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Transthyretin (TTR) stabiliser Pregnancy: US label §8.1 (VERBATIM): 'Available data with acoramidis use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproductive studies in rats and rabbits, no embryofetal abnormalities were observed at exposures up to 34 times and 13 times the clinical exposure at the maximum recommended human dose, respectively.' In pregnant rabbits, oral acoramidis throughout organogenesis resulted in increased pre-implantation loss at 200 mg/kg/day. The background risk of major birth defects and miscarriage for the indicated population is unknown. This summary may be incomplete — check the full SPC.

Acoramidis

Brand names: Beyonttra

Acoramidis is an oral transthyretin (TTR) stabiliser used in the treatment of transthyretin amyloid cardiomyopathy to slow disease progression.

Adult dose

Dose: 712 mg twice daily (given as two 356 mg tablets)
Route: Oral
Frequency: Twice daily, with or without food
VERBATIM §2.1: 'The recommended dosage of ATTRUBY is 712 mg orally twice daily (with or without food). Swallow tablets whole; do not cut, crush, or chew.' VERBATIM §3: 'ATTRUBY is available as 356 mg acoramidis, white, film-coated, oval tablets'. The safety section confirms the presentation of the dose: 'ATTRUBY 712 mg (administered as two 356 mg tablets) administered orally twice daily'. maxDose left empty deliberately: the label gives one fixed recommended dosage and states no dose ceiling with an explicit maximum cue (the phrase 'maximum recommended human dose' appears only in the animal-exposure multiples in §8.1, with no number attached). ELDERLY, VERBATIM §8.5: 'No dosage adjustment is required for elderly patients (>=65 years).' The UK/EU SPC was NOT fetched in this bundle, so this draft cannot reconcile the two figures — fetch the eMC Beyonttra SPC before the page number is changed.

Dose adjustments

Renal

No renal dose adjustment is given in the fetched sections. Relevant label text (§6.1 Laboratory Tests, VERBATIM): 'Initiation of ATTRUBY causes an increase in serum creatinine and decrease in eGFR which generally occurs within 4 weeks of starting therapy and stabilizes.' Some sections of the product information we used were incomplete — check the full SPC.

Hepatic

Not stated — the fetched sections of the US prescribing information contain no hepatic impairment dosing statement.

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • None — VERBATIM §4: 'CONTRAINDICATIONS None.'
  • Not from a UK SPC — UK product information may differ.

Side effects

  • Diarrhoea — 11.6% with acoramidis versus 7.6% with placebo (§6.1)
  • Upper abdominal pain — 5.5% versus 1.4% with placebo (§6.1)
  • Gastrointestinal reactions were more frequent than placebo but 'the majority of these GI adverse reactions were categorized as mild and resolved without drug discontinuation' (§6.1)
  • Increase in serum creatinine and decrease in eGFR on initiation, generally within 4 weeks of starting therapy, then stabilising (§6.1 Laboratory Tests)
  • Discontinuation for an adverse event occurred in 9.3% of acoramidis-treated and 8.5% of placebo-treated participants (§6.1)

Monitoring

  • Serum creatinine / eGFR — the label records a rise in creatinine and fall in eGFR within 4 weeks of initiation that then stabilises (§6.1 Laboratory Tests)
  • Sensitive CYP2C9 substrates — VERBATIM §7: 'Consider more frequent monitoring of patients for evidence of increased exposure (for example, signs of exposure related toxicity) when ATTRUBY is co administered with sensitive CYP2C9 substrates.'
  • No routine laboratory monitoring schedule is specified in the fetched sections

Clinical monograph

How it works

It binds selectively to the thyroxine-binding sites of transthyretin, stabilising the tetramer and preventing its dissociation into amyloidogenic monomers.

Prescribing in practice

  • It is a disease-modifying therapy for transthyretin amyloid cardiomyopathy and is not a substitute for standard heart failure management, which should continue as indicated.
  • Treatment is generally initiated and supervised within a specialist amyloidosis or cardiology service.
  • Diagnosis of transthyretin amyloid cardiomyopathy should be confirmed before starting therapy.

Monitoring

Monitor cardiac status and functional capacity within the specialist service to assess ongoing response to treatment.

Counselling the patient

  • This medicine aims to slow progression of the underlying heart condition and is taken long term.
  • Continue your other heart medicines and attend specialist follow-up appointments.

Evidence & guidelines

Acoramidis was evaluated for transthyretin amyloid cardiomyopathy in the ATTRibute-CM trial, which informed its licensed use.

Reference: ESC HF 2023 update; SmPC Beyonttra; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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