All About Ocaliva

What is Ocaliva taken for?

What it treats

Ocaliva is taken to treat PBC. This is an autoimmune condition in which your immune system attacks the bile ducts in your liver. Bile is a fluid that helps digest fats. Bile ducts carry bile from the liver to the intestines. When these ducts aren’t working properly due to PBC, bile can build up in the liver. This buildup can cause damage over time.

Early symptoms of PBC may include:

• tiredness
• itchy skin
• dry mouth or eyes

More specifically, Ocaliva is taken to treat PBC in adults:

• who do not have cirrhosis (scarring of the liver), or
• who have compensated cirrhosis but do not have portal hypertension (Compensated cirrhosis is scarring of the liver that’s not causing symptoms. Portal hypertension is increased pressure in the vein that carries blood to your liver.)

Ocaliva is taken along with ursodiol when ursodiol by itself isn’t helping enough. (Ursodiol [Urso] is a prescription medication that’s also known as ursodeoxycholic acid [UDCA].) Or Ocaliva may be taken alone for adults who cannot take ursodiol.

How it works

Ocaliva works by activating a protein called farnesoid X receptor (FXR), which is found in the liver and intestines. FXR helps regulate several important processes in the body, such as metabolism and production of bile acid. By Ocaliva’s mechanism of action, FXR reduces how much bile is made from cholesterol. It also helps move bile acids out of the liver.

This helps keep bile acids in the body at a healthy level. That can slow the buildup of bile in the liver and protect the liver from further damage. Studies have shown that Ocaliva can improve results of a specific blood test. This test measures liver problems in certain people with PBC.

If you have questions about how Ocaliva works, talk with your doctor or pharmacist.

What are Ocaliva’s side effects?

Like most drugs, Ocaliva may cause mild to serious side effects. The lists below contain some of the more common side effects Ocaliva may cause. But they don’t include all side effects possible with the drug.

Keep in mind that side effects of a drug can depend on:

• your age
• other health conditions you have
• other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Ocaliva. They can also suggest ways to help reduce side effects.

Mild side effects

Mild side effects of Ocaliva that have been reported include:

• mild skin itchiness
• fatigue (low energy)
• pain or discomfort in your abdomen
• rash
• sore throat
• dizziness
• constipation
• joint pain

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

To learn about other mild side effects, talk with your doctor or pharmacist. Or read Ocaliva’s prescribing information.

Serious side effects

Serious side effects from Ocaliva can occur, but they aren’t common. If you have serious side effects from Ocaliva, call your doctor right away. But if you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Ocaliva that have been reported include:

• severe skin itchiness (or itchiness that gets worse than usual)
• significantly decreased levels of high-density lipoprotein cholesterol (“good” cholesterol) in your blood
• boxed warning: risk of worsening liver problems and liver failure in people with PBC and cirrhosis (liver scarring)

For more information about the boxed warning, see the “What should be considered before taking Ocaliva?” section.

ALLERGIC REACTION

For some people, Ocaliva can cause an allergic reaction. But this side effect wasn’t reported in the drug’s studies.

In general, symptoms of allergic reaction can be mild or serious.

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. They also can determine whether you should keep taking Ocaliva.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911. Or call your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

Your doctor can confirm whether you’ve had a serious allergic reaction to Ocaliva. If so, they may have you switch to a different treatment.

What is Ocaliva’s dosage?

Your doctor will recommend the dosage of Ocaliva that’s right for you. Below are commonly used dosages, but always take the dosage your doctor prescribes.

Form and strengths

Ocaliva is available as an oral tablet in two strengths: 5 milligrams (mg) and 10 mg.

Recommended dosage

The recommended starting dosage of Ocaliva is 5 mg once daily.

After 3 months, your doctor may increase your dosage to 10 mg once daily. This depends on how well your body responds to the medication. It also depends on whether you’re having certain side effects.

Questions about taking Ocaliva

Below are some common questions about taking Ocaliva.

• Can Ocaliva be chewed, crushed, or split? The drugmaker doesn’t offer guidance on whether you can chew, crush, or split Ocaliva tablets. If you have difficulty swallowing your medication, you can get tips on how to swallow pills. Or you can ask your doctor or pharmacist for advice.
• Should I take Ocaliva with food? You can take Ocaliva with or without food.
• Is there a best time of day to take Ocaliva? You can take Ocaliva at any time of day. But it’s best to take it around the same time each day. This helps keep a consistent level of the drug in your body, which helps Ocaliva work effectively.
• What if I miss a dose of Ocaliva? If you miss a dose of Ocaliva, take it as soon as you remember. But if it’s almost time to take your next dose, skip the missed dose. And then take the next dose at its usual time. You should not take two doses together to make up for a missed dose. Doing so could raise your risk of side effects.
• Will I need to take Ocaliva long term? Ocaliva is typically taken as a long-term treatment. You and your doctor can determine whether it’s safe and effective for your condition. If you agree that it is, you’ll likely take it long term.
• How long does Ocaliva take to work? Ocaliva begins to work after you take your first dose. But you likely won’t feel the drug working in your body. Your doctor will check whether Ocaliva is working to treat your condition. To do so, they’ll order liver function tests and other blood tests throughout your treatment.

Overdose

Do not take more Ocaliva than your doctor prescribes, as this can lead to harmful effects.

Symptoms of overdose

An overdose of Ocaliva may cause new or worsening signs and symptoms of liver problems, such as:

• changes in liver function tests
• ascites (swelling in your abdomen due to fluid buildup around your liver)
• jaundice (yellowing of the skin or eyes)
• portal hypertension (increased pressure in the vein that carries blood to the liver)

What to do in case you take too much Ocaliva

Call your doctor if you think you’ve taken too much Ocaliva. You can also call 800-222-1222 to reach America’s Poison Centers or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number. Or go to the nearest emergency room.

What should be considered before taking Ocaliva?

Below is important information you should consider before taking Ocaliva.

Interactions

Taking a drug with certain medications, vaccines, foods, and other things can affect how the drug works. These effects are called interactions.

Ocaliva can interact with several other medications. No specific supplements are known to interact with Ocaliva.

Before taking Ocaliva, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, or supplements you take. Sharing this information can help you avoid potential interactions.

Drug interactions

Below is a list of medications that can interact with Ocaliva. This list does not contain all drugs that may interact with Ocaliva. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Ocaliva and alcohol

Alcohol is not known to interact with Ocaliva. But alcohol may make PBC worse. Because of this, your doctor may recommend that you avoid alcohol or limit the amount you drink.

Ocaliva and caffeine

Ocaliva may interact with caffeine. Caffeine is found in different foods and beverages, such as coffee, and certain medications. Because of this interaction, your doctor may recommend that you limit your intake of caffeine while taking Ocaliva.

Pregnancy and breastfeeding

It’s not known whether it’s safe to take Ocaliva during pregnancy or while breastfeeding. If you’re pregnant or breastfeeding or planning either, talk with your doctor before starting treatment with Ocaliva.

Boxed warning

Ocaliva has a boxed warning about the risk of worsening liver problems and liver failure in people with PBC and cirrhosis (liver scarring). A boxed warning is the most serious warning from the FDA about drug effects that may be dangerous.

Some people have had worsening liver problems and liver failure while taking Ocaliva. These problems can be serious or even life threatening. As a result, some people have had to get a liver transplant.

Because of this risk, doctors usually do not prescribe Ocaliva to treat PBC in people who have more advanced liver problems. This includes people who:

• have or ever had decompensated cirrhosis, which is scarring of the liver that causes symptoms
• have compensated cirrhosis, which is scarring of the liver that doesn’t cause symptoms yet, but have signs of portal hypertension (increased pressure in the vein that carries blood to the liver), such as enlarged veins that bleed

Your doctor will use blood tests to watch for signs of worsening liver problems. Ask your doctor how often you’ll need monitoring. Some people may need frequent testing. Also, tell your doctor right away if you develop new or unusual symptoms.

Symptoms of worsening liver problems or liver failure may include:

• abdominal pain
• bruising easily or unusual bleeding
• new or worsening stomach problems, such as nausea, vomiting, diarrhea, or loss of appetite
• jaundice (yellowing of the skin or eyes)
• unusual tiredness, confusion, or mood changes
• skin itchiness that gets worse than usual
• dark-colored urine
• bloody or black vomit

If your doctor determines that your liver problems are advancing, they’ll stop your treatment with Ocaliva.

Talk with your doctor if you’d like more information about this boxed warning.

Other warnings

Ocaliva can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors also may affect whether Ocaliva is a good treatment option for you.

Talk with your doctor about your health history before you take Ocaliva. Be sure to tell them if any of the following factors apply to you:

• severe liver problems, including decompensated cirrhosis (scarring of the liver that causes symptoms) or signs of portal hypertension (increased pressure in the vein that carries blood to the liver) (See the “Boxed warning” section just above.)
• blocked bile duct
• other types of liver problems, such as alcohol-associated liver disease
• previous allergic reaction to Ocaliva
• pregnancy
• breastfeeding

What are some frequently asked questions about Ocaliva?

What should I know about FDA approval of Ocaliva for PBC?

The FDA granted accelerated approval of Ocaliva in 2016 for certain adults who have PBC. This approval is based on certain information from clinical studies. Specifically, the studies show that Ocaliva reduces the levels of alkaline phosphatase (ALP) in people who have PBC.

ALP is a liver enzyme that can be released into your blood when your liver is stressed or damaged. People with PBC often have increased levels of ALP in their blood. This can be an early sign of the disease before they develop noticeable symptoms of liver problems.

It isn’t known yet whether Ocaliva reduces PBC symptoms or helps people live longer with the condition. The FDA might grant full approval of Ocaliva eventually. This could occur after researchers complete additional studies and the FDA reviews those findings. But the additional studies must show that the benefits of the medication outweigh its risks.

If you have questions about whether Ocaliva is right for you, talk with your doctor.

Did Ocaliva get FDA approval for NASH?

No, it did not. Ocaliva has not received approval from the FDA for nonalcoholic steatohepatitis (NASH). With NASH, fat cells build up in the liver. The condition is also known as metabolic dysfunction-associated steatohepatitis (MASH).

Currently, Ocaliva is approved only to treat PBC in certain adults. For more details, see the “What is Ocaliva taken for?” section above. To learn about more about NASH/MASH and how it’s treated, talk with your doctor.

Ocaliva cost and coupons

Whether or not you have health insurance, cost may be a factor when you’re considering Ocaliva. The price you’ll pay for Ocaliva may depend on several things, such as your treatment plan and the pharmacy you use.

If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. A program called Interconnect Savings Program may be available. The drug’s manufacturer, Intercept Pharmaceuticals, may offer an Ocaliva copay card or patient assistance program for eligible patients.

Learn more about saving on your prescriptions.