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Single dose of difelikefalin up to 12 times and multiple doses of difelikefalin up to 5 times the clinical dose of 0.5 micrograms/kg were administered in clinical studies in patients undergoing haemodialysis. A dose-dependent increase in adverse events including dizziness, somnolence, mental status changes, paraesthesia, fatigue, hypertension and vomiting, was observed.
In the event of overdose, the appropriate medical attention based on patient's clinical status should be provided. Haemodialysis for 4 hours using a high-flux dialyzer effectively cleared approximately 70-80% of difelikefalin from plasma, and difelikefalin was not detectable in plasma at the end of the second of two dialysis cycles (see Pharmacology: Pharmacokinetics under Actions).
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