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
(n=73)
10 mg Group
(n=73)
5→10 mg
Titration Groupc
(n=70)
Pruritusd 70% 56% 38%
Fatiguee 25% 19% 15%
Abdominal pain
and discomfortf
10% 19% 14%
Rashg 10% 7% 8%
Arthralgia 10% 6% 4%
Oropharyngeal
pain
8% 7% 1%
Dizzinessh 7% 7% 5%
Constipation 7% 7% 5%
Peripheral edema 7% 3% 3%
Palpitations 7% 3% 1%
Pyrexia 7% 0% 1%
Thyroid function
abnormalityi
4% 6% 3%
Eczema 3% 6% 0%

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

  • 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

Discontinuation Rates

  • 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

See the Complete Dosing Information

Liver-Related Adverse Reactions1

  • In two 3-month, placebo-controlled clinical trials, a dose-response relationship was observed for the occurrence of liver-related adverse reactions, including jaundice, worsening ascites, and primary biliary cholangitis flare with dosages of OCALIVA of 10 mg once daily to 50 mg once daily (up to 5 times the highest recommended dosage), as early as 1 month after starting treatment with OCALIVA
  • In a pooled analysis of 3 placebo-controlled trials in patients with PBC, the exposure-adjusted incidence rates for all serious and otherwise clinically significant liver-related adverse reactions, and isolated elevations in liver biochemical tests, per 100 patient-exposure-years were: 5.2 in the OCALIVA 10 mg group (highest recommended dosage), 19.8 in the OCALIVA 25 mg group (2.5 times the highest recommended dosage), and 54.5 in the OCALIVA 50 mg group (5 times the highest recommended dosage) compared to 2.4 in the placebo group
  • Monitor patients during treatment with OCALIVA for elevations in liver biochemical tests and for the development of liver-related adverse reactions. Weigh the potential risks against the benefits of continuing treatment with OCALIVA in patients who have experienced clinically significant liver-related adverse reactions. Discontinue OCALIVA in patients who develop complete biliary obstruction

Severe Pruritus1

  • Severe pruritus was defined as intense or widespread itching interfering with activities of daily living, causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical intervention
    • In a subgroup of patients in the OCALIVA 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
  • Management strategies include the addition of bile acid binding resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing

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, 9% 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.

OCALIVA obeticholic acid OCALIVA obeticholic acid

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References:

  1. OCALIVA [package insert]. New York, NY: Intercept Pharmaceuticals, Inc.; 2017.
  2. Carey EJ, Ali AH, Lindor KD. Primary biliary cirrhosis. Lancet. 2015;386(10003):1565-1575.
  3. 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.
OCALICA obeticholic acid

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