Landiolol

RAPIBLYK is a selective beta-1-adrenoreceptor antagonist that inhibits the positive chronotropic effects of the catecholamines, epinephrine and norepinephrine, on the heart, where beta-1-receptors are predominantly located. Landiolol does not exhibit any membrane-stabilizing activity or intrinsic sympathomimetic activity at the approved recommend dosage in vitro.

• RAPIBLYK is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter, and pediatric patients with supraventricular tachycardia.ICD-10: I48.91

• RAPIBLYK is contraindicated in patients with: Severe sinus bradycardia, sick sinus syndrome, heart block greater than first degree [see Warnings and Precautions ( 5.2 )] . Decompensated heart failure [see Warnings and Precautions ( 5.3 )] .contraindicated

Administer as an intravenous infusion in a monitored setting. ( 2.1 ) Titrate according to ventricular rate. ( 2.1 ) If normal cardiac function, start at 9 mcg/kg/min; adjust dose in 10-minute intervals as needed in increments of 9 mcg/kg/min to a maximum of 36 mcg/kg/min. ( 2.1 ) If impaired cardiac function, start at 1 mcg/kg/min; adjust dose in 15-minute intervals as needed in increments of 1 mcg/kg/min to a maximum of 36 mcg/kg/min. ( 2.1 ). 2.1 Recommended Dosage Administer RAPIBLYK as a continuous intravenous infusion in a monitored setting, titrating as needed for heart rate control. There are limited data beyond 24 hours of use. Adults Pediatric patients Normal cardiac function Impaired cardiac function Normal cardiac function* Starting dose 9 mcg/kg/min 1 mcg/kg/min 9 mcg kg/min Titration interval 10 min 15 min 10 min Titration step 9 mcg/kg/min 1 mcg/kg/min 9 mcg kg/min Maximum dose 36 mcg/kg/min 36 mcg/kg/min 36 mcg kg/min *There are no data to guide dosage recommendations in pediatric patients with impaired cardiac function. 2.2 Transitioning from RAPIBLYK Injection Therapy to Alternative Medications When transitioning to alternative medications consider the pharmacodynamics of the medication to which the patient is being transitioned and monitor clinical response. If switched to an oral beta-blocker, the dosage of RAPIBLYK can be reduced as follows: Ten minutes after administration of the oral beta-blocker, reduce the infusion rate of RAPIBLYK by 50%. If satisfactory control is maintained for at least one hour, discontinue RAPIBLYK.

Risk of hypotension, bradycardia, and cardiac failure: Monitor for signs and symptoms of cardiovascular adverse effects. Reduce or discontinue use ( 5.1 , 5.2 , 5.3 ) Risk of exacerbating reactive airway disease ( 5.5 ) Diabetes mellitus: May mask symptoms of hypoglycemia and alter glucose levels; monitor ( 5.6 ) Monitor for signs of myocardial ischemia when abruptly discontinuing in patients with coronary artery disease ( 5.10 ) 5.1 Hypotension Patients with hemodynamic compromise, hypovolemia, or on interacting medications are at increased risk of hypotension. Monitor blood pressure closely, especially if pretreatment blood pressure is low. Reduce or stop RAPIBLYK injection for hypotension then expect the blood pressure effect to wane within 30 minutes. 5.2 Bradycardia Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders are at increased risk of bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest. Monitor heart rate and rhythm in patients receiving RAPIBLYK injection. Reduce or stop RAPIBLYK injection for bradyarrhythmia. 5.3 Cardiac Failure Beta-blockers, like RAPIBLYK, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. At the first sign or symptom of impending cardiac failure, stop RAPIBLYK injection and start supportive therapy [see Overdosage ( 10 )] . 5.4 Reactive Airways Disease Patients with reactive airways disease should, in general, not receive beta-blockers.

The most common adverse reaction (9.9%) is hypotension ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact AOP Orphan Pharmaceuticals at drugsafety.us@aop-health.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of RAPIBLYK was evaluated in 19 placebo-controlled clinical trials involving 1,761 adult patients (in a variety of clinical in-patient settings) with supraventricular tachycardia or at high risk for supraventricular tachycardia. The most common adverse reaction is hypotension, which occurred in 9.9% of patients receiving RAPIBLYK vs. 1% in those receiving placebo [see Warnings and Precautions ( 5.1 )]. In a single-arm, unblinded clinical trial in 60 pediatric patients who received RAPIBLYK, the most common adverse reaction was hypotension, which occurred in 10% of patients aged birth to <18 years receiving RAPIBLYK [see Warnings and Precautions ( 5.1 )]. Hypotension was also the most common adverse reaction leading to treatment discontinuation.

8.1 Pregnancy Risk Summary The available published data on RAPIBLYK use in pregnant women are insufficient to inform a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Landiolol exposure was limited to a single injection at the time of Cesarean delivery in a small clinical trial. Neonatal bradycardia, hypoglycemia, and respiratory depression have been observed with use of beta-blockers in pregnancy near the time of delivery (see Clinical Considerations) . Administration of landiolol to pregnant rats showed distribution of landiolol to the placenta and the fetus. In animal reproduction studies, no embryo-fetal toxicity was observed in rats or rabbits during the period of organogenesis at landiolol exposure in rats approximately 2.7 times human exposure at the maximum recommended human dose (MRHD) (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Landiolol crosses the placenta in rats.

Metabolism

Landiolol peak plasma concentration (C max ) over the approved dosage range in healthy adult volunteers, patients with atrial fibrillation or atrial flutter and pediatric patients with supraventricular tachycardia is provided in Table 3. Table 3: Landiolol peak plasma concentration (Cmax) in healthy volunteers and patients with atrial fibrillation or atrial flutter.

10.1 Signs and Symptoms of Overdose Overdoses of RAPIBLYK injection can cause adverse cardiac and central nervous system effects. These adverse effects may precipitate severe signs, symptoms, sequelae, and complications such as severe cardiac and respiratory failure, including shock and coma, and may be fatal. Continuous monitoring of the patient is required. Cardiac adverse effects include bradycardia, atrioventricular block (1-, 2-, 3-degree), junctional rhythms, intraventricular conduction delays, decreased cardiac contractility, hypotension, cardiac failure (including cardiogenic shock), cardiac arrest/asystole, and pulseless electrical activity. Central nervous system adverse effects include respiratory depression, seizures, sleep and mood disturbances, fatigue, lethargy, and coma. In addition, bronchospasm, hyperkalemia, and hypoglycemia (especially in pediatric patients) may occur. 10.2 Treatment Recommendations Because of its approximately 4-minute elimination half-life, the first step in the management of toxicity should be to discontinue RAPIBLYK infusion.

• Nov 22, 2024NDANDA217202Aop Hlth Us

1. 1Drug Ineffective3442%
2. 2Off Label Use1215%
3. 3Bradycardia89.9%
4. 4Ventricular Fibrillation78.6%
5. 5Condition Aggravated67.4%
6. 6Drug Ineffective For Unapproved Indication67.4%
7. 7Atrial Fibrillation56.2%
8. 8Cardiac Failure56.2%
9. 9Hypotension56.2%
10. 10Product Use In Unapproved Indication56.2%
11. 11Cardiogenic Shock44.9%
12. 12Electrocardiogram Qt Prolonged44.9%
13. 13Stress Cardiomyopathy44.9%
14. 14Tachycardia44.9%
15. 15Torsade De Pointes44.9%

The 10 most recently updated of 17 ClinicalTrials.gov registrations naming Landiolol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery
  Recruiting · Phase 4 · Interventional · 114 enrolled · Insel Gruppe AG, University Hospital Bern
  NCT07168421updated 2026-05-05
• Prevention of Atrial Fibrillation by Low-dose Landiolol Administration After Cardiac Surgery
  Completed · Phase 3 · Interventional · 400 enrolled · CMC Ambroise Paré
  NCT04607122updated 2026-04-08
• Landiolol in Mitral Valve Surgery
  Recruiting · Phase 4 · Interventional · 1,500 enrolled · Università Vita-Salute San Raffaele
  NCT06793670updated 2025-12-29
• Impact of Cardio-Selective Beta-Blockers on Infarct Size After Acute Myocardial Infarction
  Recruiting · Observational · 100 enrolled · Aristotle University Of Thessaloniki
  NCT07293832updated 2025-12-19
• Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility
  Recruiting · Phase 3 · Interventional · 360 enrolled · Centre Hospitalier Universitaire, Amiens
  NCT04748796updated 2025-08-24
• Landiolol in Postoperative Atrial Fibrillation
  Completed · Phase 3 · Interventional · 58 enrolled · Hospices Civils de Lyon
  NCT03779178updated 2025-08-06
• LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS)
  Recruiting · Phase 3 · Interventional · 44 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT04931225updated 2025-08-01
• Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest
  Unknown · Phase 1 · Phase 2 · Interventional · 32 enrolled · Medical University of Vienna
  NCT05554978updated 2023-03-17
• Landiolol for Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
  Unknown · Phase 3 · Interventional · 164 enrolled · Medical University of Vienna
  NCT05084118updated 2021-10-22
• Landiolol for Rate Control in Decompensated Heart Failure Due to Atrial Fibrillation
  Unknown · Interventional · 40 enrolled · Institute for Clinical and Experimental Medicine
  NCT04694092updated 2021-01-06

Frequently asked questions

How does Landiolol work?

RAPIBLYK is a selective beta-1-adrenoreceptor antagonist that inhibits the positive chronotropic effects of the catecholamines, epinephrine and norepinephrine, on the heart, where beta-1-receptors are predominantly located. Landiolol does not exhibit any membrane-stabilizing activity or intrinsic sympathomimetic activity at the approved recommend dosage in vitro.

What is Landiolol used for?

According to FDA labeling, Landiolol carries indications including: RAPIBLYK is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter, and pediatric patients with supraventricular tachycardia.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Landiolol?

Landiolol is classified as Beta blocking agents, selective, beta-Adrenergic Blocker, Adrenergic beta1-Antagonists, Negative Chronotropy.

What are the brand names for Landiolol?

Landiolol is marketed under brand names including Rapiblyk.

What are the contraindications for Landiolol?

Landiolol labeling lists contraindications including: RAPIBLYK is contraindicated in patients with: Severe sinus bradycardia, sick sinus syndrome, heart block greater than first degree [see Warnings and Precautions ( 5.2 )] . Decompensated heart failure [see Warnings and Precautions ( 5.3 )] .. Always consult the full prescribing information and a clinician.