Obeliva 5 (Obeticholic Acid) Tablets

Indicated for the treatment of Primary Biliary Cholangitis (PBC) in adults:

• 🔹 Combination Therapy: Used with Ursodeoxycholic Acid (UDCA) in adults with an inadequate response to UDCA.
• 🔹 Monotherapy: Used alone in adults unable to tolerate UDCA.

Packaging: 5 mg film-coated tablets.

⚠️ ADMINISTRATION PROTOCOL:

• Starting Dose: 5 mg orally once daily.
• Titration: Dosage may be increased to 10 mg once daily after 6 months if the patient has not achieved an adequate reduction in alkaline phosphatase (ALP) and is tolerating the drug well.
• Administration: Can be taken with or without food. Swallow whole.
• Monitoring: Regular liver function tests are required during treatment.

• Complete biliary obstruction.
• Decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event.
• Hypersensitivity to Obeticholic Acid.
• Pregnancy and breastfeeding (safety not fully established).

The most common side effect is dose-dependent pruritus (itching).

• ✋ Dermatologic: Severe pruritus, skin rash.
• 🌀 General: Fatigue.
• 🤢 Gastrointestinal: Abdominal pain and discomfort.
• ⚠️ Liver Safety: Patients should be monitored for signs of liver decompensation (e.g., jaundice, ascites).