Rezdiffra Now Available for Noncirrhotic NASH With Liver Fibrosis

Rezdiffra™ (resmetirom) is now available for use 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).

Rezdiffra is an oral thyroid hormone receptor (THR)-β selective agonist. The treatment was granted accelerated approval based on data from the phase 3 MAESTRO-NASH study (ClinicalTrials.gov Identifier: NCT03900429). Findings showed a greater percentage of patients in the Rezdiffra arm had fibrosis improvement and NASH resolution compared with placebo. 

The most common adverse reactions with Rezdiffra include diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness. The prescribing information also includes warnings and precautions related to hepatotoxicity and gallbladder-related adverse reactions. Rezdiffra should be avoided in patients with moderate to severe hepatic impairment.

Concomitant use of Rezdiffra with strong CYP2C8 inhibitors and organic anion-transporting polypeptides (OATP) 1B1 and OATP1B3 inhibitors is not recommended. The dosage of Rezdiffra should be reduced with concomitant moderate CYP2C8 inhibitors. Patients should be monitored more frequently for substrate-related adverse reactions if Rezdiffra is coadministered with CYP2C8 substrates where minimal concentration changes may lead to serious adverse reactions.

Rezdiffra may also increase plasma concentrations of statins. For patients taking rosuvastatin and simvastatin, the statin dosage should be limited to 20mg. For those taking pravastatin and atorvastatin, limit the statin dosage to 40mg. 

Rezdiffra is supplied in 60mg-, 80mg-, and 100mg-strength tablets and is distributed through a limited specialty pharmacy network. The recommended dose is based on actual body weight. For patients weighing less than 100kg, the recommended dosage is 80mg orally once daily. For patients weighing at least 100kg, the recommended dosage is 100mg orally once daily.

More information regarding access and affordability is available through the Madrigal Patient Support program.