Endothelin-1 ET-1 is a neurohormone, the effects of which are mediated by binding to ETA and ETB receptors in the endothelium and vascular smooth muscle. ET-1 concentrations are elevated in plasma and lung tissue of patients with pulmonary arterial hypertension, suggesting a pathogenic role for ET-1 in this disease.
For additional information on Tracleer, please visit www. Lundbeck Takeda Pharmaceuticals U. Tracleer bosentan Profile. Profile Contact Information. Currently Enrolling Trials Show More.
Two additional studies looked at the effects of Tracleer dispersible tablets in children: the first study included 36 children with PAH aged between 2 and 11 years, while the second study included 64 children with PAH aged from 3 months up to 11 years.
The PAH seemed to remain stable in almost all of the children during the 12 or 24 weeks of treatment. Tracleer was more effective than placebo at reducing the development of new digital ulcers based on two studies in a total of adults. In the first study, patients taking Tracleer had an average of 1.
Similar results were seen in the second study after 24 weeks. The second study which also looked at the effect of Tracleer on digital ulcer healing in patients did not find any effect. The most common side effects with Tracleer which may affect more than 1 in 10 people are headache, fluid retention, anaemia low levels of haemoglobin, the protein in red blood cells that carries oxygen around the body and abnormal results of blood tests to check the liver.
For the full list of side effects Tracleer, see the package leaflet. Tracleer must not be used in patients who have certain liver problems, who are pregnant or could become pregnant and who are not using reliable contraceptive methods or who are taking ciclosporin a medicine that acts on the immune system. For the full list of restrictions, see the package leaflet. The company that makes Tracleer will provide a patient alert card to remind patients of the need for regular blood tests for liver function and to use effective contraception to avoid pregnancy.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tracleer have also been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Tracleer are continuously monitored. Side effects reported with Tracleer are carefully evaluated and any necessary action taken to protect patients. Tracleer received a marketing authorisation valid throughout the EU on 15 May More detail is available in the summary of product characteristics.
Efficacy has been shown in:. Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease. This product is no longer an orphan medicine. It was originally designated an orphan medicine for the following orphan indications :. Please do not include any personal data , such as your name or contact details. Skip to main content.
Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Tracleer RSS. Table of contents Overview Authorisation details Product information Assessment history. The PAH can be: primary with no identified cause or inherited ; caused by scleroderma also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs ; caused by congenital inborn heart defects with shunts abnormal passageways causing abnormal flow of blood through the heart and Some improvement with Tracleer can also occur in patients with class II PAH.
It is therefore important that patients undergo monthly liver monitoring. Due to the risk of birth defects, women who are pregnant, or may become pregnant, cannot take Tracleer. Now, for the first time, patients and their families have access to an oral treatment. In the past, the only approved treatment required an indwelling central IV line and patients had to carry a continuous infusion pump at all times.
This improvement was maintained for up to seven months. A smaller person study recently published in the medical journal The Lancet, demonstrated that patients receiving Tracleer had significant improvements in exercise capacity and hemodynamics blood circulation.
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