obeticholic acid (Ocaliva)

Brand Names: Ocaliva

Generic Name: obeticholic acid

• What is obeticholic acid (Ocaliva)?
• What are the possible side effects of obeticholic acid (Ocaliva)?
• What is the most important information I should know about obeticholic acid (Ocaliva)?
• What should I discuss with my healthcare provider before taking obeticholic acid (Ocaliva)?
• How should I take obeticholic acid (Ocaliva)?
• What happens if I miss a dose (Ocaliva)?
• What happens if I overdose (Ocaliva)?
• What should I avoid while taking obeticholic acid (Ocaliva)?
• What other drugs will affect obeticholic acid (Ocaliva)?
• Where can I get more information (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.

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 this medicine, but further studies are needed.

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

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:

• severe itching;
• 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;
• vomiting, diarrhea, weight loss;
• 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:

• itching;
• 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.

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.

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 this medicine 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.

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.

QUESTION

Long-term heavy alcohol consumption can cause: See Answer

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.

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.

• colesevelam;
• cholestyramine; or
• colestipol.

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.

Your pharmacist can provide more information about obeticholic acid.

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