Obeliva (Obeticholic Acid) Tablets
Obeliva 5 mg (Obeticholic Acid) is a potent farnesoid X receptor (FXR) agonist indicated for the treatment of Primary Biliary Cholangitis (PBC).
Manufacturer: Everest Pharmaceuticals. Each pack contains 30 tablets. The drug works by decreasing the production of bile in the liver, thereby reducing the toxic accumulation of bile acids that damage liver cells.
Key Benefit:
It acts as a second-line therapy for patients who do not respond adequately to standard treatments, helping to slow disease progression and improve liver biochemistry.
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).
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