|
Monthly pregnancy and liver-function monitoring is mandatory.1 |
|
|
Manage LFT elevations if they occur.1
|
|
|
No change of monitoring or dosage is needed for liver function
tests (LFTs) ≤3 × upper limit of normal (ULN).1
|
|
|
98% maintained treatment with Tracleer without discontinuations due to LFT
elevations.2
|
| — | Discontinuation rate in Tracleer clinical trials was 3% placebo vs 6% Tracleer.1 |
|
Tracleer can be reintroduced if LFTs return to pretreatment levels.1 |
| — | Tracleer should not be reintroduced for LFTs >8 × ULN. |
| — | Aminotransferase levels should be checked within 3 days and thereafter according to the recommendations in Warnings and Precautions. |
| Tracleer aminotransferase (ALT/AST) management1 |
|---|
| ALT/AST level | Treatment and monitoring recommendations |
| 1 to 3 × ULN | Continue to monitor; no change in monitoring schedule or dosage |
| >3 to ≤5 × ULN | Confirm by another test; if confirmed, reduce the dose or interrupt treatment and monitor LFT levels every 2 weeks
Continue or reintroduce Tracleer if levels return to pretreatment levels
|
| >5 to ≤8 × ULN | Confirm by another test; if confirmed, stop therapy; monitor LFTs at least every 2 weeks
Consider reintroduction of therapy if LFTs return to pretreatment levels
|
| >8 × ULN | Stop therapy; do not reintroduce |
If Tracleer is reintroduced, it should be at the starting dose; aminotransferase levels should be checked within
3 days and thereafter according to the recommendations above.
If liver aminotransferase elevations are accompanied by clinical symptoms of liver injury (such as nausea,
vomiting, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in bilirubin ≥2 ×
ULN, treatment should be stopped. There is no experience with the reintroduction of Tracleer in these
circumstances.
Tracleer is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in
patients with WHO Class II-IV symptoms, to improve exercise ability and decrease the rate of
clinical worsening. Patients with WHO Class II symptoms showed reduction in the rate of clinical
deterioration and a trend for improvement in walk distance. Physicians should consider whether
these potential benefits are sufficient to offset liver injury in WHO Class II patients, which may
preclude future use as their disease progresses.
Important safety information
Because of the associated risks, Tracleer may be prescribed only through the Tracleer Access Program.
Potential for serious liver injury (including, after prolonged treatment, rare cases of liver failure
and unexplained hepatic cirrhosis in a setting of close monitoring)—Liver monitoring of all patients
is essential prior to initiation of treatment and monthly thereafter.
High potential for major birth defects—Pregnancy must be excluded and prevented through the use of
reliable forms of birth control; monthly pregnancy tests should be obtained.
Contraindicated for use with cyclosporine A and glyburide.
Please see full prescribing information including BOXED WARNING.
- Tracleer (bosentan) full prescribing information. Actelion Pharmaceuticals US, Inc. August 2009.
- Data on file, Actelion Pharmaceuticals.
