Resiliva 80

✔️ Side Effects

• Diarrhea
• Nausea
• Vomiting
• Abdominal pain
• Dizziness
• Pruritus (itching)
• Constipation

✔️ Drug Interactions

Effects of Other Drugs on Resiliva

Strong or Moderate CYP2C8 Inhibitors

Concomitant use of CYP2C8 inhibitors may increase Resmetirom exposure and the risk of adverse reactions.

Strong CYP2C8 inhibitors (e.g., Gemfibrozil):

• Concurrent use is not recommended.

Moderate CYP2C8 inhibitors (e.g., Clopidogrel):

Dose reduction is recommended:

OATP1B1 and OATP1B3 Inhibitors

Concurrent administration with inhibitors of Organic Anion Transporting Polypeptides (OATP) 1B1 and 1B3 may increase Resmetirom exposure and adverse effects.

Examples include:

• Cyclosporine

Concomitant use is not recommended.

Effects of Resiliva on Other Drugs

Statins

Resmetirom may increase plasma concentrations of certain statins, potentially increasing the risk of statin-related adverse effects such as myopathy.

Affected statins include:

• Atorvastatin
• Pravastatin
• Rosuvastatin
• Simvastatin

Recommended maximum daily statin doses during concomitant therapy:

CYP2C8 Substrates

Resmetirom may increase exposure to CYP2C8 substrate drugs such as:

• Pioglitazone

Patients receiving concomitant CYP2C8 substrates should be monitored for enhanced pharmacological effects and adverse reactions.

✔️ Dosage & Administration

The recommended dosage of Resmetirom is determined according to the patient's actual body weight.

Patients Weighing Less Than 100 kg

• 80 mg orally once daily

Patients Weighing 100 kg or More

• 100 mg orally once daily

Administration

• May be taken with or without food.
• Tablets should be swallowed whole with water.
• Take the medication regularly at the same time each day for optimal therapeutic benefit.

Pediatric Use

The safety and efficacy of Resmetirom in pediatric patients have not been established.

Geriatric Use

No significant differences in overall effectiveness have been observed in elderly patients. However, a numerically higher incidence of adverse reactions has been reported in patients aged 65 years and older. Careful monitoring is therefore advised.

Renal Impairment

• No dosage adjustment is required for patients with mild to moderate renal impairment.
• Resmetirom has not been adequately studied in patients with severe renal impairment.

Hepatic Impairment

Mild Hepatic Impairment (Child-Pugh Class A)

• No dose adjustment is required.

Moderate to Severe Hepatic Impairment (Child-Pugh Class B or C)

• Use is not recommended due to an increased risk of adverse reactions.

Decompensated Cirrhosis

• Resmetirom should be avoided in patients with decompensated cirrhosis.

✔️ Pregnancy & Lactation

Pregnancy

There are currently no adequate human data regarding the use of Resmetirom during pregnancy. Therefore, the potential risk of major birth defects, miscarriage, or adverse fetal outcomes remains unknown.

Resmetirom should be used during pregnancy only if the anticipated benefit justifies the potential risk to the mother and fetus.

Lactation

It is not known whether Resmetirom is excreted into human breast milk or whether it affects milk production or the breastfed infant.

The benefits of breastfeeding should be weighed against:

• The mother's clinical need for treatment
• Any potential risks to the nursing infant
• Risks associated with the underlying maternal disease

✔️ Precautions and Warnings

Hepatotoxicity

Liver-related adverse effects have been reported during treatment with Resmetirom.

Patients should be monitored for:

• Elevations in liver function tests
• Signs and symptoms of hepatotoxicity
• Development of liver-related adverse reactions

If hepatotoxicity is suspected:

• Discontinue Resiliva immediately.
• Continue clinical and laboratory monitoring.
• Evaluate the risks and benefits before considering re-initiation of therapy.

Persistent abnormalities may warrant evaluation for drug-induced autoimmune-like hepatitis or other liver disorders.

Gallbladder-Related Events

Gallbladder complications observed during clinical studies include:

• Cholelithiasis (gallstones)
• Acute cholecystitis
• Gallstone-related obstructive pancreatitis

If gallstone disease is suspected:

• Appropriate diagnostic evaluation should be performed.
• Resiliva treatment should be interrupted during acute gallbladder events and resumed only after resolution, if clinically appropriate.

Concomitant Statin Therapy

Because Resmetirom may increase exposure to certain statins, dosage adjustments and clinical monitoring are recommended to minimize the risk of statin-related adverse reactions.

✔️ Storage:

• Store below 30°C.
• Keep in a cool and dry place.
• Protect from light and moisture.
• Keep out of the reach of children.