vernakalant

REMS

Rapid conversion of recent onset atrial fibrillation to sinus rhythm for nonsurgical (≤7 days) and post–cardiac surgery patients (≤3 days).

Action ⬆ ⬇

Prolongs atrial refractoriness without significantly affecting ventricular refractoriness by blocking specific potassium channels. Slows impulse conduction in atria by blocking sodium channels in concentration, voltage, and frequency-dependent manner.

Therapeutic effects:

Conversion of atrial fibrillation to sinus rhythm.

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Mostly metabolized by the liver via the CYP2D6 isoenzyme; the CYP2D6 isoenzyme exhibits genetic polymorphism; ∼7% of population may be poor metabolizers and may have significantly ↑ vernakalant concentrations and an ↑ risk of adverse effects.

Half-Life: 3–5.5 hr

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
IV	8–14 min	immediately	2–4 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Hypotension (systolic BP <100 mm Hg);
Severe aortic stenosis;
New York Heart Association Class III or IV HF;
QT interval >440 msec;
Congenital or acquired long QT syndrome;
Severe bradycardia;
Sinus node dysfunction or 2nd-/3rd-degree AV heart block, in the absence of a pacemaker;
Acute coronary syndrome or acute decompensated HF within the last 30 days.

Use Cautiously in:

Hepatic impairment;
OB: Safety and effectiveness not established in pregnancy;
Lactation: Safety and effectiveness not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: atrial fibrillation, atrial flutter, bradycardia, heart block, hypertension, hypotension, VENTRICULAR TACHYCARDIA

Derm: ↑sweating, hot flushing, pruritus

EENT: nasal discomfort

F and E: hypokalemia

GI: diarrhea, nausea, vomiting

Local: infusion site pain

Neuro: dizziness, dysgeusia, fatigue, headache, paresthesia

Resp: cough, dyspnea

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

IV (Adults ): 3 mg/kg infused over 10 min (for patients weighing ≥113 kg, max initial dose = 339 mg). If conversion to sinus rhythm does not occur within 15 min after the end of the initial infusion and the patient remains hemodynamically stable, a 2nd infusion of 2 mg/kg may be administered over 10 min (for patients weighing ≥113 kg, max dose of 2nd infusion = 226 mg). Cumulative doses >5 mg/kg should not be administered within 24 hr.

Availability ⬆ ⬇

Solution for injection: 20 mg/mL (each vial contains 3.5 mmol [80 mg] of sodium)

Assessment ⬆ ⬇

Ensure patient is adequately hydrated and anticoagulated in accordance with treatment guidelines.
Monitor vital signs and provide continuous cardiac rhythm monitoring before, during, and after administration. Assess for signs/symptoms of sudden ↓ in BP or HR, and significant QT interval prolongation during 1st infusion and >15 min after completion of infusion. Assess vital signs and provide continuous cardiac rhythm monitoring for >2 hr after completion of 2nd infusion.
Monitor for sinus arrest or clinically significant bradycardia after converting to sinus rhythm. Resuscitation equipment and the capability to place a temporary pacemaker should be readily available.

Lab Test Considerations:

Monitor potassium before and during treatment. May cause hypokalemia.
May ↑ AST, GGT, BUN, and serum creatinine.
May ↓ hemoglobin.

Implementation ⬆ ⬇

IV Administration:

Before administration, confirm patient eligibility for treatment by completing the supplied Pre-Infusion Checklist. The checklist is provided with the medication or is available at https://www.cipherpharma.com/products/hospital-acute-care/Brinavess-Preinfusion-ChecklistCanada.pdf.
Verify amiodarone, procainamide, flecainide, or ibutilide have not been administered within 4 hr before treatment.
Do not administer via IV push or bolus.
In case of accidental overdose or excessive infusion flow rate of injection, discontinue infusion immediately.
Y-Site Incompatibility: Do not administer other drugs through same IV line.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of treatment to patient.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Advise patient that treatment will be in a hospital or emergency room setting. Explain that the 1st infusion is to be administered for 10 min. A 2nd dose may be needed if the HR has not returned to normal within 15 min after 1st dose.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇