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Explore your possibilities with OCALIVA
Watch the video to see how OCALIVA® (obeticholic acid) works and why it may change what’s possible for your treatment of primary biliary cholangitis (PBC).
With OCALIVA, you can do more for your PBC.
Adding OCALIVA to your treatment plan may help lower your ALP level.
It works in a different way from ursodeoxycholic acid (UDCA), sometimes known as urso, which is currently the most common treatment for PBC.
OCALIVA is a pill you take once a day, with UDCA or alone, that may enhance your treatment of PBC.
For people who cannot tolerate UDCA, OCALIVA can be taken alone.
OCALIVA works in a unique way to reduce toxic bile acid buildup caused by PBC.

PBC damages the liver

PBC causes a person’s immune system to attack the bile ducts, creating damage and inflammation, which traps bile acids in the liver. This reduces or blocks the flow of bile, a condition called cholestasis.

ALP increases without adequate treatment

The continued buildup of bile acids can be toxic and lead to further damage of the bile ducts, which can cause scarring over time. If the scarring continues to worsen, it can result in cirrhosis, or even liver failure. Doctors can see evidence of cholestasis and bile duct damage through elevations in ALP.a

ALP increases without adequate treatment

The continued buildup of bile acids can be toxic and lead to further damage of the bile ducts, which can cause scarring over time. If the scarring continues to worsen, it can result in cirrhosis, or even liver failure. Doctors can see evidence of cholestasis and bile duct damage through elevations in ALP.a

Adding OCALIVA to your current treatment can help

OCALIVA works in a unique way to reduce the damaging buildup of bile acids in the liver, which results in lowered ALP levels. OCALIVA removes bile from the liver and prevents the creation of new bile acid.

 

aThe effectiveness of OCALIVA in these patients is based on a study that showed a reduction in the liver enzyme alkaline phosphatase (ALP). There is no clinical information currently available to show if patients treated with OCALIVA live longer or if their symptoms improve. There are ongoing studies to find out how OCALIVA works over a longer period of time.
Do you know why it’s important to track your ALP level with your doctor?

While UDCA lowers ALP in many people, a considerable percentage do not respond adequately to treatment and continue to have elevated ALP levels.

Your response to UDCA can be determined as early as 6 months after starting treatment.a

aIn a study of OCALIVA, all participants with PBC were taking UDCA for at least 12 months or were unable to tolerate UDCA and did not receive it for at least 3 months.
If you have elevated ALP levels while on UDCA or cannot tolerate its side effects, talk to your doctor or nurse about OCALIVA.
Start the conversation
Adding OCALIVA may positively affect key liver markers by lowering ALP and stabilizing bilirubin.
In studies, almost half of people who took OCALIVA for a year were considered "responders" to treatment.
In studies, almost half of people who took OCALIVA for a year were considered "responders" to treatment.
Most people in these studies took OCALIVA in combination with UDCA.
People were considered "responders" if they:

  • Had ALP levels less than 1.67-times the ULNa
  • Saw their ALP levels decrease by at least 15%
  • Kept their bilirubin levels within normal ranges

aMany markers of liver health such as ALP have a range of values that are considered normal. The top of that range is called the upper limit of normal (ULN).
Taking OCALIVA can lower your ALP level even further.
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Could your ALP level be even lower?
Decreases in ALP occurred in patients who maintained the same dosage throughout 12 months of OCALIVA treatment.

It may be time to talk to your doctor about optimizing your PBC treatment.
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What is OCALIVA® (obeticholic acid)?

OCALIVA (obeticholic acid) is a prescription medicine used for the treatment of primary biliary cholangitis (PBC) in adult patients. OCALIVA is taken in combination with another medicine called ursodeoxycholic acid (UDCA), or, for people who cannot tolerate UDCA, OCALIVA can be taken by itself.

The effectiveness of OCALIVA in these patients is based on a study that showed a reduction in the liver enzyme alkaline phosphatase (ALP). There is no clinical information currently available to show if patients treated with OCALIVA live longer or if their symptoms improve. There are ongoing studies to find out how OCALIVA works over a longer period of time.

Important Safety Information
Who should not take OCALIVA® (obeticholic acid)?

Do not take OCALIVA if you have been told by a healthcare provider that you have complete biliary obstruction. Report to your healthcare provider immediately if you develop symptoms of complete biliary obstruction.

What are the possible side effects of OCALIVA?

OCALIVA may cause serious side effects, including:

  • Liver-Related Adverse Reactions. Liver-related adverse reactions including jaundice (yellow pigmentation of skin and whites of the eyes), worsening ascites (accumulation of fluid in the stomach) and primary biliary cholangitis flare (sudden worsening of PBC symptoms) 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). Your healthcare provider may do blood tests periodically during your treatment with OCALIVA to check how well your liver is working. Report to your healthcare provider immediately if you develop any symptoms of worsening liver disease.
  • Severe Pruritus. Cases of severe pruritus have occurred in patients being treated with OCALIVA. Severe pruritus consists of intense or widespread itching, interfering with activities of daily living, or causing severe difficulty in staying asleep, or intolerable discomfort, and typically requiring medical interventions. Your healthcare provider may recommend taking bile acid resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing to help manage the symptoms of severe pruritus. Be sure to tell your healthcare provider if pruritus develops or worsens during treatment with OCALIVA.
  • Decreases in HDL-C Cholesterol. Decreases in HDL-C (good cholesterol) have been observed in patients taking OCALIVA. Your healthcare provider may check your lipid levels periodically during your treatment with OCALIVA.

The most common side effects of OCALIVA include: pruritus (severe itching of the skin), fatigue (feeling tired all over), stomach pain and discomfort, 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).

These are not all the possible side effects associated with OCALIVA. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

What should I tell my healthcare provider before taking OCALIVA?

Before taking OCALIVA, tell your healthcare provider about:

  • all of your medical conditions
  • all of the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins and herbal supplements. OCALIVA and other medicines may affect each other, so be sure to tell your healthcare provider if you start a new medicine.

OCALIVA may affect the way other medicines work, and other medicines may affect how OCALIVA works.

Especially tell your healthcare provider if you take:

  • Bile Acid Resins, such as cholestyramine, colestipol or colesevelam. Some medicines used to lower blood cholesterol levels, so-called bile acid resins may reduce the effectiveness of OCALIVA. If you take any of these medicines, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid resin, or at as great an interval as possible.
  • Warfarin. Your International Normalized Ratio (INR) (which measures how your blood clots) is decreased when warfarin is taken along with OCALIVA. Your physician may need to monitor your INR and/or adjust your dosage of warfarin to keep your INR in a target range while you are taking both warfarin and OCALIVA. Your healthcare provider may need to monitor the co-administration of OCALIVA and warfarin.
  • CYP1A2 Substrates with Narrow Therapeutic Index. Obeticholic acid, the active ingredient in OCALIVA, may increase the exposure to certain drugs that are CYP1A2 substrates, such as theophylline and tizanidine. Your healthcare provider may, as needed, monitor CYP1A2 Substrates with Narrow Therapeutic Index when they are taken along with OCALIVA.

Please see the full Prescribing Information for OCALIVA (obeticholic acid) 5mg and 10mg tablets.

To report negative side effects of OCALIVA, please contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or you may report to FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

What is OCALIVA® (obeticholic acid)?

OCALIVA (obeticholic acid) is a prescription medicine used for the treatment of primary biliary cholangitis (PBC) in adult patients. OCALIVA is taken in combination with another medicine called ursodeoxycholic acid (UDCA), or, for people who cannot tolerate UDCA, OCALIVA can be taken by itself. The effectiveness of OCALIVA in these patients is based on a study that showed a reduction in the liver enzyme alkaline phosphatase (ALP). There is no clinical information currently available to show if patients treated with OCALIVA live longer or if their symptoms improve. There are ongoing studies to find out how OCALIVA works over a longer period of time.

Important Safety Information

Who should not take OCALIVA?

Do not take OCALIVA if you have been told by a healthcare provider that you have complete biliary obstruction.

What is OCALIVA® (obeticholic acid)?

OCALIVA (obeticholic acid) is a prescription medicine used for the treatment of primary biliary cholangitis (PBC) in adult patients. OCALIVA is taken in combination with another medicine called ursodeoxycholic acid (UDCA), or, for people who cannot tolerate UDCA, OCALIVA can be taken by itself.

The effectiveness of OCALIVA in these patients is based on a study that showed a reduction in the liver enzyme alkaline phosphatase (ALP). There is no clinical information currently available to show if patients treated with OCALIVA live longer or if their symptoms improve. There are ongoing studies to find out how OCALIVA works over a longer period of time.

Important Safety Information
Who should not take OCALIVA® (obeticholic acid)?

Do not take OCALIVA if you have been told by a healthcare provider that you have complete biliary obstruction. Report to your healthcare provider immediately if you develop symptoms of complete biliary obstruction.

What are the possible side effects of OCALIVA?

OCALIVA may cause serious side effects, including:

  • Liver-Related Adverse Reactions. Liver-related adverse reactions including jaundice (yellow pigmentation of skin and whites of the eyes), worsening ascites (accumulation of fluid in the stomach) and primary biliary cholangitis flare (sudden worsening of PBC symptoms) 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). Your healthcare provider may do blood tests periodically during your treatment with OCALIVA to check how well your liver is working. Report to your healthcare provider immediately if you develop any symptoms of worsening liver disease.
  • Severe Pruritus. Cases of severe pruritus have occurred in patients being treated with OCALIVA. Severe pruritus consists of intense or widespread itching, interfering with activities of daily living, or causing severe difficulty in staying asleep, or intolerable discomfort, and typically requiring medical interventions. Your healthcare provider may recommend taking bile acid resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing to help manage the symptoms of severe pruritus. Be sure to tell your healthcare provider if pruritus develops or worsens during treatment with OCALIVA.
  • Decreases in HDL-C Cholesterol. Decreases in HDL-C (good cholesterol) have been observed in patients taking OCALIVA. Your healthcare provider may check your lipid levels periodically during your treatment with OCALIVA.

The most common side effects of OCALIVA include: pruritus (severe itching of the skin), fatigue (feeling tired all over), stomach pain and discomfort, 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).

These are not all the possible side effects associated with OCALIVA. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

What should I tell my healthcare provider before taking OCALIVA?

Before taking OCALIVA, tell your healthcare provider about:

  • all of your medical conditions
  • all of the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins and herbal supplements. OCALIVA and other medicines may affect each other, so be sure to tell your healthcare provider if you start a new medicine.

OCALIVA may affect the way other medicines work, and other medicines may affect how OCALIVA works.

Especially tell your healthcare provider if you take:

  • Bile Acid Resins, such as cholestyramine, colestipol or colesevelam. Some medicines used to lower blood cholesterol levels, so-called bile acid resins may reduce the effectiveness of OCALIVA. If you take any of these medicines, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid resin, or at as great an interval as possible.
  • Warfarin. Your International Normalized Ratio (INR) (which measures how your blood clots) is decreased when warfarin is taken along with OCALIVA. Your physician may need to monitor your INR and/or adjust your dosage of warfarin to keep your INR in a target range while you are taking both warfarin and OCALIVA. Your healthcare provider may need to monitor the co-administration of OCALIVA and warfarin.
  • CYP1A2 Substrates with Narrow Therapeutic Index. Obeticholic acid, the active ingredient in OCALIVA, may increase the exposure to certain drugs that are CYP1A2 substrates, such as theophylline and tizanidine. Your healthcare provider may, as needed, monitor CYP1A2 Substrates with Narrow Therapeutic Index when they are taken along with OCALIVA.

Please see the full Prescribing Information for OCALIVA (obeticholic acid) 5mg and 10mg tablets.

To report negative side effects of OCALIVA, please contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or you may report to FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

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What is OCALIVA® (obeticholic acid)?

OCALIVA (obeticholic acid) is a prescription medicine used for the treatment of primary biliary cholangitis (PBC) in adult patients. OCALIVA is taken in combination with another medicine called ursodeoxycholic acid (UDCA), or, for people who cannot tolerate UDCA, OCALIVA can be taken by itself.

The effectiveness of OCALIVA in these patients is based on a study that showed a reduction in the liver enzyme alkaline phosphatase (ALP). There is no clinical information currently available to show if patients treated with OCALIVA live longer or if their symptoms improve. There are ongoing studies to find out how OCALIVA works over a longer period of time.

Important Safety Information
Who should not take OCALIVA® (obeticholic acid)?

Do not take OCALIVA if you have been told by a healthcare provider that you have complete biliary obstruction. Report to your healthcare provider immediately if you develop symptoms of complete biliary obstruction.

What are the possible side effects of OCALIVA?

OCALIVA may cause serious side effects, including:

  • Liver-Related Adverse Reactions. Liver-related adverse reactions including jaundice (yellow pigmentation of skin and whites of the eyes), worsening ascites (accumulation of fluid in the stomach) and primary biliary cholangitis flare (sudden worsening of PBC symptoms) 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). Your healthcare provider may do blood tests periodically during your treatment with OCALIVA to check how well your liver is working. Report to your healthcare provider immediately if you develop any symptoms of worsening liver disease.
  • Severe Pruritus. Cases of severe pruritus have occurred in patients being treated with OCALIVA. Severe pruritus consists of intense or widespread itching, interfering with activities of daily living, or causing severe difficulty in staying asleep, or intolerable discomfort, and typically requiring medical interventions. Your healthcare provider may recommend taking bile acid resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing to help manage the symptoms of severe pruritus. Be sure to tell your healthcare provider if pruritus develops or worsens during treatment with OCALIVA.
  • Decreases in HDL-C Cholesterol. Decreases in HDL-C (good cholesterol) have been observed in patients taking OCALIVA. Your healthcare provider may check your lipid levels periodically during your treatment with OCALIVA.

The most common side effects of OCALIVA include: pruritus (severe itching of the skin), fatigue (feeling tired all over), stomach pain and discomfort, 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).

These are not all the possible side effects associated with OCALIVA. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

What should I tell my healthcare provider before taking OCALIVA?

Before taking OCALIVA, tell your healthcare provider about:

  • all of your medical conditions
  • all of the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins and herbal supplements. OCALIVA and other medicines may affect each other, so be sure to tell your healthcare provider if you start a new medicine.

OCALIVA may affect the way other medicines work, and other medicines may affect how OCALIVA works.

Especially tell your healthcare provider if you take:

  • Bile Acid Resins, such as cholestyramine, colestipol or colesevelam. Some medicines used to lower blood cholesterol levels, so-called bile acid resins may reduce the effectiveness of OCALIVA. If you take any of these medicines, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid resin, or at as great an interval as possible.
  • Warfarin. Your International Normalized Ratio (INR) (which measures how your blood clots) is decreased when warfarin is taken along with OCALIVA. Your physician may need to monitor your INR and/or adjust your dosage of warfarin to keep your INR in a target range while you are taking both warfarin and OCALIVA. Your healthcare provider may need to monitor the co-administration of OCALIVA and warfarin.
  • CYP1A2 Substrates with Narrow Therapeutic Index. Obeticholic acid, the active ingredient in OCALIVA, may increase the exposure to certain drugs that are CYP1A2 substrates, such as theophylline and tizanidine. Your healthcare provider may, as needed, monitor CYP1A2 Substrates with Narrow Therapeutic Index when they are taken along with OCALIVA.

Please see the full Prescribing Information for OCALIVA (obeticholic acid) 5mg and 10mg tablets.

To report negative side effects of OCALIVA, please contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or you may report to FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

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