Generic Name: obeticholic acid (oh BET i KOE lik AS id)
Brand Names: Ocaliva
Medically reviewed: April 9, 2018
What is Ocaliva?
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.
Ocaliva 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.
It is not known if taking Ocaliva will improve your chance of survival or improve your symptoms of PBC.
To determine a safe dose for you, your doctor will check your liver function. Take Ocaliva 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 Ocaliva if you are allergic to obeticholic acid, 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 Ocaliva.
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 Ocaliva?
Use Ocaliva exactly as it was prescribed for you. ollow 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 Ocaliva with or without food.
Ocaliva 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 Ocaliva. 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 this medicine for any reason, talk with your doctor before you start taking it again.
Store at room temperature away from moisture and heat.
Ocaliva 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
See also: Dosage Information (in more detail)
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 Ocaliva?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Ocaliva side effects
Get emergency medical help if you have signs of an allergic reaction to Ocaliva: 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;
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 Ocaliva 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.
See also: Side effects (in more detail)
What other drugs will affect Ocaliva?
If you take any of the following medicines, take your Ocaliva dose 4 hours before or 4 hours after you take the other medicine.
Tell your doctor about all your other medicines. Some may interact with obeticholic acid, especially:
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 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 Ocaliva only for the indication prescribed.
Copyright 1996-2018 Cerner Multum, Inc. Version: 3.01.
More about Ocaliva (obeticholic acid)
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- Drug class: miscellaneous GI agents