ACORAMIDIS TAB
Clinical Criteria Summary
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Exclusion Criteria
- Heart failure without definitive evidence of transthyretin-mediated amyloidosis (ATTR) (e.g., heart failure secondary to ischemic heart disease)
- Patient receiving concomitant therapy for ATTR (e.g., patisiran, inotersen, eplontersen, tafamidis, vutrisiran)
- End stage heart disease and anticipated survival < 1 year
Inclusion Criteria
- Provider is a VA or VA Community Care cardiologist or locally designated ATTR-CM provider
- Diagnosis of wild type or hereditary TTR genotype ATTR-CM based on endomyocardial biopsy OR echo/MRI suggestive of amyloidosis confirmed with radionuclide imaging (e.g., technetium pyrophosphate [Tc99-PYP] scintigraphy)
- Assessment of monoclonal protein screen for and exclusion of light chain (AL) amyloidosis
- History of symptomatic heart failure (at least one hospitalization for heart failure OR clinical evidence of heart failure manifested by signs and symptoms of volume overload or elevated intracardiac pressures)
- Discussion with patient/caregiver/family member regarding realistic treatment expectations and discontinuation should be documented
Additional Inclusion Criteria
- For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment
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Indication
- Treatment of cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) to reduce CV death and CV-related hospitalization.
Patient Selection & Diagnostic Criteria
- Adults with a diagnosis of ATTR-CM and clinical heart failure.
- ATTR-CM diagnosis based on endomyocardial biopsy with confirmatory typing or positive results (Perugini grade ≥2) on technetium-99m scintigraphy combined with biochemical exclusion of light chain (AL) amyloidosis.
- Clinical heart failure determined by ≥1 prior heart failure hospitalization, signs and symptoms of volume overload, or heart failure requiring diuretic treatment.
- Key clinical parameters: 6MWD ≥150m, NT-proBNP ≥300 pg/mL, LV wall thickness ≥12 mm.
Dosing & Administration
- 712 mg (2 x 356 mg tablets) orally twice daily, with or without food.
- Tablets must be swallowed whole.
Monitoring & Safety Parameters
- Monitor for increases in serum creatinine and decreases in estimated glomerular filtration rate (eGFR), generally occurring within 4 weeks of initiation.
- Renal function changes are reversible upon discontinuation.
Contraindications, Warnings & Drug Interactions
- No boxed warnings, contraindications, or other warnings stated.
- Avoid use with UGT inducers and strong CYP3A inducers.
- More frequent monitoring may be needed when co-administered with sensitive substrates of CYP2C9.