acoramidis

Therapeutic Classification: none assigned

Pharmacologic Classification: temporary class

Indications ⬆ ⬇

REMS

Cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis.

Action ⬆ ⬇

Acts as a transthyretin (TTR) stabilizer by selectively binding to TTR at the thyroxine binding sites and stabilizing the tetramer of the TTR transport protein by slowing its dissociation into monomers, which is the rate-limiting step in the amyloidogenic process.

Therapeutic effects:

Reduction in cardiovascular death and cardiovascular-related hospitalizations.

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following oral administration unknown.

Distribution: Extensively distributed to tissues.

Protein Binding: 96%.

Metabolism/Excretion: Primarily metabolized by the liver via glucuronidation. 68% excreted in the urine (<10% as unchanged drug); 32% excreted in the feces (15% as unchanged drug).

Half-Life: 6 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1 hr	12 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

GI: diarrhea, abdominal pain

GU: ↑serum creatinine

Interactions ⬆ ⬇

Drug-drug:

UGT inducers and strong CYP3A inducers may ↓ levels and effectiveness; avoid concurrent use.
May ↑ levels and risk of toxicity of CYP2C9 substrates.

Route/Dosage ⬆ ⬇

PO (Adults ): 712 mg twice daily.

Availability ⬆ ⬇

Assessment ⬆ ⬇

Assess BP, HR, and respiratory rate before and during treatment. Monitor for hypotension, bradycardia, and new arrhythmias or worsening conduction blocks.
Assess for dyspnea on exertion or at rest, peripheral edema, ascites, and orthopnea.
Assess for GI upset (nausea, diarrhea).

Lab Test Considerations:

May ↑ serum creatinine.
May ↓ serum concentrations of free thyroxine.
Assess NT-proBNP and troponin levels.

Implementation ⬆ ⬇

PO: Administer twice daily with or without food. DNC: Swallow tablets whole; do not cut, crush, or chew.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy. Explain the importance of adhering to follow-up appointments for cardiac monitoring and laboratory testing.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Educate patient on lifestyle modifications, such as low-sodium diet and fluid restriction, if needed.
Advise patient about signs and symptoms of HF (weight gain, swelling, shortness of breath) and to notify health care professional immediately if symptoms occur.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Health care providers and patients should report pregnancies to the BridgeBio reporting line at 1-844-550-2246.

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Pronunciation ⬇

Classifications ⬆ ⬇