Rapiblyk (Landiolol)

Brand Name

Rapiblyk

Generic Name

Landiolol

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FDA approval date: April 29, 2025

Classification: beta-Adrenergic Blocker

Form: Injection

What is Rapiblyk (Landiolol)?

RAPIBLYK is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter. RAPIBLYK 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.

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Brand Information

RAPIBLYK (landiolol)

1INDICATIONS AND USAGE

RAPIBLYK is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter.

2DOSAGE FORMS AND STRENGTHS

For injection: White to almost white lyophilized powder in a single-dose vial containing 280 mg of landiolol (equivalent to 300 mg landiolol HCl).

3CONTRAINDICATIONS

RAPIBLYK is contraindicated in patients with:

Severe sinus bradycardia, sick sinus syndrome, heart block greater than first degree
Decompensated heart failure
Cardiogenic shock: May precipitate further cardiovascular collapse and cause cardiac arrest.
Pulmonary hypertension: May precipitate cardiorespiratory decompensation.
Hypersensitivity reactions, including anaphylaxis, to landiolol or any of the inactive ingredients

4DESCRIPTION

RAPIBLYK (landiolol) for injection is a beta-1 adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 4 minutes). Landiolol is:

[(4S)-2,2-dimethyl-1,3-dioxolan-4-yl]methyl 3-[4-[(2S)-2-hydroxy-3-[2-(morpholine-4-carbonylamino)ethylamino]propoxy]phenyl]propionate and has the following structure:

The active pharmaceutical ingredient is the hydrochloride salt of landiolol, which has the empirical formula C
Landiolol HCl is a white crystalline powder. It is a relatively hydrophilic compound, which is very soluble in water.

RAPIBLYK is supplied as a single presentation of 280 mg landiolol (equivalent to 300 mg landiolol HCl) as a white to almost white sterile lyophilized powder for intravenous injection in a 50 mL vial. Inactive ingredients include 300 mg of mannitol and sodium hydroxide as needed to adjust pH.

5CLINICAL STUDIES

In 5 randomized, double-blind, placebo-controlled studies, treatment of 317 adults with supraventricular tachycardia with landiolol decreased heart rate in 40-90% of treated patients within about 10 minutes, compared to 0-11% of patients who received placebo; heart rate decrease was defined as a >20% decrease in heart rate or a heart rate <100 bpm or at least intermittent cessation of the arrhythmia. The infused dose of landiolol in these studies ranged from 9.3 to 74.6 mcg/kg/min (equivalent to 10 to 80 mcg/kg/min landiolol hydrochloride).