ABLYSINOL DEHYDRATED ALCOHOL INJECTION 99% 10X5ML
Generic: Alcohol
ABLYSINOL DEHYDRATED ALCOHOL INJECTION 99% 10X5ML
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Identification
Alcohol
Dehydrated Alcohol
BPI Labs, LLC
HUMAN PRESCRIPTION DRUG
Administration
INJECTION, SOLUTION
PERCUTANEOUS
NDA207987
Active Ingredients
| Ingredient | Strength |
|---|---|
| ALCOHOL | 1 mL/mL |
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
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Clinical Drug Information
Indications & Usage
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 & Administration
2 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.
Adverse Reactions
6 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 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.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.