Primary biliary cholangitis (PBC) is a chronic liver disease that can destroy bile ducts in the liver and may lead to cirrhosis (scarring of the liver) and liver failure. PBC is a progressive disease that may have no symptoms for many years.

Obeticholic acid is used to treat PBC in adults who have not developed liver cirrhosis. Obeticholic acid is sometimes used with another drug called ursodeoxycholic acid (UDCA).

Obeticholic acid may also be used for purposes not listed in this medication guide.

Call your doctor at once if you have mood changes, severe itching, swelling, weight gain, trouble breathing, stomach pain, less urination, yellowing of your skin or eyes, bloody or tarry stools, or if you cough up blood or vomit that looks like coffee grounds.

You will need liver function tests and you may need to stop taking obeticholic acid based on the results. Do not stop the medicine without your doctor's advice.

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.

Take with or without food.

You may be given medication to prevent itching, a common side effect of obeticholic acid. Call your doctor if itching becomes severe.

You will need liver function tests and you may need to stop taking obeticholic acid based on the results, even if you have no symptoms.

Do not stop taking obeticholic acid without your doctor's advice.

Store at room temperature away from moisture and heat.

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

Comments:
-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 (PBC):
-In patients without cirrhosis in combination with ursodeoxycholic acid (UDCA) with an inadequate to UDCA OR as monotherapy in patients
- In patients with compensated cirrhosis without evidence of portal hypertension in combination with UDCA with an inadequate to UDCA OR as monotherapy in patients

You should not use obeticholic acid if you are allergic to it, or if you have:

• advanced cirrhosis of the liver; or

• complete blockage of your bile ducts.

Your doctor will perform tests to make sure obeticholic acid is the right treatment for you. Tell your doctor if you've had liver problems, especially cirrhosis.

Tell your doctor if you are pregnant or breastfeeding.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Obeticholic acid may cause serious side effects. Call your doctor at once if you have:

• new or worsening feelings of weakness, tiredness, dizziness, or drowsiness;

• confusion, mood or behavior changes, slurred speech;

• severe itching;

• fever, chills, less urination;

• stomach pain, nausea, vomiting, diarrhea, loss of appetite;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• jaundice (yellowing of the skin or eyes); or

• fluid build-up around the stomach--bloating, weight gain, trouble breathing, swelling in your stomach or legs.

Your doses may be delayed or permanently discontinued if you have certain side effects.

Common side effects of obeticholic acid may include:

• skin rash, itching, dryness, 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.

Take your obeticholic acid dose 4 hours before or 4 hours after taking any of the following:

• colesevelam;

• cholestyramine; or

• colestipol.

Other drugs may affect obeticholic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.