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ADPKD — ESENeph MCQ

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HardPolycystic Kidney DiseaseADPKDESENeph

During tolvaptan treatment for rapidly progressive ADPKD, an asymptomatic patient develops ALT 9 times the upper limit of normal. Bilirubin and INR are normal. What does the UK SmPC require?

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

Reveal the answer and explanation

Correct answer: C — Permanently stop tolvaptan and investigate drug-induced liver injury now

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

C is correct. The Jinarc SmPC requires permanent discontinuation when ALT or AST exceeds eight times the upper limit of normal, even if bilirubin and INR remain normal. Lower elevations trigger immediate interruption, repeat testing and assessment against additional duration, bilirubin, INR and symptom criteria. Restarting is not appropriate after a permanent stopping criterion. The result also requires evaluation for alternative hepatic causes and appropriate clinical follow-up. This exact threshold matters because routine monitoring intervals must not delay action on a newly detected marked transaminase rise.

Reference: Jinarc Summary of Product Characteristics: https://www.medicines.org.uk/emc/product/6854/smpc