Landiolol 

Landiolol – Introduction

• Landiolol is an intravenous cardioselective beta adrenergic blocker indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter. Landiolol does not exhibit intrinsic sympathomimetic activity.
• Hypotension was the most common adverse reaction in clinical trials and necessitates close monitoring of blood pressure, especially if pre-treatment blood pressure is low, during treatment with landiolol.
• Expect the blood pressure effect of landiolol to diminish within 30 minutes of discontinuation. Landiolol was FDA-approved in November 2024.⁷¹⁵⁶³

Indications & Dosage

•  atrial fibrillation
•  atrial flutter
•  supraventricular tachycardia (SVT)

General Dosing Information

Transitioning from landiolol to alternative medications

• When transitioning to alterative medications, consider the pharmacodynamics of the medication that the individual is being transitioned to and monitor clinical response.
• If transitioning to an oral beta-blocker, reduce the landiolol infusion rate by 50% at 10 minutes after the administration of the oral beta-blocker. If satisfactory heart rate control is maintained for at least 1 hour, discontinue landiolol.⁷¹⁵⁶³

For the treatment of supraventricular tachycardia (SVT), including atrial flutter and atrial fibrillation, for the short-term reduction of ventricular rate

for the treatment of SVT with normal cardiac function

Intravenous dosage

Adults:

9 mcg/kg/minute continuous IV infusion, initially. Titrate by 9 mcg/kg/minute every 10 minutes until goal heart rate is attained. Max: 36 mcg/kg/minute. Limited data available for duration of therapy of more than 24 hours.⁷¹⁵⁶³

for the treatment of SVT with impaired cardiac function

Intravenous dosage

Adults:

1 mcg/kg/minute continuous IV infusion, initially. Titrate by 1 mcg/kg/minute every 15 minutes until goal heart rate is attained. Max: 36 mcg/kg/minute. Limited data available for duration of therapy of more than 24 hours.⁷¹⁵⁶³

Maximum Dosage Limits:

•Adults

36 mcg/kg/minute IV.

•Geriatric

36 mcg/kg/minute IV.

•Adolescents

Safety and efficacy have not been established.

•Children

Safety and efficacy have not been established.

•Infants

Safety and efficacy have not been established.

•Neonates

Safety and efficacy have not been established.

Patients with Hepatic Impairment Dosing

More conservative dose titration is recommended in individuals with mild hepatic impairment (Child-Pugh A). Avoid use in individuals with moderate or severe hepatic impairment (Child-Pugh B or C).⁷¹⁵⁶³

Patients with Renal Impairment Dosing

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

•  acute heart failure
•  bradycardia
•  cardiogenic shock
•  pulmonary hypertension
•  second or third-degree AV block
•  sick sinus syndrome

Precautions

•  abrupt discontinuation
•  asthma
•  breast-feeding
•  children
•  coronary artery disease
•  diabetes mellitus
•  dialysis
•  first-degree AV block
•  geriatric
•  hepatic disease
•  hyperthyroidism
•  hypovolemia
•  infants
•  labor
•  neonates
•  peripheral vascular disease
•  pheochromocytoma
•  pregnancy
•  Raynaud phenomenon
•  renal impairment
•  sinus node dysfunction
•  vasospastic angina
•  vomiting

Adverse Reactions

•  bradycardia
•  diabetes mellitus
•  erythema
•  heart failure
•  hyperglycemia
•  hyperkalemia
•  hypoglycemia
•  hypotension
•  injection site reaction
•  renal tubular acidosis

Landiolol may cause bradycardia and/or hypotension. Hypotension was the most common adverse reaction in clinical trials, occurring in 9.9% of landiolol-treated subjects compared to 1% of subjects receiving placebo. Monitor blood pressure closely, especially if pre-treatment blood pressure is low, as well as heart rate and rhythm during treatment with landiolol. Decrease or discontinue landiolol if bradyarrhythmia or hypotension occurs. Expect the blood pressure effect of landiolol to diminish within 30 minutes of discontinuation. Beta-blockers, including landiolol, can cause depression of myocardial contractility and may precipitate cardiac failure and cardiogenic shock. Discontinue landiolol and initiate supportive therapy if signs or symptoms of impending heart failure occur.⁷¹⁵⁶³

Beta-blockers may inhibit catecholamine-induced glycogenolysis, gluconeogenesis, and lipolysis, predisposing to hypoglycemia.^53721 67279 Additionally, beta-blockers can mask signs of hypoglycemia (e.g., tachycardia) and increase the risk for severe or prolonged hypoglycemia at any time during treatment. Monitor for signs and symptoms of hypoglycemia during treatment with landiolol.⁷¹⁵⁶³ Beta-blockers may also inhibit insulin secretion through blockade of beta-2-receptors on pancreatic islet cells, which may cause hyperglycemia or reduce insulin secretion in response to hyperglycemia; adjust the dose of antidiabetic drugs as necessary.^{26823 30575 67279} In addition to acute blood glucose effects, beta-blockers have been shown to increase the risk of developing diabetes mellitus in hypertensive adults.^{26823 67279 67280}

Beta-blockers, including landiolol, can cause increases in serum potassium and hyperkalemia. Intravenous administration of beta-blockers has been reported to cause potentially life-threatening hyperkalemia in individuals receiving dialysis. Monitor serum electrolytes during treatment with landiolol. Additionally, beta-blockers have been reported to cause hyperkalemic renal tubular acidosis (RTA). In general, acidosis may be associated with decreased cardiac contractility.⁷¹⁵⁶³

Injection site reaction, such as erythema, swelling, or pain, has occurred with landiolol use. Avoid infusions into small veins or through a butterfly catheter. If a local infusion site reaction develops, use an alternative infusion site and avoid extravasation.⁷¹⁵⁶³

Administration

• Injectable Administration
  • Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The reconstituted landiolol solution should be a clear, colorless solution.⁷¹⁵⁶³
  • Intravenous Administration
    • Reconstitution
      • Reconstitute each 280 mg vial of landiolol with 50 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection to yield a concentration of 5.6 mg/mL.
      • Gently swirl to dissolve the contents.
      • Use immediately.
      • Storage: Use landiolol reconstituted with 0.9% Sodium Chloride Injection within 4 hours at room temperature (25 degrees C, 77 degrees F), and use landiolol reconstituted with 5% Dextrose Injection within 48 hours at room temperature (25 degrees C, 77 degrees F).⁷¹⁵⁶³
      Continuous IV infusion
      • The infusion rate can be calculated as: Infusion rate (mL/hour) = target dose (mcg/kg/minute) x body weight (kg)/93.
      • Storage: Discard unused portion.⁷¹⁵⁶³

Mechanism of Action

Landiolol is a cardioselective beta-1-adrenoreceptor antagonist that inhibits the positive chronotropic effects of the catecholamines, epinephrine and norepinephrine. Landiolol does not exhibit any membrane-stabilizing activity or intrinsic sympathomimetic activity at the approved recommended dose in vitro.⁷¹⁵⁶³

Pharmacokinetics

Landiolol is administered intravenously. The steady-state Vd of landiolol is 0.4 L/kg, and protein binding is less than 10%. Steady-state is reached approximately 15 minutes after the initiation of landiolol infusion. Landiolol is primarily metabolized by pseudocholinesterases and carboxylesterases in the plasma to the active metabolite M1. M1 has less than one-fortieth of the pharmacological activity of landiolol. M1 exposure is approximately 12 times more than landiolol. Approximately 50% to 75% of the landiolol administered dose is recovered in urine at 4 hours and 89% to 99% at 24 hours after a 60-minute IV infusion. Approximately 50% of the landiolol administered dose recovered in urine is metabolite M1 and 8% is parent drug. Total body clearance of landiolol is 57 mL/kg/minute after a 20-hour continuous landiolol infusion of 37.3 mcg/kg/minute. The landiolol elimination half-life is 4.5 minutes at steady-state. Landiolol exposure-response relationships and the time course of pharmacodynamic response are not fully characterized.⁷¹⁵⁶³

Affected cytochrome P450 isoenzymes and drug transporters: CYP2D6

In vitro, landiolol and the metabolite M1 are time-dependent CYP2D6 inhibitors at exposures approximately 50 times the human exposure at the maximum recommended human dose (MRHD). Landiolol and the metabolite M1 do not inhibit CYP1A2, 2C9, 2C19, or 3A4.⁷¹⁵⁶³

•Route-Specific Pharmacokinetics

Intravenous Route

Mean landiolol peak plasma concentrations (Cmax) in healthy volunteers are 0.2 and 0.5 mcg/mL when receiving landiolol 9.3 mcg/kg/minute and 18.6 mcg/kg/minute, respectively. The mean landiolol Cmax in healthy volunteers receiving landiolol 37.3 mcg/kg/minute is 1 mcg/mL, and the mean Cmax is 0.52 to 1.77 mcg/mL in individuals with atrial flutter or atrial fibrillation receiving landiolol 37.3 mcg/kg/minute. Landiolol pharmacokinetics increase dose proportionally in the dosage range of 9.3 to 74.6 mcg/kg/minute (2 times the maximum approved recommended dose).⁷¹⁵⁶³

•Special Populations

Hepatic Impairment

Landiolol geometric mean AUC increased by 44% and Cmax increased by 42% in 5 subjects with mild hepatic impairment (Child-Pugh A) and 1 subject with moderate hepatic impairment (Child-Pugh B). The effect of moderate hepatic impairment (Child-Pugh B) on landiolol pharmacokinetics has not been fully characterized, and the effect of severe hepatic impairment (Child-Pugh C) is unknown.⁷¹⁵⁶³

Renal Impairment

The effect of renal impairment on landiolol pharmacokinetics is unknown.⁷¹⁵⁶³

Geriatric

The effect of age on landiolol pharmacokinetics is unknown.⁷¹⁵⁶³

Monitoring Parameters

Monitoring Parameters

•  blood pressure
•  ECG
•  heart rate
•  serum electrolytes

Classifications

• Cardiovascular System
  • Cardiac Therapy
    • Anti-arrhythmics
      •  Anti-arrhythmics, Class II

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