When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to obeticholic acid.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines may affect how obeticholic acid works. Tell your doctor if you are using any of the following:
  
  • Theophylline, tizanidine
  • Blood thinner (including warfarin)
• If you are taking cholestyramine, colestipol, or colesevelam, take Ocaliva™ at least 4 hours before or 4 hours after these medicines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, high cholesterol, or biliary blockage.
• This medicine may cause the following problems:
  
  • Liver problems
  • High cholesterol levels
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Constipation, stomach pain and discomfort
• Dizziness
• Muscle or joint pain
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sore throat
• Tiredness or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088