Hepafix

Resmetirom ·Delta Pharma PLC.·Tablet

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Packages & prices

Pack	Price	Details
Unit Price	৳ 1050.00	Unit Price: ৳ 35.00 (3 x 10: ৳ 1,050.00)

Administration

The recommended dose of Resmetirom is based on actual body weight. For patients weighing:

<100 kg, the recommended dose is 80 mg orally once daily.
>100 kg, the recommended dose is 100 mg orally once daily.

Resmetirom can be administered with or without food.

Effects

The common side effects of Hepafix are: Diarrhea, Nausea, Vomiting, Abdominal pain, Dizziness, Pruritus, Constipation.

Indications

Hepafix tablet 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).

Pharmacology

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 EC₅₀ 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 EC₅₀ of 3.74 pM. THR-p is the major form of THR in the liver, and stimulation of THR-β in the liver reduces intrahepatic triglycerides.

Precautions

Hepatotoxicity: Hepatotoxicity has been observed with use of Hepafix. Monitoring of patient is required during treatment with Hepafix for elevations in liver tests, for the development of liver-related adverse reactions and for sign & symptoms of hepatotoxicity. If hepatotoxicity is suspected, Hepafix should be discontinued and monitoring of the patient should be continued. If laboratory values return to baseline, the potential risks against the benefits of restarting Hepafix should be considered. If laboratory values do not return to baseline, DI-ALH or autoimmune liver disease should be considered in the evaluation of elevations in liver tests.

Gallbladder-Related Adverse Reactions: In clinical trials, cholelithiasis, acute cholecystitis, and obstructive pancreatitis (gallstone) were observed in Hepafix-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated , If an acute gallbladder event is suspected, Hepafix treatment
should be interrupted until the event is resolved.

Drug Interaction with Certain Statins: An increase in exposure of Atorvastatin, Pravastatin, Rosuvastatin and Simvastatin was observed when concomitantly administered with Hepafix, which may increase the risk of adverse reactions related to these drugs. Dosage adjustment for certain statins is recommended.