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Tolvaptan Alcohol Hepatotoxicity Contraindication — ESENeph MCQ

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HardPolycystic Kidney DiseaseTolvaptan Alcohol Hepatotoxicity ContraindicationESENeph

A 46-year-old man with rapidly progressive autosomal dominant polycystic kidney disease is being assessed for tolvaptan. His eGFR is 62 mL/min/1.73 m². He drinks 4 units of alcohol each evening. Blood tests show ALT 132 U/L (upper limit of normal 40 U/L), total bilirubin 48 micromol/L (upper limit of normal 20 micromol/L), normal alkaline phosphatase and INR 1.0. Ultrasound also shows multiple hepatic cysts without features of cirrhosis. Which finding constitutes a formal contraindication to initiating tolvaptan?

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

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Correct answer: B — ALT 132 U/L with total bilirubin 48 micromol/L

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

C is correct. His baseline ALT is 3.3 times ULN and total bilirubin is 2.4 times ULN. This combination meets a Jinarc SmPC permanent-discontinuation criterion and therefore contraindicates initiation; the liver abnormality requires investigation. Alcohol intake of 4 units daily is above UK low-risk drinking recommendations, but no threshold of more than 3 units daily is specified as a tolvaptan contraindication. Alcohol use should instead be addressed and considered as a possible cause of liver injury. An eGFR of 62 mL/min/1.73 m² represents CKD stage 2 and is compatible with NICE eligibility when disease is rapidly progressive. Age 46 years and male sex are not contraindications. Polycystic liver disease without hepatocellular disease is also not itself a contraindication.

Reference: Jinarc 15 mg tablets, Summary of Product Characteristics, sections 4.3–4.4, text revised 28 May 2025. https://www.medicines.org.uk/emc/product/6849/smpc