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 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 obeticholic acid, but further studies are needed.
Obeticholic acid may also be used for purposes not listed in this medication guide.
To determine a safe dose for you, your doctor will check your liver function. Take the medicine exactly as directed.
Call your doctor at once if you have signs of worsening liver problems, such as swelling around your midsection, changes in your mental status, yellowing of your skin or eyes, bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.
Before taking this medicine
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 obeticholic acid 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.
Before and during treatment with this medicine, your doctor will check your liver function. This will help determine a safe dose for you.
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.
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).
Your doses may be delayed or permanently discontinued based on the results of your liver tests while using obeticholic acid. You may not notice any change in symptoms, but tests will help your doctor determine if this medicine is safe and effective.
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.
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:
changes in your mental status, confusion, drowsiness, unusual tiredness;
fever, swelling around your midsection, rapid weight gain;
right-sided upper stomach pain, nausea, loss of appetite;
urinating less often, dark urine;
jaundice (yellowing of the skin or eyes); or
bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Common side effects may include:
skin rash, redness, oozing, or crusting;
fever, dizziness, feeling tired;
stomach pain, constipation;
pain in your mouth or throat;
fast or irregular heart rate;
swelling in your hands or lower legs;
joint pain; or
abnormal thyroid function.
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.
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
-This drug was approved via accelerated approval process due to ALP reductions; an improvement in survival or disease-related symptoms was not established.
-Patients and prescribers should note that continued approval may be contingent upon verification and clinical benefit in additional confirmatory trials.
-Healthcare providers should determine the Child-Pugh classification in any patient with suspected ascites prior to starting treatment.
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?
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.
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.
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.
Copyright 1996-2018 Cerner Multum, Inc. Version: 3.01.
More about obeticholic acid
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- 1 Review
- Drug class: miscellaneous GI agents
- FDA Alerts (2)
Other brands: Ocaliva