The Food and Drug Administration (FDA) has approved new dosing, monitoring, and evaluation recommendations for intravenous (IV) sotalol (Altathera), allowing for a reduction in hospital stay from 3 days to 1 day in patients with atrial fibrillation.
Sotalol is an antiarrhythmic agent that has both beta-adrenoreceptor blocking and cardiac action potential duration prolongation properties. The IV formulation is approved for substitution for oral sotalol in patients who are unable to take sotalol orally. Prior to the approval, initiating sotalol in new patients would involve a hospital stay of 3 days in order to monitor patients. The new recommendations allow for initiation with sotalol IV followed by a transition to oral sotalol.
Under close medical monitoring, sotalol IV can be used to achieve near steady-state exposure to sotalol prior to initiating or increasing oral dosing. The IV loading dose depends on the target oral dose and creatinine clearance; the dosing interval for oral administration of sotalol and the minimum delay between the end of the infusion and the first oral dose also depend on renal function. Intravenous loading doses were derived using computer-based simulations incorporating sotalol dose-exposure-QTc relationships.
Commenting on the approval John Somberg, MD, Clinical and Regulatory Consultant to AltaThera, Cardiology Professor Emeritus, Rush University, said: “The new FDA-approved dosing will make initiation of sotalol faster and much easier for patients and physicians. We are especially grateful to the FDA and to Sander Vinks, PharmD, PhD, FCP and professor of pediatrics and pharmacology at the University of Cincinnati, College of Medicine who worked closely with AltaThera throughout the process of determining the correct dosing and monitoring for these new AFib indications of initiation and escalation of sotalol.”
For more information visit altathera.com.