OCALIVA Safety and Tolerability Profile
Studied in a Total of 432 Patients With PBC in 3 Placebo-Controlled Trials1
Most Common Adverse Reactions (N=216)1,a,b
|Adverse Reactions||OCALIVA + UDCA||Placebo
+ UDCA Group
|10 mg Group
a 16 patients (7%) who were intolerant did not receive concomitant UDCA: 6 patients (8%) in the OCALIVA 10 mg arm, 5 patients (7%) in the OCALIVA 5→10 mg titration arm, and 5 patients (7%) in the placebo arm.
b Occurring in ≥5% of patients in either OCALIVA treatment arm and at an incidence ≥1% higher than in the placebo treatment arm.
cPatients randomized to OCALIVA titration received OCALIVA 5 mg for the initial 6-month period. At Month 6, patients who did not achieve the composite endpoint and did not have evidence of tolerability issues were titrated from 5 mg to 10 mg for the final 6 months of the trial.
dIncludes skin eruptions, prurigo, pruritus, pruritus generalized, eye pruritus, ear pruritus, anal pruritus, vulvovaginal pruritus, and rash pruritic.
e Includes fatigue, tiredness, and asthenia.
fIncludes abdominal pain upper, abdominal pain, abdominal discomfort, abdominal pain lower, abdominal tenderness, and gastrointestinal pain.
gIncludes urticaria, rash, rash macular, rash papular, rash maculo-papular, heat rash, and urticaria cholinergic.
hIncludes dizziness, syncope, and presyncope.
iIncludes thyroxine free decreased, blood thyroid stimulating hormone increased, and hypothyroidism.
- Pruritus is a common symptom associated with PBC2
- Approximately 60% of the patients in the trial had a baseline
history of pruritus1
- Treatment-emergent pruritus generally started within the first month following the initiation of treatment with OCALIVA1
- Relative to patients who started on 10 mg once daily in the OCALIVA 10 mg group, patients in the OCALIVA 5→10 mg titration group had a lower discontinuation rate due to pruritus (10% vs 1%, respectively)1
- Placebo + UDCA: 4%1
- OCALIVA 5→10 mg titration + UDCA: 10%1
- OCALIVA 10 mg + UDCA: 12%1
- 97% of patients who completed the
12-month trial chose to continue in the
long-term extension study3
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Learn the Dosing Schedule for OCALIVA
The recommended starting dose of OCALIVA is 5 mg, up-titrating to 10 mg after 3 months, if tolerated.1
Liver-Related Adverse Reactions1
- Dose-related, liver-related adverse reactions including jaundice, worsening ascites and primary biliary cholangitis flare have been observed in clinical trials, as early as one month after starting treatment with OCALIVA 10 mg once daily up to 50 mg once daily (up to 5-times the highest recommended dosage)
- Monitor patients during treatment with OCALIVA for elevations in liver biochemical tests and for the development of liver-related adverse reactions
- 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 a subgroup of patients in the titration group who increased their dose from 5 mg to 10 mg (n=33), the incidence of severe pruritus was 15% from Months 6 to 12
- Severe pruritus was reported in 23% of patients in the OCALIVA 10 mg group, 19% of patients in the OCALIVA 5→10 mg titration group, and in 7% of patients in the placebo group
- Consider clinical evaluation of patients with new onset or worsening severe pruritus. Management strategies include the addition of bile acid resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing. Doses should be adjusted according to Child-Pugh classification. Consider discontinuing OCALIVA in patients who continue to experience persistent, intolerable pruritus despite management strategies
Reduction in HDL‑C1
- 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)
- Dose-dependent reductions from baseline in mean HDL‑C levels were observed at 2 weeks in OCALIVA-treated patients, 20% and 9% in the 10 mg and titration groups, respectively, compared to 2% in the placebo group
- At Month 12, the reduction from baseline in mean HDL‑C level was observed to be 19% in the OCALIVA 10 mg group, 12% in the OCALIVA titration group, and 2% in the placebo group
- Monitor patients for changes in serum lipid levels during treatment. For patients who do not respond to OCALIVA 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
PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid.
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- OCALIVA [package insert]. New York, NY: Intercept Pharmaceuticals, Inc.; 2018.
- Carey EJ, Ali AH, Lindor KD. Primary biliary cirrhosis. Lancet. 2015;386(10003):1565-1575.
- Nevens F, Andreone P, Mazzella G, et al; for the POISE Study Group. A placebo-controlled trial of obeticholic acid in primary biliary cholangitis. N Engl J Med. 2016;375(7):631-643.