Obeticholic Acid
.svg)
Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
Farnesoid X Receptor Agonist
Controlled Drug Substance
No
Obeticholic Acid
Summary
Obeticholic Acid is used to treat primary biliary cholangitis (PBC), a liver disease that damages the bile ducts. It can be used on its own or with another medication called ursodeoxycholic acid (UDCA) in patients who do not respond well to UDCA alone.
Obeticholic Acid works by activating a receptor in the liver and intestine called the farnesoid X receptor. This reduces bile acid production in the liver and increases bile acid removal, which reduces liver damage.
The usual daily dose of Obeticholic Acid for adults with PBC is 5 mg once daily for the first 3 months. If needed, the dose can be increased to a maximum of 10 mg once daily based on the patient's response and tolerability.
Common side effects of Obeticholic Acid include itching, fatigue, abdominal pain, and discomfort. Serious side effects include liver damage, especially in patients with cirrhosis.
Obeticholic Acid can cause serious liver damage, especially in patients with cirrhosis. It is not recommended for patients with decompensated cirrhosis or compensated cirrhosis with portal hypertension. Patients should inform their doctor of any liver-related symptoms.
Indications and Purpose
How does Obeticholic Acid work?
Obeticholic Acid works by activating a receptor in the liver called the farnesoid X receptor. This activation reduces bile acid production and increases bile flow, which helps protect the liver from further damage. Think of it like adjusting the flow of water in a pipe to prevent overflow. This medication is effective for people with primary biliary cholangitis, a liver disease that damages the bile ducts.
Is Obeticholic Acid effective?
Obeticholic Acid is effective for treating primary biliary cholangitis, which is a liver disease that damages the bile ducts. Clinical studies show it improves liver function and slows disease progression. It works by activating a receptor in the liver that reduces bile acid production. This helps protect the liver from further damage. Always follow your doctor's advice to achieve the best results.
What is Obeticholic Acid?
Obeticholic Acid is a medication used to treat primary biliary cholangitis, which is a liver disease that damages the bile ducts. It belongs to a class of drugs called farnesoid X receptor agonists. This medication works by reducing bile acid production in the liver, which helps protect the liver from further damage. Obeticholic Acid is used in combination with other therapies or alone if other treatments are not suitable.
Directions for Use
For how long do I take Obeticholic Acid?
Obeticholic Acid is usually a long-term medication for managing chronic liver conditions like primary biliary cholangitis. You'll typically take it every day as a lifelong treatment unless your doctor suggests otherwise. Stopping this medication without medical advice could cause your condition to worsen. How long you'll need this medication depends on your body's response and any side effects you experience. Always talk with your doctor before changing or stopping your treatment.
How do I dispose of Obeticholic Acid?
To dispose of Obeticholic Acid, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of this medicine properly so it doesn't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. Mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag, and throw it away.
How do I take Obeticholic Acid?
Take Obeticholic Acid exactly as your doctor prescribes. It's usually taken once daily, with or without food. Do not crush or chew the tablets. If you miss a dose, take it as soon as you remember unless it's almost time for your next dose. In that case, skip the missed dose and continue your regular schedule. Do not take two doses at once. Always follow your doctor's specific advice about diet and fluid intake while taking this medication.
How long does it take for Obeticholic Acid to start working?
Obeticholic Acid begins working in your body shortly after you take it, but you may not notice all the benefits right away. Improvements in liver function tests can be seen within a few weeks, but more significant changes typically take several months. How quickly the medication works can depend on your liver function, age, and overall health. Take it exactly as prescribed for the best results.
How should I store Obeticholic Acid?
Store Obeticholic Acid at room temperature, away from moisture and light. Keep it in a tightly closed container to protect it from damage. Don't store your medicine in humid places like bathrooms, where moisture in the air could affect how well the medication works. Always store Obeticholic Acid out of children's reach to prevent accidental swallowing. Check the expiration date regularly and properly dispose of any unused or expired medication.
What is the usual dose of Obeticholic Acid?
The usual starting dose of Obeticholic Acid for adults is 5 mg once daily. Your doctor may increase your dose to 10 mg daily if needed. Always follow your doctor's specific dosing instructions for your personal health needs. Dose adjustments may be necessary for special populations, such as the elderly or those with liver problems. Consult your doctor for guidance tailored to your condition.
Warnings and Precautions
Can I take Obeticholic Acid with other prescription drugs?
Obeticholic Acid can interact with certain medications, such as bile acid-binding resins, which may reduce its effectiveness. It can also interact with medications that affect liver enzymes, potentially increasing the risk of side effects. Always inform your doctor about all the medications you take to avoid interactions. Your doctor will help manage your treatment safely and effectively.
Can Obeticholic Acid be taken safely while breastfeeding?
Obeticholic Acid is not recommended while breastfeeding. We don't have much information about whether this medication passes into human breast milk. If you're taking Obeticholic Acid and want to breastfeed, talk with your doctor about safer medication options that would allow you to nurse your baby safely. Your doctor can help you make the best decision for your situation.
Can Obeticholic Acid be taken safely while pregnant?
Obeticholic Acid is not recommended during pregnancy due to limited safety data. Animal studies suggest potential risks, but human data is lacking. If you're pregnant or planning to become pregnant, talk with your doctor about the safest way to manage your condition. Your doctor can help create a treatment plan that protects both you and your baby.
Does Obeticholic Acid have adverse effects?
Adverse effects are unwanted reactions to a medication. With Obeticholic Acid, common adverse effects include itching and fatigue. Serious side effects can include liver problems, which require immediate medical attention. If you notice symptoms like jaundice or severe itching, contact your doctor. Always inform your healthcare provider about any new or worsening symptoms while taking this medication.
Does Obeticholic Acid have any safety warnings?
Yes, Obeticholic Acid has important safety warnings. It can cause liver problems, so regular liver function tests are necessary. If you experience symptoms like jaundice, which is yellowing of the skin or eyes, or severe itching, contact your doctor immediately. Not adhering to these warnings can lead to serious liver damage. Always follow your doctor's advice and report any unusual symptoms promptly.
Is it safe to drink alcohol while taking Obeticholic Acid?
It's best to avoid alcohol while taking Obeticholic Acid. Alcohol can worsen liver damage, which is the condition this medication treats. Drinking alcohol may also increase the risk of side effects like liver problems. If you do choose to drink occasionally, limit how much alcohol you consume and discuss it with your doctor to get personalized advice based on your specific health situation.
Is it safe to exercise while taking Obeticholic Acid?
You can exercise while taking Obeticholic Acid, but keep a few things in mind. This medication can cause fatigue, which might affect your exercise capacity. Listen to your body and avoid strenuous activities if you feel unusually tired. To exercise safely, stay hydrated and watch for signs of dizziness or unusual fatigue. If you notice these symptoms, slow down or stop exercising and rest.
Is it safe to stop Obeticholic Acid?
Stopping Obeticholic Acid suddenly can cause your condition to worsen. It's usually used for long-term management of chronic liver conditions. Always talk with your doctor before stopping the medication. They might suggest gradually reducing your dose or switching to a different medication to keep your condition under control. Your doctor will help you make any medication changes safely.
Is Obeticholic Acid addictive?
Obeticholic Acid is not addictive or habit-forming. This medication doesn't cause dependency or withdrawal symptoms when you stop taking it. It works by affecting your liver to help manage certain conditions, and this mechanism doesn't affect brain chemistry in ways that could lead to addiction. You won't experience cravings for this medication or feel compelled to take more than prescribed.
Is Obeticholic Acid safe for the elderly?
Elderly patients may be more vulnerable to the side effects of Obeticholic Acid, such as liver problems. It's important for older adults to have regular check-ups and liver function tests while taking this medication. Your doctor will monitor your condition closely and adjust your treatment as needed to ensure safety and effectiveness. Always follow your doctor's advice and report any unusual symptoms.
What are the most common side effects of Obeticholic Acid?
Side effects are unwanted reactions that can happen when taking a medication. Common side effects of Obeticholic Acid include itching and fatigue. These effects vary from person to person. If you notice new symptoms after starting Obeticholic Acid, they might be temporary or unrelated to the medication. Talk with your doctor before stopping any medication.
Who should avoid taking Obeticholic Acid?
Do not take Obeticholic Acid if you have a complete biliary obstruction, which is a blockage in the bile ducts. This medication is also not recommended for people with severe liver impairment. Always inform your doctor about your medical history before starting Obeticholic Acid. Your doctor will assess the risks and benefits to determine if this medication is suitable for you.
Forms / Brands
