obeticholic acid 5 mg tablet

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Medication name

Generic name:
Obeticholic acid - oral

Pronunciation
(oh-BET-i-KOE-lik AS-id)

Brand name(s)
Ocaliva

Warning

Although this medication is used to treat a certain liver disease, it has caused serious (even fatal) worsening of liver function, especially when taken at a higher dose than recommended. Your doctor should prescribe your dose based on your medical condition and response to treatment. For some patients whose liver disease is more serious, the starting dose is decreased to once weekly. To lower your chance of side effects, follow your doctor's dosage instructions carefully.

Uses

This medication is used alone or in combination treatment for a certain liver disease (primary biliary cholangitis-PBC). This disease slowly destroys the bile ducts in the liver. When bile ducts are damaged, harmful substances can build up in bile and scar the liver. Obeticholic acid works by causing your liver to make less bile, and by helping bile flow out of the liver. Obeticholic acid may help slow worsening of primary biliary cholangitis and decrease symptoms such as tiredness, itchy skin, abdominal pain, and dry eyes and mouth.

How to use

See also Warning section.

Read the Medication Guide provided by your pharmacist before you start taking obeticholic acid and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. The dosage is based on your medical condition, lab tests, and response to treatment. If you have side effects, your doctor may direct you to temporarily stop taking this medication, or to take it less often. Ask your doctor or pharmacist if you are not sure about your dosage instructions.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day you have a scheduled dose. If your doctor has prescribed a once- or twice-weekly schedule, it may help to mark your calendar.

If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take obeticholic acid at least 4 hours before or at least 4 hours after taking these medications. These products can keep you from absorbing obeticholic acid fully.

Tell your doctor if your condition does not get better or if it gets worse.

Side effects

Tiredness, mouth/throat pain, or fast/pounding heartbeat may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Although this medication is used to treat primary biliary cholangitis (PBC), it may also cause worsening of some liver symptoms. Tell your doctor right away if you have symptoms such as new or worsening skin itching, nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine, muscle/joint pain, swelling legs/feet/abdomen, or mental/mood changes. Your doctor may prescribe other medications such as bile acid-binding resins or antihistamines, or temporarily stop/adjust your dose of medication to help manage some side effects. Talk with your doctor about the risks and benefits of taking this medication.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking obeticholic acid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • bile duct blockage

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as cholesterol levels, liver function tests) should be done while you are taking this medication. Keep all medical and lab appointments.

Missed dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised May 2018.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.