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Ocaliva Dosage

Generic name: Obeticholic Acid 5mg
Dosage form: tablet, film coated

Medically reviewed on March 2, 2018.

Important Dosage and Administration Instructions

Table 1: Child-Pugh Nomogram
Parameter Points Scored for Observed Findings
1 point 2 points 3 points
Encephalopathy grade None 1 or 2 3 or 4
Ascites Absent Slight Moderate
Serum bilirubin (mg/dL) < 2 2 to 3 > 3
Serum albumin (g/dL) > 3.5 2.8 to 3.5 < 2.8
International Normalized Ratio (INR) < 1.7 1.7 to 2.3 > 2.3
Child-Pugh Class is obtained by adding the points from all 5 parameters to derive a total score, which can range from 5 to 15 points.
Child-Pugh Class A: 5 to 6 points
Child-Pugh Class B: 7 to 9 points
Child-Pugh Class C: 10 to 15 points
  • Routinely monitor patients during OCALIVA treatment for biochemical response, tolerability, progression of PBC disease, and re-evaluate Child-Pugh classification to determine if dosage adjustment is needed.
  • Reduce the dosing frequency from once daily to once weekly as appropriate for patients who progress to advanced disease (i.e., from Child-Pugh Class A to Child-Pugh Class B or C) [see Dosage and Administration (2.2)].

Recommended Dosage Regimen

The recommended starting dose and titration dosage regimen of OCALIVA for 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)] is dependent upon disease stage, as shown in Table 2:

  • Non-cirrhotic patients or compensated cirrhotic patients with no or mild hepatic impairment (Child-Pugh Class A) are dosed once daily.
  • Cirrhotic patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) or patients who have previously experienced a decompensation event are dosed initially once weekly and not more than twice weekly.
Table 2: Dosage Regimen by Disease Stage
Staging / Classification Non-Cirrhotic or Compensated Child-Pugh Class A Child-Pugh Class B or C or Patients with a Prior Decompensation Eventa
Starting OCALIVA Dosage for first 3 months 5 mg once daily 5 mg once weekly
OCALIVA Dosage Titration after first 3 months, for patients who have not achieved an adequate reduction in ALP and/or total bilirubin and who are tolerating OCALIVAb 10 mg once daily [see Clinical Pharmacology (12.2), Clinical Studies (14)] 5 mg twice weekly (at least 3 days apart)

Titrate to 10 mg twice weekly (at least 3 days apart) based on response and tolerability [see Use in Specific Populations (8.6)]
Maximum OCALIVA Dosage 10 mg once daily 10 mg twice weekly (at least 3 days apart)
aGastroesophageal variceal bleeding, new or worsening jaundice, spontaneous bacterial peritonitis, etc.
bPrior to dosage adjustment, re-calculate the Child-Pugh classification [see Dosage and Administration (2.1)].

Monitoring to Assess Safety, Treatment Interruption or Discontinuation

Routinely monitor patients during OCALIVA treatment for progression of PBC disease with laboratory and clinical assessments to determine whether dosage adjustment is needed. Reduce the dosing frequency for patients who progress from Child-Pugh Class A to Child-Pugh Class B or C (see Table 2 above). Close monitoring is recommended for patients at an increased risk of hepatic decompensation, including those with laboratory evidence of worsening liver function (i.e., total bilirubin, INR, albumin) and/or progression to cirrhosis [see Warnings and Precautions (5.1)].

Interrupt treatment with OCALIVA in patients with laboratory or clinical evidence of worsening liver function indicating risk of decompensation, and monitor the patient's liver function.

If the patient's condition returns to baseline, weigh the potential risks and benefits of restarting OCALIVA treatment. If OCALIVA is re-initiated, use the recommended starting dosage with adjustment for Child-Pugh classification [see Dosage and Administration (2.2)].

Consider discontinuing OCALIVA in patients who have experienced clinically significant liver-related adverse reactions.

Management of Patients with Intolerable Pruritus on OCALIVA

For patients with intolerable pruritus on OCALIVA, consider one or more of the following management strategies:

For Non-Cirrhotic or Compensated Cirrhotic Child-Pugh Class A Patients:

  • Add an antihistamine or bile acid binding resin [see Dosage and Administration (2.5), 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. Restart at a reduced dosage.

    For patients whose dosage is reduced or interrupted, titrate the dosage based on biochemical response, tolerability and adjust according to Child-Pugh classification [see Dosage and Administration (2.2)].

For Child-Pugh Class B or C or Patients with a Prior Decompensation Event:

Treatment Discontinuation

Consider discontinuing OCALIVA treatment in patients who continue to experience persistent, intolerable pruritus despite management strategies [see Warnings and Precautions (5.3)].

Administration Instructions

  • Take OCALIVA with or without food.
  • For patients taking a bile acid binding resin, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid binding resin, or at as great an interval as possible [see Drug Interactions (7.1), Clinical Studies (14)].

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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