, sore throat, runny or stuffy nose, joint pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these medicines together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alfuzosin (Uroxatral)
• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), and diazepam (Valium)
• Antibiotics such as bedaquiline (Sirturo), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifampin (Rifadin), telithromycin (Ketek), and tetracycline
• Antidepressants such as citalopram (Celexa), escitalopram (Lexapro), mirtazapine (Remeron), nefazodone, and vilazodone (Viibryd)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), haloperidol (Haldol), lurasidone (Latuda), and pimozide (Orap)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ethosuximide (Zarontin), felbamate (Felbatol), and tiagabine (Gabitril)
• Antiviral medicines such as daclatasvir (Daklinza), elbasvir/grazoprevir (Zepatier), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), simeprevir (Olysio), and sofosbuvir/velpatasvir (Epclusa)
• Cancer medicines such as abiraterone (Zytiga), axitinib (Inlyta), bosutinib (Bosulif), capecitabine (Xeloda), ceritinib (Zykadia), cobimetinib (Cotellic), crizotinib (Xalkori), enzalutamide (Xtandi), erlotinib (Tarceva), ibrutinib (Imbruvica), idelalisib (Zydelig), imatinib (Gleevec), nilotinib (Tasigna), olaparib (Lynparza), romidepsin (Istodax), sonidegib (Odomzo), venetoclax (Venclexta), vinblastine, and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), gemfibrozil (Lopid), lovastatin (Altoprev), and simvastatin (Zocor)
• Conivaptan (Vaprisol)
• Diabetes medicines such as glyburide (Glynase), linagliptin (Tradjenta), repaglinide (Prandin), saxagliptin (Onglyza), and tolbutamide
• Eliglustat (Cerdelga)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Flibanserin (Addyi)
• Heart medicines such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to block or prevent stomach acid such as lansoprazole (Prevacid), omeprazole (Prilosec), and rabeprazole (AcipHex)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Mifepristone (Korlym, Mifeprex)
• Naloxegol (Movantik)
• Nausea medicines such as aprepitant (Emend) and netupitant/palonosetron (Akynzeo)
• Other medicines to treat pulmonary hypertension such as sildenafil (Revatio) and tadalafil (Adcirca)
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), methadone (Dolophine, Methadose), and oxycodone (OxyContin, Roxicodone)
• Praziquantel (Biltricide)
• Roflumilast (Daliresp)
• Sleeping pills such as flurazepam, suvorexant (Belsomra), triazolam (Halcion), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Ulipristal (ella)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.