TRB 80

✔️ Composition

Dosage & Administration

The recommended dose of TRB is based on actual body weight:

Patients <100 kg: 80 mg orally once daily

Patients ≥100 kg: 100 mg orally once daily

TRB may be taken with or without food.

Pediatric Patients: Safety and efficacy have not been established.

Geriatric Patients: No significant difference in efficacy; however, a higher incidence of adverse reactions has been observed in patients aged ≥65 years.

Renal Impairment: No dose adjustment is required for mild to moderate renal impairment. TRB has not been studied in severe renal impairment.

Hepatic Impairment:

Avoid use in patients with decompensated cirrhosis (Child-Pugh B or C).

No dose adjustment is needed for mild hepatic impairment (Child-Pugh A).

✔️ Side Effects

Common adverse reactions associated with TRB include:

• Diarrhea
• Nausea
• Vomiting
• Abdominal pain
• Dizziness
• Pruritus
• Constipation

✔️ Drug Interactions

Effect of Other Drugs on TRB

Strong or Moderate CYP2C8 Inhibitors:
Concomitant use may increase TRB exposure and adverse effects.

Use with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended.

If co-administered with moderate CYP2C8 inhibitors (e.g., clopidogrel), dose reduction is required:

<100 kg: 60 mg once daily

≥100 kg: 80 mg once daily

OATP1B1 and OATP1B3 Inhibitors:
Co-administration with OATP inhibitors (e.g., cyclosporine) is not recommended, as it may increase the risk of adverse reactions.

Effect of TRB on Other Drugs

Statins (atorvastatin, pravastatin, rosuvastatin, simvastatin):
TRB increases statin plasma concentrations, raising the risk of statin-related adverse effects.

Rosuvastatin & Simvastatin: Maximum 20 mg/day

Pravastatin & Atorvastatin: Maximum 40 mg/day

CYP2C8 Substrates (e.g., pioglitazone):
TRB may increase exposure to CYP2C8 substrates. Patients should be monitored closely, particularly when small concentration changes may cause serious adverse reactions.

✔️ Pregnancy & Lactation

Pregnancy:
There are no adequate data on the use of Resmetirom in pregnant women to assess drug-associated risks of major birth defects, miscarriage, or adverse fetal outcomes.

Lactation:
It is unknown whether Resmetirom is excreted in human or animal milk, or its effects on the breastfed infant or milk production. The benefits of breastfeeding should be weighed against the mother’s clinical need for TRB and any potential risks to the infant.

✔️ Precautions & Warnings

Hepatotoxicity:
TRB has been associated with hepatotoxicity. Regular monitoring of liver function tests is required. If liver injury is suspected, TRB should be discontinued and appropriate evaluation initiated. Re-initiation should be carefully considered based on risk-benefit assessment.

Gallbladder-Related Events:
Clinical trials reported cases of cholelithiasis, acute cholecystitis, and gallstone-related pancreatitis. If gallbladder disease is suspected, appropriate diagnostic evaluation should be performed, and TRB therapy should be interrupted until resolution.

Statin Interaction:
Increased statin exposure may elevate the risk of statin-associated adverse reactions; dose adjustments are recommended as outlined above.

✔️ Storage:

Store below 30°C in a cool, dry place. Protect from light. Keep out of reach of children.