Obeticholic acid

Name: Obeticholic acid

How should this medicine be used?

Obeticholic acid comes as a tablet to take by mouth. It is taken usually once a day with or without food. Take obeticholic acid at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take obeticholic acid exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may adjust your dose of obeticholic acid or delay your treatment. This will depend on how well the medication works for you or if you experience certain side effects. Continue to take obeticholic acid even if you feel well. Do not stop taking obeticholic acid without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Obeticholic acid Overview

Obeticholic acid is a prescription medication used to treat primary biliary cholangitis. 

Obeticholic acid is a semi-synthetic derivative of bile acid. This drug works by binding to a receptor in the liver, intestines, kidney, and adipose tissue and changing the body’s metabolism of lipids.

This medication is available as a tablet and is typically taken once a day, with or without food. 

Common side effects of obeticholic acid include itching, fatigue, stomach pain, joint pain, throat pain, and constipation. Obeticholic acid may cause dizziness. Do not drive or operate heavy machinery until you know this medication affects you. 

What should I discuss with my healthcare provider before taking obeticholic acid?

You should not use obeticholic acid if you are allergic to it, or if you have complete blockage of your bile ducts.

To make sure obeticholic acid is safe for you, tell your doctor if you have:

  • pre-existing liver disease.

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 is not known whether obeticholic acid passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Stability

Storage

Oral

Tablets

20–25°C (may be exposed to 15–30°C).1

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Importance of advising patients to report immediately to their clinician any symptoms of worsening liver disease or symptoms of complete biliary obstruction.1 Periodic laboratory testing may be warranted to assess liver function and/or monitor for changes in serum lipid concentrations.1

  • Importance of advising patients to contact their clinician if they experience pruritus or an increase in severity of pruritus.1

  • Importance of informing patients that obeticholic acid may be taken without regard to meals.1

  • Importance of taking obeticholic acid at least 4 hours (or as long an interval as possible) before or after taking a bile acid sequestrant.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription (e.g., bile acid sequestrants, warfarin) and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., hepatic impairment).1

  • Importance of advising women to inform clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Uses For obeticholic acid

Obeticholic acid is used alone or in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in patients who have received UDCA but did not work well.

obeticholic acid is available only with your doctor's prescription.

Brand Names U.S.

  • Ocaliva

Contraindications

Complete biliary obstruction

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to obeticholic acid or any component of the formulation.

Dosing Geriatric

Refer to adult dosing.

Dosing Renal Impairment

There are no dosage adjustments provided in the manufacturer′s labeling (has not been studied in patients with eGFR <60 mL/minute/1.73 m2).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience loss of strength or energy, abdominal pain, joint pain, throat pain, dizziness, constipation, or eczema. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of thyroid problems (change in weight without trying, anxiety, feeling restless, feeling very weak, hair thinning, depression, neck swelling, difficulty focusing, inability handling heat or cold, menstrual changes, tremors, or sweating), severe itching, swelling in the arms or legs, or abnormal heartbeat (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

For the Consumer

Applies to obeticholic acid: oral tablet

Along with its needed effects, obeticholic acid may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking obeticholic acid:

More common
  • Fever
  • severe itching skin
Incidence not known
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • dizziness
  • headache
  • loss of appetite
  • nausea
  • rash
  • stomach pain and bloating
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • yellow eyes or skin

Some side effects of obeticholic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach discomfort
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • fast, irregular, pounding, or racing heartbeat or pulse
  • muscle pain or stiffness
  • pain in the joints
  • rapid weight gain
  • sore throat
  • tingling of the hands or feet
  • unusual weight gain or loss
Less common
  • Skin rash, encrusted, scaly and oozing

Dose Adjustments

No adjustment recommended.

Dialysis

Data not available

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