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Ablysinol Generic Name & Formulations
Legal Class
Rx
General Description
Dehydrated alcohol ≥99% (by volume); soln for intra-arterial inj; preservative-free.
Pharmacological Class
Ablative agent.
How Supplied
Single-dose ampules (1mL, 5mL)—10
Manufacturer
Generic Availability
NO
Ablysinol Indications
Indications
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 Dosage and Administration
Adult
Use minimum dose necessary to achieve desired reduction in peak LV outflow tract pressure gradient. Inject 1–2mL percutaneously over 1–2mins into septal arterial branches; max: 5mL per single procedure. Stop procedure if unable to reduce LV outflow tract pressure gradient to <10mmHg when reaching total dose of 5mL.
Children
Not established.
Ablysinol Contraindications
Not Applicable
Ablysinol Boxed Warnings
Not Applicable
Ablysinol Warnings/Precautions
Warnings/Precautions
Should only be administered under supervision of a trained and experienced cardiologist. Transient or persistent heart block. Baseline PQ interval >160ms, baseline minimum HR <50bpm, baseline LV outflow gradient >70mmHg, max QRS during first 48hrs >155ms, 3rd-degree AV block during procedure, no clinical recovery between 12–48hrs post-op, >60yrs: risk for permanent pacemaker dependency. Increased risk of excessive tissue necrosis with higher volume used or higher number of septal branches injected to reduce LV outflow tract gradient. Perform continuous ECG monitoring for 48hrs post-op. Elderly. Pregnancy: not recommended; postpone until postpartum period. Nursing mothers.
Ablysinol Pharmacokinetics
See Literature
Ablysinol Interactions
Not Applicable
Ablysinol Adverse Reactions
Adverse Reactions
Arrhythmias (eg, ventricular tachycardia, ventricular fibrillation); myocardial infarction.
Ablysinol Clinical Trials
See Literature
Ablysinol Note
Not Applicable
Ablysinol Patient Counseling
See Literature
