About Obeticholic Acid
Class: | Farnesoid X receptor (FXR) agonist
Use: | Obeticholic Acid (OCALIVA) is used for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
Adult dose: | The initial dose is 5 mg orally once daily. If adequate reduction in alkaline phosphatase and/or total bilirubin is not achieved after 3 months and the patient is tolerating the drug, the dose ca
Drug Class
Farnesoid X receptor (FXR) agonist
Uses & Indications
Obeticholic Acid (OCALIVA) is used for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
Storage Requirements
Store at room temperature, between 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F).
Manufacturer & Packaging
Manufacturer: Advanz Pharma Specialty Medicine Deutschland GmbH, Germany
Package Size
30's
Price & Supplier
Price in UAE: AED 12486.90
Dosage Information
Adult Dose
The initial dose is 5 mg orally once daily. If adequate reduction in alkaline phosphatase and/or total bilirubin is not achieved after 3 months and the patient is tolerating the drug, the dose can be increased to 10 mg once daily.
Pediatric Dose
Safety and efficacy in pediatric patients have not been established.
Side Effects
Common side effects include pruritus, fatigue, abdominal pain and discomfort, rash, arthralgia, oropharyngeal pain, and dizziness.
Contraindications & Precautions
Contraindicated in patients with complete biliary obstruction.
Important Warnings
Important safety warnings include the risk of liver-related adverse reactions, including hepatic decompensation and failure in patients with advanced cirrhosis. Monitor liver function tests and adjust dosing or discontinue use as necessary. Use caution in patients with moderate to severe hepatic impairment.
Medical Disclaimer
This information is for educational purposes only and should not replace professional medical advice.
Always consult with a licensed healthcare provider or pharmacist in the UAE before taking any medication.
The information presented here is specific to medicines available in UAE pharmacies and is regularly updated
to ensure accuracy for patients and healthcare professionals in the United Arab Emirates.