Drug reference
Pulmonary arterial hypertension (initiated under Cardiovascular system specialist supervision) ▶BY MOUTH ▶Adult: Initially 62.5 mg twice daily for 4 weeks, then increased to 125 mg twice daily (max. per dose 250 mg); maximum 500 mg per day Systemic sclerosis with ongoing digital ulcer disease (to reduce number of new digital ulcers) ▶BY MOUTH ▶Adult: Initially 62.5 mg twice daily for 4 weeks, then increased to 125 mg twice daily
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Acute porphyrias p. 1120
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Not to be initiated if systemic systolic blood pressure is below 85 mmHg. pulmonary veno-occlusive disease
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→Appendix 1: bosentan
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▶Common or very common Anaemia. diarrhoea. flushing. gastrooesophageal reflux disease. headache. nasal congestion. palpitations. skin reactions. syncope ▶Uncommon Hepatic disorders. leucopenia. neutropenia. thrombocytopenia ▶Rare or very rare Angioedema ▶Frequency not known Vision blurred
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Effective contraception required during administration (hormonal contraception not considered effective). Monthly pregnancy tests advised.
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Avoid (teratogenic in animal studies).
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Manufacturer advises avoid—no information available.
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Manufacturer advises avoid in moderate-to-severe impairment or if baseline serum transaminases exceed 3 times the upper limit of normal.
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▶Monitor haemoglobin before and during treatment (monthly for first 4 months, then 3-monthly). ▶Monitor liver function before treatment, at monthly intervals during treatment, and 2 weeks after dose increase (reduce dose or suspend treatment if liver enzymes raised significantly)—discontinue if symptoms of liver impairment.
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There can be variation in the licensing of different medicines containing the same drug. Tablet ▶Bosentan (Non-proprietary) Bosentan (as Bosentan monohydrate) 62.5 mg Bosentan 62.5mg tablets | 56 tablet P £112.50 (Hospital only) | 56 tablet P £1,359.19–£1,510.21 Bosentan (as Bosentan monohydrate) 125 mg Bosentan 125mg tablets | 56 tablet P £112.50 (Hospital only) | 56 tablet P £1,359.19–£1,510.21 ▶Stayveer (Advanz Pharma) Bosentan (as Bosentan monohydrate) 62.5 mg Stayveer 62.5mg tablets | 56 tablet P £208.34 Bosentan (as Bosentan monohydrate) 125 mg Stayveer 125mg tablets | 56 tablet P £208.34 ▶Tracleer (Actelion Pharmaceuticals UK Ltd) Bosentan (as Bosentan monohydrate) 62.5 mg Tracleer 62.5mg tablets | 56 tablet P £1,510.21 Bosentan (as Bosentan monohydrate) 125 mg Tracleer 125mg tablets | 56 tablet P £1,510.21
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Avoid abrupt withdrawal— withdraw treatment gradually.
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Initially 62.5 mg twice daily for 4 weeks, then
First-line fragment. Read the complete Indications and Dose section above.
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Initially 62.5 mg twice daily for 4 weeks, then
First-line fragment. Read the complete Indications and Dose section above.
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