bosentan pk in pah patients concentrations after 62 5 mg single dose
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Bosentan PK in PAH Patients Concentrations after 62.5 mg Single Dose. 9409.01. Interaction with Ketoconazole Bosentan Trough Plasma Levels. 9416.01. Choice of Doses for Clinical Trials. Maintenance / Target Dose

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choice of doses for clinical trials
Choice of Doses for Clinical Trials

Maintenance / Target Dose

  • 100/125 mg bid – top of hemodynamic dose response (decrease BP)
  • Higher doses – higher incidence of elevated LFTs
  • 250 mg bid – exploratory

Starting dose

  • 62.5 mg bid for 4 weeks(due to increased worsening HF with high starting doses and rapid up-titration in CHF patients)

9459.01

long term exposure to bosentan
Long-term Exposureto Bosentan

Exposure (years)

Total pt-yrs

Range

Mean  SD

Studies

N

PAH Studies

NC15462+OL

ENABLE*

235

267

1613

0.58  0.37

0.87  1.16

1.13  0.48

0.07 – 1.71

0.00 – 4.11

0.00 – 1.93

137.2

233.5

1824.2

* Treatment still blinded (approximately 807 patients on bosentan)

9511.01

change in wbc and platelets 8 placebo controlled studies
Change in WBC and Platelets8 Placebo-controlled Studies

Placebo

Bosentan

Mean change from BL

WBC

Platelets

Marked decrease [n (%)]

WBC

Platelets

0.0%

3.2%

2/273 (0.7%)

2/262 (0.8%)

9.3%

0.9%

7/640 (1.1%)

3/600 (0.5%)

9837.01

patient registry to be discussed with the fda

“1-800-ACTELION”

  • Central clearing house
  • Patient + physician database
  • PHYSICIAN
  • Liver Monitoring reminder
  • Spontaneous AE reporting
  • PATIENT
  • Ship drug
  • Liver monitoring reminder
  • Follow-up discontinuations/ AE reporting
Patient Registry(To Be Discussed with the FDA)

Specialty pharmacy network

9858.01

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