Vernakalant

The SPC itself names the indication in §4.2 ('rapid conversion of recent onset atrial fibrillation to sinus rhythm'). || VERBATIM POSOLOGY (§4.2): 'Vernakalant is dosed by patient body weight, with a maximum calculated dose based upon 113 kg. The recommended initial infusion is 3 mg/kg to be infused over a 10-minute period with a maximum initial dose of 339 mg (84.7 ml of 4 mg/ml solution). If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10-minute infusion of 2 mg/kg may be administered (maximum second infusion of 226 mg (56.5 ml of 4 mg/ml solution)). Cumulative doses of greater than 5 mg/kg should not be administered within 24 hours.' || PATIENTS OVER 113 kg, verbatim: 'For patients above 113 kg, vernakalant has a fixed dose. The initial dose is 339 mg (84.7 ml of 4 mg/ml solution). If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10-minute infusion of 226 mg (56.5 ml of 4 mg/ml solution) may be administered. Cumulative doses above 565 mg have not been evaluated.' || STOPPING RULES DURING THE INFUSION (§4.2): the patient must be watched throughout the initial infusion for any sign or symptom of a sudden decrease in blood pressure or heart rate; 'If such signs develop, with or without symptomatic hypotension or bradycardia, the infusion should be stopped immediately.' If conversion has not occurred, observe vital signs and cardiac rhythm for a further 15 minutes before the second infusion. If conversion to sinus rhythm occurs during either infusion, that infusion should be continued to completion. If haemodynamically stable atrial flutter is seen after the initial infusion, the second infusion may still be given as patients may convert to sinus rhythm. || §4.4 adds that if a sudden drop in blood pressure or heart rate, hypotension, bradycardia or the listed ECG changes occur during the FIRST infusion, 'patients should not receive the second dose', and the patient should be monitored for 2 hours after the start of the infusion and until clinical and ECG parameters have stabilised. || BEFORE INFUSING (§4.4): patients should be adequately hydrated and haemodynamically optimised, anticoagulated in accordance with treatment guidelines if necessary, and uncorrected hypokalaemia (serum potassium less than 3.5 mmol/l) must be corrected first. A pre-infusion eligibility checklist is supplied with the product and should be placed on the infusion container. || SPECIAL POPULATIONS (§4.2): post-cardiac surgery, renal impairment, hepatic impairment and elderly (65 years and over) all require NO dose adjustment. || DILUTION: §6.6 holds the dilution instructions and was NOT fetched — the 4 mg/ml figures above are the diluted-solution volumes quoted in §4.2, not a dilution method. || TRUNCATION: §4.4 was cut mid-sentence inside the congestive-heart-failure paragraph and §4.8 was cut inside the bradycardia paragraph, so neither is complete here. §4.2 itself is complete.

NO PAEDIATRIC DOSE EXISTS — vernakalant must not be used under 18. §4.2 verbatim: 'There is no relevant use of vernakalant in children and adolescents < 18 years of age for rapid conversion of recent onset atrial fibrillation to sinus rhythm and therefore it should not be used in this population.' No paediatric figure has been invented or scaled from the adult mg/kg dose. For any under-18 arrhythmia management, verify against a children's formulary and discuss with paediatric cardiology.