TRACLEER ADULT DOSAGE AND ADMINISTRATION
Managing Adult Patients
Setting patient expectations
When starting a patient on TRACLEER® (bosentan), it is important to set
expectations. Setting patient expectations is essential in a chronic disease such as
pulmonary arterial hypertension (PAH) because you and your patient will be working together
closely to evaluate outcomes during treatment with TRACLEER.
The safe use of TRACLEER requires ongoing monthly monitoring of liver function test (LFT)
results and, if applicable, pregnancy test results. You must counsel your patients about the
importance of monthly testing and ensure that test results are obtained and reviewed by your
LFT monitoring algorithm
Elevated monthly LFT results do not always preclude treatment with TRACLEER. The table below provides recommendations on the management of patients taking TRACLEER with elevated LFT results.
If liver aminotransferase elevations are accompanied by clinical symptoms of hepatotoxicity
(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: Management of aminotransferase (ALT/AST) elevations1|
|ALT/AST levels||Treatment and monitoring recommendations|
|>3 and ≤5 × ULN||Confirm by another aminotransferase test; if confirmed,
- in adults and pediatric patients >12 years and >40 kg, reduce the daily dose to 62.5 mg twice daily or interrupt treatment, and monitor aminotransferase levels at least every 2 weeks. If the aminotransferase levels return to pretreatment values, treatment may continue or be reintroduced at 62.5 mg twice daily, with reassessment of aminotransferase levels within 3 days.
- in all other pediatric patients, interrupt treatment with no prior dose reduction. If the aminotransferase levels return to pretreatment values, reintroduce at the dose used prior to treatment interruption, with reassessment of aminotransferase levels within 3 days.
|>5 to ≤8 × 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 pretreatment values,
- in adults and pediatric patients >12 years and >40 kg, consider reintroduction of treatment at 62.5 mg twice daily, with reassessment of aminotransferase levels within 3 days.
- in all other pediatric patients, consider reintroduction at the dose used prior to treatment interruption, with reassessment of aminotransferase levels within 3 days.
|>8 × ULN||Stop treatment permanently. There is no experience with reintroduction of TRACLEER in these circumstances.|
ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
*If TRACLEER is reintroduced, it should be at the starting dose; aminotransferase levels
should be checked within three days and thereafter according to the recommendations
The specialty pharmacy will confirm with your patients that monthly LFTs and, if applicable,
pregnancy tests have been obtained. If a patient does not confirm having the monthly tests
or becomes pregnant, the pharmacy will contact you.
Please notify Janssen and/or FDA of any pregnancies or adverse events, including
hepatotoxicity, by calling toll-free at 1-800-Janssen (1-800-526-7736), or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
TRACLEER® Adult Dosage and Administration
TRACLEER adult dosing1
Healthcare professionals who prescribe TRACLEER must enroll in the TRACLEER REMS Program and must comply with the required monitoring to minimize the risks associated with TRACLEER.
- Initiate at 62.5 mg twice daily (BID) with or without food for four weeks; then increase to 125 mg twice daily.
- Patients with low body weight (<40 kg) and >12 years old: Initial and maintenance dose is 62.5 mg twice daily.
- Reduce the dose or interrupt treatment and closely monitor patients developing aminotransferase elevations >3 × upper limit of normal (ULN).
- Discontinue TRACLEER 36 hours prior to initiation of ritonavir. Patients on ritonavir: Initiate TRACLEER at 62.5 mg once daily or every other day.