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Resmirom80 mg
Beacon Pharmaceuticals PLC
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Generic medicine
Resmetirom: Brands, Price & Uses in Bangladesh
Resmetirom is indicated, in combination with diet and exercise, for the treatment of adults with non-cirrhotic nonalcoholic steatohepatitis (NASH) and more.
About Resmetirom
Indications of Resmetirom
Resmetirom is indicated, in combination with diet and exercise, for the treatment of adults with non-cirrhotic nonalcoholic steatohepatitis (NASH), also termed metabolic dysfunction-associated steatohepatitis (MASH), who have moderate to advanced liver fibrosis (consistent with fibrosis stages F2 to F3).
- Established/approved use: Non-cirrhotic MASH/NASH with moderate-to-advanced fibrosis (F2-F3), always used together with diet and exercise, not as monotherapy replacing lifestyle measures.
- Regulatory status: Resmetirom was approved under an accelerated approval pathway based on improvement in liver histology (fibrosis and steatohepatitis); continued approval may depend on verification of clinical benefit in ongoing confirmatory trials.
- Not indicated for patients with compensated or decompensated cirrhosis (F4 fibrosis) - safety and efficacy have not been established in this population.
The diagnosis of MASH/NASH and the stage of fibrosis should be confirmed by a physician, typically using liver biopsy or validated non-invasive tests, before starting Resmetirom.
Dosage & Administration of Resmetirom
Adult Dosing (by body weight)
| Body weight | Recommended dose of Resmetirom |
|---|---|
| Less than 100 kg | 80 mg orally once daily |
| 100 kg or more | 100 mg orally once daily |
Administration
- Take Resmetirom orally once daily, with or without food.
- Swallow tablets whole; do not crush, split, or chew unless a specific formulation permits it.
- Continue diet and exercise measures alongside Resmetirom therapy, as the two are used together, not as alternatives.
Dose Adjustment
If Resmetirom is co-administered with a moderate CYP2C8 inhibitor, the dose should be reduced (e.g., from 100 mg to 80 mg, or from 80 mg to 60 mg daily), per physician guidance. Use with strong CYP2C8 inhibitors should generally be avoided. No dedicated dose adjustment has been established for mild hepatic or renal impairment; use with caution and physician oversight. Resmetirom has not been studied in decompensated cirrhosis and should not be used in that setting.
Pediatric Dosing
Safety and effectiveness of Resmetirom in pediatric patients have not been established.
Side Effects of Resmetirom
The most commonly reported side effects of Resmetirom include:
- Diarrhea (usually mild to moderate, often occurring early in treatment)
- Nausea and vomiting
- Pruritus (itching)
- Constipation
- Abdominal pain
- Dizziness
Liver enzyme elevations: Changes in liver function tests can occur; periodic monitoring is recommended (see Precautions and Warnings).
Gallbladder-related events: Cholelithiasis (gallstones) and cholecystitis have been reported more frequently with Resmetirom than with placebo in clinical trials; report symptoms such as severe upper abdominal pain, fever, or jaundice promptly.
Contact a physician if side effects are severe, persistent, or concerning.
Contraindications of Resmetirom
Resmetirom is contraindicated in patients with known hypersensitivity to Resmetirom or to any component of the formulation.
Resmetirom is not indicated for use in patients with decompensated cirrhosis, as it has not been studied and is not approved for this population; this represents an important scope limitation of therapy rather than a general precaution.
Frequently Asked Questions about Resmetirom
What is Resmetirom used for?
Resmetirom is used, together with diet and exercise, to treat adults with non-cirrhotic MASH/NASH (metabolic dysfunction-associated/nonalcoholic steatohepatitis) who have moderate to advanced liver fibrosis (stage F2-F3). It is not a cure and does not replace lifestyle changes.
Can Resmetirom be used if I have cirrhosis?
No. Resmetirom is not indicated and has not been adequately studied in patients with cirrhosis, including decompensated cirrhosis. It is only approved for non-cirrhotic MASH/NASH with fibrosis. Discuss your specific liver disease stage with your physician.
What are the common side effects of Resmetirom?
Common side effects include diarrhea, nausea, vomiting, itching, constipation, abdominal pain, and dizziness. Some patients experience elevated liver enzymes or gallbladder problems (gallstones, cholecystitis), so periodic liver monitoring is recommended while on Resmetirom.
Can I take Resmetirom with my cholesterol (statin) medicine?
Resmetirom can increase blood levels of certain statins. If you take atorvastatin or pravastatin, your physician may limit the dose to 40 mg daily; for rosuvastatin or simvastatin, to 20 mg daily, while you are on Resmetirom. Always tell your doctor about all medicines you take.
Is Resmetirom safe during pregnancy or breastfeeding?
Data are limited. Resmetirom should generally be avoided during pregnancy unless your physician determines the benefit clearly outweighs potential risks, and its safety during breastfeeding is not established. Discuss your situation with your physician before use.
What should I do if I miss a dose or suspect an overdose of Resmetirom?
If you miss a dose, take it as soon as you remember unless it is close to the next dose; do not double up. If an overdose of Resmetirom is suspected, seek immediate medical attention or contact a poison control center right away.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.