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Bosentan Oral tablet

It is used to treat a serious heart and lung disorder called primary pulmonary hypertension

Generic Name: bosentan  |  Brand Name: Tracleer

Brand Names: Tracleer

There is an FDA Alert for this drug. Click here to view it.

  • Risk of developing serious hepatic injury. With close monitoring, unexplained hepatic cirrhosis and liver failure reported rarely after prolonged bosentan therapy (>12 months) during postmarketing surveillance.
  • Serum aminotransferase (AST/ALT) concentrations must be measured prior to initiation of therapy and monthly thereafter. (See Hepatic Effects under Cautions.)
  • In patients with adverse hepatic effects, dosage reduction or discontinuance of the drug may be necessary. (See Patients with Adverse Hepatic Effects under Dosage and Administration.)
  • Bosentan generally should be avoided in patients with elevated aminotransferases (>3 × ULN) at baseline (because monitoring for liver injury may be more difficult) and in those with preexisting moderate to severe hepatic impairment.

  • May cause fetal harm; contraindicated in pregnant women. Pregnancy must be excluded before start of treatment and prevented thereafter by use of reliable contraception. (See Fetal/Neonatal Morbidity and Mortality under Cautions.) Oral, injectable, transdermal, and implantable hormonal contraceptives may not be reliable when used concomitantly with bosentan and should not be used as the sole contraceptive method; additional forms of nonhormonal contraception should be used. (See Specific Drugs under Interactions.)


FDA approved a REMS for bosentan to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of bosentan and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

BOSENTAN (boe SEN tan) is used to treat a serious heart and lung disorder called primary pulmonary hypertension. This medicine may help to increase your ability to exercise and improve your breathing.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • liver disease
  • an unusual or allergic reaction to bosentan, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • cyclosporine
  • female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections
  • glyburide
  • ritonavir

This medicine may also interact with the following medications:

  • amiodarone
  • amprenavir
  • certain medicines for fungal infections like fluconazole, itraconazole or ketoconazole
  • certain medicines for high cholesterol like atorvastatin, cerivastatin, lovastatin, simvastatin
  • diltiazem
  • erythromycin
  • rifampicin
  • sildenafil
  • tacrolimus

What should I watch for while using this medicine?

Visit your doctor or health care professional for checks on your progress. Despite receiving this medicine, your condition may worsen and you may need your dose adjusted. Call your doctor or health care professional if your conditions gets worse.

Pregnancy must be avoided while taking this medicine due to the potential for serious side effects to an unborn child. If you are female of child-bearing potential, you will have to have pregnancy tests regularly (at least monthly) while you are taking this medicine. Discuss options to prevent pregnancy with your physician. This medicine may reduce the effectiveness of hormonal birth control methods, including birth control pills, patches, implanted hormonal products, or injections.

This medicine has caused reduced sperm counts in some men. This may interfere with the ability to father a child. You should talk to your doctor or health care professional if you are concerned about your fertility.

Your health care professional will have to check blood tests regularly (at least monthly) to check the effect of this medicine on your liver.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • cool, pale skin
  • dark urine
  • fast, irregular heartbeat
  • feeling faint or lightheaded, falls
  • fever
  • swelling of the ankles or legs
  • stomach pain, nausea, vomiting

-unusual bleeding or bruising

  • unusually weak or tired
  • yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • flushing of the skin
  • headache
  • itching of the skin
  • runny nose or sore throat
  • stomach upset

Last Updated: March 31, 2009
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