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Obeticholic Acid: Comprehensive Liver Disease Treatment Guide
Summary of Key Points
Obeticholic acid is a medication used to treat specific liver conditions, including primary biliary cholangitis (PBC) and other liver diseases. It works by reducing the buildup of bile in the liver, which helps prevent further liver damage. This medication is typically prescribed when other treatments have not been effective. Always consult your healthcare provider before starting or adjusting your dose. You can also connect with one of our providers through telemedicine for personalized advice.
Names of Medication
US Brand Name: Ocaliva
Generic Name: Obeticholic acid
The generic name refers to the active ingredient in the medication, while the brand name is assigned by the manufacturer. In this case, Obeticholic acid is the generic name, and Ocaliva is the brand name.
Pharmacologic Category
Farnesoid X receptor (FXR) agonist
Obeticholic Acid Dosage
Obeticholic acid is prescribed for various liver conditions, with the dosage tailored to the specific condition being treated. Always follow your doctor’s instructions and consult them before making any changes to your dose. If you need guidance, our telemedicine providers are available to assist.
Primary Biliary Cholangitis (PBC)
Initial Dose: 5 mg orally once daily
Maintenance Dose: After 3 months, the dose may be increased to 10 mg once daily if needed
Duration: Long-term treatment
Nonalcoholic Fatty Liver Disease (NAFLD)
Initial Dose: 5 mg orally once daily
Maintenance Dose: May be increased to 10 mg once daily based on response
Duration: Long-term treatment
Nonalcoholic Steatohepatitis (NASH)
Initial Dose: 5 mg orally once daily
Maintenance Dose: May be increased to 10 mg once daily based on response
Duration: Long-term treatment
Cholestatic Liver Disease
Initial Dose: 5 mg orally once daily
Maintenance Dose: May be increased to 10 mg once daily based on response
Duration: Long-term treatment
Obeticholic Acid for Liver Fibrosis
Initial Dose: 5 mg orally once daily
Maintenance Dose: May be increased to 10 mg once daily based on response
Duration: Long-term treatment
Cirrhosis
Initial Dose: 5 mg orally once daily
Maintenance Dose: May be increased to 10 mg once daily based on response
Duration: Long-term treatment
Biliary Obstruction
Initial Dose: 5 mg orally once daily
Maintenance Dose: May be increased to 10 mg once daily based on response
Duration: Long-term treatment
Hepatic Impairment
Initial Dose: 5 mg orally once daily
Maintenance Dose: May be increased to 10 mg once daily based on response
Duration: Long-term treatment
Cholestasis
Initial Dose: 5 mg orally once daily
Maintenance Dose: May be increased to 10 mg once daily based on response
Duration: Long-term treatment
Gallbladder Disease
Initial Dose: 5 mg orally once daily
Maintenance Dose: May be increased to 10 mg once daily based on response
Duration: Long-term treatment
Dosage Forms and Strengths
Tablet, Oral: 5 mg
Tablet, Oral: 10 mg
Administration Instructions for Obeticholic Acid
Obeticholic acid is taken orally, usually once daily. It can be taken with or without food. If you miss a dose, take it as soon as you remember, unless it’s close to your next dose. Do not double up on doses. Always follow your doctor’s instructions carefully and consult them if you have any questions. If you need assistance, our telemedicine providers are available to help.
Contraindications
A contraindication is a specific situation where a medication should not be used because it may be harmful. If you have any of the conditions listed below, you should not take Obeticholic acid or should discuss it with your healthcare provider to determine if it is safe for you.
Complete Biliary Obstruction: Obeticholic acid is contraindicated in patients with a complete bile duct blockage. The medication increases bile flow, and if the ducts are fully blocked, this could lead to serious complications.
Severe Hepatic Impairment (Child-Pugh Class C): Patients with severe liver damage should not take Obeticholic acid. The liver may not process the medication properly, increasing the risk of toxicity or worsening liver function.
Hypersensitivity to Obeticholic Acid: If you’ve had an allergic reaction to Obeticholic acid or any of its components, avoid taking it. Allergic reactions can range from mild to severe, including symptoms like rash, itching, swelling, or difficulty breathing.
Drug to Drug Interactions
Obeticholic acid can interact with other medications, potentially affecting its effectiveness or increasing the risk of side effects. Inform your healthcare provider about all medications you are taking, including over-the-counter drugs and supplements. Below are some medications that may interact with Obeticholic acid:
Warfarin (Coumadin): Obeticholic acid may affect how your body processes warfarin, a blood thinner, potentially altering your INR levels, which measure blood clotting time.
Statins (e.g., Atorvastatin [Lipitor], Simvastatin [Zocor]): These cholesterol-lowering drugs may interact with Obeticholic acid, increasing the risk of liver damage or muscle problems.
Bile Acid Sequestrants (e.g., Cholestyramine [Questran], Colestipol [Colestid]): These medications can reduce the absorption of Obeticholic acid, making it less effective. Your healthcare provider may adjust the timing of your doses if both medications are needed.
Obeticholic Acid in Pregnancy
Is it safe to take Obeticholic acid during pregnancy? The safety of Obeticholic acid in pregnant individuals has not been fully established. While animal studies suggest potential risks, there is limited data on its effects in humans. If you are pregnant or planning to become pregnant, it’s essential to discuss the potential risks and benefits with your healthcare provider before starting this treatment. Together, you can weigh the importance of managing your liver condition against any possible risks to your baby.
Obeticholic Acid while Breastfeeding
Is it safe to take Obeticholic acid while breastfeeding? It is currently unclear whether Obeticholic acid passes into breast milk. Given the potential for serious side effects in a nursing infant, it’s important to consult your healthcare provider before using this medication while breastfeeding. Your provider can help you decide whether to continue breastfeeding or explore alternative treatments that may be safer for both you and your baby.
Estimated Cost of Obeticholic Acid
The cost of a 30-day supply of Obeticholic acid without insurance can vary. With a GoodRX coupon, the price typically ranges from $6,000 to $7,000 for a 30-day supply. Prices may differ depending on the pharmacy and location. Be sure to check GoodRX or other discount programs for the most current pricing information.
Possible Alternatives to Obeticholic Acid
If Obeticholic acid isn’t the right option for you, there are alternative treatments and lifestyle changes that may help manage your liver condition. Always consult your healthcare provider before making any changes to your treatment plan. Our telemedicine providers are available to help you explore these alternatives.
Primary Biliary Cholangitis (PBC)
Ursodeoxycholic acid (UDCA) is often the first-line treatment for primary biliary cholangitis (PBC). In addition, lifestyle changes such as maintaining a healthy weight and avoiding alcohol can help manage symptoms and improve overall liver health.
Nonalcoholic Fatty Liver Disease (NAFLD)
For nonalcoholic fatty liver disease (NAFLD), weight loss, regular exercise, and a healthy diet are key to managing the condition. In some cases, medications like pioglitazone or vitamin E may be prescribed to help reduce liver inflammation.
Nonalcoholic Steatohepatitis (NASH)
Similar to NAFLD, lifestyle changes such as weight loss and regular physical activity are crucial for managing nonalcoholic steatohepatitis (NASH). Medications like vitamin E or pioglitazone may also be used to help reduce liver inflammation and prevent further damage.
Cholestatic Liver Disease
Ursodeoxycholic acid (UDCA) is commonly prescribed to treat cholestatic liver diseases. In some cases, corticosteroids or immunosuppressants may also be recommended, depending on the severity of the condition.
Liver Fibrosis
Treating liver fibrosis involves addressing the underlying cause, such as reducing alcohol intake or managing hepatitis. While antifibrotic medications are currently under research, they are not yet widely available. Your healthcare provider will focus on managing the root cause to slow the progression of fibrosis.
Cirrhosis
Managing cirrhosis involves treating the underlying cause, such as hepatitis or alcohol use. Medications to reduce portal hypertension, along with lifestyle changes like avoiding alcohol, are essential to managing the condition and preventing complications.
Biliary Obstruction
Treatment for biliary obstruction often involves surgery or procedures to remove the blockage. In some cases, medications to dissolve gallstones may be used as part of the treatment plan.
Hepatic Impairment
Managing hepatic impairment requires treating the underlying cause and avoiding medications that could further harm liver function. Your healthcare provider may also adjust your medication doses to ensure they are safe for your liver’s current condition.
Cholestasis
Ursodeoxycholic acid (UDCA) is frequently used to treat cholestasis. In some cases, medications to relieve itching or bile acid sequestrants may also be prescribed to help manage symptoms.
Gallbladder Disease
Treatment for gallbladder disease may involve surgery to remove the gallbladder (cholecystectomy) or medications to dissolve gallstones. Dietary changes, such as reducing fat intake, can also help alleviate symptoms and prevent further complications.
Recent Updates on Obeticholic Acid Research
Recent studies have explored the potential use of Obeticholic acid for treating nonalcoholic steatohepatitis (NASH) and liver fibrosis. A phase 3 clinical trial, known as the REGENERATE study, demonstrated that Obeticholic acid could improve liver fibrosis in patients with NASH. However, the FDA has requested additional data on the long-term safety and efficacy of the medication before approving it for this use. Ongoing research is also investigating the potential benefits of Obeticholic acid in other liver diseases, such as primary sclerosing cholangitis (PSC). As more data becomes available, we may see expanded uses for this bile acid analog in the future.
If you have any questions about Obeticholic acid or your treatment options, our telemedicine providers are here to help. Schedule an appointment today to discuss your liver health and receive personalized advice from the comfort of your home.
