Obeticholic Acid

Obeticholic acid can cause liver damage, sometimes serious enough to require liver transplantation or cause death, especially in patients that have cirrhosis (scarring) of the liver. Tell your doctor if you have or have ever had cirrhosis of the liver. Your doctor may tell you not to take obeticholic acid. If you experience any of the following symptoms while taking obeticholic acid, call your doctor immediately: yellowing of the skin or eyes, dark urine, black tarry stools, coughing up or vomiting blood, swelling in and around the stomach area, confusion, slurred speech, anxiety, mood swings, or changes in personality. If you experience any of the following symptoms and they are severe or do not go away, call your doctor right away: nausea, vomiting, diarrhea, abdominal pain, weight loss, loss of appetite, tiredness or weakness, lightheadedness, fever, chills, or less frequent urination.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to check your liver function and your body's response to obeticholic acid.

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.

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 obeticholic acid 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 obeticholic acid 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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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 while taking obeticholic acid. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking cholestyramine (Prevalite), colestipol (Colestid), or colesevelam (Welchol), take them at least 4 hours before or 4 hours after obeticholic acid.
• the following nonprescription product may interact with obeticholic acid: caffeine supplements. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking obeticholic acid. Do not start this medication while taking obeticholic acid without discussing with your healthcare provider.
• 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 ever drunk large amounts of alcohol, or 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.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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
• rash
• dizziness
• fainting
• swelling of the hands, feet, ankles, or lower legs
• joint or muscle pain
• constipation

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• severe itching
• 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.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• yellowing of the skin or eyes
• dark colored urine
• loss of appetite
• pain in the upper right part of the stomach
• nausea
• vomiting
• swelling in the area around the stomach

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.

• Ocaliva^®