- Adcirca® FAQ
- BiPAP / CPAP
- Calcium Channel Blockers
- Endothelin Receptor Antagonists
- Epoprostenol for Injection
- Epoprostenol sodium
- Inhaled Treprostinil
- Nitric Oxide
- Other Drugs and Treatments
- Phosphodiesterase type-5 Inhibitor
- Sildenafil Citrate
- Sitaxsentan Sodium
- Tracleer® FAQ
- Under FDA Review
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.
Fda approval date
- 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.
Headache, sore throat, and flushing are reported by some users.
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
Page Reviewed/Edited: October 2010
In The News
- October 22, 2013
- Safety and Tolerability of Targeted Therapies for Pulmonary Hypertension in Children.
- September 30, 2013
- Improvement of plasma endothelin-1 and nitric oxide in patients with systemic sclerosis by bosentan therapy.
- September 17, 2013
- Bosentan Treatment Is Associated With Improvement of Right Ventricular Function and Remodeling in Chronic Thromboembolic Pulmonary Hypertension.
- July 19, 2013
- Association of CYP2C9*2 with Bosentan-Induced Liver Injury.
- January 29, 2013
- New Zealand approves funding of sildenafil for Raynaud's phenomenon and bosentan for children with PAH
- January 28, 2013
- Universiy of Giessen and Marburg, Germany starts Children-PAH-rehab study
- August 7, 2012
- Bosentan in heart transplantation candidates
- July 26, 2012
- Changes in Exercise Capacity and Cardiac Performance in a Series of Patients with Eisenmenger's Syndrome Transitioned from Selective to Dual Endothelin Receptor Antagonist.
- June 13, 2012
- Altered expression and signal transduction of endothelin-1 receptors in heritable and idiopathic pulmonary arterial hypertension.
- June 7, 2012
- Mylan wins approval for generic Tracleer in Canada
- January 8, 2012
- Use of Bosentan in Pediatric Pulmonary Hypertension
- December 7, 2011
- Usefulness of first-line combination therapy with epoprostenol and bosentan in pulmonary arterial hypertension: An observational study.
- November 13, 2011
- Bosentan Benefits Persist in Eisenmenger's Syndrome
- October 26, 2011
- VIP and endothelin receptor antagonist: An effective combination against experimental PAH
- August 2, 2011
- Therapy for pulmonary arterial hypertension due to congenital heart disease and Down's syndrome.
- July 3, 2011
- Long-Term (5 Years) Effects of Bosentan in Patients With Pulmonary Arterial
- June 3, 2011
- Bosentan in Clinical Practice for Treating Digital and Other Ischemic Ulcers in Spanish Patients with Systemic Sclerosis: IBER-DU Cohort Study.
- May 15, 2011
- Bosentan No Help in Idiopathic Pulmonary Fibrosis
- December 16, 2010
- EMA Reviewing Drug Class That Includes Pfizer’s Thelin
- October 5, 2010
- FDA Warns Actelion Unit On Post-Marketing Drug Report Failures
- September 20, 2010
- Actelion Pharmaceuticals Ltd: Actelion Pharmaceuticals US, Inc. has received subpoena relating to Tracleer
- April 27, 2010
- Standard PAH therapy improves long term survival in CTEPH patients.
- August 26, 2009
- Funding of Tracleer will bring relief to Kiwi PAH sufferers
- August 14, 2009
- FDA Approves Bosentan for Treating Early-Stage PAH