OCALIVA Titration Assessment

OCALIVA Treatment Algorithm1,2

a If an adequate reduction in alkaline phosphatase has not been achieved after 3 months, and the patient is tolerating the drug, increase to 10 mg once daily. In the clinical study, an adequate reduction in alkaline phosphatase is defined as achievement of the primary composite endpoint (percentage of subjects achieving alkaline phosphatase <1.67x ULN, total bilirubin ≤ ULN, and an alkaline phosphatase decrease of ≥15%).1

b Generally localized; causing no limitation of usual activities or minimal sleep disturbance; the patient may experience slight discomfort. Medicinal intervention is not indicated.2

cIntense or widespread; causing some limitation of usual activities or sleep disturbance; the patient may experience annoying discomfort. Medicinal intervention may be indicated.2

d Intense or widespread and interfering with activities of daily living or severe sleep disturbance; the patient may experience intolerable discomfort. Medicinal intervention is typically indicated.2

ePlease consult the OCALIVA Full Prescribing Information for the Management of Patients With Intolerable Pruritus Protocol.

PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.

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References:

  1. OCALIVA [package insert]. New York, NY: Intercept Pharmaceuticals, Inc.; 2017.
  2. Data on file: GL-PB-MED-00068.
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