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Same active ingredient — pay up to 10% less
These brands contain the same active ingredient (Obeticholic Acid). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Liverty is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Important Dosage and Administration Instructions: Prior to the initiation of Obeticholic acid, healthcare providers should determine whether the patient has decompensated cirrhosis (e.g., Child-Pugh Class B or C) has had a prior decompensation event or has compensated cirrhosis with evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia) because Obeticholic acid is contraindicated in these patients.Recommended Dosage Regimen: The recommended dosage of Obeticholic acid for PBC patients without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, who have not achieved an adequate biochemical response to an appropriate dosage of UDCA for at least 1 year or are intolerant to UDCA follows below: Start with a dosage of 5 mg once daily for the first 3 months. After the first 3 months, for patients who have not achieved an adequate reduction in ALP and/or total bilirubin and who are tolerating Obeticholic acid increase to a maximum dosage of 10 mg once daily. Monitoring to Assess Safety, Need for Obeticholic acid Discontinuation: Routinely monitor patients during Obeticholic acid treatment for biochemical response, tolerability and progression of PBC. Closely monitor patients with compensated cirrhosis, concomitant hepatic disease (e.g., autoimmune hepatitis, alcoholic liver disease) and/or severe intercurrent illness for new evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia) or increases above the upper limit of normal in total bilirubin, direct bilirubin or prothrombin time. Permanently discontinue Obeticholic acid in patients who develop laboratory or clinical evidence of hepatic decompensation, have compensated cirrhosis and develop evidence of portal hypertension, experience clinically significant hepatic adverse reactions, or develop complete biliary obstruction.Management of Patients with Intolerable Pruritus on Obeticholic acid: For patients with intolerable pruritus on Obeticholic acid consider one or more of the following management strategies. Add an antihistamine or bile acid-binding resin. Reduce the dosage of Obeticholic acid 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 Obeticholic acid 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 and tolerability. Consider discontinuing Obeticholic acid treatment in patients who continue to experience persistent, intolerable pruritus despite management strategies.
Side Effects
The most common side effects of Liverty include: Pruritus, Fatigue & Stomach pain and discomfort. Other common side effects include rash, arthralgia (joint pain), oropharyngeal pain (pain in the middle part of the throat), dizziness, constipation, abnormal thyroid function, and eczema (inflammation of the skin).
Cautions & Contraindications
Warnings & Precautions
Hepatic Decompensation and Failure in PBC Patients with Cirrhosis: Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant have been reported with Liverty treatment in PBC patients with cirrhosis either compensated or decompensated. Among postmarketing cases reporting it, median time to hepatic decompensation (e.g., new onset ascites) was 4 months for patients with compensated cirrhosis; median time to a new decompensation event (e.g., hepatic encephalopathy) was 2.5 months for patients with decom- pensated cirrhosis. Some of these cases occurred in patients with decompensated cirrhosis when they were treated with higher than the recommended dosage for that patient population; however, case of hepatic decompensation and failure have continued to be reported in patients with decompensated cirrhosis even when they received the recommended dosage. Hepatotoxicity was observed in the Liverty clinical trials. A dose-response relationship was observed for the occurrence of hepatic adverse reactions including jaundice, worsening ascites and primary biliary cholangitis flare with dosages of Liverty of 10mg once daily to 50mg once daily (up to 5-times the highest recommended dosage) as early as one month after starting treatment with Liverty in two 3-month, placebo-controlled clinical trials in patients with primarily early stage PBC. In a pooled analysis of three placebo-controlled clinical trials in patients with primarily early-stage PBC the exposure-adjusted incidence rates for all serious and otherwise clinically significant hepatic adverse reactions and isolated elevations in liver biochemical tests per 100 patient exposure years (PEY) were: 5.2 in the Liverty 10mg group (highest recommended dosage) 19.8 in the Liverty 25mg group (2.5-times the highest recommended dosage) and 54.5 in the Liverty 50mg group (5-times the highest recommended dosage) compared to 2.4 in the placebo group.Severe Pruritus: Severe pruritus was reported in 23% of patients in the Liverty 10mg arm, 19% of patients in the Liverty titration arm and 7% of patients in the placebo arm in Trial 1, a 12-month double-blind randomized controlled clinical trial of 216 patients. Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living or causing severe sleep disturbance or intolerable discomfort and typically requiring medical interventions. In the subgroup of patients in the Liverty titration arm who increased their dosage from 5mg once daily to 10mg once daily after 6 months of treatment (n=33), the incidence of severe pruritus was 0% from months 0 to 6 and 15% from months 6 to 12. The median time to onset of severe pruritus was 11, 158 and 75 days for patients in the Liverty 10 mg, Liverty titration and placebo arms respectively. Consider clinical evaluation of patients with new onset or worsening severe pruritus. Management strategies include the addition of bile acid binding resins or antihistamines, Liverty dosage reduction and/or temporary interruption of Liverty dosing.Reduction in HDL-C: Patients with PBC generally exhibit hyperlipidemia characterized by a significant elevation in total cholesterol primarily due to increased levels of high-density lipoprotein-cholesterol (HDL-C). In Trial, dose-dependent reductions from baseline in mean HDL-C levels were observed at 2 weeks in Liverty-treated patients, 20% and 9% in the 10 mg and titration arms respectively, compared to 2% in the placebo arm. At Month 12, the reduction from baseline in mean HDL-C level was 19% in the Liverty 10 mg arm, 12% in the Liverty titration arm and 2% in the placebo arm. Nine patients in the Liverty 10mg arm, 6 patients in the Liverty titration arm versus 3 patients in the placebo arm had reductions in HDL-C to less than 40 mg/dL. Monitor patients for changes in serum lipid levels during treatment. For patients who do not respond to Liverty after 1 year at the highest recommended dosage that can be tolerated (maximum of 10 mg once daily) and who experience a reduction in HDL-C, weigh the potential risks against the benefits of continuing treatment.
Contraindications
Obeticholic acid is contraindicated in patients with: Decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event Compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia) Complete biliary obstruction