Livadox 5

✔️ Overdose of Livadox 5

Overdoses (e.g., doses up to 5 times the recommended) have been linked to severe liver-related side effects, including ascites, jaundice, and portal hypertension. Provide supportive care as needed.

✔️ Side Effects of Livadox 5

Common (>10%):

• Itching, fatigue, abdominal discomfort.

Other Side Effects (1-10%):

• Rash, joint pain, sore throat, dizziness, constipation, eczema, abnormal thyroid function.

✔️ Dosage & Administration

• Pediatrics: Safety and efficacy have not been established.
• Geriatrics: No significant differences were noted, but older adults may show greater sensitivity.
• Hepatic Impairment: Contraindicated in decompensated cirrhosis or patients with portal hypertension.

• Before starting treatment, assess for decompensated cirrhosis (e.g., Child-Pugh Class B or C), history of decompensation, or evidence of portal hypertension (e.g., ascites, varices). Livadox is contraindicated in these conditions.
• Start with 5 mg once daily for the first 3 months.
• If no adequate reduction in alkaline phosphatase (ALP) and bilirubin is observed and the drug is tolerated, increase to 10 mg once daily.
• Regularly monitor for response, safety, and disease progression, especially in patients with compensated cirrhosis, hepatic disease, or severe illnesses.
• Discontinue if signs of decompensation (e.g., portal hypertension) or liver failure appear.

For intolerable itching, consider:

• Adding antihistamines or bile acid-binding resins.
• Reducing the dose (e.g., to 5 mg every other day or once daily).
• Temporarily stopping treatment for up to 2 weeks, then restarting at a lower dose.
• Discontinuing if symptoms persist despite interventions.

✔️ Drug Interactions

• Bile Acid Binding Resins: These (e.g., cholestyramine) may reduce the absorption and efficacy of Livadox. Separate doses by at least 4 hours.
• Warfarin: Co-administration may lower INR. Monitor INR levels and adjust warfarin as needed.
• CYP1A2 Substrates: Livadox can increase exposure to drugs metabolized by CYP1A2 (e.g., theophylline). Monitor levels.
• BSEP Inhibitors: Avoid concurrent use with bile salt efflux pump (BSEP) inhibitors like cyclosporine, as they may worsen bile salt accumulation and cause liver symptoms.

✔️ Do not use Livadox in patients with:

• Decompensated cirrhosis (Child-Pugh Class B or C) or a history of decompensation.
• Compensated cirrhosis with portal hypertension (e.g., ascites, varices).
• Complete biliary obstruction.

✔️ Pregnancy & Lactation

Pregnancy: Limited human data is available. Animal studies show no fetal harm at doses up to 13 times the recommended human dose.
Lactation: It is unknown if obeticholic acid is excreted in human milk. Weigh the benefits of breastfeeding against potential risks to the infant.

✔️ Precautions & Warnings

1. Hepatic Decompensation and Failure:
   • Liver failure and decompensation (sometimes fatal) have occurred, particularly in cirrhotic patients (compensated or decompensated).
   • Monitor closely, as adverse reactions are dose-dependent.
2. Severe Itching:
   • Severe pruritus was reported in 23% of patients on a 10 mg dose. Management may require dosage adjustments or discontinuation.
3. HDL Reduction:
   • Dose-dependent reductions in HDL cholesterol levels have been observed. Monitor lipid levels regularly.

✔️ Storage

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