Ocaliva (obeticholic acid) is used to treat primary biliary cholangitis, which is liver damage caused by bile build-up. It can be used alone or with another medication called ursodiol (Actigall). There's currently no available generic version of Ocaliva (obeticholic acid), and it's typically found at specialty pharmacies only. Common side effects include itchiness, fatigue, and stomach pain, but it also has a warning for liver problems.
Primary biliary cholangitis is an autoimmune condition that damages the bile ducts in the liver that typically carry bile to the intestine. This causes bile to build up in the liver, which can lead to liver damage.
Ocaliva (obeticholic acid) is a farnesoid X receptor agonist that works in the liver. It turns on a protein in your body called farnesoid X receptor. As a result, the medication lowers how much bile your body makes and moves bile out of the liver to protect your liver.
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
Only need to take once per day
Can take with or without food
Good option if you can't tolerate ursodiol (Actigall) well
Can cause intense itching or itching over much of your body
Can lower your "good" cholesterol (HDL)
Can't use if you have severe liver problems or liver failure
Not a first-choice option for treating primary biliary cholangitis
Mark your appointments to see your provider and get any blood tests done on your calendar. These blood tests check your liver function and cholesterol levels. These follow-ups make sure Ocaliva (obeticholic acid) is working well and is safe for you.
Ocaliva (obeticholic acid) can cause itchiness and fatigue. Speak to your provider if these side effects prevent you from doing your normal daily activities, are unbearable, or get worse. Your provider might give you medication to help with these side effects, lower your dose of Ocaliva (obeticholic acid), or stop treatment.
If you're taking colesevelam (Welchol), colestipol (Colestid), or cholestyramine (Prevalite), take them at least 4 hours before or 4 hours after Ocaliva (obeticholic acid). If this isn't doable, try to take them as far apart as possible from Ocaliva (obeticholic acid). Taking them too close to Ocaliva (obeticholic acid) can lower how much Ocaliva (obeticholic acid) gets into your body, which can make it not work as well.
If you're taking warfarin (Coumadin), tell the provider who's managing your blood thinner medication that you're taking Ocaliva (obeticholic acid). This medication can affect your blood clotting time international normalized ratio (INR) when it's taken with the blood thinner, so your provider might want to follow up with you more often. If your INR changes, your warfarin (Coumadin) dose might be adjusted.
You might need to get blood tests done regularly to check your cholesterol levels. This is because Ocaliva (obeticholic acid) can lower your "good" cholesterol levels. It's important to have a healthy and balanced diet and to regularly exercise while taking this medication to help with your cholesterol levels.
Ocaliva (obeticholic acid) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Cirrhosis (scarring of the liver) | History of liver problems
Ocaliva (obeticholic acid) can cause serious liver problems. In addition, some people with primary biliary cholangitis and cirrhosis (liver scarring) had worsening liver problems during treatment with Ocaliva (obeticholic acid). In some cases, these worsening problems led to the need for liver transplant or death.
You'll need to get regular blood tests done so your provider can check your liver health throughout treatment. Get medical help right away if you notice signs of serious liver damage, such as swelling of your stomach; yellowing of your skin or the whites of your eyes; black or bloody stools; bloody cough or vomit; confusion; or changes in personality or mood. You might need to stop using the medication to prevent further liver damage.
Ocaliva (obeticholic acid) can cause intense or widespread itching that can interfere with your daily activities, cause sleep problems, or cause discomfort. Talk to your provider if you notice these symptoms or if the itching gets worse. Your provider might recommend other medications to take to help manage the itchiness. They also might lower your Ocaliva (obeticholic acid) dose or decide to stop treatment with Ocaliva (obeticholic acid).
Ocaliva (obeticholic acid) can lower your levels of "good" cholesterol (high-density lipoprotein, HDL) in the body. You'll need to get regular lab tests while you're taking the medication to make sure your cholesterol levels don't drop. If your HDL levels become too low and your liver doesn't get better after taking Ocaliva (obeticholic acid) for 1 year, you might have to stop taking the medication.
The typical starting dose is 5 mg by mouth once per day for the first 3 months.
After 3 months of treatment, your provider might raise the dose to 10 mg by mouth once per day depending on the results of lab tests that measure your liver's health.
History of worsening liver function or liver failure
Certain types of cirrhosis (severe liver scarring)
Complete bile duct blockage
Dissolve gallstones
Prevention of gallstone formation in overweight people experiencing rapid weight loss
Liver disease (primary biliary cirrhosis)
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