On August 27, 2026, the AQVESME label carried a boxed warning stating that AQVESME can cause serious hepatocellular injury. The warning directs clinicians to measure liver laboratory tests at baseline and every 4 weeks for 24 weeks; the supplied label summary also indicates monitoring after that period.
Background
AQVESME is a brand name associated with mitapivat. The supplied data identify mitapivat, AQVESME, and PYRUKYND as related names. The event concerns a revision to the AQVESME label and specifically records the presence of a boxed warning.
The warning addresses hepatocellular injury, a form of liver injury involving liver cells. The data supplied for this update do not include an indication, dosing information, mechanism of action, prevalence estimate, or prior approval details. They also do not identify whether the warning changed any particular treatment population or prescribing restriction.
Label change
The label warning is headed “WARNING: HEPATOCELLULAR INJURY”. It states that AQVESME can cause serious hepatocellular injury. The monitoring instructions name four laboratory measures: alanine aminotransferase, or ALT; aspartate aminotransferase, or AST; alkaline phosphatase; and total bilirubin with fractionation.
The supplied summary specifies that these liver laboratory tests should be measured at baseline and every 4 weeks for 24 weeks. The available text ends after indicating a subsequent monitoring instruction, so the later schedule is not reproduced here.
What this means
The effective label change puts serious hepatocellular injury in a boxed warning for AQVESME and establishes liver-test monitoring early in treatment. Clinicians reviewing the label should use the FDA-linked prescribing information for the complete instructions, including the portion of the monitoring schedule that follows the first 24 weeks.
The supplied data do not provide rates of liver injury, laboratory thresholds, treatment interruptions, patient outcomes, or comparative safety results. They therefore support reporting the warning and its stated monitoring schedule, but not an estimate of risk or a comparison with another drug.
Source
Source: FDA, AQVESME label, a DailyMed drug-label document, effective August 27, 2026. The source is hosted at dailymed.nlm.nih.gov: dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1d4e2654-1636-0d01-e063-6394a90af303.