WARNING

While Ocaliva can be an effective medication for certain liver conditions, it is important to be aware of the potential risks associated with its use. Here is a brief overview of the risks of taking Ocaliva:

• Liver problems: Ocaliva can cause or worsen liver problems, including liver injury, liver failure, and even death. It is crucial for healthcare providers to closely monitor liver function through regular blood tests while a patient is taking Ocaliva.
• Worsening of itching: Although Ocaliva can help alleviate itching in many patients, there have been reports of the medication actually worsening pruritus in some cases. If the itching becomes severe or intolerable, it should be promptly reported to a healthcare professional.
• Interactions with other medications: Ocaliva can interact with certain medications, including cholesterol-lowering drugs (statins) and immunosuppressive agents. These interactions can affect the effectiveness or safety of both Ocaliva and the other medications. It is important to inform healthcare providers about all the medications, supplements, and herbal products being taken to avoid potential interactions.
• Gastrointestinal side effects: Ocaliva may cause side effects in the digestive system, such as nausea, diarrhea, abdominal pain, and indigestion. These symptoms should be reported to a healthcare professional if they persist or become severe.
• Pregnancy and breastfeeding: Ocaliva is not recommended for use during pregnancy due to the potential risk to the fetus. It is also not known whether Ocaliva passes into breast milk, so breastfeeding should be avoided while taking this medication.

These are just some of the potential risks associated with Ocaliva. It is essential to discuss any concerns or questions about the risks and benefits of Ocaliva with a healthcare professional before starting the medication. They can provide more detailed information and guidance based on the individual’s specific medical situation.

Why is this medication prescribed?

Ocaliva (generic name: obeticholic acid) is a medication that is prescribed for certain liver conditions. It is primarily used to treat primary biliary cholangitis (PBC), which is a chronic liver disease characterized by the inflammation and destruction of the bile ducts in the liver.

Here are some key reasons why Ocaliva may be prescribed for patients with PBC:

• Slows disease progression: Ocaliva helps slow down the progression of PBC by reducing the damage and inflammation in the bile ducts. It can help preserve liver function and delay the need for a liver transplant.
• Reduces itching: One of the common symptoms of PBC is severe itching, known as pruritus. Ocaliva has been shown to effectively alleviate itching associated with PBC, improving the patient’s quality of life.

How should this medicine be used?

Ocaliva (obeticholic acid) should be used exactly as prescribed by a healthcare professional. It comes in tablet form and is typically taken once daily. Here are some general guidelines for the use of Ocaliva:

• Dosage: The recommended starting dose of Ocaliva for most patients is 5 mg once daily. However, the actual dosage may vary depending on the individual’s specific condition and response to treatment. The healthcare provider will determine the appropriate dosage.
• Timing: Ocaliva should be taken at the same time each day to maintain a consistent level of the medication in the body. It can be taken with or without food.
• Swallowing the tablets: The Ocaliva tablets should be swallowed whole with water and should not be crushed, chewed, or split.
• Additional medications: Ocaliva is often used in combination with other medications for the management of primary biliary cholangitis (PBC). It is important to follow the healthcare provider’s instructions regarding the timing and dosage of other medications being taken alongside Ocaliva.
• Regular monitoring: While taking Ocaliva, it is essential to have regular follow-up appointments with a healthcare professional. They will monitor liver function and overall response to the medication through blood tests and may adjust the dosage as needed.
• Compliance: It is important to take Ocaliva consistently and not miss doses. If a dose is missed, it should be taken as soon as remembered unless it is close to the time for the next scheduled dose. In such cases, the missed dose should be skipped, and the regular dosing schedule should be resumed.

It is crucial to follow the prescribed instructions and consult with a healthcare professional for any specific guidance related to the use of Ocaliva. They can provide personalized recommendations and address any concerns or questions regarding the medication.

Other uses for this medicine

It’s important to consult with your healthcare provider for specific information on the appropriate use of Ocaliva and whether it is suitable for your particular medical condition.

What special precautions should I follow?

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

• Liver function monitoring: Ocaliva can cause liver problems or worsen existing liver conditions. Therefore, regular monitoring of liver function through blood tests is crucial during treatment. If there are any signs of liver injury or worsening liver function, the medication may need to be adjusted or discontinued.
• Pregnancy and breastfeeding: Ocaliva is not recommended for use during pregnancy due to potential harm to the fetus. It is important to use effective contraception while taking Ocaliva. The medication’s safety during breastfeeding is not known, and it is generally recommended to avoid breastfeeding while using Ocaliva.
• Interactions with other medications: Ocaliva can interact with certain medications, including cholesterol-lowering drugs (statins) and immunosuppressive agents. It is important to inform healthcare providers about all the medications, supplements, and herbal products being taken to avoid potential interactions.
• Itching: Ocaliva is known to help alleviate itching in PBC patients, but it can occasionally cause or worsen itching in some individuals. If severe or intolerable itching occurs, it should be reported to a healthcare professional.

These precautions are not exhaustive, and it is important to discuss specific concerns and considerations with a healthcare professional before starting Ocaliva. They can provide personalized advice and guidance based on an individual’s medical history and condition.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with taking Ocaliva (obeticholic acid). However, it is generally recommended to follow a healthy and balanced diet as advised by healthcare professionals for overall liver health.

What should I do if I forget a dose?

If you forget to take a dose of Ocaliva, here are some general guidelines to follow:

• Timing: If you remember that you missed a dose and it is still a significant amount of time before your next scheduled dose, you can take the missed dose as soon as you remember.
• Close to the next dose: If it is close to the time for your next scheduled dose, it is generally recommended to skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for the missed one.
• Consult your healthcare provider: If you are unsure about what to do or if you missed multiple doses, it is best to consult your healthcare provider for specific guidance. They can provide you with instructions based on your individual circumstances.

What side effects can this medication cause?

Ocaliva (obeticholic acid) can cause several side effects, and it is important to be aware of them. Some individuals may experience these side effects, while others may not experience any or only experience mild side effects. It is recommended to discuss potential side effects with a healthcare professional before starting Ocaliva. Here are some common side effects associated with Ocaliva:

• Itching (pruritus): Itching, including severe itching, is a common side effect of Ocaliva. However, it is also a symptom of the condition it is prescribed for (primary biliary cholangitis). In some cases, Ocaliva may alleviate itching, but it can also worsen itching in certain individuals.
• Fatigue: Fatigue, or feeling tired, is a common side effect reported by some individuals taking Ocaliva. It is important to rest and manage your activities accordingly if you experience fatigue while on this medication.
• Abdominal pain: Abdominal pain or discomfort, including upper abdominal pain, can occur as a side effect of Ocaliva. If the pain is severe or persistent, it should be reported to a healthcare professional.
• Nausea and vomiting: Some individuals may experience nausea and vomiting as side effects of Ocaliva. If these symptoms become severe or persistent, it is important to inform your healthcare provider.
• Diarrhea: Diarrhea is another potential side effect of Ocaliva. If diarrhea is severe, persistent, or accompanied by other concerning symptoms such as dehydration, it should be reported to a healthcare professional.
• Headache: Headache is a relatively common side effect reported by some individuals taking Ocaliva. If headaches become severe or frequent, it is recommended to consult with a healthcare professional.

It’s important to note that this list is not exhaustive, and other side effects may occur. Additionally, individual experiences with side effects can vary. If you experience any side effects that are persistent, bothersome, or concerning, it is crucial to contact your healthcare provider for further evaluation and guidance.

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

Storage:

• Keep Ocaliva tablets in their original container or packaging.
• Store at room temperature, away from excessive heat, moisture, and direct sunlight.
• Do not freeze Ocaliva.
• Keep the medication out of reach of children and pets.

Disposal:

• Follow local guidelines or regulations for the proper disposal of medications.
• Do not dispose of Ocaliva by flushing it down the toilet or pouring it down the drain unless specifically instructed to do so.
• If you are unsure about how to properly dispose of Ocaliva, consult your healthcare provider or pharmacist for guidance.

In case of emergency/overdose

• Contact emergency services: If someone is experiencing severe symptoms or has collapsed, call emergency services immediately (e.g., 911 in the United States) for assistance.
• Poison control: If you suspect an overdose or have concerns about Ocaliva, contact your local poison control center or a healthcare professional for guidance. They can provide specific instructions based on the situation.

What other information should I know?

• Medication adherence: It is important to take Ocaliva as prescribed by your healthcare provider and to follow the recommended dosing schedule consistently. Missing doses or altering the dosage without medical guidance may affect the effectiveness and safety of the medication.
• Regular follow-up: Regular monitoring and follow-up appointments with your healthcare provider are necessary while taking Ocaliva. They will assess your response to the medication, monitor liver function, and make any necessary adjustments to your treatment plan.
• Inform healthcare providers: Make sure to inform all healthcare professionals involved in your care about any other medications, supplements, or herbal products you are taking. This will help them identify and manage any potential interactions or contraindications.
• Medication changes: Do not stop or change the dosage of Ocaliva without consulting your healthcare provider. They will provide guidance on any necessary adjustments or discontinuations based on your specific condition and response to the medication.

It is crucial to consult your healthcare provider or pharmacist for any additional information or instructions related to the use, storage, disposal, and potential emergencies involving Ocaliva. They can provide personalized advice based on your individual circumstances.