Acoramidis: clinical use

Prescribing considerations

• Treatment should be initiated by a physician knowledgeable in ATTR-CM management.
• The indication covers adults with wild-type or variant ATTR-CM.
• There are no efficacy data for NYHA class IV disease.
• The medicine is under additional monitoring.

Contraindications and cautions

• Hypersensitivity to acoramidis or any excipient.
• Not recommended in hepatic impairment because it has not been studied.
• Use cautiously in severe renal impairment; evidence is limited and there are no data for dialysis.

Monitoring

• Serum creatinine may rise and eGFR may initially fall because of a non-progressive renal haemodynamic effect. Investigate progressive or clinically concerning deterioration.
• Acoramidis may lower free thyroxine without changing TSH or producing clinical thyroid dysfunction; interpret thyroid results accordingly.
• Report suspected adverse reactions through the MHRA Yellow Card scheme.

Clinical pharmacology

Acoramidis selectively binds within both thyroxine-binding sites of the TTR tetramer and increases tetramer stability, inhibiting dissociation into amyloidogenic monomers. It is rapidly absorbed, highly protein-bound, predominantly glucuronidated and has low renal clearance.

Formulation and product differences

• The UK product is a white, oval film-coated tablet supplied in dual-cavity blisters.
• The tablets should be swallowed whole and may be taken with or without food.
• The formulation is essentially sodium-free.

Tablet

Route: Oral

Strengths: 356 mg