TLPH Remetiro Resmetirom 60mg

Product Information

• Product name: Remetiro Resmetirom 60mg
• Manufacturer / brand: Laos TLPH Pharma
• Active ingredient: Resmetirom
• Current strength: 60mg
• SKU: AM-ITEM-10
• Site category: fatty liver disease, general medicines

Product Summary

Remetiro Resmetirom 60mg is an AISTIKA-listed product supplied by Laos TLPH Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Resmetirom is the active ingredient used for this product page. Public prescribing information for Resmetirom was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Resmetirom is a partial agonist of the thyroid hormone receptor-beta (THR-β). Resmetirom produced 83.8% of the maximum response compared to triiodothyronine (T3), with an EC 50 of 0.21 µM in an in vitro functional assay for THR-β activation. The same functional assay for thyroid hormone receptor-alpha (THR-α) agonism showed 48.6% efficacy for resmetirom relative to T3, with an EC 50 of 3.74 µM.

Reference Indications

Resmetirom 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). This indication is approved under accelerated approval based on improvement of NASH and fibrosis . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitations of Use Avoid use of Resmetirom in patients with decompensated cirrhosis . Resmetirom is a thyroid hormone receptor-beta (THR-beta) agonist 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).

Reference Dosage and Administration

The public label should be checked for the indication-specific recommended dosage. Available administration instructions note that the medicine may be taken recommended dosage of Resmetirom is based on actual body weight. Administer Resmetirom with or without food.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Discontinue Resmetirom and continue to monitor the patient if hepatotoxicity is suspected. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated. If an acute gallbladder event such as acute cholecystitis is suspected, interrupt Resmetirom treatment until the event is resolved. One patient had normal alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TB) levels at baseline, who received Resmetirom 80 mg daily, developed substantial elevations of liver biochemistries that resolved when treatment was interrupted. After reinitiating Resmetirom, the patient had elevations of ALT, AST, and TB. Peak values observed were 58 x upper limit of normal (ULN) for ALT, 66 x ULN for AST, 15 x ULN for TB, with no elevation of alkaline phosphatase (ALP).

Common Adverse Reactions and Monitoring

The safety of Resmetirom was evaluated in two randomized, double-blind, placebo-controlled trials that enrolled a total of 2019 patients. Trial 1 Trial 1 included patients who had noncirrhotic NASH with stages F2 and F3 fibrosis at eligibility (n=888) . Diarrhea and nausea were the most common causes of treatment discontinuation. b Median exposure duration was 68 weeks for placebo, 74 weeks for Resmetirom 80 mg once daily, and 66 weeks for Resmetirom 100 mg once daily. c EAIRs are per 100 person-years (PY) where total PYs were 435, 435, and 407 for placebo, 80 mg once daily, and 100 mg once daily arms, respectively.

Drug Interactions and Special Populations

Strong or Moderate CYP2C8 Inhibitors: Concomitant use not recommended (strong inhibitor [e.g., gemfibrozil]); or reduce Resmetirom dosage (moderate inhibitor [e.g., clopidogrel]). (2.2 , 7.1) Atorvastatin, Pravastatin, Rosuvastatin and Simvastatin : Limit the daily dosage of the statin as recommended. Table 3: Clinically Significant Interaction Effects of Strong or Moderate CYP2C8 Inhibitors on Resmetirom Clinical Impact Resmetirom is a CYP2C8 substrate. Intervention Concomitant use of Resmetirom with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended. Reduce Resmetirom dosage if used concomitantly with a moderate CYP2C8 inhibitor (e.g., clopidogrel) . Intervention Rosuvastatin and simvastatin: Limit daily statin dosage to 20 mg. Pravastatin and atorvastatin: Limit daily statin dosage to 40 mg.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: REZDIFFRA public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.