Brand name: Attruby
Drug class: Cardiac Drugs, Miscellaneous

Medically reviewed by Drugs.com on May 10, 2025. Written by ASHP.

Introduction

Transthyretin stabilizer.

Uses for Acoramidis

Transthyretin-mediated Amyloidosis

Treatment of cardiomyopathy in adults with wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization.

Designated an orphan drug by FDA for treatment of transthyretin amyloidosis.

Transthyretin-mediated amyloidosis (ATTR) can be inherited as an autosomal dominant trait caused by pathogenic variants/mutations in the TTR gene (ATTRv) or by deposition of wild-type TTR protein (ATTRwt). Selection of an appropriate disease-modifying therapy in patients with ATTR is based on the presence of cardiomyopathy and polyneuropathy and the distinction between ATTRv and ATTRwt amyloidosis.

The American Heart Association (AHA) has issued guidelines on management of cardiac amyloidosis. Place of therapy for acoramidis is not discussed as the guidelines predate drug approval. In a recent evidence analysis, acoramidis was given a moderate certainty recommendation for treating ATTR-CM based on improvements in clinical outcomes but uncertain mortality benefits.

Acoramidis Dosage and Administration

Administration

Oral Administration

Administer orally with or without food.

Swallow tablets whole; do not cut, crush, or chew.

Dosage

Commercially available as the hydrochloride salt; dosage expressed in terms of acoramidis.

Adults

Transthyretin-mediated Amyloidosis

Oral

712 mg (two 356 mg tablets) orally twice daily.

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No dosage adjustment needed for patients ≥65 years of age.

Cautions for Acoramidis

Contraindications

• None.

Warnings/Precautions

Specific Populations

Pregnancy

Insufficient data to determine risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Report pregnancies to the BridgeBio reporting line at 1-844-550-2246.

Lactation

No data on the presence of acoramidis in human milk, or whether the drug has any effects on a breastfed child or on milk production.

Pediatric Use

Not studied in pediatric patients ≤18 years of age.

Geriatric Use

In a clinical trial, 97% of patients were ≥65 years of age.

Hepatic Impairment

Not evaluated in hepatic impairment.

Renal Impairment

Initiation causes transient, reversible increases in serum creatinine (+0.2 mg/dL) and decreases in estimated GFR (-8.2 mL/minute per 1.73 m²), stabilizing within 4 weeks. Renal impairment does not significantly affect pharmacokinetics.

Common Adverse Effects

Diarrhea and upper abdominal pain.

Drug Interactions

Substrate of UGT1A9, UGT1A1, and UGT2B7.

Substrate for organic anion transporter 1 (OAT1) and breast cancer resistance protein (BCRP). Inhibits OAT1 and OAT3; does not inhibit multidrug and toxin extrusion protein 1 (MATE1), organic cation transporter 1 (OCT1), OCT2, organic anion transporting polypeptide 1B1 (OATP1B1), OATP1B3, MATE2-K, BCRP, P-glycoprotein (P-gp), or bile salt export pump (BSEP).

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

CYP2C9 substrates: acoramidis may increase concentrations of the substrate drug. Monitor patients for signs of toxicity when used concomitantly.

Strong CYP3A inducers (which also induce UGT enzymes): may reduce acoramidis exposure. Avoid concomitant use.

Drugs Affecting or Affected by Transport Systems

UGT inducers may reduce acoramidis exposure. Avoid concomitant use.

Specific Drugs and Laboratory Tests

Acoramidis Pharmacokinetics

Absorption

Plasma Concentration

Exhibits non-linear pharmacokinetics, with AUC increasing by 130% across the 89-712 mg twice-daily dosage range.

Mean time to steady-state concentration: 4 days.

Peak plasma concentration: 1 hour.

Food

Pharmacokinetics remain unaffected by a high-fat meal (800-1000 total calories, ≥50% fat).

Special Populations

Pharmacokinetics not significantly affected by age, race/ethnicity, sex, or renal impairment.

Distribution

Protein Binding

96% primarily to transthyretin.

Elimination

Metabolism

Glucuronidation via UGT1A9, UGT1A1, and UGT2B7.

Active metabolite: Acoramidis-β-D-glucuronide (acoramidis-AG); 33% as active as acoramidis and accounts for 8% of circulating drug.

Elimination Route

Feces: 32% with 15% unchanged.

Urine: 68% with <10% unchanged.

Half-life

Effective half-life is 6 hours.

Stability

Storage

Oral

Tablets

Store at 20-25°C; excursions between 15-30°C permitted.

Keep in original blister card until use to protect from moisture.

Actions

• Transthyretin stabilizer.

• Binds to thyroxine-binding sites, reducing tetramer dissociation, the rate-limiting step in amyloid formation.

Advice to Patients

• Advise patients to read the FDA-approved patient labeling (Patient Information).

• Advise patients who are exposed to acoramidis during pregnancy to contact the BridgeBio reporting line at 1-844-550-2246. Advise patients to inform their healthcare provider of a known or suspected pregnancy.

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Advise patients to inform their clinician if they are or plan to become pregnant or plan to breast-feed.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Acoramidis is available through designated specialty pharmacies. Contact the manufacturer or consult the acoramidis website ([Web]) for specific availability information.

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