Tracleer

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

What is Tracleer (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 other purposes not listed in this medication guide.

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

Do not use bosentan if you are pregnant. You will need to have a negative pregnancy test before starting this treatment. You must use two highly effective birth control methods to prevent pregnancy while you are using this medication and for at least 30 days after your treatment ends.

Slideshow: Flashback: FDA Drug Approvals 2013

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

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.

Call your doctor at once if you have signs of liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

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

What should I discuss with my healthcare provider before taking Tracleer (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;

  • glyburide; or

  • HIV/AIDS medication that contains lopinavir or ritonavir.

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

  • liver disease;

  • diabetes;

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

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

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use bosentan if you are pregnant. 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 may also be re-tested every month during your treatment, and 1 month after you stop taking this medicine.

Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

While taking bosentan 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).

This medication 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 Tracleer (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.

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. 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 Tracleer (bosentan)?

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

Tracleer (bosentan) side effects

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

Call your doctor at once if you have signs of liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

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; 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);

  • joint pain; or

  • stuffy nose, sinus pain, 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)

What other drugs will affect Tracleer (bosentan)?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with bosentan, especially:

  • rifampin;

  • tacrolimus;

  • warfarin (Coumadin, Jantoven);

  • antifungal medication--fluconazole, itraconazole, ketoconazole, voriconazole; 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: 6.01. Revision Date: 2013-12-05, 11:49:07 AM.

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