bosentan monohydrate at a glance
Medicine class
Dual endothelin A and B receptor antagonist
Main roles
Pulmonary arterial hypertension and prevention of new systemic-sclerosis digital ulcers
Taking the tablets
Swallow with water, with or without food
Essential monitoring
Liver function, haemoglobin and, where relevant, pregnancy testing
What is bosentan monohydrate used for?
Licensed uses represented by the selected product include:
Pulmonary arterial hypertension to improve exercise capacity and symptoms, particularly WHO functional class III disease. Some improvement has also been shown in functional class II disease.
Reducing new digital ulcers in adults with systemic sclerosis and ongoing digital-ulcer disease. It has not been shown to speed healing of existing ulcers.
How does bosentan monohydrate work?
Endothelin-1 narrows blood vessels and contributes to vascular remodelling and fibrosis. Bosentan blocks ETA and ETB receptors, reducing pulmonary and systemic vascular resistance.
bosentan monohydrate preparations and strengths
Tablet
Route: Oral
Strengths: 62.5 mg, 125 mg
How to take bosentan monohydrate
Follow the specialist prescription and Patient Alert Card. Swallow the film-coated tablet with water, with or without food.
Do not stop suddenly unless directed by the treating specialist, because the underlying condition may worsen.
Attend all requested blood tests and pregnancy tests.
bosentan monohydrate side effects
Common or expected effects
- Headache
- Ankle or leg swelling and fluid retention
- Abnormal liver-function tests
- Anaemia or reduced haemoglobin
- Flushing, low blood pressure or palpitations
- Rash, itching or other hypersensitivity reactions
- Nasal congestion
- Diarrhoea or acid reflux
Get urgent medical advice
- Liver injury: yellow skin or eyes, abdominal pain, vomiting, fever, severe tiredness or flu-like symptoms
- Severe allergic reaction: facial or throat swelling, breathing difficulty or collapse
- Significant anaemia causing marked tiredness, pallor, breathlessness or chest symptoms
- Fainting, rapidly worsening breathlessness or substantial new fluid retention
bosentan monohydrate in pregnancy
Bosentan is contraindicated in pregnancy. Pregnancy must be excluded before treatment; reliable contraception and regular pregnancy testing are required. Hormonal contraception must not be used alone because bosentan can reduce its effectiveness. Contact the specialist team promptly if pregnancy occurs or is planned, and avoid unplanned treatment changes.
bosentan monohydrate while breastfeeding
Breastfeeding is not recommended during treatment. Bosentan has been detected in human milk, and harm to the infant cannot be excluded. Discuss feeding options with the specialist team.
bosentan monohydrate interactions
Bosentan affects several drug-metabolising enzymes and is affected by medicines that alter these pathways. Ask the specialist or pharmacist to check the complete medicine list.
Ciclosporin A
Contraindicated because bosentan exposure can rise substantially while ciclosporin concentrations fall.
Hormonal contraceptives
Bosentan can reduce contraceptive exposure, so hormonal methods must not be relied upon alone.
Glibenclamide
Not recommended because glucose-lowering effectiveness may fall and liver-enzyme abnormalities may increase.
Common questions about bosentan monohydrate
Answers are fully visible for fast scanning and source review.
Is bosentan monohydrate the same as bosentan?
Bosentan monohydrate is the salt form used in the tablet; product information expresses the active amount as bosentan.
Does it heal existing digital ulcers?
It has not been shown to speed healing. Its licensed role is to reduce new digital ulcers in systemic sclerosis.
Why are blood tests needed?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.