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Tracleer Dosage

Generic name: bosentan 62.5mg
Dosage form: tablet, film coated

Medically reviewed on December 5, 2017.

Required Monitoring

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 (5.3)].

Obtain a pregnancy test in females of reproductive potential prior to Tracleer treatment, monthly during treatment and one month after stopping Tracleer. Initiate treatment with Tracleer in females of reproductive potential only after a negative pregnancy test [see Boxed Warning, Contraindications (4.1), Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)].

Measure liver aminotransferase levels prior to initiation of treatment and then monthly [see Warnings and Precautions (5.1)].

Recommended Dosage

Administer Tracleer orally following the dosing recommendations in Table 1. Doses above 125 mg twice daily did not appear to confer additional benefit sufficient to offset the increased risk of hepatotoxicity.

Table 1: Dosing Recommendations
Initial 4 weeks Maintenance (after 4 weeks)
Patients >12 years of age and >40 kg 62.5 mg twice daily 125 mg twice daily
Patients >12 years of age and <40 kg 62.5 mg twice daily 62.5 mg twice daily
Patients ≤12 years of age
≥4-8 kg 16 mg twice daily 16 mg twice daily
>8-16 kg 32 mg twice daily 32 mg twice daily
>16-24 kg 48 mg twice daily 48 mg twice daily
>24-40 kg 64 mg twice daily 64 mg twice daily

Administration

Tracleer film-coated tablets and tablets for oral suspension (dispersible tablets) should be administered orally twice daily.

Disperse tablets for oral suspension, or dispersable tablet half, in a minimal amount of water immediately before administration.

Store divided dispersible tablet pieces at 20ºC – 25ºC (68ºF – 77ºF) in the opened blister for up to 7 days.

Dosage Adjustments for Aminotransferase Elevations

If aminotransferase levels increase, adjust monitoring and treatment plan according to Table 2.

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 bilirubin ≥ 2 × Upper Limit of Normal (ULN). There is no experience with the reintroduction of Tracleer in these circumstances.

Table 2: Dosage Adjustment and Monitoring in Patients Developing Aminotransferase Elevations > 3 × ULN
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 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,
- 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.

Use with Ritonavir

Co-administration of Tracleer in Patients on Ritonavir

In patients who have been receiving ritonavir for at least 10 days, start Tracleer at the recommended initial dose once daily or every other day based upon individual tolerability [see Cytochrome P450 Drug Interactions (7.1)].

Co-administration 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 the recommended initial dose once daily or every other day based upon individual tolerability [see Cytochrome P450 Drug Interactions (7.1)].

Use in Patients with Pre-existing Hepatic Impairment

Avoid initiation of Tracleer in patients with 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)].

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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