| Active substance(s) | Vernakalant |
| Country of admission | gb |
| Marketing authorisation holder | Merck Sharp & Dohme Ltd. |
| ATC Code | C01BG11 |
| Pharmacological groups | Antiarrhythmics, class i and iii |
BRINAVESS contains the active substance vernakalant hydrochloride. BRINAVESS works by changing your irregular or fast heart beat to a normal heart beat.
In adults it is used if you have a fast, irregular heart beat called atrial fibrillationwhich has started recently (? 7 days) for non-surgery patients and ? 3 days for post-cardiac surgery patients . Your doctor will decide whether you should be treated with BRINAVESS.
You should not be given BRINAVESS if any of the above apply to you. If you are not sure, talk to your doctor before you are given this medicine.
Check with your doctor before you are given BRINAVESS if:
If you have very low blood pressure or slow heart rate or certain changes in your ECG while using this medicine, your doctor may stop your treatment.
Your doctor will consider if you need additional rhythm control medicine 4 hours after BRINAVESS. BRINAVESS may not work in treating some other kinds of abnormal heart rhythms, however your doctor will be familiar with these
Tell your doctor if you have a pacemaker.
If any of the above apply to you (or you are not sure), talk to your doctor.
Before giving you this medicine, your doctor will decide whether to test your blood to see how well it clots and also to see your potassium level.
There is no experience on the use of BRINAVESS in children and adolescents less than 18 years of age; therefore its use is not recommended.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.
Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding.
It should be taken into account that some people may get dizzy after receiving BRINAVESS, usually within the first two hours. (See POSSIBLE SIDE EFFECTS.) If you get dizzy, you should avoid driving or operating machinery after receiving BRINAVESS.
Important information about some of the ingredients of BRINAVESS
This medicinal product contains approximately 1.4 mmol (32 mg) sodium in each 200 mg vial. Each vial of 500 mg contains approximately 3.5 mmol (80 mg) of sodium.
Take into consideration if you are on a controlled sodium diet.
If you think that you may have been given too much BRINAVESS, tell your doctor straight away.
If you have any further questions on the use of this medicine, ask your doctor.
The following terms are used to describe how often side effects have been reported. very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
Like all medicines, BRINAVESS can cause side effects, although not everybody gets them. Your doctor may decide to stop the infusion if your doctor observes any abnormal changes of:
Other side effects include:
Common:
Uncommon:
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Keep out of the reach and sight of children.
Do not use BRINAVESS after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
BRINAVESS must be diluted before it is used. The diluted sterile concentrate is chemically and physically stable for 12 hours at or below 25° C
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2° C to 8 C, unless dilution has taken place in controlled and validated aseptic conditions.
Do not administer BRINAVESS if you notice particulate matter or discolouration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
BRINAVESS is a concentrate for solution for infusion (sterile concentrate) which is clear and colourless to pale yellow.
Pack size of 1 vial
Marketing Authorisation Holder Manufacturer
Merck Sharp Dohme Ltd. Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom Merck Sharp Dohme B. V. Waarderweg 39, Postbus 581 NL-2003 PC Haarlem The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
LT Lietuva UAB Merck Sharp Dohme Tel. 370 5 278 02 47 msdlietuvamerck.com BELU Merck Sharp Dohme B.V. Succursale belgeBelgisch bijhuis TélTel 32 0 800 38693 MSDBelgiuminfomerck.com
BG . 359 2 819 3740 info-msdbgmerck.com HU MSD Magyarország Kft. Tel. 361 888 53 00 hungarymsdmerck.com
CS Merck Sharp Dohme IDEA, Inc., org. sl. Tel. 420 233 010 111 msdcrmerck.com MT Merck Sharp Dohme Cyprus Limited Tel 357 22866700 maltainfomerck.com
DK Merck Sharp Dohme Tlf 45 43 28 77 66 dkmailmerck.com NL Merck Sharp Dohme BV Tel 31 0 23 5153153 ms dbvnlmerck.com
DE MSD SHARP DOHME GMBH Tel 49 0 89 4561 2612 Infocentermsd.de NO MSD Norge AS Tlf 47 32 20 73 00 msdnorgemsd.no
EE Merck Sharp Dohme OÜ Tel. 372 613 9750 msdeestimerck.com AT Merck Sharp Dohme Ges.m.b.H. Tel 43 0 1 26 044 msd-medizinmerck.com
EL MSD 30 210 98 97 300 cora.greece.gragcmmerck.com PL MSD Polska Sp.z o.o. Tel. 48 22 549 51 00 msdpolskamerck.com
ES España Merck Sharp Dohme de España, S.A. Tel 34 91 321 06 00 BRINAVESSmsd.es PT Merck Sharp Dohme, Lda Tel 351 21 4465700 informacaodoentemerck.com
RO Merck Sharp Dohme Romania S.R.L. Tel 4021 529 29 00 msdromaniamerck.com FR France Laboratoires Merck Sharp Dohme Chibret Tél 33 0 1 47 54 87 00 contactmsd-france.com
SI Merck Sharp Dohme, inovativna zdravila d.o.o. Tel 386 1 5204201 msdsloveniamerck.com IE Merck Sharp and Dohme Ireland Human Health Limited Tel 353 01 2998700 medinfoirelandmerck.com
ÍS Icepharma hf. Sími 354 540 8000 ISmailmerck.com SK Merck Sharp Dohme IDEA, Inc. Tel. 421 2 58282010 msdskmerck.com
IT Merck Sharp Dohme Italia S.p.A. Tel 39 06 361911 doccenmerck.com FI MSD Finland Oy PuhTel 358 0 9 804650 infomsd.fi
CY Merck Sharp Dohme Cyprus Limited 357 22866700 cyprusinfomerck.com SE Merck Sharp Dohme Sweden AB Tel 46 0 8 626 1400 medicinskinfomerck.com
LV Latvija SIA Merck Sharp Dohme Latvija Tel 371 67364 224 msdlvmerck.com UK Merck Sharp and Dohme Limited Tel 44 0 1992 467272 medinfoukmerck.com
This leaflet was last approved in {MM/YYYY} .
Please refer to the Summary of Product Characteristics and the educational material for additional information prior to the use of BRINAVESS
Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults
-For non-surgery patients: atrial fibrillation ? 7 days duration
-For post-cardiac surgery patients: atrial fibrillation ? 3 days duration
BRINAVESS should be administered by intravenous infusion, byqualified medical personnel in a monitored clinical setting appropriate for cardioversion.
Posology
BRINAVESS is dosed by patient body weight, with a maximum calculated dose based upon 113 kgs. The recommended initial infusion is 3 mg/kg to be infused over a 10 minute period. For patients weighing ? 113 kg, do not exceed the 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. For patients weighing ? 113 kg, do not exceed the 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.There are no clinical data on repeat doses after the initial and second infusions. By 24 hours there appears to be insignificant levels of vernakalant.
If conversion to sinus rhythm occurs during either the initial or second infusion, that infusion should be continued to completion. If haemodynamically stable atrial flutter is observed after the initial infusion, the second infusion of BRINAVESS may be administered as patients may convert to sinus rhythm. (See sections 4.4 and 4.8.)
An infusion pump is the preferred delivery device. However, a syringe pump is acceptable provided that the calculated volume can be accurately given within the specified infusion time.
Do not administer as an intravenous push or bolus.
Recommended diluents are 0.9% Sodium Chloride for Injection, Lactated Ringers for Injection, or 5% Glucose for Injection.
Read all steps before administration.
Preparation of BRINAVESS for infusion
Step 1: Visually inspect BRINAVESS vials for particulate matter and discolouration before administration. Do not use any vials exhibiting particulate matter or discolouration. Note: BRINAVESS concentrate for solution for infusion ranges from colourless to pale yellow. Variations of colour within this range do not affect potency.
Step 2: Dilution of concentrate
To ensure proper administration, a sufficient amount of BRINAVESS 20 mg/ml should be prepared at the outset of therapy to deliver the initial and second infusion should it be warranted. Create a solution with a concentration of 4 mg/ml following the dilution guidelines below:Patients ? 100 kg: 25 ml of BRINAVESS 20 mg/ml is added to 100 ml of diluent. Patients > 100 kg: 30 ml of BRINAVESS 20 mg/ml is added to 120 ml of diluent.
Step 3: Inspect solution
The diluted sterile solution should be clear, colourless to pale yellow. Visually re-inspect the solution for particulate matter and discolouration before administering.
Method of administration
BRINAVESS vials are for single use only and must be diluted prior to administration.
Step 4: Administration of the initial infusion
The initial infusion of BRINAVESS is administered as a 3 mg/kg dose over 10 minutes.
Step 5: Patient observation
If conversion to sinus rhythm has not occurred, observe the patient?s vital signs and cardiac rhythm for an additional 15 minutes.
Step 6: Administration of second infusion
If conversion to sinus rhythm did not occur with the initial infusion or within the 15 minute observation period, administer a 2 mg/kg second infusion over 10 minutes.
Cumulative doses above 565 mg have not been evaluated.
Post-cardiac surgery patients:
No dose adjustment necessary.
No dose adjustment necessary (see section 5.2).
No dose adjustment necessary (see sections 4.4 and 5.2).
Elderly (? 65 years):
No dose adjustment necessary.
Paediatric population:
There is no relevant use of BRINAVESS in children and adolescents < 18 years of age in the current indication and therefore should not be used in this population.
Patients should be observed with assessment of vital signs and continuous cardiac rhythm monitoring during and after administration of BRINAVESS, until clinical and ECG parameters have stabilised.
Direct-current cardioversion may be considered for patients who do not respond to therapy.There is no clinical experience with direct-current cardioversion under two hours postdose.
Prior to attempting pharmacological cardioversion, ensure that patients are adequately hydrated and haemodynamically optimized and if necessary patients should be anticoagulated in accordance with treatment guidelines. In patients with uncorrected hypokalemia (serum potassium of less than 3.5 mmol/l), potassium levels should be corrected prior to use of BRINAVESS.
During infusion of BRINAVESS, if patients develop clinically meaningful bradycardia and/or hypotension or develop ECG changes (such as a clinically meaningful sinus pause, complete heart block, new bundle branch block, significant prolongation of the QRS or QT interval, changes consistent with ischaemia or infarction and ventricular arrhythmia), the administration of BRINAVESS should be discontinued and these patients should receive appropriate medical management. If these events occur during the first infusion of BRINAVESS, patients should not receive the second dose of BRINAVESS.
Hypotension
Hypotension can occur in a small number of patients (vernakalant 7.6 %, placebo 5.1%). Hypotension typically occurs early, either during the infusion or early after the end of the infusion, and can usually be corrected by standard supportive measures. Patients with congestive heart failure (CHF) have been identified as a population at higher risk for hypotension. (See section 4.8.)
Congestive Heart Failure
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 (16.1% versus 4.7%, respectively). In patients without CHF the incidence of hypotension was not significantly different during the first 2 hours after dose in patients treated with vernakalant compared to patients receiving placebo (5.7% versus. 5.2%, respectively). Hypotension reported as a serious adverse experience or leading to medicine discontinuation occurred in CHF patients following exposure to BRINAVESS in 2.9% of these patients compared to 0% in placebo.
Patients with a history of CHF showed a higher incidence of ventricular arrhythmia in the first two hours post dose (7.3% for BRINAVESS compared to 1.6% in placebo). These arrhythmias typically presented as asymptomatic, monomorphic, non-sustained (average 3-4 beats) ventricular tachycardias. By contrast, ventricular arrhythmias were reported with similar frequencies in patients without a history of CHF who were treated with either BRINAVESS or placebo (3.2% for BRINAVESS versus 3.6% for placebo).
Due to the higher incidence of the adverse events 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 (see section 4.3).
Atrial Flutter
BRINAVESS was not found to be effective in converting typical primary atrial flutter to sinus rhythm. Patients receiving BRINAVESS have a higher incidence of converting to atrial flutter within the first 2 hours post-dose. This risk is higher in patients who use Class I antiarrhythmics (see section 4.8). If atrial flutter is observed as secondary to treatment, continuation of infusion should be considered (see section 4.2)
Use of AADs (anti-arrhythmic drugs) prior to or after BRINAVESS
BRINAVESS can not be recommended in patients previously administered intravenous AADs (class I and III) 4-24 hours prior to vernakalant, due to lack of data. BRINAVESS should not be administered in patients who received intravenous AADs (class I and III) within 4 hours prior to vernakalant (see section 4.3).
BRINAVESS should be used with caution in patients on oral AADs (class I and III), due to limited experience. Risk of atrial flutter may be increased in patients receiving class I AADs (see above).
There is limited experience with the use of intravenous rhythm control anti-arrhythmics (class I and class III) in the first 4 hours after BRINAVESS administration, therefore these agents should be used cautiously within this period. Resumption or initiation of oral maintenance antiarrhythmic therapy can be considered starting 2 hours after vernakalant administration.
Valvular Heart Disease
In patients with valvular heart disease, there was a higher incidence of ventricular arrhythmia events in vernakalant patients. These patients should be monitored closely.
Other Diseases and Conditions not Studied
BRINAVESS has been administered to patients with an uncorrected QT less than 440 msec without an increased risk of torsade de pointes.
Furthermore, BRINAVESS has not been evaluated in patients with clinically meaningful valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis and its use can not be recommended in such cases. There is limited experience with BRINAVESS in patients with pacemakers.
As the clinical trial experience in patients with advanced hepatic impairment is limited, vernakalant is not recommended in these patients.
This medicinal product contains approximately 1.4 mmol (32 mg) sodium in each 200 mg vial. Each vial of 500 mg contains approximately 3.5 mmol (80 mg) of sodium. This should be taken into consideration by patients on a controlled sodium diet.
No formal interaction studies have been undertaken with vernakalant injection. Within the clinical development program, oral maintenance antiarrhythmic therapy was halted for a minimum of 2 hours after BRINAVESS administration. Resumption or initiation of oral maintenance antiarrhythmic therapy after this time period can be considered (see sections 4.3 and 4.4).
Although vernakalant is a substrate of CYP2D6, population pharmacokinetic (PK) analyses demonstrated that no substantial differences in the acute exposure of vernakalant (Cmax and AUC0-90 min) were observed when weak or potent CYP2D6 inhibitors were administered within 1 day prior to vernakalant infusion compared to patients that were not on concomitant therapy with CYP2D6 inhibitors. In addition, acute exposure of vernakalant in poor metabolisers of CYP2D6 is only minimally different when compared to that of extensive metabolisers. No dose adjustment of vernakalant is required on the basis of CYP2D6 metaboliser status, or when vernakalant is administered concurrently with 2D6 inhibitors.
Vernakalant is a moderate, competitive inhibitor of CYP2D6 However, acute intravenous administration of vernakalant is not expected to markedly impact the PK of chronically administered 2D6 substrates, as a consequence of vernakalant's short half life and the ensuing transient nature of 2D6 inhibition. Vernakalant given by infusion is not expected to perpetrate meaningful drug drug interactions due to the rapid distribution and transient exposure, low protein binding, lack of inhibition of other CYP P450 enzymes tested (CYP3A4, 1A2, 2C9, 2C19 or 2E1) and lack of P-glycoprotein inhibition in a digoxin transport assay.
Any unused product or waste material should be disposed of in accordance with local requirements BRINAVESS does not contain a preservative.
Last updated on 22.08.2022
The following drugs also contain the active ingredient Vernakalant. Consult your doctor about a possible substitute for BRINAVESS 20 mg/ml, concentrate for solution for infusion
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