Tracleer (Bosentan)

What it is:
Tracleer® was the first oral medication approved for treatment of PAH. It is a dual endothelin receptor antagonist, meaning that it blocks both endothelin receptors.

How it is Administered:
Tracleer® is an oral medication, so it is taken in a tablet form. It is available in different strengths and is usually taken twice a day.

Benefits:
Tracleer® has been shown to improve exercise ability and decrease the rate of clinical worsening in PAH patients with WHO Class II - IV symptoms. As with any medication, patients who take Tracleer® as directed by their physician achieve the optimal benefit.

Tracler has been shown to offer these important benefits to people with PAH:

• Tracleer® can improve symptoms and the ability to perform normal daily activities.
• Tracleer® can improve the worsening of symptoms.
• Tracleer® can lower high blood pressure in the lungs.
• Tracleer® can enable the heart to pump blood more effectively.
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How quickly will I respond to Tracleer®?
Every individual will respond to treatment in different ways. It's important to discuss this with your doctor and have realistic expectations of what your therapy can do for you. You may find that you can walk further without resting, that you can breathe more easily, and that you will generally be better able to perform the tasks of daily living.

Risks:
There are two important issues that every patient must know:

1. Tracleer® may cause liver damage; therefore monitoring liver enzyme levels is necessary. This is done by a blood test every month.
2. Tracleer® may cause birth defects; therefore, it is essential that patients on Tracleer® are not pregnant and don't become pregnant. Monthly pregnancy tests must be obtained.
   Oral, injected and implanted contraceptives may not be reliably effective because Tracleer® may alter their metabolism in a way that reduces the effectiveness of hormonal contraceptives, so these methods must be supplemented by other methods or barrier methods must be used. Therefore, it is important for patients to consult with a gynecologist or other physician knowledgeable about contraceptives.

Side Effects:
Headache, sore throat, and flushing are reported by some users.

Tracleer® Distributor and Manufacturer:
Tracleer® is prescribed and dispensed by a specialty pharmacy distributor and is available only through the Tracleer® Access Program (TAP), a direct distribution program. Your doctor can give you more information on how Tracleer® is distributed.

Tracleer® is manufactured by Patheon Inc., Mississauga, Ontario, Canada. Tracleer® is marketed by Actelion Pharmaceuticals, South San Francisco, California, USA.

Costs:
Because Tracleer® is classified as a drug, instead of a treatment, it is covered differently by insurance companies and Medicare. Co-pay rates have varied widely. At this time, arrangements with individual insurance companies vary.

For Additional Information, visit the Tracleer Website.

Frequently Asked Questions about Tracleer.

September 2009 - Page reviewed and updated.

• Latest News
• August 26, 2009
•   Funding of Tracleer will bring relief to Kiwi PAH sufferers
• Tracleer (bosentan), a leading treatment for Pulmonary Arterial Hypertension (PAH), is now funded by PHARMAC. This will give New Zealanders suffering from this incurable disease a chance to improve both the quality and length of their lives and provide physicians with much needed options to improve treatment outcomes.
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• August 14, 2009
• FDA Approves Bosentan for Treating Early-Stage PAH
• (MEDSCAPE) -- August 13, 2009 - The US Food and Drug Administration (FDA) has approved an expanded indication for bosentan (Tracleer, Actelion, Ltd) for the treatment of mildly symptomatic World Health Organization (WHO) functional class 2 pulmonary arterial hypertension (PAH).
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