Obeticholic acid is used alone or in combination with ursodiol (Actigall, Urso) to treat primary biliary cholangitis (PBC; a type of liver disease that destroys bile ducts, which allows bile to stay in the liver and cause damage) in people who cannot take ursodiol or in people who were not treated successfully with ursodiol alone. Obeticholic acid is in a class of medications called farnesoid X receptor agonists. It works by decreasing the production of bile in the liver and increasing the removal of bile from the liver.
Side Effects Of Obeticholic Acid
Obeticholic acid may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- mouth or throat pain
- fast, irregular, or pounding heartbeat
- swelling of the hands, feet, ankles, or lower legs
- tiredness or weakness
- joint or muscle pain
Some side effects can be serious. If you experience any of these symptoms or those listed in the WARNINGS and PRECAUTIONS section, call your doctor immediately:
- severe itching
- fever, chills, or other signs of infection
- dryness, irritation, redness, crusting, or drainage of the skin
Obeticholic acid may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
Warnings & Precautions
Before taking obeticholic acid:
- tell your doctor and pharmacist if you are allergic to obeticholic acid, any other medications, or any of the ingredients in obeticholic acid tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: caffeine (found in certain medications to treat drowsiness and headaches), theophylline (Elixophyllin, Theo-24, Theochron, others), tizanidine (Zanaflex), or warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with obeticholic acid, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- if you are taking cholestyramine (Prevalite), colestipol (Colestid), or colesevelam (Welchol), take them at least 4 hours before or 4 hours after obeticholic acid.
- tell your doctor if you have bile duct obstruction (blockage in the tubes that carry bile from the liver to the gallbladder and small intestine). Your doctor may tell you not to take obeticholic acid.
- tell your doctor if you have or have ever had high cholesterol or thyroid disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking obeticholic acid, call your doctor.
Dosage Of Obeticholic Acid
Obeticholic acid comes as a tablet to take by mouth. It is taken usually once a day with or without food. Take obeticholic acid at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take it exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may need to temporarily or permanently stop your treatment or decrease your dose of obeticholic acid during your treatment. This will depend on how well the medication works for you or if you experience certain side effects. Continue to take it even if you feel well. Do not stop taking obeticholic acid without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.