Resmetirom (Rezdiffra) is a thyroid hormone receptor-beta agonist approved for marketing by the U.S. Food and Drug Administration (FDA) in 2024. When used in combination with diet and exercise, this medication provides a new treatment option for patients with specific liver diseases.

Indications for Resmetirom (Rezdiffra)

Core Therapeutic Area

Resmetirom is indicated for the treatment of adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) accompanied by moderate to advanced liver fibrosis (corresponding to F2 to F3 stage fibrosis).

It is important to note that this indication was approved through the accelerated approval pathway, based on the drug’s effect in improving NASH and fibrosis.

Use Restrictions and Contraindications

Contraindications: No explicit contraindications are listed in the current package insert.

Important Restrictions: The drug is prohibited for use in patients with decompensated cirrhosis. It should also be avoided in patients with moderate to severe liver impairment (Child-Pugh Class B or C).

Specifications and Properties of Resmetirom (Rezdiffra)

60 mg Tablets

Properties: White, oval, film-coated tablets, engraved with "P60" on one side and blank on the other side.

80 mg Tablets

Properties: Yellow, oval, film-coated tablets, engraved with "P80" on one side and blank on the other side.

100 mg Tablets

Properties: Beige to pink, oval, film-coated tablets, engraved with "P100" on one side and blank on the other side.

Storage Methods for Resmetirom (Rezdiffra)

Temperature Control Requirements

The medication must be stored at room temperature between 20°C and 25°C (68°F and 77°F).

Although short-term fluctuations within the range of 15°C to 30°C (59°F to 86°F) are permitted, frequent temperature changes should be avoided as much as possible.

Packaging and Environmental Protection

Packaging Specifications: Packaged in white high-density polyethylene bottles, equipped with child-resistant caps and an induction sealing system.

Environmental Protection: The medication should be kept away from direct sunlight, humid environments, and heat sources (such as heating systems and stoves).

Safe Medication Administration Standards

Immediately tighten the bottle cap after each use to ensure the integrity of the seal.

The medication must be stored in a safe place out of the reach of children to prevent accidental ingestion.