Adult Dosing
Pulmonary arterial hypertension
- < 40 kgs:
- Start 62.5 mg PO bid
- Max: 125 mg/day
- Refer package insert for modifications based on AST/ALT evaluation
- > 40 kgs:
- Initial dose: 62.5 mg PO bid x 4wk
- Maintenance dose: 125 mg PO bid
- Max: 250 mg/day
- Reduce dose to 62.5 mg PO bid for 3-7 days to discontinue
- Refer package insert for modifications based on AST/ALT evaluation
- > 12 yrs and < 40 kgs
- Start 62.5 mg PO bid
- Max: 125 mg/day
- Refer package insert for modifications based on AST/ALT evaluation
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
[Outline]
- Prescribed and dispensed only through Tracleer Access Program to minimize risk of hepatic injury and fetal exposure [US Black Box Warning]
- Measure baseline and monthly AST/ALT as elevations of AST/ALT of at least three times ULN have occurred associated with elevated bilirubin. Avoid use if baseline AST/ALT >3x ULN, if elevated ALT/AST occurs, reduce dosage accordingly
- Fluid retention may occur within weeks after starting therapy. Treat appropriately with a diuretic/fluid management or hospitalization for decompensating heart failure, if clinically significant fluid retention associated with or without weight gain is due to underlying heart failure or therapy provide appropriate treatment or discontinue therapy of bosentan
- Possibility of decreased sperm counts have occurred
- Dose related decreases in hemoglobin and hematocrit have occurred. Monitor Hb at baseline, then at 1 and 3 months, then q3 months thereafter
- Discontinue therapy on occurrence of pulmonary veno-occlusive disease
- Strictly avoid use during pregnancy due to major birth defect risk
- In women of child bearing potential use reliable forms of contraception, during therapy and for 4wks after discontinuation as hormonal contraceptives may not be effective in combination with bosentan
- Perform pregnancy test during 1st 5 days of normal menstrual period and >11 days after last unprotected intercourse, then monthly
Cautions: Use cautiously in
- Mild hepatic impairment
- Hx of liver disease
- Use of hepatotoxic drugs
- CHF
- Fluid retention
- Elderly patients
Pregnancy Category:X
Breastfeeding: Safety unknown. Because of the potential for possible serious adverse reactions in nursing infants a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Drug Name: Tracleer 125 MG Oral Tablet
Ingredient(s): Bosentan
Imprint: 125
Color(s): White
Shape: Oval
Size (mm): 11.00
Score: 1
Inactive Ingredient(s): N/A
Drug Label Author:
Actelion Pharmaceuticals US, Inc.
DEA Schedule:
Non-Scheduled
Drug Name: Tracleer 62.5 MG Oral Tablet
Ingredient(s): Bosentan
Imprint: 62;5
Color(s): White
Shape: Oval
Size (mm): 6.00
Score: 1
Inactive Ingredient(s): N/A
Drug Label Author:
Actelion Pharmaceuticals US, Inc.
DEA Schedule:
Non-Scheduled
2x ULN, discontinue therapy. There is no experience with treatment re-introduction
