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Resmetirom(Rezdiffra)

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Reference price:

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Formulation:

TABLET

Validity period:

Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.

REZDIFFRA (resmetirom) is a first-in-class thyroid hormone receptor-beta (THR-β) agonist approved for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate-to-advanced liver fibrosis (F2–F3). It selectively activates hepatic THR-β, reducing intrahepatic lipid accumulation, inflammation, and fibrosis while minimizing systemic effects. Approval under the FDA’s accelerated pathway is based on histopathologic improvement; confirmatory trials are required to verify clinical outcomes such as reduced cirrhosis-related morbidity.

Key considerations include weight-based dosing, monitoring for hepatotoxicity and gallbladder adverse events, and avoidance in decompensated cirrhosis. Common adverse reactions (e.g., diarrhea, nausea) are manageable, but drug interactions with CYP2C8 inhibitors and statins necessitate dose adjustments or avoidance. Resmetirom represents a targeted therapeutic advance for a condition with previously limited treatment options.

Generic name

Resmetirom(Rezdiffra)

English name

Resmetirom

Alternative Names

Rezdiffra

Drug prices

Indications

REZDIFFRA is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

Accelerated Approval: Based on improvement in liver histology (NASH resolution and fibrosis improvement). Continued approval is contingent on verification of clinical benefit in confirmatory trials.

Therapeutic Target

Partial agonist of thyroid hormone receptor-beta (THR-β).

Active Ingredients

Resmetirom.

Dosage form

TABLET

specifications

60 mg: NDC 82576-060-30 (30-count bottle). 80 mg: NDC 82576-080-30 (30-count), NDC 82576-080-90 (90-count). 100 mg: NDC 82576-100-30 (30-count), NDC 82576-100-90 (90-count).

Description

Composition:

Active: Resmetirom.

Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose.

Coating: Polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide; yellow iron oxide (80 mg/100 mg), red iron oxide (100 mg).

Solubility: Low aqueous solubility below pH 6; higher solubility above pH 7.

Dosage and Administration

Weight-Based Dosing:

<100 kg: 80 mg once daily.

≥100 kg: 100 mg once daily.

Administration:

Take with or without food.

Swallow whole; do not crush or split.

Dosage Adjustments:

Strong inhibitors (e.g., gemfibrozil): Avoid concomitant use.

Moderate inhibitors (e.g., clopidogrel): Reduce dose to 60 mg (<100 kg) or 80 mg (≥100 kg).

CYP2C8 Inhibitors:

Strong inhibitors (e.g., gemfibrozil): Avoid concomitant use.

Moderate inhibitors (e.g., clopidogrel): Reduce dose to 60 mg (<100 kg) or 80 mg (≥100 kg).

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