Fibrocon

Indications

Resmetirom is used in adults to treat metabolic dysfunction-associated steatohepatitis (MASH, previously called NASH) with moderate to advanced liver scarring (fibrosis) but without cirrhosis. MASH is inflammation and damage of the liver caused by fat building up in it, and is often linked to obesity, diabetes and high cholesterol. It is used together with a healthy diet and regular exercise.

How It Works

Resmetirom acts on the thyroid hormone receptor beta, a switch found mainly in the liver. This makes the liver burn more fat, which lowers liver fat and, over time, can reduce inflammation and scarring. It works mainly in the liver and is not a treatment for thyroid disease.

Dosage and Administration

Take by mouth once a day, with or without food, as prescribed by a liver specialist. The usual adult dose depends on body weight: 80 mg once daily for people under 100 kg, and 100 mg once daily for people weighing 100 kg or more. The doctor may lower the dose if certain other medicines are also taken. It is not used in children. Regular liver blood tests are needed during treatment.

Interactions

• Gemfibrozil and other strong CYP2C8 blockers greatly raise resmetirom levels and should not be used with it.
• Clopidogrel may require a lower resmetirom dose.
• Ciclosporin and some other medicines that block liver transport proteins should be avoided.
• Resmetirom raises the blood levels of some statins, so the doses of Rosuvastatin, Simvastatin, Atorvastatin and Pravastatin may need to be limited.

Tell the doctor about every medicine and supplement you take.

Contraindications

Allergy to resmetirom or any ingredient of the product. It is not recommended for people whose cirrhosis has already caused complications (decompensated cirrhosis).

Side Effects

Common: diarrhoea, nausea, itching, vomiting, constipation, stomach pain and dizziness, mostly in the first weeks. Less common: liver injury and gallbladder problems such as gallstones or an inflamed gallbladder.

Get urgent medical help for yellow skin or eyes, dark urine, pain in the upper right part of the belly, severe tiredness or loss of appetite, severe or ongoing belly pain with fever, or signs of an allergic reaction such as swelling of the face or lips or difficulty breathing.

Pregnancy and Lactation

There is very little information on use in pregnancy. Tell the doctor if you are pregnant or planning a pregnancy; it should only be used if the doctor decides the benefit outweighs the risk. It is not known whether it passes into breast milk, so talk to the doctor before breastfeeding.

Precautions and Warnings

The doctor will check liver blood tests during treatment. Report any sign of liver or gallbladder trouble promptly. Keep following the diet and exercise plan, avoid alcohol, and keep diabetes, blood pressure and cholesterol under control.

Overdose

There is no specific antidote. If much more than the prescribed dose is taken, contact a doctor or go to hospital; treatment is based on symptoms.

Therapeutic Class

Liver medicine (thyroid hormone receptor beta agonist).

Storage

Store below 30°C in a dry place, away from light and out of the reach of children.