Generic name: Obeticholic Acid 5mg
Dosage form: tablet, film coated
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The recommended starting dosage of OCALIVA is 5 mg orally once daily in adult patients who have not achieved an adequate biochemical response to an appropriate dosage of UDCA for at least 1 year or are intolerant to UDCA [see Clinical Studies (14)].
If an adequate reduction in ALP and/or total bilirubin has not been achieved after 3 months of OCALIVA 5 mg once daily, and the patient is tolerating OCALIVA, increase the dosage of OCALIVA to 10 mg once daily [see Clinical Pharmacology (12.2), Clinical Studies (14)].
The maximum recommended dosage of OCALIVA is 10 mg once daily [see Warnings and Precautions (5.1)].
Management of Patients with Intolerable Pruritus on OCALIVA
For patients with intolerable pruritus on OCALIVA, consider one or more of the following:
- Add an antihistamine or bile acid binding resin [see Dosage and Administration (2.4), Clinical Studies (14)].
- Reduce the dosage of OCALIVA to:
- 5 mg every other day, for patients intolerant to 5 mg once daily.
- 5 mg once daily, for patients intolerant to 10 mg once daily.
- Temporarily interrupt OCALIVA dosing for up to 2 weeks followed by restarting at a reduced dosage.
Increase the dosage of OCALIVA to 10 mg once daily, as tolerated, to achieve optimal response.
Consider discontinuing OCALIVA treatment in patients who continue to experience persistent, intolerable pruritus.
Dosage Adjustment in Hepatic Impairment
Treatment with OCALIVA in patients with moderate and severe hepatic impairment should be initiated and monitored by a healthcare provider with experience managing PBC.
The recommended starting dosage of OCALIVA for moderate (Child-Pugh Class B) and severe (Child-Pugh Class C) hepatic impairment is 5 mg once weekly. If an adequate reduction in ALP and/or total bilirubin has not been achieved after 3 months of OCALIVA 5 mg once weekly, and the patient is tolerating the drug, increase the dosage of OCALIVA to 5 mg twice weekly (at least three days apart) and subsequently to 10 mg twice weekly (at least three days apart) depending on response and tolerability [see Use in Specific Populations (8.6)].
Monitor patients during treatment with OCALIVA for the occurrence of liver-related adverse reactions [see Warnings and Precautions (5.1)]. Weigh the potential risks against the benefits of continuing treatment with OCALIVA in patients who have experienced clinically significant liver-related adverse reactions.