QTMeds

Drug Database Monograph

GHRYVELIN 60 mg granulés pour suspension buvable en sachet

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Active Ingredient: MACIMORELINE

QTc Interval Status:
prolongation

Clinical Description (Database Summary)

Macimorelin is associated with a statistically significant, dose-dependent prolongation of the QT interval. In a thorough QT study of 60 healthy subjects, a single supratherapeutic dose (2.0 mg/kg, which is 4x the clinical dose) caused a maximum mean QTcF increase (ΔΔQTcF) of 9.61 ms (90% CI: 7.81–11.41 ms) at 4 hours post-dose. The effect is transient, appearing 3 to 4 hours after the peak plasma concentration (Cmax​) and returning to baseline by 5 hours. Due to this risk, macimorelin should be avoided in patients with congenital or acquired long QT syndrome and with concomitant QT-prolonging drugs.

Scientific Sources / References

https://doi.org/10.1002/cpdd.872

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