Beyonttra

Treatment should be initiated by a physician knowledgeable in the management of patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Posology The recommended dose of acoramidis is 712 mg (two tablets, 356 mg) orally, twice daily, corresponding to a total daily dose of 1 424 mg.

1). Missed dose No double dose should be taken to make up for missed individual doses. Dosing should resume at the next scheduled time. 2). 2). 2) and there are no data for patients on dialysis. Hence acoramidis should be used with caution in this population.

2). Paediatric population There is no relevant use of acoramidis in the paediatric population for the indication of “the treatment of wild-type or variant transthyretin amyloidosis with cardiomyopathy”. Method of administration Oral use.

The film-coated tablets should be swallowed whole. BEYONTTRA can be taken with water, with or without food.

2%). Tabulated list of adverse reactions The safety data reflect exposure of 421 participants with ATTR-CM to acoramidis 712 mg (as two tablets of 356 mg) administered orally twice daily in a pivotal Phase 3 randomised, double-blind, placebo-controlled study of 30 months fixed treatment duration in patients diagnosed with ATTR-CM.

Adverse reactions are listed below by MedDRA System Organ Class (SOC) and frequency categories using the standard convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), and Uncommon (≥ 1/1 000 to < 1/100). Adverse reactions listed in the table below are from cumulative clinical data in ATTR-CM participants.

Table 1:

List of adverse reactions System Organ Class Very common Gastrointestinal disorders Diarrhoea Metabolism and nutrition disorders Gout Description of selected adverse reactions The majority of events of diarrhoea and gout were non-serious and resolved.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

2). 2) and there are no data for patients on dialysis. Hence acoramidis should be used with caution in this population. 1). This change in eGFR and serum creatinine was non-progressive, reversible in those patients whose treatment was interrupted, and not associated with kidney injury, consistent with a renal haemodynamic effect.

Information about excipients Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free’. 4

1.