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Livadox is prescribed for adult patients with primary biliary cholangitis (PBC) who:
- Do not have cirrhosis, or
- Have compensated cirrhosis without signs of portal hypertension.
It can be used:
- In combination with ursodeoxycholic acid (UDCA) for patients with an inadequate response to UDCA, or
- As a standalone treatment for patients unable to tolerate UDCA.
Note: Use only as advised by a registered physician.
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✅ Description:
Obeticholic acid, the active ingredient in Livadox, works as an agonist of the Farnesoid X Receptor (FXR), a nuclear receptor found in the liver and intestines. FXR regulates bile acid levels, inflammation, fibrosis, and metabolic pathways. Activation of FXR lowers bile acid levels in liver cells by reducing production and promoting bile acid excretion, thereby minimizing liver exposure to bile acids.
- In clinical trials, daily administration of 10 mg of obeticholic acid resulted in a 173% increase in FGF-19, an enterokine involved in bile acid balance, by the 12th month. Levels of cholic acid and chenodeoxycholic acid decreased by 2.7 µM and 1.4 µM, respectively.
- Obeticholic acid does not significantly prolong QT intervals, even at doses 10 times higher than the recommended maximum dose.
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✔️ 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
- 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.
- Severe Itching:
- Severe pruritus was reported in 23% of patients on a 10 mg dose. Management may require dosage adjustments or discontinuation.
- 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.
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