QTMeds

Drug Database Monograph

OPDIVO 10 mg/ml

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Active Ingredient: NIVOLUMAB

QTc Interval Status:
neutre

Clinical Description (Database Summary)

Nivolumab is an anti-PD-1 fully human monoclonal antibody used in cancer immunotherapy that demonstrates no clinically meaningful effect on cardiac repolarization or QTc intervals. In a phase 2 clinical study across 146 cancer patients evaluating doses up to 10.0 mg/kg every 3 weeks, maximum mean QTcF increases were minimal (under 5 ms across all dose tiers). Categorical analyses revealed no patients with QTcF exceeding 480 ms or changes greater than 60 ms from baseline, and pharmacokinetic-pharmacodynamic modeling showed no concentration-QTc relationship

Scientific Sources / References

https://doi.org/10.1007/s00280-016-2980-3

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