This site is intended for US healthcare professionals only

For adults with primary biliary cholangitis (PBC)1

For adults with primary biliary cholangitis (PBC)1

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PROACTIVE MANAGEMENT OF PRURITUS & FATIGUE

Pruritus: Proactive lifestyle modifications for patients

Pruritus affects over 80% of patients with PBC.2 Patients can incorporate the following suggestions into their daily routine to help manage pruritus and, if done proactively, these may even help avoid issues:

Sleep

Practice good sleep habits. Pruritus can cause sleep deprivation.3 Patients also report that itching can become worse at night.4 Practicing good sleep habits and strategies can help improve sleep duration and quality.5

  • Play “white noise” in the bedroom5
  • Use aromatherapy and massage5
  • Maintain a cooler room temperature at night2
  • Consider wearing gloves to bed6

OTC Treatments

  • Apply topical corticosteroids, such as hydrocortisone2
  • Add an antihistamine1

Hygiene

  • Take cool showers7
  • Apply a daily moisturizer, such as Eucerin®2,7
  • Keep fingernails trimmed2,3
  • Switch to mild or clear/unscented soaps and laundry detergents7

General

  • Stay hydrated by drinking enough water6
  • Wear loose-fitting clothes7
  • Engage in relaxation techniques, such
    as meditation or aromatherapy2,5,7
  • Use cold packs or fabric strips soaked in cold water2,7

Avoiding the following can help manage itching:

  • Hot and spicy foods2
  • Contact with allergenic and irritant substances (eg, fragrances)2
  • Activities and situations that contribute to dry skin (eg, saunas, dry climate)2
  • Overexcitement and stress2
  • Clothing made from materials that can irritate the skin (eg, wool)7
  • Smoking tobacco7

Keeping treatment goals top of mind is an important reminder for patients when discussing a pruritus management plan.

Pruritus management kit for your patients taking OCALIVA

Pruritus management kit

This evidence-based kit gets ahead of pruritus management for your patients starting their OCALIVA journey. It contains, but is not limited to, samples to soothe itching, such as Biofreeze® gel, moisturizing cream, an oatmeal bath packet, and hydrocortisone ointment.

Talk to your Intercept representative about a helpful pruritus resource kit for your patients.

Monitor patients for treatment success on OCALIVA7

Monitoring schedule
START
OF TREATMENT

INITIATE OCALIVA at 5 mg once daily1

MANAGE patient expectations regarding the possibility of pruritus and time to treatment response (ie, some patients may see reductions in ALP as early as the first 2 weeks)1

IMPLEMENT proactive pruritus management and patient lifestyle modifications

DISTRIBUTE Intercept Pruritus Management Kita

2
WEEKS

CALL patient and assess for pruritus (may present within first month of treatment with OCALIVA)1

REMIND patients of the importance of staying on OCALIVA

REINFORCE proactive pruritus management and patient lifestyle modifications

1
MONTH

EVALUATE for pruritus and other side effects and review management strategies7,b

CONTINUE TO ENCOURAGE adherence to OCALIVA7

3
MONTHS

EVALUATE pruritus and other side effects to determine if the patient is appropriate for up-titration to 10 mg1,7,b

3-6
MONTHS

PERFORM liver monitoring every 3 to 6 months8

CONTINUE monitoring for pruritus and other side effects7

aThe Living with PBC Pruritus Sample Kit is available in the US only and is not provided outside of the US.

bAfter the first 3 months, for patients who have not achieved an adequate reduction in ALP and/or total bilirubin and who are tolerating OCALIVA, increase to maximum of 10 mg once daily.1

Helping patients reach their treatment goals

In order for patients to achieve their treatment goals, adherence is critical. If lifestyle modifications alone aren’t sufficiently managing your patient’s pruritus, consider adjusting the OCALIVA dosage and re-evaluating as needed.1,7

OCALIVA titration schedule for patients with pruritus1,7,a

IF AT 5 MG ONCE DAILY IF AT 10 MG ONCE DAILY
None or Mild Up-titrate to 10 mgb once daily after the first 3 months Stay at 10 mg
Moderate Stay at 5 mgc Stay at 10 mg
OR
Down-titrate per clinical judgmentc
Severe Reduce to 5 mgc every other day
OR
Temporarily pause treatment up to 2 weeks,d then restart at a reduced dosage 		Reduce to 5 mg once dailyc

Adapted from Pate J, et al. BMJ Open Gastroenterol. 2019.

  • Add an antihistamine or bile acid binding resin1
  • Consider discontinuing OCALIVA treatment in patients who continue to experience persistent, intolerable pruritus despite management strategies1

aPruritus severity can be assessed using objective measurement tools, such as the Visual Analogue Scale (VAS), 5-D Itch Scale, PBC-40 tool, or PBC-27 tool.7

bAfter the first 3 months, for patients who have not achieved an adequate reduction in ALP and/or total bilirubin and who are tolerating OCALIVA, increase to maximum of 10 mg once daily.1

cBased on clinical judgment and patient feedback, which may include factors other than pruritus severity and should reflect patient choice and comfort.7

dIf treatment is paused for 2 weeks, restart at 5 mg every other day, then gradually up-titrate to 5 mg daily and, if tolerated, to 10 mg daily.7

Facilitating adherence for patients new to OCALIVA

  • Remind patients to focus on the long-term treatment goal
  • Encourage patients to download the PBC Living® app to help track symptoms and progress
  • Share lifestyle tips to help patients manage pruritus
  • Encourage patients to access patient support through Interconnect®

Fatigue: considerations and management techniques

Fatigue is reported in up to 78% of patients with PBC and, when severe, can cause a significant impairment in quality of life.9

Like pruritus, there are a range of techniques your patients can employ to manage fatigue. Some things for patients to keep in mind:

House icon

Avoid social isolation, which can exacerbate fatigue10

Barbell icon

Structured exercise may be beneficial (when initiated at tolerable levels)10

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A support group or patient awareness group can help to manage chronic symptoms like fatigue10,11

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In cases where another related sleep disorder exists, prescription therapies may be beneficial10,11

ALP, alkaline phosphatase; OTC, over-the-counter; PBC, primary biliary cholangitis.

References

  1. OCALIVA full prescribing information. Morristown, NJ: Intercept Pharmaceuticals, Inc; 2022.
  2. Weisshaar E, Szepietowski JC, Dalgard FJ, et al. European S2k Guideline on chronic pruritus. Acta Derm Venereol. 2019;99(5):469-506. doi:10.2340/00015555-3164
  3. Düll MM, Kremer AE. Newer approaches to the management of pruritus in cholestatic liver disease. Curr Hepatology Rep. 2020;19:86-95. doi:10.1007/s11901-020-00517-x
  4. Rishe E, Azarm A, Bergasa NV. Itch in primary biliary cirrhosis: a patients' perspective. Acta Derm Venereol. 2008;88(1):34-37.
  5. Albakri U, Drotos E, Meertens R. Sleep health promotion interventions and their effectiveness: an umbrella review. Int J Environ Res Public Health. 2021;18(11):1-39.
  6. Pullen R. A clinical review of primary biliary cholangitis. Gastroenterol Nurs. 2020;43(2):E48-E55. doi:10.1097/SGA.0000000000000480
  7. Pate J, Gutierrez JA, Frenette CT, et al. Practical strategies for pruritus management in the obeticholic acid-treated patient with PBC: proceedings from the 2018 expert panel. BMJ Open Gastroenterol. 2019;6(1):e000256. doi:10.1136/bmjgast-2018-000256
  8. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019;69(1):394-419. doi:10.1002/hep.30145
  9. Levy C, Manns M, Hirschfield G. New treatment paradigms in primary biliary cholangitis. Clin Gastro Hepatol. 2023;21:2076-2087. doi:10.1016/j.cgh.2023.02.005
  10. European Association for the Study of the Liver. EASL clinical practice guidelines: the diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017;67(1):145-172. doi:1016/j.jhep.2017.03.022
  11. Khanna A, Leighton J, Wong LL, Jones DE. Symptoms of PBC—pathophysiology and management. Best Pract Res Clin Gastroenterol. 2018:41-47. doi:10.1016/j.bpg.2018.06.007

INDICATION AND IMPORTANT SAFETY INFORMATION

WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY CHOLANGITIS PATIENTS WITH CIRRHOSIS

  • Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in primary biliary cholangitis (PBC) patients with either compensated or decompensated cirrhosis.
  • OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension.
  • Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension; or experience clinically significant hepatic adverse reactions while on treatment.

INDICATION

OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)

  • without cirrhosis or
  • with compensated cirrhosis who do not have evidence of portal hypertension,

either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.

This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Contraindications

OCALIVA 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.

Warnings and 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 OCALIVA 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 decompensated 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, cases 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 OCALIVA 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 OCALIVA of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with OCALIVA in two 3-month, placebo-controlled clinical trials in patients with primarily early stage PBC.

Routinely monitor patients for progression of PBC, including hepatic adverse reactions, with laboratory and clinical assessments to determine whether drug discontinuation is needed. Closely monitor patients with compensated cirrhosis, concomitant hepatic disease (e.g., autoimmune hepatitis, alcoholic liver disease), and/or with 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 to determine whether drug discontinuation is needed. Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation (e.g., ascites, jaundice, variceal bleeding, hepatic encephalopathy), have compensated cirrhosis and develop evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), experience clinically significant hepatic adverse reactions, or develop complete biliary obstruction. If severe intercurrent illness occurs, interrupt treatment with OCALIVA and monitor the patient’s liver function. After resolution of the intercurrent illness, consider the potential risks and benefits of restarting OCALIVA treatment.

Severe Pruritus

Severe pruritus was reported in 23% of patients in the OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arm in 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. Consider clinical evaluation of patients with new onset or worsening severe pruritus. 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-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). 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 arms, respectively, compared to 2% in the placebo arm. 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.

Adverse Reactions

The most common adverse reactions (≥5%) are: pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema.

Drug Interactions

  • Bile Acid Binding Resins
    Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the absorption, systemic exposure, and efficacy of OCALIVA. If 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.
  • Warfarin
    The International Normalized Ratio (INR) decreased following coadministration of warfarin and OCALIVA. Monitor INR and adjust the dose of warfarin, as needed, to maintain the target INR range when co-administering OCALIVA and warfarin.
  • CYP1A2 Substrates with Narrow Therapeutic Index
    Obeticholic acid may increase the exposure to concomitant drugs that are CYP1A2 substrates. Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index (e.g., theophylline and tizanidine) is recommended when co-administered with OCALIVA.
  • Inhibitors of Bile Salt Efflux Pump
    Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Concomitant medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate accumulation of conjugated bile salts including taurine conjugate of obeticholic acid in the liver and result in clinical symptoms. If concomitant use is deemed necessary, monitor serum transaminases and bilirubin.

Please click here for Full Prescribing Information, including Boxed WARNING.

To report SUSPECTED ADVERSE REACTIONS, contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

If you have questions or would like more information about OCALIVA, contact Intercept Medical Information.