Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Dehydrated alcohol injection, USP is a clear, colorless liquid supplied in clear, glass, single-dose ampules. Each mL contains ≥ 99% by volume ethyl alcohol. NDC Volume Single ampule Carton of 10 ampules 5 mL 39822-9300-1 39822-9300-2 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.; PRINCIPAL DISPLAY PANEL - 5 mL - 10 Ampule carton Dehydrated Alcohol Injection, USP 5 mL NDC 39822-9300-1 For Cardiac Septal Branch Intra-Arterial Use. Usual Dose: see prescribing information. Store away from any heat source. Each mL contains: ≥ 99% by volume ethyl alcohol (a sterile, preservative free solution) WARNING:Do not use if discolored or precipitated. 10 Single Dose Ampules x 5 mL HIGHLY FLAMMABLE Rx Only dha-vl-00.jpg; PRINCIPAL DISPLAY PANEL - 5 mL - 10 Ampule carton Dehydrated Alcohol Injection, USP 5 mL NDC 39822-9300-2 For Cardiac Septal Branch Intra-Arterial Use. Usual Dose: see prescribing information. Store away from any heat source. Each mL contains: ≥ 99% by volume ethyl alcohol (a sterile, preservative free solution) WARNING: Do not use if discolored or precipitated. 10 Single Dose Ampules x 5 mL HIGHLY FLAMMABLE Rx Only LOT EXP dha-cm-00.jpg
- 16 HOW SUPPLIED/STORAGE AND HANDLING Dehydrated alcohol injection, USP is a clear, colorless liquid supplied in clear, glass, single-dose ampules. Each mL contains ≥ 99% by volume ethyl alcohol. NDC Volume Single ampule Carton of 10 ampules 5 mL 39822-9300-1 39822-9300-2 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.
- PRINCIPAL DISPLAY PANEL - 5 mL - 10 Ampule carton Dehydrated Alcohol Injection, USP 5 mL NDC 39822-9300-1 For Cardiac Septal Branch Intra-Arterial Use. Usual Dose: see prescribing information. Store away from any heat source. Each mL contains: ≥ 99% by volume ethyl alcohol (a sterile, preservative free solution) WARNING:Do not use if discolored or precipitated. 10 Single Dose Ampules x 5 mL HIGHLY FLAMMABLE Rx Only dha-vl-00.jpg
- PRINCIPAL DISPLAY PANEL - 5 mL - 10 Ampule carton Dehydrated Alcohol Injection, USP 5 mL NDC 39822-9300-2 For Cardiac Septal Branch Intra-Arterial Use. Usual Dose: see prescribing information. Store away from any heat source. Each mL contains: ≥ 99% by volume ethyl alcohol (a sterile, preservative free solution) WARNING: Do not use if discolored or precipitated. 10 Single Dose Ampules x 5 mL HIGHLY FLAMMABLE Rx Only LOT EXP dha-cm-00.jpg
Overview
Dehydrated alcohol injection, USP is a sterile, preservative-free solution of ≥ 99% by volume ethyl alcohol and no excipients. Dehydrated alcohol injection, USP 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
Indications & Usage
Dehydrated alcohol injection 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. Dehydrated alcohol injection 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 & 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 dehydrated alcohol injection that should be used in a single procedure is 5 mL. 2.2 Administration Dehydrated alcohol injection 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. Dehydrated alcohol injection should appear as a clear, colorless solution. Discard unused portion.
Warnings & 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 dehydrated alcohol injection, 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, 3rd 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.
Contraindications
None. None ( 4 )
Adverse Reactions
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 dehyrated alcohol injection, 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 XGen Pharmaceuticals DJB, Inc. at 1-866-390-4411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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