URL of this page: https://medlineplus.gov/druginfo/meds/a616033.html

Obeticholic Acid

pronounced as (oh be'' i koe' lik)

Notice:

[Posted 09/21/2017]

AUDIENCE: Pharmacy, Hepatology, Gastroenterology

ISSUE: FDA is warning that the liver disease medicine obeticholic acid (Ocaliva) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them. Obeticholic acid may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. The recommended dosing and monitoring for patients on obeticholic acid are described in the current drug label. FDA is working with the drug manufacturer, Intercept Pharmaceuticals, to address these safety concerns.

BACKGROUND: Obeticholic acid is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC). PBC causes the bile ducts in the liver to become inflamed, damaged and destroyed. This causes bile, a fluid that helps in digestion, to build up in the liver. This build-up damages the liver over time, eventually causing it to lose its ability to function. Obeticholic acid has been shown to improve a certain blood test that measures liver problems.

RECOMMENDATIONS:

Health care professionals

  1. Determine the patient's baseline liver function prior to starting obeticholic acid.
  2. Patients with moderate to severe liver impairment (Child-Pugh B and C) should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5 mg daily dosing used for other PBC patients, and if needed, can be increased up to a maximum approved dose of 10 mg twice weekly.
  3. Health care professionals should monitor patients frequently for disease progression, and reduce the dosing frequency to once- or twice-weekly for patients who progress to moderate or severe liver impairment.
  4. In all patients treated with obeticholic acid, monitor frequently for liver injury (e.g., worsened liver blood tests and adverse liver-related reactions that may be inconsistent with the patient's extent of disease). If liver injury is suspected, discontinue obeticholic acid. After the patient has stabilized, weigh the benefits against the risks when deciding whether to re-initiate treatment.
  5. Educate patients on the symptoms of potential liver injury.

Patients

  1. Contact your health care professional if you have questions or concerns about taking obeticholic acid.
  2. Report new or worsening severe skin itching to your health care professional.
  3. Contact your health care professional immediately if you develop any of the following symptoms that may be signs of liver injury:
    1. New or worsening fatigue
    2. Diarrhea
    3. Weight loss
    4. Abdominal pain
    5. Decreased appetite
    6. Nausea and vomiting
    7. Change in behavior or confusion
    8. Vague symptoms such as anxiety or unease
    9. Abdominal swelling
    10. Yellow eyes or skin
    11. Bloody stools

For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

Why is this medication prescribed?

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 patients who cannot take ursodiol or in patients 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.

How should this medicine be used?

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 adjust your dose of obeticholic acid or delay 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.

Other uses for this medicine

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

What special precautions should I follow?

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 (Theo-24, Theochron, Uniphyl), tizanidine (Zanaflex), or warfarin (Coumadin). 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 liver disease or high cholesterol.
  • 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.

What special dietary instructions should I follow?

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

What should I do if I forget a dose?

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.

What side effects can this medication cause?

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
  • irregular or pounding heartbeat
  • rash
  • stomach pain
  • dizziness
  • fainting
  • swelling of the hands, feet, ankles, or lower legs
  • tiredness or weakness
  • joint or muscle pain
  • constipation

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

  • itching
  • yellowing of the skin or eyes
  • dark colored urine
  • pain in the upper right part of the stomach
  • nausea
  • vomiting
  • fever
  • pale colored stools
  • swelling in the area around the stomach

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

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).

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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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. http://www.upandaway.org

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local 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

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to obeticholic acid.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking obeticholic acid.

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.

Brand names

  • Ocaliva®
Last Revised - 10/15/2017