Overview: Ocaliva is used to treat primary biliary cholangitis (PBC), a rare liver disease where the bile ducts in your liver get damaged and blocked. It works by lowering the amount of bile acid (a component of bile) made by your liver, reducing the harmful buildup of bile. Common side effects include itching, tiredness, stomach pain and discomfort, rash or eczema, mouth and throat pain, dizziness, constipation, joint pain, and thyroid problems. Serious side effects include liver failure.
Uses
What is Ocaliva used for?
Ocaliva (obeticholic acid) is commonly used to treat primary biliary cholangitis (PBC), a rare liver disease where the bile ducts in your liver get damaged and blocked. This blockage can cause bile buildup, which can eventually damage your liver and other organs.
Ocaliva may also be used for other conditions as determined by your health care provider.
How does Ocaliva work (mechanism of action)?
Ocaliva works by lowering the amount of bile acid (a component of bile) made by your liver, reducing the harmful buildup of bile.
How is Ocaliva supplied (dosage forms)?
Brands and other names
- Ocaliva
Dosage forms and strengths
- 5 mg oral tablets
- 10 mg oral tablets
How should I store Ocaliva?
Ocaliva should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Side Effects
What are the most common side effects of Ocaliva?
The most common side effects of Ocaliva are listed below. Tell your health care provider if you have any of these side effects that bother you.
- Itching (see below)
- Tiredness
- Stomach pain and discomfort
- Rash or eczema
- Mouth and throat pain
- Dizziness
- Constipation
- Joint pain
- Thyroid problems
There may be other side effects of Ocaliva that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Ocaliva?
While less common, the most serious side effects of Ocaliva are described below, along with what to do if they happen.
Severe Allergic Reactions. Ocaliva may cause allergic reactions, which can be serious. Stop taking Ocaliva and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Liver Failure. Ocaliva may be associated with worsening of liver disease and an increased risk of liver failure, which can be fatal. The risk is higher in patients with cirrhosis (scarring of the liver). Tell your health care provider right away if you notice the following signs and symptoms of liver damage or failure.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
- Fluid retention and swelling in your belly (ascites)
- Confusion or trouble performing daily activities
Severe Itching. Ocaliva may cause itching that is severe enough to interfere with your daily activities and sleep. Tell your health care provider if you experience bothersome itching.
High Cholesterol. Ocaliva may cause high blood cholesterol levels. Your health care provider may regularly check your cholesterol levels to make sure Ocaliva is safe for you to take. Keep all appointments with your health care provider to check your blood tests.
Warnings & Precautions
Who should not use Ocaliva?
Allergies to Ingredients. People who are allergic to any of the following should not take Ocaliva.
- Obeticholic acid
- Ocaliva
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in the specific Ocaliva products they stock.
Severe Scarring of the Liver (Decompensated Cirrhosis). Ocaliva should not be taken if you have severe scarring in the liver that requires medical attention or have had similar episodes in the past.
High Blood Pressure in the Liver (Portal Hypertension). Ocaliva should not be taken if you have scarring of the liver that causes high blood pressure within the portal venous system, a system of veins that extend from various organs and pass through the liver.
Complete Bile Duct Blockage (Biliary Obstruction). Ocaliva should not be taken if your bile ducts are completely blocked.
What should I know about Ocaliva before using it?
Do not take Ocaliva unless it has been prescribed to you by a health care provider. Take it as prescribed.
Do not share Ocaliva with other people, even if they have the same condition as you. It may harm them.
Keep Ocaliva out of the reach of children.
Your health care provider may regularly check your liver function while you are taking Ocaliva to make sure this medicine is safe and effective for you. Keep all appointments you make with your health care provider.
What should I tell my health care provider before using Ocaliva?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Ocaliva is right for you.
In particular, make sure that you discuss any of the following.
Scarring of the Liver (Cirrhosis). Tell your health care provider if you have cirrhosis, or scarring of the liver. People with cirrhosis may be at a higher risk of experiencing certain serious side effects while taking Ocaliva.
Other Medicines and Supplements. Ocaliva may interact with other medicines and supplements. Before taking Ocaliva, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. It is not known if or how Ocaliva could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant.
Breastfeeding. It is not known if Ocaliva passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Ocaliva while breastfeeding.
How can I get more information about Ocaliva?
For more information about Ocaliva, you can visit the manufacturer’s website at www.ocaliva.com or call them at 844-782–4278.
Interactions
Does Ocaliva interact with foods or drinks?
There are no known interactions between Ocaliva and foods or drinks.
It is unknown if drinking alcohol will affect Ocaliva.
Does Ocaliva interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Ocaliva.
- A bile acid sequestrant, such as cholestyramine (Prevalite), colesevelam (Welchol), or colestipol (Colestid), which is a medicine to lower cholesterol (Ocaliva should be taken at least four hours before or four hours after taking these medicines)
- Warfarin, which is a blood thinner
- Theophylline (Elixophyllin, Theo-24), which is a medicine for asthma or certain other breathing problems
- Tizanidine (Zanaflex), which is a muscle relaxant
- A medicine that can worsen the buildup of bile salt in the liver, such as cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine that suppresses your immune system
Ocaliva may alter the blood levels of some other medicines. Tell your health care provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Ocaliva. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Ocaliva?
If you or someone else has used too much Ocaliva, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Ocaliva?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.