Tracleer (Bosentan) 62.5mg/125mg*30's | Endothelin Receptor Antagonist | GLT

Generic Information: Tracleer (Switzerland)

Tracleer is the original brand of bosentan, developed and marketed by Actelion Pharmaceuticals, a Swiss company now part of Johnson & Johnson. This listing covers the 62.5 mg and 125 mg film-coated tablets, each supplied in a 30-tablet carton of hospital unit-dose blister strips, matching the two steps of the standard dosing schedule. Bosentan, first approved by the US FDA in 2001, was the world's first oral treatment for pulmonary arterial hypertension and remains a reference product in the endothelin receptor antagonist class.

What Is Tracleer Used For?

Tracleer treats pulmonary arterial hypertension (PAH), WHO functional class II to IV, in adults, improving exercise ability and reducing clinical worsening. It is also approved for children aged three years and older with idiopathic or congenital PAH. The condition is driven by elevated endothelin-1, a potent vasoconstrictor, and Tracleer counteracts this by blocking endothelin's effects on the lung's blood vessels.

How Does Bosentan Work?

Bosentan is a dual endothelin receptor antagonist that binds both the ETA and ETB receptors. By blocking endothelin-1 signaling, it relaxes constricted pulmonary blood vessels, lowers pulmonary vascular resistance, and eases the burden on the right ventricle of the heart. In the BREATHE-1 pivotal trial, bosentan produced a statistically significant improvement in six-minute walk distance and delayed the time to clinical worsening compared with placebo, establishing it as a foundational PAH therapy.

Indications

Tracleer is indicated for adults with pulmonary arterial hypertension (WHO Group 1) with functional class II to IV symptoms, and for pediatric patients three years and older with idiopathic or congenital PAH. The primary etiologies in the registration studies were idiopathic or heritable PAH, PAH associated with connective tissue disease, and PAH associated with congenital heart disease with left-to-right shunting.

Dosage

Adults begin with 62.5 mg twice daily for four weeks, then increase to 125 mg twice daily if tolerated. The tablets are taken morning and evening, with or without food. Because of the risk of liver toxicity and birth defects, liver enzymes are checked before treatment and monthly, and women of childbearing potential must use reliable contraception. Bosentan is dispensed only through a restricted program that requires prescriber, patient, and pharmacy enrollment.

Side Effects

The most common side effects are headache, flushing, fluid retention, and abnormal liver function tests. A dose-related reduction in hemoglobin can also occur, so blood counts are monitored during therapy. The serious risks are hepatotoxicity and embryo-fetal toxicity, which are managed through monthly liver monitoring and strict contraception. Patients should promptly report edema, weight gain, or new or worsening shortness of breath.

Storage

Store Tracleer at controlled room temperature, between 15°C and 30°C, in the original packaging, protected from moisture, and away from children. No cold-chain handling is required.

Why Choose the GLT?

GLT helps buyers source genuine, internationally approved medicines with verified supply chains and clear documentation. Tracleer is the originator bosentan, and while its list price in Western markets is high, we work with both institutions and individual patients to explain the pricing and regulatory differences across sourcing origins, so each buyer understands exactly what they are ordering and where it comes from.

How to Order

To order Tracleer through GLT, message us on WhatsApp at +86 15234153837 or write to [email protected]. Provide the strength, pack size, and delivery country, and our team will confirm availability, sourcing origin, and shipping terms. We work with hospitals, pharmacies, and individual patients.

FAQ

Who makes Tracleer? Tracleer is made by Actelion Pharmaceuticals, a Swiss company that is now part of Johnson & Johnson. Bosentan was originally approved by the FDA in 2001.

Is bosentan the same as Tracleer? Bosentan is the generic name, and Tracleer is the originator brand name. They refer to the same active ingredient.

Does bosentan require special monitoring? Yes. Because of the risks of liver toxicity and birth defects, patients require monthly liver function tests and women of childbearing potential must use reliable contraception.