RESOURCES and PATIENT PROFILES

Educate patients, promote adherence, and hear from real patients taking OCALIVA® (obeticholic acid).

RandyRandy
RandyFocused on Disease Progression
View Profile >
ElishaElisha
ELISHAA Different Approach to Treatment
View Profile >
WendyWendy
WENDYSupport Is Key
View Profile >
AnnAnn
ANNFinding a Treatment That Works
View Profile >
LeslieLeslie
LESLIETake Aim at PBC Progression
View Profile >
RosaliaRosalia
ROSALIAManaging Her Numbers and Managing Pruritus
View Profile >
« View All Profiles

Next: Elisha »

RANDY San Diego, californiaFocused on Disease progression

It weighs heavy on a person’s mind. I was only 50 years old at the time and wondered if a transplant was my only option. I totally worried about the progression of the disease.

The measurable results I’ve seen with OCALIVA have changed my outlook.

Randy’s Journey

2011

  • Diagnosed with PBC after his doctor noticed elevated ALP and bilirubin
  • Started taking UDCA
  • Found it difficult to move on with life: PBC was an “unknown” situation
2012

  • His doctor tried adjusting UDCA dosage to get numbers closer to normal, but it didn’t work
  • Worried a lot about disease progression leading to a liver transplant
  • Struggled to make lifestyle changes to improve his health
2016

  • Started taking OCALIVA and saw his numbers go down
  • Continued to see sustained results, with markers closer to normal
  • Thankful for having a specialist that cared about treating the disease

Select adverse reactions (≥5%) in the OCALIVA pivotal clinical trial included pruritus, fatigue, abdominal pain and discomfort, rash, arthralgia, and oropharyngeal pain.

Real patient diagnosed with PBC in 2011.

Individual results may vary.

These are actual PBC patients taking OCALIVA. They were compensated by Intercept for their participation. These statements reflect self-reported experience, and all treatment decisions were made under a physician’s care. These patients did not participate in the OCALIVA pivotal trial, and their experiences are not intended to represent data from an OCALIVA clinical trial.

ALP, alkaline phosphatase; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid.

Next: Wendy »« Previous: Randy

Elisha Manchester, MissouriA different approach
To treatment

UDCA was keeping my numbers in check, but the side effects affected my quality of life. My new doctor suggested the switch to OCALIVA.

The 5-mg dose of OCALIVA is keeping my numbers in check. So far, I haven’t needed to increase my dosage.

Elisha’s Journey

2012

  • Diagnosed with PBC; started on UDCA
  • Educated herself about PBC to overcome her fears
  • Fatigue kept her from spending time with friends or pursuing hobbies
2017

  • UDCA kept liver numbers in check, but began causing GI side effects
  • Tried for a year to manage side effects with dose adjustment
  • Became frustrated with lack of success and changed doctors
2018

  • New doctor switched her to OCALIVA monotherapy, starting at 5 mg daily
  • Concerns about pruritus made her hesitant to titrate up to 10 mg
  • Stayed on OCALIVA 5 mg daily. Her numbers were under control, and she did not experience any itching
  • Able to participate in life more while managing fatigue with naps

Select adverse reactions (≥5%) in the OCALIVA pivotal clinical trial included pruritus, fatigue, abdominal pain and discomfort, rash, arthralgia, and oropharyngeal pain.

Real patient diagnosed with PBC in 2012.

Individual results may vary.

These are actual PBC patients taking OCALIVA. They were compensated by Intercept for their participation. These statements reflect self-reported experience, and all treatment decisions were made under a physician’s care. These patients did not participate in the OCALIVA pivotal trial, and their experiences are not intended to represent data from an OCALIVA clinical trial.

GI, gastrointestinal; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid.

Next: Ann »« Previous: Elisha

Wendy Staatsburg, New YorkSupport Is Key

If I was talking to someone who had just been diagnosed with PBC, I’d tell them to breathe, it will be OK. Get the support you need … family and friends, the right doctor, and the right medication.

Now, I feel like I’m doing everything I can to keep my liver healthy and to keep my PBC stable.

Wendy’s Journey

2002

  • Diagnosed with Hashimoto’s disease* during her college years
2011

  • Diagnosed with PBC and autoimmune hepatitis* and started taking UDCA
  • Responded to UDCA but ALP remained elevated
  • She was scared about disease progression and found a hepatologist
    experienced in PBC
2016

  • Started OCALIVA soon after FDA approval
  • Titrated to the 10 mg dose, has experienced mild to moderate fatigue
2019

  • Family and friends continue to be a great support system
  • Likes getting the opportunity to support others diagnosed with PBC

*OCALIVA is not indicated for Hashimoto’s disease or autoimmune hepatitis.

Select adverse reactions (≥5%) in the OCALIVA pivotal clinical trial included pruritus, fatigue, abdominal pain and discomfort, rash, arthralgia, and oropharyngeal pain.

Real patient diagnosed with PBC in 2011.

Individual results may vary.

These are actual PBC patients taking OCALIVA. They were compensated by Intercept for their participation. These statements reflect self-reported experience, and all treatment decisions were made under a physician’s care. These patients did not participate in the OCALIVA pivotal trial, and their experiences are not intended to represent data from an OCALIVA clinical trial.

ALP, alkaline phosphatase; FDA, US Food & Drug Administration; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid.

Next: Leslie »« Previous: Wendy

Ann Missouri City, TexasFinding a treatment that works

My numbers were going up and I was concerned and felt I needed to do something different. I want to keep my alkaline phosphatase levels as low as possible.

After OCALIVA, my doctor told me my alkaline phosphatase was in the normal range for the first time in years. I was so relieved.

Ann’s Journey

2007

  • Elevated ALP, but no liver issues identified
2009

  • Diagnosed with PBC after gallbladder removed
  • Started on UDCA
  • Experienced debilitating chronic fatigue
2011

  • ALP levels were slowly rising
  • Changed to a liver specialist and found the PBC care she needed
2017

  • Started taking OCALIVA
  • ALP levels returned to normal for the first time in years
  • Continued working with her doctor to find ways to help manage PBC

Select adverse reactions (≥5%) in the OCALIVA pivotal clinical trial included pruritus, fatigue, abdominal pain and discomfort, rash, arthralgia, and oropharyngeal pain.

Real patient diagnosed with PBC in 2009.

Individual results may vary.

These are actual PBC patients taking OCALIVA. They were compensated by Intercept for their participation. These statements reflect self-reported experience, and all treatment decisions were made under a physician’s care. These patients did not participate in the OCALIVA pivotal trial, and their experiences are not intended to represent data from an OCALIVA clinical trial.

ALP, alkaline phosphatase; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid.

Next: Rosalia »« Previous: Ann

Leslie Houston, TexasTake aim AT pbc progression

After years on UDCA, my ALP had spiked again, and a biopsy confirmed PBC progression. I was in shock. How could I be doing everything I could to maintain my health, yet my liver disease was progressing?

That’s when my doctor suggested I start on OCALIVA, and he and I are pleased with the results.

Leslie’s Journey

2003

  • Routine blood test revealed high ALP levels; no health issues were identified
2007

  • Diagnosed with PBC and started UDCA
2010

  • Recommitted herself to a diet and exercise program and keeping a positive attitude
  • Worked with doctor to manage swollen joints and fatigue experienced while on UDCA
2017

  • ALP levels spiked. Biopsy confirmed her PBC had advanced from stage 1 to 3
  • Discussed OCALIVA and potential side effects with her doctor
  • Started OCALIVA; saw a further reduction in ALP levels
  • Attended PBC support group meetings

Select adverse reactions (≥5%) in the OCALIVA pivotal clinical trial included pruritus, fatigue, abdominal pain and discomfort, rash, arthralgia, and oropharyngeal pain.

Real patient diagnosed with PBC in 2007.

Individual results may vary.

These are actual PBC patients taking OCALIVA. They were compensated by Intercept for their participation. These statements reflect self-reported experience, and all treatment decisions were made under a physician’s care. These patients did not participate in the OCALIVA pivotal trial, and their experiences are not intended to represent data from an OCALIVA clinical trial.

ALP, alkaline phosphatase; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid.

« Previous: Leslie

Rosalia Glendale, ArizonaManaging her numbers And managing pruritus

My ALP numbers have been holding steady with OCALIVA. I titrated up to the 10-mg dose in 2016, but began experiencing severe pruritus. We discussed my options, and agreed I should go back to the 5-mg dose.

With OCALIVA, my doctor and I are doing everything in our power to help manage my PBC.

Rosalia’s Journey

2015

  • Routine lab tests showed elevated liver enzymes
  • Diagnosed with PBC; started on UDCA
  • Overwhelmed by stress, she quit her job to focus on treatment
  • Researched PBC extensively, learned about OCALIVA
  • Found a more experienced specialist
  • Made positive lifestyle changes with the help of a health diary
2016

  • Started OCALIVA within weeks of FDA approval, titrating to 10 mg daily
  • Experienced pruritus, sometimes severe
  • Titrated back down to OCALIVA 5 mg to manage pruritus
  • Continues on OCALIVA to keep ALP numbers closer to normal

Select adverse reactions (≥5%) in the OCALIVA pivotal clinical trial included pruritus, fatigue, abdominal pain and discomfort, rash, arthralgia, and oropharyngeal pain.

Real patient diagnosed with PBC in 2015.

Individual results may vary.

These are actual PBC patients taking OCALIVA. They were compensated by Intercept for their participation. These statements reflect self-reported experience, and all treatment decisions were made under a physician’s care. These patients did not participate in the OCALIVA pivotal trial, and their experiences are not intended to represent data from an OCALIVA clinical trial.

ALP, alkaline phosphatase; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid.

These are actual PBC patients taking OCALIVA. They were compensated by Intercept for their participation. These statements reflect self-reported experience, and all treatment decisions were made under a physician’s care. These patients did not participate in the OCALIVA pivotal trial, and their experiences are not intended to represent data from an OCALIVA clinical trial.

PBC, primary biliary cholangitis.

INDICATION AND IMPORTANT SAFETY INFORMATION

WARNING: HEPATIC DECOMPENSATION AND FAILURE IN INCORRECTLY DOSED PBC PATIENTS WITH CHILD-PUGH CLASS B OR C OR DECOMPENSATED CIRRHOSIS

  • In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with Primary Biliary Cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed more frequently than recommended.
  • The recommended starting dosage of OCALIVA is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event.

INDICATION

OCALIVA is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults 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 complete biliary obstruction.

Warnings and Precautions

Hepatic Decompensation and Failure in Incorrectly Dosed PBC Patients with Child-Pugh Class B or C or Decompensated Cirrhosis

In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with decompensated cirrhosis or Child-Pugh B or C hepatic impairment when OCALIVA was dosed more frequently than the recommended starting dosage of 5 mg once weekly. Reported cases typically occurred within 2 to 5 weeks after starting OCALIVA and were characterized by an acute increase in total bilirubin and/or ALP concentrations in association with clinical signs and symptoms of hepatic decompensation (e.g., ascites, jaundice, gastrointestinal bleeding, worsening of hepatic encephalopathy). Patients who died due to liver-related complications generally had decompensated cirrhosis prior to treatment and were started on OCALIVA 5 mg once daily, which is 7-fold greater than the once-weekly starting regimen in this population.

Routinely monitor patients for progression of PBC disease, including liver-related complications, with laboratory and clinical assessments. Dosage adjustment, interruption or discontinuation may be required. Close monitoring is recommended for patients at an increased risk of hepatic decompensation. Severe intercurrent illnesses that may worsen renal function or cause dehydration (e.g., gastroenteritis), may exacerbate the risk of hepatic decompensation. 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. Consider discontinuing OCALIVA in patients who have experienced clinically significant liver-related adverse reactions. Discontinue OCALIVA in patients who develop complete biliary obstruction.

Liver-Related Adverse Reactions

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

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 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 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 occurring in ≥5% of subjects taking OCALIVA were pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema.

Drug Interactions

Bile Acid Binding ResinsBile 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.

WarfarinThe 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 coadministering OCALIVA and warfarin.

CYP1A2 Substrates with Narrow Therapeutic IndexObeticholic acid, the active ingredient in OCALIVA, 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 coadministered with OCALIVA.

Inhibitors of Bile Salt Efflux PumpAvoid 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 see Full Prescribing Information, including Boxed WARNING for OCALIVA.

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.

INDICATION AND IMPORTANT SAFETY INFORMATION

WARNING: HEPATIC DECOMPENSATION AND FAILURE IN INCORRECTLY DOSED PBC PATIENTS WITH CHILD-PUGH CLASS B OR C OR DECOMPENSATED CIRRHOSIS

  • In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with Primary Biliary Cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed more frequently than recommended.
  • The recommended starting dosage of OCALIVA is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event.

INDICATION

OCALIVA is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults 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 complete biliary obstruction.

Warnings and Precautions

Hepatic Decompensation and Failure in Incorrectly Dosed PBC Patients with Child-Pugh Class B or C or Decompensated Cirrhosis

In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with decompensated cirrhosis or Child-Pugh B or C hepatic impairment when OCALIVA was dosed more frequently than the recommended starting dosage of 5 mg once weekly. Reported cases typically occurred within 2 to 5 weeks after starting OCALIVA and were characterized by an acute increase in total bilirubin and/or ALP concentrations in association with clinical signs and symptoms of hepatic decompensation (e.g., ascites, jaundice, gastrointestinal bleeding, worsening of hepatic encephalopathy). Patients who died due to liver-related complications generally had decompensated cirrhosis prior to treatment and were started on OCALIVA 5 mg once daily, which is 7-fold greater than the once-weekly starting regimen in this population.

Routinely monitor patients for progression of PBC disease, including liver-related complications, with laboratory and clinical assessments. Dosage adjustment, interruption or discontinuation may be required. Close monitoring is recommended for patients at an increased risk of hepatic decompensation. Severe intercurrent illnesses that may worsen renal function or cause dehydration (e.g., gastroenteritis), may exacerbate the risk of hepatic decompensation. 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. Consider discontinuing OCALIVA in patients who have experienced clinically significant liver-related adverse reactions. Discontinue OCALIVA in patients who develop complete biliary obstruction.

Liver-Related Adverse Reactions

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

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 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 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 occurring in ≥5% of subjects taking OCALIVA were pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema.

Drug Interactions

Bile Acid Binding ResinsBile 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.

WarfarinThe 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 coadministering OCALIVA and warfarin.

CYP1A2 Substrates with Narrow Therapeutic IndexObeticholic acid, the active ingredient in OCALIVA, 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 coadministered with OCALIVA.

Inhibitors of Bile Salt Efflux PumpAvoid 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 see Full Prescribing Information, including Boxed WARNING for OCALIVA.

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.