The full, clinically endorsed recommendation should be obtained from Lareb [link].   

Clinical Overview  

Sotalol is used during pregnancy for the treatment of foetal indications, including supraventricular tachycardia and atrial flutter. Foetal tachycardia lacks a standardized pharmacological treatment guideline, and sotalol is commonly used despite limited evidence supporting a dosing regimen. Sotalol poses risks of dose-related maternal and foetal side effects. The severity of these adverse events and the importance of effective foetal therapy emphasises the need for establishing an optimal dosing regimen. Researchers at Radboudumc conducted PBPK modelling simulations to create more evidence regarding sotalol dosing in pregnancy.  

Pharmacokinetics of sotalol in pregnancy 

Sotalol is mainly eliminated by the kidneys, which activity increases during pregnancy. This can result in lower drug concentrations in both the mother and the foetus. However, sotalol extensively crosses the placenta, with foetal plasma levels approximating maternal concentrations. Pharmacokinetic modelling suggests that dose escalation should be discontinued earlier in pregnancy to avoid supratherapeutic exposure and associated adverse effects.  

Efficacy and safety of sotalol in pregnancy 

Clinical experience suggests that sotalol can restore foetal sinus rhythm, but the response is inconsistent and not all cases benefit from higher doses. Evidence for dose-related efficacy is weak and based on small, heterogeneous studies. Maternal safety concerns, particularly QT prolongation, increase with higher doses, while foetal risks of pro-arrhythmia are reported but not well quantified.  

Conclusion  

Pregnancy increases sotalol clearance, while foetal exposure is similar to maternal exposure. Therefore, earlier discontinuation of dose escalation is advised to prevent potential side effects. Evidence for dose-related efficacy and safety is limited, highlighting the need for careful monitoring.