WARNING

Obeticholic acid is a medication used to treat certain liver conditions, such as primary biliary cholangitis (PBC). While it can be effective in managing these conditions, it also carries some potential risks and side effects. Here are some of the risks associated with taking Obeticholic acid:

• Worsening Liver Function: In some cases, Obeticholic acid can cause an increase in liver enzyme levels and lead to liver problems. Regular monitoring of liver function is necessary during treatment.
• Pruritus (Itching): One of the most common side effects of Obeticholic acid is itching, which can be mild to severe. It may require additional medications or measures to manage this symptom.
• Fatigue: Fatigue or tiredness is another frequently reported side effect of Obeticholic acid. It can range from mild to severe and may affect daily activities.
• Gastrointestinal Symptoms: Some people experience abdominal pain, nausea, vomiting, diarrhea, or indigestion while taking this medication. These symptoms can be temporary or persistent.
• Weight Loss: Obeticholic acid may cause unintentional weight loss in some individuals. This weight loss can be significant, and it is important to monitor it during treatment.
• Increased LDL Cholesterol Levels: Obeticholic acid can raise low-density lipoprotein (LDL) cholesterol levels in the blood. Regular monitoring and management of cholesterol levels are necessary, especially in individuals with pre-existing heart disease or high cholesterol.
• Interactions with Other Medications: Obeticholic acid can interact with certain medications, such as cyclosporine or bile acid sequestrants. It is essential to inform your healthcare provider about all the medications you are taking to prevent potential interactions.
• Pregnancy and Breastfeeding: Obeticholic acid may cause harm to a developing fetus or newborn, so it is generally not recommended during pregnancy or breastfeeding. Women of childbearing age should use effective contraception while taking this medication.

It’s important to note that these risks vary from person to person, and not everyone will experience them. It’s crucial to discuss the potential risks and benefits of Obeticholic acid with a healthcare professional before starting or adjusting the treatment. They can provide personalized advice and closely monitor your progress to minimize the risks associated with this medication.

Why is this medication prescribed?

Obeticholic acid is prescribed for the treatment of a liver condition called primary biliary cholangitis (PBC). PBC is a chronic autoimmune disease that affects the bile ducts in the liver, leading to inflammation, damage, and eventually, the destruction of these ducts. Obeticholic acid is the first-line therapy for PBC and is used to slow down the progression of the disease.

Here are the main reasons why Obeticholic acid is prescribed for PBC:

• Slows Disease Progression: Obeticholic acid helps slow down the progression of primary biliary cholangitis by reducing liver inflammation and improving liver function. It can help preserve the remaining healthy bile ducts and delay the need for a liver transplant.
• Alleviates Symptoms: Obeticholic acid can help alleviate symptoms associated with PBC, such as fatigue, itching (pruritus), and jaundice. By improving liver function, it may reduce the burden of these symptoms on patients’ daily lives.
• Improves Liver Enzyme Levels: PBC often leads to elevated levels of liver enzymes in the blood, indicating liver damage. Obeticholic acid can help normalize these enzyme levels, indicating improved liver health.
• Potential Fibrosis Improvement: PBC can lead to the development of liver fibrosis, which is the accumulation of scar tissue in the liver. Obeticholic acid has shown potential in reducing liver fibrosis in some patients, although further research is needed to fully understand its long-term effects.

It’s important to note that Obeticholic acid is a prescription medication, and its use should be determined by a healthcare professional who can evaluate the individual’s specific condition, medical history, and other factors.

How should this medicine be used?

Obeticholic acid should be used exactly as prescribed by a healthcare professional. It is typically taken orally in the form of tablets. Here are some general guidelines for using Obeticholic acid:

• Dosage: The dosage of Obeticholic acid will be determined by your healthcare provider based on your specific condition and individual factors. It is important to follow the prescribed dosage and not exceed or skip any doses without consulting your doctor.
• Timing: Obeticholic acid is usually taken once daily, with or without food. It is important to take it at the same time each day to maintain a consistent level of the medication in your body.
• Swallowing: Take the tablet(s) with a glass of water. Do not crush, chew, or break the tablets unless your doctor advises you to do so.
• Compliance: It is important to take Obeticholic acid regularly and as prescribed by your doctor, even if you start feeling better. Stopping the medication abruptly or missing doses may affect its effectiveness.
• Follow-up and Monitoring: Regular follow-up appointments with your healthcare provider are crucial while taking Obeticholic acid. They will monitor your liver function, assess the medication’s effectiveness, and manage any potential side effects or complications.
• Interactions with Other Medications: Inform your doctor about all the medications, supplements, or herbal products you are currently taking. Obeticholic acid can interact with certain medications, so it’s important to discuss potential interactions with your healthcare provider to avoid any complications.
• Pregnancy and Breastfeeding: Obeticholic acid is not recommended during pregnancy or breastfeeding, as it may harm the fetus or newborn. If you are pregnant, planning to become pregnant, or breastfeeding, discuss alternative treatment options with your doctor.

Always consult your healthcare provider or pharmacist for specific instructions on how to use Obeticholic acid based on your unique circumstances. They will provide you with the most accurate and up-to-date information regarding dosage, timing, and any other considerations specific to your situation.

Other uses for this medicine

Currently, the primary approved use of Obeticholic acid is for the treatment of primary biliary cholangitis (PBC). However, research is ongoing to explore its potential use in other liver diseases and conditions.

What special precautions should I follow?

Regarding special precautions, here are some important considerations when using Obeticholic acid:

• Pregnancy and Breastfeeding: Obeticholic acid can cause harm to a developing fetus, so it is generally not recommended during pregnancy. It is important to use effective contraception while taking this medication. Additionally, Obeticholic acid may pass into breast milk, so it should be avoided while breastfeeding.
• Liver Function Monitoring: Regular monitoring of liver function, including liver enzyme levels, is essential while taking Obeticholic acid. It is done through blood tests to ensure the medication is not causing any significant liver problems.
• Pre-existing Liver Disease: Obeticholic acid should be used with caution in individuals with moderate to severe liver impairment or advanced liver disease. Close monitoring is necessary to assess its safety and effectiveness in such cases.
• Concomitant Medications: Inform your healthcare provider about all the medications, supplements, or herbal products you are currently taking. Obeticholic acid can interact with certain medications, such as cyclosporine or bile acid sequestrants, potentially affecting their efficacy or safety. Your doctor will evaluate and adjust your medications accordingly to prevent any adverse effects.
• Cholesterol Monitoring: Obeticholic acid may increase low-density lipoprotein (LDL) cholesterol levels in the blood. Regular monitoring of cholesterol levels is important, particularly in individuals with pre-existing heart disease or high cholesterol.
• Itching (Pruritus): Obeticholic acid is associated with a common side effect of itching (pruritus). If itching becomes severe or persistent, additional medications or interventions may be necessary to manage this symptom.

These are general precautions associated with Obeticholic acid, but it’s important to consult with your healthcare provider or pharmacist for specific precautions based on your medical history, existing conditions, and any other medications you are taking. They will provide personalized advice and closely monitor your progress to ensure the safe and effective use of the medication.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with taking Obeticholic acid. However, it is generally recommended to maintain a healthy and balanced diet to support overall liver health. It is important to follow any dietary recommendations provided by your healthcare provider for your specific condition.

What should I do if I forget a dose?

If you forget to take a dose of Obeticholic acid, here’s what you should do:

• Timing: Take the missed dose as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, skip the missed dose and resume your regular dosing schedule.
• Do not double dose: Do not take a double dose of Obeticholic acid to make up for the missed dose. Taking more than the prescribed amount can increase the risk of side effects.
• Consult your healthcare provider: If you are unsure about what to do or if you have missed multiple doses, it is advisable to consult your healthcare provider for guidance. They can provide specific instructions based on your situation.

What side effects can this medication cause?

Obeticholic acid may cause several side effects. It’s important to note that not everyone will experience these side effects, and their severity can vary from person to person. Here are some of the common side effects associated with Obeticholic acid:

• Itching (Pruritus): Itching, ranging from mild to severe, is one of the most commonly reported side effects of Obeticholic acid. It may affect various parts of the body and can be managed with additional medications or interventions.
• Fatigue: Fatigue or tiredness is another commonly reported side effect. It can range from mild to severe and may impact daily activities.
• Gastrointestinal Symptoms: Obeticholic acid can cause abdominal pain, nausea, vomiting, diarrhea, indigestion, or discomfort in the upper abdomen. These symptoms can be temporary or persistent.
• Headache: Some individuals may experience headaches while taking Obeticholic acid. These headaches are typically mild and transient.
• Back Pain: Back pain has been reported as a side effect, although the frequency and severity may vary.
• Increased LDL Cholesterol Levels: Obeticholic acid can raise low-density lipoprotein (LDL) cholesterol levels in the blood. Regular monitoring and management of cholesterol levels are necessary, especially in individuals with pre-existing heart disease or high cholesterol.
• Worsening Liver Function: In some cases, Obeticholic acid can cause an increase in liver enzyme levels, indicating potential liver problems. Regular monitoring of liver function is important during treatment.
• Weight Loss: Some individuals may experience unintentional weight loss while taking Obeticholic acid. This weight loss can be significant, and it is important to monitor it during treatment.

It’s important to report any side effects you experience to your healthcare provider. They can provide guidance, advice, and potential strategies to manage these side effects. They will also evaluate the risks and benefits of continuing the medication based on your individual situation.

What should I know about storage and disposal of this medication?

Storage:

• Store Obeticholic acid tablets at room temperature, away from excessive heat, moisture, and direct sunlight.
• Keep the medication in its original packaging or container to protect it from light and moisture.
• Ensure that Obeticholic acid is stored out of reach of children and pets.
• Do not use Obeticholic acid if it has expired or if the tablets appear damaged, discolored, or show any signs of deterioration.

Disposal:

• Do not dispose of Obeticholic acid in household trash or wastewater. Follow your local guidelines or consult a healthcare professional or pharmacist for proper disposal methods.
• Some areas provide specific instructions for medication disposal, such as local take-back programs or designated collection sites. Check with your local authorities or pharmacies for information on safe disposal options.

In case of emergency/overdose

• In case of an emergency or suspected overdose, contact your local emergency services or go to the nearest emergency room immediately.
• It may be helpful to bring the medication packaging or container to the healthcare professionals to provide them with accurate information about the medication.

What other information should I know?

• Keep a list of all the medications you are currently taking, including Obeticholic acid, and share it with your healthcare provider. This includes prescription medications, over-the-counter drugs, supplements, or herbal products.
• Attend all scheduled appointments with your healthcare provider for regular monitoring of your condition and the effectiveness of Obeticholic acid.
• Inform your healthcare provider about any pre-existing medical conditions, allergies, or previous adverse reactions to medications before starting Obeticholic acid.
• If you are planning to undergo any surgical or dental procedures, inform the healthcare professional about your Obeticholic acid treatment.

It is important to follow all the instructions provided by your healthcare provider, including storage, disposal, and emergency procedures. If you have any specific questions or concerns about Obeticholic acid, consult your healthcare provider or pharmacist for accurate and personalized information.