Dehydrated Alcohol
Alcohol · Injection, Solution · Percutaneous, Intra-arterial
Uses
1 INDICATIONS AND USAGE ABLYSINOL ® is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. ABLYSINOL is an ablative agent indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. ( 1 )
Dosage and administration
Inject small volumes over 1 to 2 minutes percutaneously into septal arterial branches, using the minimal dose necessary to achieve the desired reduction in peak left ventricular outflow tract pressure gradient. ( 2.1 ) In most situations, a dose of 1 mL to 2 mL is sufficient. The maximum dose that should be used in a single procedure is 5 mL. ( 2.1 ) 2.1 Recommended Dosing Use the minimum dose necessary to achieve the desired reduction in peak left ventricular outflow tract pressure gradient. Inject small volumes over 1 to 2 minutes percutaneously into septal arterial branches, guided by assessment of the gradient. In most situations, a dose of 1 mL to 2 mL is sufficient. The maximum dose of ABLYSINOL that should be used in a single procedure is 5 mL. 2.2 Administration ABLYSINOL should only be administered under the supervision of a qualified interventional cardiologist experienced in the percutaneous transluminal septal myocardial ablation procedure. Inspect visually for particulate matter and discoloration prior to administration. ABLYSINOL should appear as a clear, colorless solution.
Dosage forms and strengths
Injection: 1 mL or 5 mL of ethyl alcohol ≥ 99% by volume as a clear, colorless liquid in a single-dose glass ampule. Injection: 5 mL of ethyl alcohol ≥ 99% by volume as a clear, colorless liquid in a single-dose glass vial. Injection: 1 mL or 5 mL of ethyl alcohol ≥ 99% by volume as a clear, colorless liquid in a single-dose glass ampule. ( 3 ) Injection: 5 mL of ethyl alcohol ≥ 99% by volume as a clear, colorless liquid in a single-dose glass vial. (3)
Contraindications
None. None ( 4 )
Warnings and precautions
Transient heart block: Transient heart block is common at the time of injection. A temporary pacing wire is routinely inserted to mitigate transient heart block. (5.1) Persistent heart block: Approximately 10% of complete heart block events become permanent and require placement of a permanent pacemaker. (5.1) Remove the temporary pacemaker lead if no episode of high-degree atrioventricular block occurs. (5.1) Monitor the patient for heart failure, chest pain, and arrhythmias several days after the procedure. (5.1, 5.2 , 5.3 ) 5.1 Heart Block Transient Heart Block Transient heart block is common at the time of dehydrated alcohol, such as ABLYSINOL, injection into a septal artery. Prior to the injection, a temporary pacing wire is routinely inserted into the apex of the right ventricle, usually via the femoral vein, to treat transient heart block. The pacing lead can be removed if no episode of high-degree atrioventricular block occurs, usually after several hours of observation following percutaneous transluminal septal myocardial ablation. Persistent Heart Block Approximately 10% of complete heart block events become permanent and require placement of a permanent pacemaker following percutaneous transluminal septal myocardial ablation. Risk factors for permanent pacemaker dependency after septal ablation include a baseline PQ interval > 160 ms, baseline minimum heart rate < 50 bpm, baseline left ventricular outflow gradient > 70 mmHg, maximum QRS during the first 48 hours > 155 ms, 3 rd degree atrio-ventricular block occurring during the procedure, and no clinical recovery between 12-48 hours after the procedure. 5.2 Myocardial Infarction Injection of dehydrated alcohol is intended to create a controlled myocardial infarction for therapeutic purposes. However, excessive myocardial necrosis and subsequent heart failure have been reported. Factors increasing the risk of excessive tissue necrosis include higher volume of alcohol used and a higher number of septal branches injected to reduce the left ventricular outflow tract gradient. 5.3 Ventricular Arrhythmia Ventricular tachycardia and ventricular fibrillation requiring electrocardioversion occurred at a frequency of approximately 1%. Perform continuous electrocardiographic monitoring for 48 hours after the procedure.
Side effects
Heart block [ see Warnings and precautions (5.1)] The following other adverse reactions associated with percutaneous transluminal septal myocardial ablation with the use of dehydrated alcohol, such as ABLYSINOL, were identified in the literature: Ventricular tachycardia and ventricular fibrillation. Adverse reactions include arrhythmias, including ventricular tachycardia and/or ventricular fibrillation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact BPI Labs, LLC at (727) 471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Use in specific populations
8 USE IN SPECIFIC POPULATIONS ABLYSINOL is not recommended during pregnancy. Maternal use is not expected to result in fetal exposure to the drug. ( 8.1 ) The rate of heart blocks and dysrhythmia increased with age. (8.5) See 17 for PATIENT COUNSELING INFORMATION 8.1 Pregnancy Risk Summary The concentrations of alcohol in blood after PTSMA were not measured, but ABLYSINOL is not expected to increase significantly the systemic concentrations of endogenous alcohol following administration into a septal artery during percutaneous transluminal septal myocardial ablation. Maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations ABLYSINOL for percutaneous transluminal septal myocardial ablation has not been evaluated in pregnant women and is not recommended during pregnancy. When possible, the percutaneous transluminal septal myocardial ablation procedure should be postponed in women until the postpartum period. Data Animal reproduction studies have shown an adverse effect on the fetus and chronic fetal alcohol exposure is known to cause developmental defects in human. The developmental effects of acute ethanol exposure, such as from percutaneous transluminal septal myocardial ablation, have not been studied in pregnant or lactating women. 8.2 Lactation ABLYSINOL is not expected to increase significantly the systemic concentrations of endogenous alcohol following administration into a septal artery during percutaneous transluminal septal myocardial ablation and breastfeeding is not expected to result in exposure of the child to the drug. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use A comparison of the outcomes in patients with hypertrophic obstructive cardiomyopathy in patients < 60 years old and in patients ≥ 60 years old showed similar improvement in exercise capacity after ablation. The rate of heart blocks and dysrhythmia increased with age. Permanent pacemaker dependency increased to 34% in patients > 60 years old.
Pregnancy
8.1 Pregnancy Risk Summary The concentrations of alcohol in blood after PTSMA were not measured, but ABLYSINOL is not expected to increase significantly the systemic concentrations of endogenous alcohol following administration into a septal artery during percutaneous transluminal septal myocardial ablation. Maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations ABLYSINOL for percutaneous transluminal septal myocardial ablation has not been evaluated in pregnant women and is not recommended during pregnancy. When possible, the percutaneous transluminal septal myocardial ablation procedure should be postponed in women until the postpartum period. Data Animal reproduction studies have shown an adverse effect on the fetus and chronic fetal alcohol exposure is known to cause developmental defects in human. The developmental effects of acute ethanol exposure, such as from percutaneous transluminal septal myocardial ablation, have not been studied in pregnant or lactating women.
Pediatric use
8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Geriatric use
8.5 Geriatric Use A comparison of the outcomes in patients with hypertrophic obstructive cardiomyopathy in patients < 60 years old and in patients ≥ 60 years old showed similar improvement in exercise capacity after ablation. The rate of heart blocks and dysrhythmia increased with age. Permanent pacemaker dependency increased to 34% in patients > 60 years old.
Overdosage
There is a direct correlation between the volume of alcohol and size of iatrogenic myocardial infarction. Stop the procedure if there is failure to reduce the left ventricular outflow tract pressure gradient to less than 10 mmHg when reaching a total dose of 5 mL.
Description
(dehydrated alcohol) injection is a sterile, preservative free solution of ≥ 99% by volume ethyl alcohol and no excipients. ABLYSINOL is for cardiac septal branch intra-arterial use. It has a molecular formula of C 2 H 6 O and a molecular weight of 46.07. Dehydrated Alcohol Injection, USP is a potent tissue toxin. Ethanol is a clear, colorless, volatile, and flammable liquid miscible with water. It has the following structural formula: chemicalstructure
Mechanism of action
12.1 Mechanism of Action Dehydrated alcohol is a tissue toxin that produces a myocardial infarction when injected through an intra-arterial catheter into a target septal vessel, which causes the hypertrophied septum to thin.
How supplied
(dehydrated alcohol) injection is a clear, colorless liquid supplied in clear, glass, single-dose ampules and single-dose vials. Each mL contains 99% by volume ethyl alcohol. Volume NDC Single ampule Carton of 10 ampules 1 mL 54288-105-01 54288-105-10 5 mL 54288-105-02 54288-105-15 Single Vial Carton of 10 Vials 5 mL 54288-144-01 54288-144-10 Store at room temperature, between 20°C and 25°C (68°F and 77°F). Do not refrigerate or freeze. Highly flammable, store away from any heat source.
Label text from the FDA structured product label by BPI Labs, LLC (revised Jan 5, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Alcohol in 9 products
- Dehydrated Alcohol in 1 product
Dehydrated Alcohol NDC products (10)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7643 | Alcohol 1 mL/mL Injection, Solution | A-S Medication Solutions | ANDA |
| 16729-710 | Alcohol 1 mL/mL Injection, Solution | Accord Healthcare, Inc. | ANDA |
| 83634-306 | Alcohol 1 mL/mL Injection, Solution | Avenacy, LLC | ANDA |
| 51991-999 | Alcohol 1 mL/mL Injection, Solution | Breckenridge Pharmaceutical Inc | ANDA |
| 50742-539 | Dehydrated Alcohol 5 mL/5mL Injection, Solution | Ingenus Pharmaceuticals, LLC | ANDA |
| 55579-306 | Alcohol 1 mL/mL Injection | Solupharm Pharmazeutische Erzeugnisse GmbH | ANDA |
| 39822-9300 | Alcohol 1 mL/mL Injection, Solution | XGen Pharmaceuticals DJB, Inc. | ANDA |
| 82983-426 | Alcohol 1 mL/mL Injection, Solution | Ajenat Pharmaceuticals LLC | NDA |
| 54288-105 | Alcohol 1 mL/mL Injection, Solution | BPI Labs, LLC | NDA |
| 54288-144 | Alcohol 1 mL/mL Injection, Solution | BPI Labs, LLC | NDA |
Frequently asked questions
What is Dehydrated Alcohol used for?
1 INDICATIONS AND USAGE ABLYSINOL ® is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. ABLYSINOL is an ablative agent indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic…
What are the side effects of Dehydrated Alcohol?
Heart block [ see Warnings and precautions (5.1)] The following other adverse reactions associated with percutaneous transluminal septal myocardial ablation with the use of dehydrated alcohol, such as ABLYSINOL, were identified in the literature: Ventricular tachycardia and ventricular fibrillation. Adverse reactions include arrhythmias, including ventricular tachycardia and/or ventricular… See the full label for the complete list.
Who makes Dehydrated Alcohol?
Dehydrated Alcohol is listed by 9 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare, Inc., Avenacy, LLC, Breckenridge Pharmaceutical Inc.