Obeticholic acid (By mouth)

Obeticholic Acid (oh-bet-i-KOE-lik AS-id)

Treats primary biliary cholangitis (swelling of the bile duct).

Brand Name(s):

Ocaliva

There may be other brand names for this medicine.

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, or if you have liver disease (including compensated or decompensated cirrhosis) or complete biliary blockage.

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.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
  • 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 medicines may affect how obeticholic acid works. Tell your doctor if you are using any of the following:
    • Cyclosporine, 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 high cholesterol.
  • This medicine may cause the following problems:
    • Liver problems
    • Severe itching skin
    • High cholesterol levels
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

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, stomach pain or discomfort, yellow skin or eyes
  • Fever, chills, change in how much or how often you urinate, dry mouth, increased thirst, dizziness, lightheadedness
  • Rapid weight gain, swelling in your hands, ankles, or feet

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

  • Constipation
  • Muscle or joint pain
  • Sore throat
  • Tiredness

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


Last Updated: 9/6/2024

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