Vernakalant

In patients with valvular heart disease, there was a higher incidence of ventricular arrhythmia events in vernakalant patients until 24 hours after dosing. Within the first 2 hours, ventricular arrhythmia occurred in 6.4% of patients treated with vernakalant versus none after placebo. These patients should be monitored closely.

Patients with CHF showed a higher overall incidence of hypotensive events, during the first 2 hours after dose in patients treated with vernakalant compared to patients receiving placebo (13.4% versus 4.7%, respectively). Hypotension reported as a serious adverse experience or leading to medicinal product discontinuation occurred in CHF patients following exposure to vernakalant in 1.8% of these patients compared to 0.3% in placebo.

Patients with a history of CHF showed a higher incidence of ventricular arrhythmia in the first two hours post dose (6.4% for vernakalant compared to 1.6% in placebo). These arrhythmias typically presented as asymptomatic, monomorphic, non-sustained (average 3-4 beats) ventricular tachycardias. Due to the higher incidence of the adverse reactions of hypotension and ventricular arrhythmia in patients with CHF, vernakalant should be used cautiously in haemodynamically stable patients with CHF functional classes NYHA I to II. There is limited experience with the use of vernakalant in patients with previously documented LVEF ≤35%. Its use in these patients is not recommended. The use in CHF patients corresponding to NYHA III or NYHA IV is contraindicated.

There are no data from the use of vernakalant in pregnant women. Studies in animal have shown malformations after repeated oral exposure. As a precautionary measure, it is preferable to avoid the use of vernakalant during pregnancy.

It is unknown whether vernakalant/metabolites are excreted in human milk. There is no information on the excretion of vernakalant/metabolites in animal milk. A risk to the newborns/infants cannot be excluded. Caution should be exercised when used in breast-feeding women.

Fertility

Vernakalant was not shown to alter fertility in animal studies.

Vernakalant has a minor to moderate influence on the ability to drive and use machines. Dizziness has been reported within the first 2 hours after receiving it.