Prescribing Information

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At Interconnect®, we provide the very best in personalized treatment support.

Interconnect provides comprehensive support to help you manage your primary biliary cholangitis (PBC) with OCALIVA® (obeticholic acid). From financial assistance to personalized support and education, we’re here to help every step of the way.

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. Report to your healthcare provider immediately if you develop symptoms of complete biliary obstruction.

Expand
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.