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Bosentan Hepatotoxicity — SCE Rheumatology MCQ

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ModerateSystemic SclerosisBosentan HepatotoxicitySCE Rheumatology

A 55-year-old woman with limited cutaneous systemic sclerosis takes bosentan to prevent new digital ulcers. Routine monthly monitoring shows an ALT of 4 times the upper limit of normal; previous results were normal. She has no nausea, abdominal pain, jaundice, lethargy or other symptoms of liver injury, and her bilirubin is normal. What is the most appropriate next step?

Educational content. Not a substitute for clinical judgement or local policy.

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Correct answer: C — Repeat aminotransferases promptly; if confirmed, individualise dose reduction or cessation and monitor at least 2-weekly

Explanation lettering: D = shown as A · A = shown as B · E = shown as C · B = shown as D · C = shown as E

The correct answer is E. An isolated ALT elevation of 4 times ULN falls within the bosentan SmPC category of greater than 3 but no more than 5 times ULN. The result should first be confirmed with a second liver test. If confirmed, the decision to continue bosentan, potentially at a reduced dose, or to stop it is individualised, and aminotransferases are monitored at least every 2 weeks. Immediate permanent withdrawal (B) is not mandated at this level in an asymptomatic patient with normal bilirubin; it is required for elevations above 8 times ULN or symptoms of liver injury. Routine monthly or three-monthly review (A or C) is insufficiently frequent, and ursodeoxycholic acid (D) is not the recommended management.

Reference: Electronic Medicines Compendium. Bosentan 62.5 mg film-coated tablets, Summary of Product Characteristics, section 4.4: Liver function and recommendations for ALT/AST elevations. Revised October 2025. https://www.medicines.org.uk/emc/product/820/smpc