Bosentan
Bosentan is an approved active ingredient.
Chemical compound
Boxed warning (US label)
RISKS OF HEPATOTOXICITY and EMBRYO-FETAL TOXICITY Because of the risk of hepatotoxicity, TRACLEER is available only through a restricted program called the Bosentan Risk Evaluation and Mitigation Strategy (REMS).
What it is used for
- Pulmonary hypertension
- Systemic scleroderma
- Arterial hypertension
- Arterial pulmonary hypertension
- Congenital heart disease
- Primary pulmonary hypertension
TRACLEER is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening.
Some improvements have also been shown in patients with PAH WHO functional class II. Stayveer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital-ulcer disease.
How it works
- Endothelin receptor, ET-A/ET-B antagonist
Common side effects
The following important adverse reactions are described elsewhere in the labeling: Hepatotoxicity Embryo-fetal Toxicity Fluid Retention Common adverse reactions (≥3% more than placebo) for the film-coated tablet are respiratory tract infection and anemia.
Who should not take it
. Use with Cyclosporine A. Use with Glyburide.
Pregnancy and breastfeeding
Based on data from animal reproduction studies, TRACLEER may cause fetal harm, including birth defects and fetal death, when administered to a pregnant female and is contraindicated during pregnancy.
Interactions
- Amiodarone
- Atazanavir
- Ciclosporin
- Darunavir
- Diltiazem
- Erythromycin
- Etonogestrel
- Fluconazole
- Glibenclamide
- Indinavir anhydrous
- Medroxyprogesterone
- Nelfinavir
- Ritonavir
- Saquinavir
Brand names
United States
Tracleer
European Union
Stayveer · Tracleer
Canada
Alembic-Bosentan · Auro-Bosentan · Pms-Bosentan · Taro-Bosentan · Tracleer
Approval status
- US Food and Drug Administration
- prescription · since 2001
- European Medicines Agency
- authorised · since 2002
- Health Canada
- prescription · marketed
- First approval anywhere
- 2001
Codes
- ATC
- C02KX01
- RxNorm CUI
- 1468845
- ChEMBL
- CHEMBL957
- PubChem CID
- 104865
- UNII
- XUL93R30K2
- Wikidata
- Q419769
Frequently asked questions
What is Bosentan used for?
Bosentan is used for: Pulmonary hypertension, Systemic scleroderma, Arterial hypertension, Arterial pulmonary hypertension, Congenital heart disease, and Primary pulmonary hypertension.
What are the brand names of Bosentan?
Brand names of Bosentan include Tracleer, Stayveer, Alembic-Bosentan, Auro-Bosentan, Pms-Bosentan, and Taro-Bosentan.
Sources and licences
- ChEMBL (CC BY-SA 3.0)
- Wikidata (CC0 1.0)
- openFDA / DailyMed (public domain)
- European Medicines Agency (reuse with acknowledgement)
- Health Canada Drug Product Database (Open Government Licence – Canada)