QTMeds

Drug Database Monograph

DARZALEX 1800 mg

✓ VERIFIED BY DOCTOR

Active Ingredient: DARATUMUMAB

QTc Interval Status:
prolongation

Clinical Description (Database Summary)

Daratumumab is an anti-CD38 monoclonal antibody used in multiple myeloma that produces a small effect on cardiac repolarization. In a phase 2 clinical QTc substudy of 31 patients, maximum mean QTcF increases were 9.1 ms (upper 90% CI of 14.1 ms) and PK/PD modeling predicted a maximum QTcF increase of 8.5 ms (upper 90% CI of 13.5 ms), thus exceeding regulatory threshold (>10ms). Caution is required.

Scientific Sources / References

https://doi.org/10.1007/s12325-020-01601-w

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