Chemical formula: C₁₅H₁₇FN₂O₃ Molecular mass: 292.122 g/mol PubChem compound: 71464713
Acoramidis interacts in the following cases:
Acoramidis was shown to be an inhibitor of CYP2C8 and CYP2C9 in vitro. No in vivo study has been performed. Therefore, concomitant CYP2C8 and CYP2C9 substrates with narrow therapeutic index should be used with caution.
Acoramidis is metabolized by UGT enzyme-mediated glucuronidation. Concomitant use of UGT inducers can potentially decrease acoramidis exposure. While acoramidis is not metabolized by CYP3A, strong CYP3A inducers can also induce UGT enzymes. Avoid concomitant use of acoramidis with UGT inducers and strong CYP3A inducers.
Acoramidis has not been studied in patients with hepatic impairment and therefore is not recommended for use in this population.
Data in patients with severe renal impairment (creatinine clearance <30 mL/min) are limited and there are no data for patients on dialysis. Hence acoramidis should be used with caution in this population.
There are no data on the use of acoramidis in pregnant women.
Studies in animals have shown developmental toxicity at a dose which also caused maternal toxicity. Acoramidis is not recommended during pregnancy and in women of childbearing potential not using contraception.
It is unknown whether acoramidis or its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Acoramidis should not be used during breast-feeding.
No human data on fertility is available. Impairment of fertility has not been observed in non-clinical studies in supratherapeutic exposures.
Acoramidis has no or negligible influence on the ability to drive and use machines.
Based on the clinical study, the most frequently reported adverse reactions were diarrhoea (11.6%) and gout (11.2%).
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.
List of adverse reactions:
| System Organ Class | Very common |
|---|---|
| Gastrointestinal disorders | Diarrhoea |
| Metabolism and nutrition disorders | Gout |
The majority of events of diarrhoea and gout were non-serious and resolved.
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