Ocaliva is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone in adults who cannot tolerate UDCA.

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.

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.

Do not take Ocaliva if you have primary biliary cholangitis with liver cirrhosis with symptoms such as fluid in the stomach-area or confusion (decompensated liver cirrhosis) or with abnormalities in certain tests that check your liver.

Take Ocaliva exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take with or without food.

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

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

Do not stop taking this medicine 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:

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

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

• advanced cirrhosis of the liver; or

• complete blockage of your bile ducts.

Your doctor will perform tests to make sure Ocaliva 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 to Ocaliva: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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 Ocaliva side effects 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 Ocaliva dose 4 hours before or 4 hours after taking any of the following:

• colesevelam;

• cholestyramine; or

• colestipol.

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