Ocaliva

Pronunciation: o-CAL-eh-vah
Generic name: obeticholic acid
Dosage form: oral tablets
Drug class: Miscellaneous GI agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 29, 2024.

What is Ocaliva?

Ocaliva may be used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone in adults who cannot tolerate UDCA. Ocaliva can only be used in patients without cirrhosis or with compensated cirrhosis but no evidence of portal hypertension.

• It is not known if taking Ocaliva will improve your chance of survival or improve your symptoms of PBC.

Ocaliva's mechanism of action involves activating the farnesoid X receptor (FXR) in the liver and intestines. This receptor plays a vital role in regulating the body's balance of bile acids, lipids, and glucose. When activated by Ocaliva, FXR helps reduce the liver's production of bile acids, which helps to alleviate cholestasis (the accumulation of bile acids in the liver), a key feature of PBC.

The FDA declined full approval for Ocaliva on November 12, 2024, stating that Ocaliva did not have a favorable benefit-risk profile as a second-line agent in PBC patients. It is not clear if Ocaliva will be withdrawn in the future. Ocaliva was granted accelerated approval by the FDA in 2016, but this approval is based on a continued benefit being shown in clinical trials. There is no Ocaliva generic.

Ocaliva cost

Through the Intercept Copay Card Program, Ocaliva costs $0 with an Ocaliva Copay card for 90% of commercially insured patients. 

For people with Medicare or Medicaid, your Care Coordinator can identify independent financial assistance that can help cover the cost of treatment. If you have no insurance or limited insurance, you may be able to receive Ocaliva at little to no cost.

For the full cost of Ocaliva see Ocaliva Prices, Coupons, Copay Cards & Patient Assistance.

Ocaliva side effects

The most common side effects of Ocaliva are:

• tiredness
• stomach pain and discomfort
• rash
• joint pain
• mouth and throat pain
• dizziness
• constipation
• swelling in your hands, ankles, or feet
• fast or irregular heartbeat
• fever
• changes in how your thyroid gland works
• dryness, irritation, redness, crusting, or drainage of the skin (eczema).

Serious side effects and warnings

Ocaliva has a Boxed Warning for worsening of liver problems or liver failure.

Worsening of liver problems or liver failure, in some cases leading to liver transplant or death has happened in people with primary biliary cholangitis (PBC) with liver cirrhosis when taking Ocaliva. Tell your healthcare provider right away if you have any of the following symptoms of worsening liver problems during treatment with Ocaliva:

• 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, or your vomit looks like “coffee grounds”
• mental changes such as confusion, sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality.

Also, tell your healthcare provider right away if you have any of the following symptoms during treatment with
Ocaliva 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.

Severe itching (pruritus). Itching is a common side effect of Ocaliva and can sometimes become severe (intense itching or itching over much of your body). Severe itching can cause discomfort, problems sleeping, and problems doing daily activities and usually needs to be treated. Tell your healthcare provider if you get severe itching or if your itching gets worse.

Lower HDL-C (“good” cholesterol) levels. Ocaliva can lower high levels of HDL-C. Your healthcare provider will check your cholesterol levels during your treatment.

Get emergency medical help if you have signs of an allergic reaction to Ocaliva: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

It is not known if Ocaliva is safe and effective in children.

These are not all the possible side effects of Ocaliva. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking this medicine

Do not take Ocaliva if you:

• are allergic to obeticholic acid, Ocaliva, or any of the inactive ingredients in the tablets
• have PBC with liver cirrhosis with symptoms such as fluid in the stomach area or confusion (decompensated liver cirrhosis) or with abnormalities in certain tests that check your liver
• have a complete blockage of the bile ducts in your liver or gallbladder.

Before taking Ocaliva, tell your doctor about all your medical conditions, including if you:

• have liver problems, especially cirrhosis
• are pregnant or planning to become pregnant
• are breastfeeding or intend to breastfeed.

Before you start taking Ocaliva, and during your treatment, your healthcare provider will do tests to check your liver. These tests will help your healthcare provider decide if it is safe for you to start taking Ocaliva and safe to continue taking it. 

Pregnancy

It is not known if Ocaliva will harm your unborn baby.

Breastfeeding

It is not known if Ocaliva passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take Ocaliva.

How should I take Ocaliva?

Take Ocaliva exactly as prescribed by your doctor. Follow all directions on the Ocaliva Package Insert and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

• Ocaliva is usually taken 1 time per day.
• Do not take more Ocaliva than your healthcare provider tells you to.
• Take Ocaliva with or without food.

If you take a bile acid binding resin, take Ocaliva at least 4 hours before or 4 hours after you take your bile acid binding resin. If this is not possible, space the time between taking Ocaliva and your bile acid-binding resin as far apart as possible.

You may be given medication to prevent itching, a common side effect of Ocaliva. Call your doctor if itching becomes severe.

You will need liver function tests and you may need to stop taking Ocaliva based on the results, even if you have no symptoms.

Do not stop taking this medicine without your doctor's advice.

Ocaliva dosing information

Usual Ocaliva adult dose for primary biliary cholangitis (PBC): Ocaliva 5 mg once daily for the first 3 months. 

• After the first 3 months, your healthcare provider will measure your alkaline phosphatase (ALP) and total bilirubin levels.
• In patients who have achieved an adequate reduction in ALP, or who are not tolerating Ocaliva, keep the maintenance dose at Ocaliva 5 mg once a day.
• In patients who have not achieved an adequate reduction in ALP, and who are tolerating Ocaliva, increase the dose of Ocaliva to 10 mg once a day.
• Maximum dose: Ocaliva 10 mg/day

Related/similar drugs

ursodiol, Actigall, Livdelzi, seladelpar, Iqirvo

What happens if I miss a dose?

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.

What happens if I take too much Ocaliva?

If you take too much Ocaliva, call your healthcare provider, get emergency medical help right away, or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Ocaliva?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect Ocaliva?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ocaliva can affect the way certain medicines work. Certain other medicines may affect the way Ocaliva works. Especially tell your healthcare provider if you take:

• Warfarin. There is the potential for Ocaliva to interact with warfarin and lower the INR. The dosage of warfarin may need to be adjusted to maintain the INR in the target range
• CYP1A2 substrates with a narrow therapeutic index, such as theophylline and tizanidine. Levels of these substrates may increase if used at the same time as Ocaliva. Monitor. 
• Inhibitors of the bile salt efflux pump, such as cyclosporine. Avoid use. If concomitant use is necessary, monitor serum transaminases and bilirubin.

Take your Ocaliva dose 4 hours before or 4 hours after taking any of the following: colesevelam, cholestyramine, or colestipol.

This is not a complete list of interactions. See the Ocaliva Prescribing Information for a full list.

Storage

Store Ocaliva at room temperature away from moisture and heat.

Keep out of the reach of children.

Ocaliva ingredients

Active ingredient: obeticholic acid

Inactive ingredients: microcrystalline cellulose, sodium starch glycolate, magnesium stearate

Film coating: Opadry II (Yellow) containing polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol (polyethylene glycol 3350), talc, iron oxide yellow.

Who makes Ocaliva?

Intercept Pharmaceuticals, Inc. makes Ocaliva.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer