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What it is:
Tracleer® is 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 III or 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.
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:
- Tracleer®
may cause liver damage; therefore monitoring liver enzyme levels
is necessary. This is done by a blood test every month.
- 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.
Insurance
Coverage of Tracleer®:
Please see Frequently
Asked Questions about Insurance and Tracleer® or call the Tracleer®
Access Program at 1-866-228-3546
Frequently
Asked Questions
Recent items from the PHCentral Newsroom:
-
Bosentan Aids Treprostinil In PAH
(Medscape/Reuters Health ) -- In certain patients with moderate-to-severe pulmonary artery hypertension (PAH), the addition of oral bosentan to subcutaneous treprostinil-based therapy can produce further clinical improvement, investigators report in the July issue of Chest.
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Tracleer® Receives EU Approval For Treatment Of Patients With Mildly Symptomatic PAH
(Actelion ) -- Tracleer® is the first PAH treatment ever to be investigated in a clinical study that exclusively enrolled patients with mildly symptomatic WHO FC II. This 185-patient randomized, double-blind, placebo-controlled study provided the basis for this EU approval. The indication extension reads: "Some improvements have also been shown in patients with PAH WHO functional class II (see section 5.1)"
For Additional Information Visit:
- Actelion;
Tracleer®
- FDA
Talk Paper
- FDA Drug Search: For information about this drug and any other drug approved by the U.S. FDA – patient info sheets, label info, approval history etc.
- If you are taking Tracleer® and reside in the United States, you will want to check out a new program launched by Actelion they call Sure Steps.. Sure Steps has been designed to provide education and support for Tracleer® users. To find out more, go here.
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