What is the most important information I should know about obeticholic acid?
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
What is obeticholic acid?
Primary biliary cholangitis (PBC) is a chronic liver disease that gradually destroys bile ducts in the liver. These ducts deliver bile to the small intestines, to help your body digest fats and nutrients. When PBC destroys these ducts, the bile stays in your liver and damages its cells. This can lead to cirrhosis (scarring of the liver) and liver failure. PBC is a progressive disease that may have no symptoms for many years. Treating PBC can help keep the liver functioning normally.
Obeticholic acid is used to treat PBC in adults and is sometimes used together with another drug called ursodeoxycholic acid (UDCA).
Obeticholic acid was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people with PBC responded to this medicine, but further studies are needed.
Obeticholic acid may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking obeticholic acid?
You should not use obeticholic acid if you are allergic to it, or if you have complete blockage of your bile ducts.
Tell your doctor if you have ever had liver disease. Your doctor will perform tests to make sure you do not have liver conditions that would prevent you from safely using obeticholic acid.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.
How should I take obeticholic acid?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
You may take obeticholic acid with or without food.
Obeticholic acid can cause itching, and you may be given medicine to treat this side effect if it occurs. If itching is severe, your doctor may ask you to stop taking the medicine for a short time.
While using obeticholic acid, you may need frequent blood tests. You may not notice any change in symptoms, but tests will help your doctor determine if this medicine is effective.
Call your doctor if your symptoms do not improve, or if they get worse. The most common symptom of PBC is intense itching (especially in the arms, legs, and back).
If you stop taking obeticholic acid for any reason, talk with your doctor before you start taking it again.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking obeticholic acid?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of obeticholic acid?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe itching;
- right-sided upper stomach pain, nausea, vomiting;
- dark urine, clay-colored stools;
- jaundice (yellowing of the skin or eyes);
- weight loss; or
- rapid weight gain, especially in your face and midsection.
Common side effects may include:
- itching;
- skin rash or redness;
- feeling tired;
- sore throat;
- abnormal thyroid function tests;
- stomach pain, constipation;
- dizziness; or
- joint pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect obeticholic acid?
If you take any of the following medicines, take your obeticholic acid dose 4 hours before or 4 hours after you take the other medicine.
- colesevelam;
- cholestyramine; or
- colestipol.
Tell your doctor about all your other medicines. Some may interact with obeticholic acid, especially:
- alosetron;
- duloxetine;
- theophylline;
- tizanidine; or
- warfarin.
This list is not complete. Other drugs may affect obeticholic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Where can I get more information?
Your pharmacist can provide more information about obeticholic acid.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2018 Cerner Multum, Inc. Version: 2.01. Revision date: 2/13/2018.
