Obeticholic acid belongs to the class of medications called FXR agonists and bile acid analogues. It is used in addition to other medications to treat primary biliary cholangitis (PBC), a form of liver disease, when other treatments have not been successful. It may also be taken alone if other medications are not tolerated.

PBC causes bile to build up in the liver, causing inflammation in the bile ducts of the liver. Obeticholic acid decreases the amount of bile produced and increases the flow of bile out of the liver. This may slow or prevent disease progression.

Obeticholic acid has been granted a notice of compliance with conditions (NOC/c) by Health Canada. This means that Health Canada has approved Ocaliva (Obeticholic-acid) to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.

Ocaliva (Obeticholic-acid) may be available under multiple brand names and/or in several different forms. Any specific brand name of Ocaliva (Obeticholic-acid) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Ocaliva (Obeticholic-acid) may not be used for all of the conditions discussed here.

Your doctor may have suggested Ocaliva (Obeticholic-acid) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Ocaliva (Obeticholic-acid), speak to your doctor. Do not stop taking Ocaliva (Obeticholic-acid) without consulting your doctor.

Do not give Ocaliva (Obeticholic-acid) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Ocaliva (Obeticholic-acid) if their doctor has not prescribed it.

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For adults, the recommended starting dose of obeticholic acid is 5 mg taken by mouth, once daily. After 6 months, your doctor may recommend increasing the dose to 10 mg taken once daily, if the medication hasn't had the desired effect. Your doctor will determine the effectiveness of the medication by testing your blood for liver enzymes. A decrease in the amount of liver enzymes in the blood may indicate benefit from the medication.

The maximum dose of obeticholic acid is 10 mg taken once daily.

Take Ocaliva (Obeticholic-acid) 30 minutes before breakfast. If you are taking a bile acid binding resin, such as Cholestyramine or Colestipol, take obeticholic acid at least 4 hours before or 4 hours after taking the bile acid binding resin.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Ocaliva (Obeticholic-acid) exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice

Store Ocaliva (Obeticholic-acid) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Ocaliva (Obeticholic-acid). If you are concerned about side effects, discuss the risks and benefits of Ocaliva (Obeticholic-acid) with your doctor.

The following side effects have been reported by at least 1% of people taking Ocaliva (Obeticholic-acid). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Constipation
• dizziness
• dry or red skin
• fatigue
• itchy skin
• mouth pain
• stomach pain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• fast, pounding, or irregular heart beat
• Fever
• joint pain
• rash
• severe, widespread itchiness
• swelling of the hands and feet
• symptoms of Hypothyroidism (e.g., dry skin, constipation, weight gain, fatigue, aches, pains and stiffness, intolerance to cold, Depression, memory problems)
• yellowing skin

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Ocaliva (Obeticholic-acid).

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5 mg
Each off-white-to-yellow, round tablet, debossed with INT on one side and 5 on the other side, contains 5 mg of obeticholic acid. Nonmedicinal ingredients: microcrystalline cellulose, sodium starch glycolate, and magnesium stearate; film coating: Opadry II (Yellow) containing polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol (Polyethylene Glycol 3350), talc, and iron oxide yellow.

10 mg
Each off-white-to-yellow, triangular tablet, debossed with INT on one side and 10 on the other side, contains 10 mg of obeticholic acid. Nonmedicinal ingredients: microcrystalline cellulose, sodium starch glycolate, and magnesium stearate; film coating: Opadry II (Yellow) containing polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol (polyethylene glycol 3350), talc, and iron oxide yellow.

Do not take Ocaliva (Obeticholic-acid) if you:

• are allergic to obeticholic acid or any ingredients of the medication
• have a complete blockage in the biliary ducts (biliary obstruction)

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There may be an interaction between obeticholic acid and any of the following:

• Asenapine
• Bromazepam
• caffeine
• cholestyramine
• Clomipramine
• Clozapine
• Colesevelam
• colestipol
• Cyclobenzaprine
• Cyclosporine
• Dacarbazine
• Duloxetine
• Flutamide
• Fluvoxamine
• lidocaine
• melatonin
• Mexiletine
• Mirtazapine
• Olanzapine
• Pimozide
• Pirfenidone
• Propranolol
• Rasagiline
• Ropinirole
• Sorafenib
• Stiripentol
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• tipranavir
• Tizanidine
• trifluoperazine
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Ocaliva (Obeticholic-acid). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Ocaliva (Obeticholic-acid).

Cholesterol: Ocaliva (Obeticholic-acid) can cause a decrease in the amount of HDL ("good cholesterol"), which can contribute to increased risk of heart disease. If you have or are at risk of developing heart disease, discuss with your doctor how Ocaliva (Obeticholic-acid) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ocaliva (Obeticholic-acid), and whether any special monitoring is needed.

Itchiness: Itchiness is a common effect of taking obeticholic acid. It usually decreases in severity over time. If itchiness becomes widespread or intense, contact your doctor.

Liver function:  Liver disease or reduced liver function may cause Ocaliva (Obeticholic-acid) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Ocaliva (Obeticholic-acid) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ocaliva (Obeticholic-acid), and whether any special monitoring is needed.

Obeticholic acid can cause further decreases in liver function and produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking Ocaliva (Obeticholic-acid). If you have severe changes in liver function, your doctor may recommend that you take a lower dose of Ocaliva (Obeticholic-acid) or stop taking it altogether.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Pregnancy: Ocaliva (Obeticholic-acid) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Ocaliva (Obeticholic-acid), contact your doctor immediately.

Breast-feeding: It is not known if obeticholic acid passes into breast milk. If you are a breast-feeding mother and are taking Ocaliva (Obeticholic-acid), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Ocaliva (Obeticholic-acid) have not been established for children less than 16 years old.

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