Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: BridgeBio Europe B.V., Weerdestein 97, Amsterdam, 1083 GG, The Netherlands
BEYONTTRA is indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
Treatment should be initiated by a physician knowledgeable in the management of patients with transthyretin amyloid cardiomyopathy (ATTR-CM).
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.
There are no efficacy data in patients with New York Heart Association (NYHA) Class IV (see section 5.1).
No double dose should be taken to make up for missed individual doses. Dosing should resume at the next scheduled time.
No dose adjustment is required in elderly patients (≥65 years, see section 5.2).
Based on low renal clearance of acoramidis, no dose adjustment is required (see section 5.2). Data in patients with severe renal impairment (creatinine clearance <30 mL/min) are limited (see sections 4.4 and 5.2) and there are no data for patients on dialysis. Hence acoramidis should be used with caution in this population.
Acoramidis has not been studied in patients with hepatic impairment and therefore is not recommended for use in this population (see sections 4.4 and 5.2).
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”.
Oral use.
The film-coated tablets should be swallowed whole. BEYONTTRA can be taken with water, with or without food.
There is no clinical experience with overdose.
In case of suspected overdose, treatment should be symptomatic and supportive.
30 months.
This medicinal product does not require any special storage conditions.
Blister packs – Thermoformed dual-cavity blisters of PVC/PCTFE with aluminium foil lidding.
Pack sizes: 120 tablets in 6 blister strips, each with 10 cavities (2 tablets per cavity).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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