PBC is a rare autoimmune disease of the liver
PBC is chronic, meaning long-lasting, and progressive, meaning it can become worse over time.
PBC causes inflammation in the bile ducts of the liver
Over time, scarring from this inflammation can block the bile ducts, leading to liver damage and reduced liver function
If left untreated or not treated well enough, PBC can lead to end-stage liver disease and the need for a liver transplant
What causes PBC?
Measuring PBC progression
Your healthcare provider may monitor a few things to see if your PBC is under control or progressing, including:
ALP
An enzyme also known as alkaline phosphatase or “alk phos.”
Scarring
FibroScans are used to measure the amount of scarring in your liver.
Research has shown that elevated ALP levels
are associated with liver damage that may ultimately require a liver transplant
PBC symptoms
When the liver doesn’t function properly due to PBC, it can lead to symptoms that you may not realize are caused by liver disease. Some of the most common PBC symptoms include:
Up to 70% of people with PBC experience itch. For some people, itch can even interrupt sleep, which may contribute to daytime sleepiness and fatigue
Diagnosing PBC
Diagnosing PBC early is important so you can take steps to try to prevent further liver damage as PBC progresses.
Healthcare providers can typically diagnose PBC using:
- Blood tests to measure abnormal amounts of certain substances in your blood that are caused by PBC
- FibroScans to measure the amount of scarring in your liver caused by PBC
- Biopsy: Although less common, biopsy can be used to help diagnose, stage, and monitor PBC
Actor portrayals.
Actor portrayals.
Working with a specialist
When you’re first diagnosed with PBC, your healthcare provider
may refer you to a specialist.
- Hepatologists are doctors who specialize in treating the liver
- Gastroenterologists are doctors who specialize in treating the organs in your digestive tract, including the liver
These specialists have experience treating liver diseases and may have treated other people living with PBC. As such, these doctors should be more aware of the latest PBC treatment options and should be able to offer well-informed PBC management advice.
Treating PBC
PBC can’t be cured, but it can be managed with treatment. When treating PBC, your healthcare team will aim to improve key PBC lab results, including ALP. Getting your ALP to a lower level has been shown to reduce the risk of PBC progression.
PBC treatment goals
Lower your
ALP to:
Less than 1.67 x the upper limit of normal (ULN)
Lower the risk of disease progression
Disease progression may include:
- Liver scarring (fibrosis)
- Irreversible damage (cirrhosis)
- Liver failure and transplant
Reduce the symptoms caused by PBC
One of the most common PBC symptoms is itchy skin
First-line PBC treatment
The current primary treatment for PBC is ursodiol (also known as urso or UDCA). But about 40% of people with PBC continue having high ALP levels despite taking ursodiol.
Expanding treatment options
For the first time since 2016, there are additional treatment options available for people with PBC.
Tap for Important Safety Information, including serious side effects for bone fractures and changes in liver tests.
What is LIVDELZI?
LIVDELZI is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well to UDCA, or used alone in patients unable to tolerate UDCA.
LIVDELZI is not recommended for use in people who have advanced liver disease (decompensated cirrhosis). Symptoms of advanced liver disease may include confusion; having fluid in the stomach area (abdomen); black, tarry, or bloody stools; coughing up or vomiting blood; or having vomit that looks like “coffee grounds”.
It is not known if taking LIVDELZI will improve your chance of survival or prevent liver decompensation.
It is not known if LIVDELZI is safe and effective in children.
Important Safety Information
What are the possible side effects of LIVDELZI?
LIVDELZI can cause serious side effects, including:
- Bone fractures. Taking LIVDELZI may increase your risk of bone fractures. Tell your healthcare provider about any bone fractures, or if you develop pain, or have changes in your ability to move around.
- Changes in liver tests. Increased liver enzymes in the blood have happened when taking more LIVDELZI than prescribed. Your healthcare provider will do tests to check your liver before you start and during treatment with LIVDELZI.
Tell your healthcare provider right away if you have any of the following signs or symptoms of worsening liver problems during treatment with LIVDELZI:
- swelling of your stomach area (abdomen) from a build-up of fluid
- yellowing of your skin or the whites of your eyes
- pain on the right side of your stomach (abdomen)
- black, tarry, or bloody stools
- coughing up or vomiting blood, or your vomit looks like “coffee grounds”
- mental changes such as confusion, being sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality
The most common side effects of LIVDELZI include headache, stomach (abdominal) pain, nausea, abdominal swelling (distension), and dizziness.
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of LIVDELZI.
What should I tell my healthcare provider before taking LIVDELZI?
Tell your healthcare provider about all of your medical conditions, including if you:
- have advanced liver disease.
- think you may have a blockage of the bile ducts in your liver (biliary obstruction).
- are pregnant or plan to become pregnant. It is not known if LIVDELZI will harm your unborn baby.
- Pregnancy safety study. If you become pregnant while taking LIVDELZI, tell your healthcare provider right away. There is a pregnancy safety study for women who take LIVDELZI during pregnancy. Talk to your healthcare provider about providing information to the LIVDELZI pregnancy safety study. The purpose of this pregnancy safety study is to capture information about your health and your baby’s health. You or your healthcare provider can report your pregnancy by calling 1-800-445-3235.
- are breastfeeding or plan to breastfeed. It is not known if LIVDELZI passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take LIVDELZI.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LIVDELZI can affect the way certain medicines work. Certain other medicines may affect the way LIVDELZI works.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
Please see Important Facts about LIVDELZI.