Generic name: bosentan 62.5mg
Dosage form: tablet, film coated
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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 [see Warnings and Precautions (5.2)].
Initiate treatment at 62.5 mg twice daily for 4 weeks and then increase to the maintenance dose of 125 mg twice daily. Doses above 125 mg twice daily did not appear to confer additional benefit sufficient to offset the increased risk of hepatotoxicity.
Tracleer should be administered in the morning and evening with or without food.
Dosage Adjustments for Patients Developing Aminotransferase Elevations
Measure liver aminotransferase levels prior to initiation of treatment and then monthly. If aminotransferase levels increase, revise the monitoring and treatment plan. The table below summarizes the dosage adjustment and monitoring recommendations for patients who develop aminotransferase elevations >3 × ULN during therapy with Tracleer. Discontinue Tracleer 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. There is no experience with the reintroduction of Tracleer in these circumstances.
|ALT/AST levels||Treatment and monitoring recommendations|
|> 3 and ≤ 5 × ULN||Confirm by another aminotransferase test; if confirmed, 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, continue or reintroduce the treatment as appropriate*.|
|> 5 and ≤ 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, consider reintroduction of the treatment*.|
|> 8 × ULN||Treatment should be stopped and reintroduction of Tracleer should not be considered. There is no experience with reintroduction of Tracleer in these circumstances.|
Pregnancy Testing in Females of Reproductive Potential
Initiate treatment with Tracleer in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy test during treatment [see Use in Specific Populations (8.1)].
Patients with Low Body Weight
In patients with a body weight below 40 kg but who are over 12 years of age, the recommended initial and maintenance dose is 62.5 mg twice daily. There is limited information about the safety and efficacy of Tracleer in children between the ages of 12 and 18 years [see Use in Specific Populations (8.4)].
Use with Ritonavir
Coadministration of Tracleer in Patients on Ritonavir
In patients who have been receiving ritonavir for at least 10 days, start Tracleer at 62.5 mg once daily or every other day based upon individual tolerability [see Drug Interactions (7.5)].
Coadministration of Ritonavir in Patients on Tracleer
Discontinue use of Tracleer at least 36 hours prior to initiation of ritonavir. After at least 10 days following the initiation of ritonavir, resume Tracleer at 62.5 mg once daily or every other day based upon individual tolerability [see Dosage and Administration (2.7), Drug Interactions (7.5)].
Use in Patients with Pre-existing Hepatic Impairment
Tracleer should generally be avoided in patients with moderate or severe liver impairment. Initiation of Tracleer should generally be avoided in patients with elevated aminotransferases >3 × ULN. No dose adjustment is required in patients with mildly impaired liver function [see Warnings and Precautions (5.3), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
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