Generic Name: obeticholic acid (oh BET i KOE lik AS id)
Brand Name: Ocaliva
What is obeticholic acid?
Primary biliary cholangitis (PBC) is a chronic type of liver disease that can gradually destroy bile ducts. These ducts deliver bile from the liver to the small intestines, to help your body digest fats and certain vitamins. When bile ducts are destroyed by PBC, bile stays in the liver and damages liver cells, which can cause cirrhosis (scarring of the liver) and lead to liver failure. PBC is a slow progressive disease that may have no symptoms for many years. Treating PBC to keep the liver functioning normally can allow for a normal life expectancy.
Obeticholic acid is used to treat PBC. This medicine 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, patients with PBC responded to obeticholic acid. However, further studies are needed to determine if this medicine can improve survival or disease-related symptoms.
Obeticholic acid may also be used for purposes not listed in this medication guide.
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 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.
To make sure obeticholic acid is safe for you, tell your doctor if you have:
pre-existing liver disease.
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 is not known whether obeticholic acid passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I take obeticholic acid?
Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Obeticholic acid is usually taken once per day, with or without food.
To be sure this medicine is helping your condition, you may need frequent blood tests. You may not notice any change in your symptoms, but your blood work will help your doctor determine how best to treat you with obeticholic acid.
You may be given other medications to treat itching that may be caused by obeticholic acid.
If you stop taking obeticholic acid for any reason, you may need to use a lower dose when you start taking it again. Follow your doctor's dosing instructions carefully.
Call your doctor if your symptoms do not improve, or if they get worse. The most common symptoms of PBC is intense itching, especially in your arms, legs, and back.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
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?
If you also take a bile acid resin (such as colesevelam, cholestyramine, or colestipol), avoid taking the bile acid resin within 4 hours before or 4 hours after you take obeticholic acid.
Obeticholic acid side effects
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:
rapid weight gain, especially in your face and midsection;
swelling in your ankles;
dark urine, clay-colored stools;
jaundice (yellowing of the skin or eyes);
tiredness, joint pain;
dry eyes or mouth;
darkening of your skin; or
puffiness around your eyes.
Common side effects may include:
stomach pain, constipation;
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.
See also: Side effects (in more detail)
Obeticholic acid dosing information
Usual Adult Dose for Biliary Cirrhosis:
Initial dose: 5 mg orally once a day
Maintenance dose: 5 mg orally once a day; if adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin is not achieved after 3 months, increase the dosage to 10 mg orally once a day
Maximum dose: 10 mg/day
Uses: For the treatment of primary biliary cholangitis:
-As monotherapy in adults unable to tolerate ursodeoxycholic acid (UDCA)
-In combination with UDCA in adults with an inadequate response to UDCA
What other drugs will affect obeticholic acid?
Tell your doctor about all your current medicines and any you start or stop using, especially:
warfarin (Coumadin, Jantoven).
This list is not complete. Other drugs may interact with obeticholic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
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.
- Disclaimer: 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 1996-2012 Cerner Multum, Inc. Version: 1.01. Revision Date: 2016-07-12, 9:11:03 AM.