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Tablet

Resmit 80 FC Tablet 80 mg Tablet

Generic: Resmetirom

Manufacturer: Eskayef Pharmaceuticals Ltd., Tongi,Gazipur

Therapeutic class: Thyroid hormone receptor-beta agonist

What is Resmit 80 FC Tablet used for?

Resmit 80 FC Tablet 80 mg tablet by Eskayef Pharmaceuticals Ltd., Tongi,Gazipur is a prescription medicine containing Resmetirom.

What is Resmit 80 FC Tablet?

Resmit 80 FC Tablet 80 mg tablet by Eskayef Pharmaceuticals Ltd., Tongi,Gazipur is a prescription medicine containing Resmetirom. In Bangladesh, its main use is for adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) with moderate to advanced liver fibrosis, when prescribed along with diet and exercise.

Resmetirom works mainly in the liver by activating thyroid hormone receptor-beta, which can help reduce liver fat and improve features of steatohepatitis. A key caution is that it is not meant for people with decompensated cirrhosis or as a substitute for lifestyle measures and regular liver follow-up.

Indications

  • Treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH/NASH) with moderate to advanced liver fibrosis, as an adjunct to diet and exercise.
  • It is not indicated for simple fatty liver without steatohepatitis and fibrosis, or for decompensated cirrhosis.

Dosage & Administration

For adults, Resmetirom is usually taken by mouth once daily, with the dose selected according to body weight and other medicines being used. It may be taken with or without food. The exact dose, need for dose adjustment, and duration of treatment should be decided by the prescribing doctor, especially if CYP2C8-interacting medicines or statins are being used.

Side Effects

  • Common side effects include diarrhea, nausea, vomiting, abdominal discomfort, indigestion, constipation, and dizziness.
  • It may cause itching or changes in thyroid hormone blood tests, especially lower free T4 levels.
  • Serious but less common risks include liver enzyme elevation or liver injury symptoms, and gallbladder-related problems such as gallstones or cholecystitis.
  • Seek urgent medical advice for yellowing of the skin or eyes, dark urine, severe right upper abdominal pain, persistent vomiting, or signs of an allergic reaction.

Precautions & Warnings

Use caution in people with liver cirrhosis, previous gallbladder disease, significant thyroid disease, severe diarrhea or dehydration risk, or those taking statins or medicines that affect CYP2C8/OATP transporters. Liver tests and clinical follow-up may be needed during treatment. Use under a registered doctor's or pharmacist's guidance, and do not start, stop, or change the dose without professional advice.

Drug Interactions

  • Strong CYP2C8 inhibitors such as gemfibrozil can greatly increase Resmetirom exposure and should generally be avoided.
  • Moderate CYP2C8 inhibitors such as clopidogrel may require dose adjustment by the doctor.
  • OATP1B1/OATP1B3 inhibitors such as cyclosporine may increase Resmetirom levels and are generally avoided.
  • Resmetirom can increase exposure to some statins, including atorvastatin, rosuvastatin, pravastatin, and simvastatin; statin dose limits and monitoring for muscle pain or weakness may be needed.
  • No specific food restriction is required; it can be taken with or without food unless the doctor advises otherwise.

Contraindications

  • Do not use in anyone with known hypersensitivity to Resmetirom or any tablet ingredient.
  • It should not be used for decompensated cirrhosis or severe advanced liver disease unless a specialist specifically determines it is appropriate.
  • Concomitant use with medicines that are specifically advised to be avoided, such as gemfibrozil or cyclosporine, should not be done without specialist review.

Pregnancy & Lactation

There are limited human data on Resmetirom use during pregnancy, and the risk to an unborn baby is not well established. It should be used in pregnancy only if the doctor decides the potential benefit justifies the potential risk. It is not known whether Resmetirom passes into breast milk, so breastfeeding patients should discuss the need for treatment and possible alternatives with their doctor.

Storage Conditions

Store tablets at room temperature, away from excess heat, moisture, and direct sunlight. Keep in the original container, tightly closed, and out of the reach of children. Do not use after the expiry date.

Frequently Asked Questions

What is Resmit 80 FC Tablet used for?

Resmit 80 FC Tablet is used in adults with non-cirrhotic MASH/NASH with moderate to advanced liver fibrosis, along with diet and exercise, when prescribed by a doctor. It is not for simple fatty liver without steatohepatitis and fibrosis.

How should I take Resmit 80 FC Tablet?

Take Resmit 80 FC Tablet exactly as your doctor prescribes. It is usually taken once daily by mouth and may be taken with or without food. Do not change the dose or stop it without medical advice.

What side effects should I watch for with Resmit 80 FC Tablet?

Common effects include diarrhea, nausea, vomiting, abdominal discomfort, indigestion, constipation, dizziness, and itching. Seek urgent medical help if you develop yellow skin or eyes, dark urine, severe right upper abdominal pain, persistent vomiting, or signs of allergy.

Can Resmit 80 FC Tablet be taken with statins or other medicines?

Resmit 80 FC Tablet can interact with some medicines, including gemfibrozil, cyclosporine, clopidogrel, and several statins such as atorvastatin, rosuvastatin, pravastatin, and simvastatin. Tell your doctor and pharmacist about all medicines you take.

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