Ocaliva: Uses, Side Effects and Dosage

What is OCALIVA used for?

OCALIVA is used to treat primary biliary cholangitis (PBC). PBC is a disease of the liver causing destruction of the bile ducts.

For the following indication(s) OCALIVA has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional.

• the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or
• as monotherapy in adults unable to tolerate UDCA.

Serious Warnings and Precautions

• Your healthcare professional will check your liver before you take OCALIVA and while you are taking it.
• These liver tests will help your healthcare professional decide if it is safe for you to start taking OCALIVA and safe for you to continue taking OCALIVA.
• Worsening of liver problems or liver failure has happened in people with primary biliary cholangitis (PBC) with liver cirrhosis when taking OCALIVA. This can lead to liver transplant or death.
• Do not take OCALIVA if you have PBC with liver cirrhosis with symptoms such as blood in your stool or vomiting blood, developing fluid in your stomach area, confusion or if your healthcare professional found abnormalities in certain tests that check your liver.

What is a Notice of Compliance with Conditions (NOC/c)?

How does OCALIVA work?

Obeticholic acid decreases the production of bile acids in your liver and increases the removal of bile from the liver. This may slow or prevent progression of the disease.

What are the ingredients in OCALIVA?

Medicinal ingredients: obeticholic acid

Non-medicinal ingredients: magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating is Opadry II (Yellow) containing polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol (polyethylene glycol 3350), talc, and iron oxide yellow.

OCALIVA comes in the following dosage forms:

5 mg and 10 mg tablets

Do not use OCALIVA if:

• You have an allergy to obeticholic acid or to any other ingredient in OCALIVA (see

  “What are the Ingredients in OCALIVA?”).

• You have late stage liver cirrhosis (decompensated cirrhosis) or have previously experienced a prior decompensation event with symptoms such as blood in your stool or vomiting blood, developing fluid in your stomach area, or confusion.

• You have liver cirrhosis (compensated cirrhosis) and show signs of portal hypertension

  (high blood pressure in the veins in your liver).

• You have complete blockage of bile flow.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OCALIVA. Talk about any health conditions or problems you may have, including if you:

• Are pregnant or planning to become pregnant.

• Are breast-feeding or planning to breast-feed.

• See any signs of liver disease or biliary obstruction getting worse:

  • Tiredness.
  • Yellowish skin.
  • Stomach or abdominal pain.

Talk to your healthcare professional if the following occurs while taking OCALIVA:

• You develop severe, intense, widespread or persistent itching or itching that causes discomfort and sleep loss.

• You develop any of the following symptoms of worsening liver problems such as:

  • swelling of your stomach-area from a build-up of fluid
  • yellowing of your skin or the whites of your eyes
  • black, tarry, or bloody stools
  • coughing up or vomiting blood
  • mental changes

• You develop any of the following symptoms and they are severe or do not go away:

  • stomach-area pain
  • nausea, vomiting, or diarrhea
  • loss of appetite or weight loss
  • new or worsening fatigue
  • weakness
  • fever and chills
  • light-headedness
  • less frequent urination

Other warnings you should know about:

Patients with PBC may have high blood fat (lipid) levels. While you are taking OCALIVA, your healthcare professional may order tests to check your blood lipid levels.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with OCALIVA:

• Cholestyramine
• Colestipol
• Colesevelam
• Warfarin
• Theophylline
• Tizanidine
• Caffeine

You may feel the effects of caffeine for longer while taking OCALIVA.

How to take OCALIVA:

• Take OCALIVA 30 minutes before breakfast.

• Take OCALIVA more than 4 hours before or after taking any of the following drugs:

  • Cholestyramine
  • Colesevelam
  • Colestipol

Usual dose:

• The recommended starting dosage of OCALIVA is 5 mg orally once daily.
• Before you start OCALIVA, and while you are taking it, your healthcare professional will do tests to check your liver. These tests will help them decide if it is safe for you to start taking OCALIVA and safe for you to continue taking OCALIVA.
• Do not exceed the dosage that your healthcare professional prescribes for you.
• If your healthcare professional feels your liver function tests are not improving enough, they may increase the dosage.

Overdose:

If you think you, or a person you are caring for, have taken too much OCALIVA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you do miss a dose of OCALIVA, take the tablet as soon as possible. Then take the next dose as usual.

If it is nearly time for your next dose, wait and take the next dose at your usual time. Do not take a double dose (two doses close together).

What are possible side effects from using OCALIVA?

These are not all the possible side effects you may have when taking OCALIVA. If you experience any side effects not listed here, tell your healthcare professional.

Some patients may experience side effects including the following:

Very common side effects (may affect more than 1 in 10 people):

• Stomach pain
• Itching of the skin
• Feeling tired

Common side effects (may affect up to 1 in 10 people):

• Thyroid hormone difficulty
• Dizziness
• Fast or irregular heart beat (palpitations)
• Pain in the mouth
• Constipation
• Dry skin, redness of the skin (eczema)
• Rash
• Pain in your joints
• Swelling in the hands and feet
• Fever

While you are taking OCALIVA, lab tests will be run by your healthcare professional every so often. This is to assess liver function.

Tell your healthcare professional right away if you have new onset or worsening of these conditions.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store at controlled room temperature 15°to 30°.

Keep out of reach and sight of children.

If you want more information about OCALIVA:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); the manufacturer’s website, www.advanzpharma.com, or by calling 1-800-982-0340.

Last Revised NOV 16, 2022.