INDICATION

RAPIBLYK® (landiolol) for injection is a beta-adrenergic blocker indicated for the short-term reduction of ventricular rate in:

• Adults with supraventricular tachycardia, including atrial fibrillation and atrial flutter
• Pediatric patients with supraventricular tachycardia

Important Safety Information

Contraindications

RAPIBLYK® is contraindicated in patients with:

• Severe sinus bradycardia
• Sick sinus syndrome
• Heart block greater than first degree
• Decompensated heart failure
• Cardiogenic shock
• Pulmonary hypertension
• Hypersensitivity to landiolol or any of the inactive ingredients

Warnings and Precautions

• Patients with hemodynamic compromise, hypovolemia, or receiving interacting medications are at increased risk of hypotension. Monitor blood pressure closely. Reduce or discontinue RAPIBLYK if hypotension occurs.
• Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest, may occur. Monitor heart rate and rhythm. Reduce or discontinue RAPIBLYK for bradyarrhythmia.
• Beta-blockers may cause depression of myocardial contractility and may precipitate heart failure or cardiogenic shock. At the first sign of impending cardiac failure, discontinue RAPIBLYK and initiate supportive therapy.
• Beta-blockers may exacerbate bronchospasm. Use caution in patients with reactive airway disease. Discontinue infusion if bronchospasm occurs.
• Beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia) and may increase the risk for severe or prolonged hypoglycemia. Monitor blood glucose in patients with diabetes or those at risk.
• Infusion site reactions including pain, swelling, and erythema have occurred. Avoid infusions into small veins or through butterfly catheters. Use an alternative site if reactions develop.
• Abrupt discontinuation of beta-blocker therapy in patients with coronary artery disease may result in exacerbations of angina, myocardial infarction, or ventricular arrhythmias. Monitor for signs of myocardial ischemia when discontinuing RAPIBLYK.
• Beta-blockers may increase serum potassium. Monitor electrolytes during therapy, especially in patients with renal impairment.
• Beta-adrenergic blockade may mask clinical signs of hyperthyroidism. Abrupt withdrawal may precipitate thyroid storm.
• Patients at risk of anaphylaxis may be more reactive to allergen exposure and may be unresponsive to usual doses of epinephrine.

Adverse Reactions

The most common adverse reaction was hypotension in adults and pediatric patients.

Drug Interactions

• Avoid concomitant use with negative inotropes or medications that slow heart rate or cardiac conduction.
• Beta-adrenergic agonists may antagonize the effects of RAPIBLYK.
• Use caution with catecholamine-depleting drugs due to increased risk of hypotension or bradycardia.

For more information about RAPIBLYK, see full Prescribing Information