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Recent News and Articles on the Keywords: tracleer + hepatotoxity + linked  Related to the article below (Last Update: 12/1/2008)

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Recent News and Articles on the Keywords: tracleer + 0.21 + web  Related to the article below (Last Update: 8/7/2008)

Tracleer(R) (bosentan) receives EU approval for treatment of ... FOXBusiness - Aug 4, 2008 Since 2002, Tracleer(R) has been approved and available in the European Union for PAH patients with WHO FC III. Tracleer(R) is the first PAH treatment ever ... Tracleer? (bosentan) receives EU approval for treatment of ... Ad-Hoc-News (Pressemitteilung) all 9 news articles »  VTX:ATLN - OTC:CMTX EU Extends Indication of Bosentan to Pulmonary Arterial ... DG News - NEW YORK -- August 6, 2008 -- The European Union (EU) has approved bosentan (Tracleer) for the treatment of patients with mildly symptomatic pulmonary ... Actelion Wins European Approval for Pulmonary Arterial ... RedOrbit, TX - Aug 5, 2008 Actelion has announced that Tracleer, a dual endothelin receptor antagonist, has been approved in the European Union for the treatment of patients with ...VTX:ATLN A Drug That Improves Exercise Capacity by a Greater Percentage ... PR Newswire (press release), NY - Jul 22, 2008 ... Tracleer at 16 weeks, would earn a 48 percent patient share in the treatment of pulmonary arterial hypertension, according to surveyed pulmonologists. ... UPDATE 1-Actelion Q2 profit falls 19 pct, raises forecast Reuters - Jul 21, 2008 The company is trying to cut its dependence on key drug Tracleer, used for treating a rare lung and heart condition, by using the medicine against more ... Actelion Q2 net profit beats forecast, ups 2008 forecast Economic Times all 9 news articles »  VTX:ATLN Actelion Announces Half Year Financial Results 2008 ABN Newswire (press release), Australia - Jul 21, 2008 At the end of March 2008, Tracleer? was commercially available in over 50 countries worldwide, including all major pharmaceutical markets. ...VTX:ATLN Maktoob Business (press release) Actelion signs key accord with GSK Swissinfo, Switzerland - Jul 14, 2008 For Actelion, the successful development of almorexant is considered key to reducing its dependence on its main drug Tracleer. Last week the Swiss stock ... Actelion and GSK in deal on almorexant Reuters Actelion seals lucrative deal with GSK for insomnia drug almorexant Pharma Times (subscription) Actelion Sells Glaxo Almorexant Sleep Medicine Rights (Update1) Bloomberg Reuters UK - Wall Street Journal all 72 news articles »  VTX:ATLN - GSK New drug for PAH in Vietnam Thanh Nien Daily, Vietnam - Jul 10, 2008 The drug, tradename Tracleer, that was developed by Actelion, is the leading PAH treatment ? a rare, chronic blood vessel disorder of the lungs in which ... HUGIN NEWS/Tracleer? (Bosentan) erh?lt EU-Zulassung f?r die ... FOCUS Online, Germany - Aug 3, 2008 Seit 2002 ist Tracleer? in der Europ?ischen Union f?r PAH-Patienten der WHO-Funktionsklasse III zugelassen und erh?ltlich. Tracleer? ist das erste ... Actelion erh?lt erweiterte EU-Zulassung f?r Tracleer Reuters Deutschland Actelion: Tracleer erh?lt Ad-Hoc-News (Pressemitteilung) Actelion "hold" AktienCheck WELT ONLINE all 35 news articles » Actelion: homologation EU pour Tracleer chez patients avec PAH ? Romandie.com, Switzerland - Aug 4, 2008 Allschwil (AWP) - Actelion Ltd a re?u une homologation de la part de l'Union Europ?enne (UE) pour le Tracleer (Bosentan) dans le traitement des patients ...

Hepatotoxity linked to Tracleer

The FDA ( U.S. Food and Drug Administration ) has changed labelling for Tracleer ( Bosentan ). The notification underscored the need to continue monthly liver function monitoring ( LFT ) for the duration of Tracleer treatment and the need to adhere to the recommended dosage adjustment and monitoring guidelines described in the product labeling.

The labeling changes are based on rare cases of hepatotoxicity.

In one case, a female patient, treated for pulmonary arterial hupertension since childhood, with multiple co-morbidities and on multiple drug therapies was treated with Tracleer for 21 months at the recommended dosage.
After her first year of treatment, her LFTs ( aminotransferases, alkaline phosphatase, and total bilirubin ) remained near her baseline values, but about one year after starting Tracleer her ALT gradually rose from baseline ( 2-4 x baseline ) but stayed within normal limits.
After another nine months of treatment, marked elevations in aminotransferase and bilirubin levels were noted and Tracleer was discontinued.
After discontinuation of Tracleer, AST and ALT remained elevated and bilirubin continued to rise. In this period, she was hospitalized for an i.v. catheter line infection.
The patient developed liver failure and biopsy-confirmed cirrhosis.
A contribution of Tracleer to the development of liver failure could not be ruled out. Eventually, her liver failure abated and her LFTs recovered about seven months after discontinuation of Tracleer.

This case underscores the need to continue monthly monitoring for the duration of Tracleer treatment.
It also emphasizes the need to adhere to the recommended dosage adjustment and monitoring guidelines.


Dosage adjustment and monitoring in patients developing aminotransferase abnormalities

ALT/AST levels: > 3 and < / = 5 x ULN

Confirm by another aminotransferase test; if confirmed, reduce the daily dose or interrupt treatment, and monitor aminotransferase levels at least every 2 weeks.
If the aminotransferase levels return to pre-treatment values, continue or re-introduce the treatment as appropriate.

ALT/AST levels: > 5 and < / = 8 x ULN

Confirm by another aminotransferase test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks. Once the aminotransferase levels return to pre-treatment values, consider re-introduction of the treatment.

ALT/AST levels: > 8 x ULN

Treatment should be stopped and re-introduction of Tracleer should not be considered.
There is no experience with re-introduction of Tracleer in these circumstances.


Tracleer received FDA approval on November 20, 2001. Tracleer is the first of a new class of orally active, dual endothelin-receptor antagonists available for the treatment of Pulmonary Arterial Hypertension ( PAH ). Tracleer is indicated for the treatment of PAH patients in the World Health Organization ( WHO ) functional Class III or IV, a life-threatening condition that can severely impair the function of the heart and the lungs.

Tracleer inhibits the activity of endothelin-1 ( ET-1 ) by competitively binding to both ETA and ETB receptors. ET-1 plays an important role in the pathophysiology of PAH by inducing vasoconstriction of the pulmonary arteries and promoting proliferation of the vascular smooth muscle and profibrotic effects of the endothelium. Inhibition of the ET-1 leads to therapeutic effects of decreased pulmonary fibrosis and inflammation, decreased pulmonary vascular hypertrophy and right ventricular hypertrophy, and decreased pulmonary artery pressure.

Source: FDA, 2006