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bosentan

Generic Name: bosentan (boe SEN tan)
Brand Name: Tracleer

What is bosentan?

Bosentan lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Bosentan is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

Bosentan is available only under a special program from a certified pharmacy. You must be registered in the program and understand the risks and benefits of taking this medication.

Bosentan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about bosentan?

Do not use bosentan if you are pregnant or think you might be pregnant. You will need to take a pregnancy test before, during, and after treatment with bosentan. Use highly effective birth control to prevent pregnancy while using this medicine and for at least 30 days after your last dose.

Certain other medicines can interact with bosentan and should not be used at the same time. Tell your doctor about all your current medicines.

Bosentan can cause severe liver problems. Your liver function will need to be tested often.

Call your doctor right away if you have have signs of liver problems such as nausea, vomiting, fever, upper stomach pain, tiredness, or jaundice (yellowing of the skin or eyes).

Bosentan is available only from a certified pharmacy under a special program.

What should I discuss with my healthcare provider before taking bosentan?

You should not use bosentan if you are allergic to it, or if you are pregnant or might become pregnant during treatment.

Some medicines can interact with bosentan and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cyclosporine; or

  • glyburide.

To make sure bosentan is safe for you, tell your doctor if you have:

  • liver disease;

  • fluid retention;

  • diabetes;

  • an autoimmune disorder such as rheumatoid arthritis or psoriasis; or

  • if you have had or will have a heart or kidney transplant.

Do not use bosentan if you are pregnant or think you might be pregnant. This medicine can cause serious birth defects, especially if taken during early pregnancy. Tell your doctor right away if you miss a menstrual period or think you may have become pregnant during treatment.

You will need to have a negative pregnancy test before starting this treatment. You will be re-tested every month during your treatment, and 1 month after you stop taking this medicine.

Even if you are not planning a pregnancy, you are considered able to become pregnant if:

  • you have entered puberty (even if you have not yet started having periods);

  • you have never had a hysterectomy or had your ovaries removed; or

  • you have not gone through menopause (you have never gone 12 months in a row without a menstrual period).

While taking bosentan and for at least 30 days after your last dose, you must use a highly effective form of birth control or two methods together.

  • A tubal ligation alone is an effective birth control method.

  • An intrauterine device (IUD) alone is also an effective birth control method.

  • If you use birth control pills, implants, injections, skin patches, or vaginal rings, you must use a back-up barrier form of birth control, such as a condom or diaphragm or cervical cap. Always use a spermicide gel or insert together with a barrier form of birth control.

  • If you use only a barrier method, you must use a second barrier method as a back-up. For example, use a diaphragm or cervical cap in addition to a condom, plus a spermicide gel or insert.

  • If your sexual partner has had a vasectomy, you must still use a second method of birth control--either a barrier method or a hormonal form (birth control pills, injections, skin patch, or vaginal ring).

Bosentan comes with patient instructions about acceptable forms of birth control to use while taking this medicine. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If you are the parent or caregiver of a female child taking this medicine, talk to the child's doctor once you notice any signs of puberty (breast development or pubic hair), even if menstrual periods have not yet begun.

Bosentan can decrease sperm count and may affect fertility in men (your ability to have children).

It is not known whether bosentan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take bosentan?

Bosentan is usually taken 2 times per day. Your doctor may change your dose after 4 weeks of treatment. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take bosentan with or without food.

Bosentan can cause severe liver problems. Your liver function will need to be tested before you start taking bosentan, and again each month during your treatment.

Your blood cells may also need to be tested during treatment and for up to 3 months after you stop taking this medicine.

You should not stop using bosentan suddenly. Stopping suddenly may make your condition worse. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using bosentan?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Bosentan side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, bosentan may cause a severe drug reaction that can affect many parts of the body. This type of reaction can start several weeks after you begin using this medicine. Seek medical treatment if you have new or worsening symptoms of:

  • fever, flu symptoms, swollen glands, feeling weak or tired;

  • facial swelling;

  • a red or blistering skin rash, severe tingling or numbness;

  • cough, chest pain, trouble breathing;

  • weight loss; or

  • pain or burning when you urinate, lower back pain, swelling in your legs or feet.

Call your doctor at once if you have:

  • swelling in your legs or ankles, with or without weight gain;

  • pale skin, feeling short of breath, rapid or irregular heart rate, trouble concentrating;

  • a light-headed feeling, like you might pass out;

  • liver problems--nausea, vomiting, fever, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • new lung problems--anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Common side effects may include:

  • headache;

  • flushing (warmth, redness, or tingly feeling);

  • irregular heartbeats;

  • low blood pressure, fainting;

  • joint pain; or

  • cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Bosentan dosing information

Usual Adult Dose for Pulmonary Hypertension:

greater than or equal to 40 kg:
Initial dose: 62.5 mg twice daily for 4 weeks
Maintenance dose: increase to a maintenance dose of 125 mg twice daily

less than 40 kg:
Initial dose: 62.5 mg twice daily for 4 weeks
Maintenance dose: continue dosing of 62.5 mg twice daily

Usual Pediatric Dose for Pulmonary Hypertension:

Full Term Neonate: Oral: 1 mg/kg/dose orally twice daily short-term use (2 to 16 days) in three full term neonates has been reported. In the initial report, two full term neonates (8 days and 14 days old) with persistent pulmonary hypertension of the newborn (PPHN) and transposition of the great arteries received bosentan prior to cardiac surgery; patients also received other therapies. A case report describes the use of bosentan monotherapy for PPHN in a full term neonate as primary course of treatment initiated at 29 hours of life; therapy was weaned after 72 hours through the following dose reductions: 0.5 mg/kg/dose orally twice daily followed by 0.5 mg/kg once daily and subsequent discontinuation at 96 hours of treatment.

1 month to 12 years:
less than 10 kg: Initial: 1 to 2 mg/kg orally twice daily for 4 weeks; increase to maintenance dose of 2 to 4 mg/kg orally twice daily.
10 to 20 kg: Initial: 31.25 mg orally daily for 4 weeks; increase to maintenance dose of 31.25 mg orally twice daily.
over 20 to 40 kg: Initial: 31.25 mg orally twice daily for 4 weeks; increase to maintenance dose of 62.5 mg orally twice daily.
over 40 kg: Initial: 62.5 mg orally twice daily for 4 weeks; increase to maintenance dose of 125 mg orally twice daily.

over 12 years:
less than 40 kg: 62.5 mg orally twice daily.
40 kg or more: 62.5 mg orally twice daily for 4 weeks; increase to maintenance dose of 125 mg twice daily.

What other drugs will affect bosentan?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • rifampin;

  • tacrolimus;

  • warfarin (Coumadin, Jantoven);

  • antifungal medication--fluconazole, itraconazole, ketoconazole, voriconazole;

  • HIV/AIDS medication that contains ritonavir--Norvir, Kaletra, Technivie, Viekira, and others;

  • hormonal forms of birth control--birth control pills, injections, skin patches, or implants; or

  • "statin" medicine to treat high cholesterol--Crestor, Lipitor, Mevacor, Pravachol, Vytorin, Zocor, and others.

This list is not complete. Other drugs may interact with bosentan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about bosentan.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 7.01.

Date modified: November 30, 2016
Last reviewed: November 14, 2016

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