Who can administer
Administration RESTRICTED - see Appendix 1
Important information
-
Pre-infusion check list in packaging must be completed prior to administration
| Drug interaction (potentially serious) |
Interval |
Recommendation |
| INTRAVENOUS antiarrythmic drugs (Class I and III) e.g. amiodarone, lidocaine, flecainide, sotalol |
Within 4 hours before OR after vernakalant administration |
Combined use contraindicated within this time-frame |
| If given 4 to 24 hours before vernakalant |
No data- not recommended to give vernakalant |
| ORAL antiarrythmic drugs (class I and III) |
Use vernakalant with caution due to limited experience. Risk of atrial flutter may be increased in patients receiving Class I and III antiarrythmics (e.g. sotalol, flecainide, amiodarone) |
| Resumption or initiation of oral maintenance treatment with antiarrythmic drugs |
Can be restarted two hours after vernakalant |
Dose is based on body weight. There are two different dosages depending on initial infusion or second infusion
- For patients weighing greater than 113kg, do no exceed the maximum of 339mg for initial dose and 226mg for second dose
Indicated for rapid conversion of recent onset AF in adults who are
- non surgical with AF less than or equal to 7 days duration
- post cardiac surgery with AF less than or equal to 3 days duration
In their pharmacoeconomic evaluation of vernakalant, the NCPE recommends reimbursement for vernakalant for the treatment of haemodynamically stable, symptomatic patients with atrial fibrillation of less than 48 hours duration in the hospital setting (ref 1)
Available preparations
Vernakalant hydrochloride 500mg in 25ml vial (Brinavess) (=20mg/ml)
200mg vial may be considered for purchase at a later date if available
Reconstitution
Already in solution
Dilute further prior to administration
Infusion fluids
Sodium Chloride 0.9% or Glucose 5%
Prepare a 4mg per ml infusion solution as follows:
| Patient weight |
Volume of Vernakalant injection solution |
Volume of diluent |
Final volume of diluted solution |
| 100kg or less |
25ml (500mg) |
100ml |
125ml |
| over 100kg |
30ml (600mg) |
120ml |
150ml |
Methods of intravenous administration
Intravenous infusion (administer using an electronically controlled infusion device)
- Initial infusion: Administer over 10 mins, wait 15 minutes after the end of the initial infusion, then if still symptomatic give the second infusion: administer over 10 mins
Dose in adults
- Dose is based on body weight
- Body weight can be rounded to nearest 5kg as per dosage chart below
- There are two different dosages depending on initial infusion or second infusion
- For patients weighing greater than 113kg, do not exceed the maximum of 339mg for initial dose and 226mg for second dose
- If conversion to sinus rythym occurs during either the initial or second infusion, that infusion should be completed. If haemodynamically stable atrial flutter is observed after the initial infusion, the second infusion of vernakalant may be administered, as patients may convert to sinus rythym
| First infusion of Vernakalant is administered as a 3mg/kg dose over 10 minutes |
Second infusion of Vernakalant is administered as a 2mg/kg dose over 10 minutes |
| Patient weight |
Volume of 4mg/ml solution prepared as above |
Patient weight |
Volume of 4mg/ml solution prepared as above |
| 40kg |
30ml |
40kg |
20ml |
| 45kg |
33.7ml |
45kg |
22.5ml |
| 50kg |
37.5ml |
50kg |
25ml |
| 55kg |
41.2ml |
55kg |
27.5ml |
| 60kg |
45ml |
60kg |
30ml |
| 65kg |
48.7ml |
65kg |
32.5ml |
| 70kg |
52.5ml |
70kg |
35ml |
| 75kg |
56.2ml |
75kg |
37.5ml |
| 80kg |
60ml |
80kg |
40ml |
| 85kg |
63.7ml |
85kg |
42.5ml |
| 90kg |
67.5ml |
90kg |
45ml |
| 95kg |
71.2ml |
95kg |
47.5ml |
| 100kg |
75ml |
100kg |
50ml |
| Important: preparation of solution differs for weights above 100kg |
| 105kg |
78.7ml |
105kg |
52.5ml |
| 110kg |
82.5ml |
110kg |
55ml |
| 113kg |
84.7ml |
113kg |
56.5ml |
| For patients weighing greater than 113kg, do not exceed the maximum of 339mg for initial dose and 226mg for second dose |
Renal impairment: No dosage adjustment necessary, but see further information below
Hepatic impairment: No dosage adjustment necessary
Post cardiac surgery: No dosage adjustment necessary
Monitoring
Prior to infusion
- Ensure patients are adequately hydrated and haemodynamically optimised including anticoagulation if necessary.
- Potassium levels less than 3.5mmol/l should be corrected
- Assess for signs or symptoms of cardiac failure prior to administration of vernakalant (higher incidence of hypotensive adverse reaction and ventricular arrythmias)
During and after infusion:
- During the entire duration of the vernakalant infusion and for at least 15 minutes after the completion of the infusion, the patient should be frequently monitored for any signs or symptoms of a sudden decrease in blood pressure or heart rate.
- If adverse events occur, assess vital signs and continuously monitor ECG during the infusions and for 2 hours after the start of the infusions, until clinical and ECG parameters have stabilised.
- If signs of a sudden decrease in blood pressure or heart rate develop, with or without symptomatic hypotension or bradycardia, vernakalant infusion must be stopped immediately. Contact the cardiology doctors. If these events occur during the first infusion of vernakalant, the second dose should not be given.
Further information
- Resumption or initiation of oral-maintenance antirrhythmic medication can be considered 2 hours after vernakalant administration
- Cumulative doses of greater than 5mg/kg should not be administered within 24 hours
- Cumulative doses above 565mg have not been evaluated
- Contraindicated in patients with acute coronary syndrome, including MI within the last 30 days
- Contraindicated in patients with severe aortic stenosis, systolic BP < 100mmHg and patients with heart failure class NYHA III and IV
- Contraindicated in patients with prolonged QT at baseline (uncorrected >440msec), or severe bradycardia, sinus node dysfunction or second degree and third degree heart block in the absence of a pacemaker
- Cardioversion may be considered for patients who do not respond to vernakalant. There is no clinical experience with direct current cardioversion under 2 hours post dose.
Storage
Store below 250C
References
SPC December 2021
1. "Economic evaluation of vernakalant for haemodynamically stable, symptomatic patients with atrial fibrillation of less than 48 hours duration". May 2011. National Centre for Pharmacoeconomics. Dublin. Ireland.
Therapeutic classification
Antiarrythmic
