Tracleer^® has a well-established safety profile

• In placebo-controlled trials the adverse drug reactions that occurred in ≥ 3% of Tracleer^®-treated patients(125 mg and 250 mg bid), 2% more frequently than in the placebo group, were nasopharyngitis, flushing, abnormal hepatic function, leg oedema, hypotension, palpitations, dyspepsia, fatigue and pruritus (Table 3)

Table 3: Tracleer^® adverse events versus placebo in PAH trials

• The safety profile of Tracleer® has been confirmed by data captured in almost 5,000 patients in the Tracleer post-marketing surveillance programme, particularly with respect to elevated liver enzymes (figure 16)⁴⁴
  
  

Figure 16: A well established safety profile confirmed in nearly 5,000 patients in real clinical practice⁴⁴

• Clinical experience gained in more than 31,000 patients exposed to Tracleer to date confirms this known safety profile

Importance of LFT monotoring

• Like all ERAs, Tracleer^® is associated with dose-dependent elevations in liver aminotransferases (AST and/or ALT), causing at least a 3-fold upper limit of normal (ULN) elevation in approximately 11% of patients²
• Serum AST/ALT levels must be measured prior to initiation of treatment and monthly thereafter. In addition AST/ALT levels must be measured 2 weeks after any dose increase
• Tracleer^® is contraindicated in patients with AST/ALT > 3 x ULN at baseline

Recommendations in case of ALT/AST elevations

• The use of T racleer® is associated with a high risk of major birth defects and pregnancy must be excluded and prevented

Please consult prescribing information for details of drug interactions