Acoramidis Application Scope

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

Acoramidis Characteristics

Ingredients:

Active Ingredient: Acoramidis hydrochloride
Inactive Ingredients: Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, hypromellose, polyvinyl alcohol, propylene glycol, talc, titanium dioxide, black iron oxide, glyceryl monocaprylocaprate, vinyl alcohol graft copolymer

Properties: Acoramidis is a selective stabilizer of transthyretin (TTR). It binds to TTR at thyroxine binding sites, slowing the dissociation of the TTR tetramer into monomers, which is the rate-limiting step in amyloidogenesis.

Packaging Specification: Supplied as a carton containing 112 tablets (4 blister cards of 28 tablets each)

Storage: Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in original blister card until use to protect from moisture.

Expiry Date: Refer to the packaging for the expiration date.

Executive Standard: Refer to the manufacturer’s specifications and regulatory approvals.

Approval Number: NDA216540

Date of Revision: November 2024

Manufacturer: BridgeBio Pharma, Inc., Palo Alto, CA 94304

Guidelines for the Use of Acoramidis

Dosage and Administration:

Recommended Dosage: 712 mg orally twice daily (two 356 mg tablets per dose)
Administration: Can be taken with or without food. Swallow tablets whole; do not cut, crush, or chew.

Adverse Reactions:

Common (>10%): Gastrointestinal issues, including diarrhea (11.6%)
Less Common (1–10%): Upper abdominal pain (5.5%)
Frequency Not Defined: Increased serum creatinine and decreased estimated glomerular filtration rate (eGFR)

Contraindications: None identified.

Precautions:

Safety and efficacy have not been established in patients younger than 18 years.
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Advise patients to inform their healthcare provider of a known or suspected pregnancy.

Acoramidis Interactions

Drug Interactions:

Avoid concomitant use with UDP-glucuronosyltransferase (UGT) inducers and strong CYP3A inducers, as they can decrease acoramidis exposure.
Acoramidis inhibits CYP2C9 and may increase concentrations of CYP2C9 substrates; monitor patients for signs of increased exposure when coadministered.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.