How is LIVDELZI different?
LIVDELZI is the only treatment for adults with PBC to significantly improve key PBC lab results and itch.
In the clinical trial, LIVDELZI:
Improved key
PBC lab results
in significantly more people compared with placebo at 1 year
Lowered alkaline phosphatase (ALP) to normal
at 1 year, in significantly more people compared with placebo
Reduced
itch
starting at 1 month, with significant improvement seen at 6 months
Trial design
In a clinical trial of 193 people with PBC, 128 people took LIVDELZI with or without ursodeoxycholic acid (ursodiol). The results were compared with 65 people who took placebo (a treatment that does not contain medicine) with or without ursodiol.
Trial data
Key PBC lab results: The main trial goal was to improve key PBC lab results by achieving ALP levels of less than 1.67 times the upper limit of normal (ULN), achieving ALP decreases of at least 15% from the start of the trial, and maintaining normal bilirubin levels at 1 year. 62% of people taking LIVDELZI met the main trial goal for PBC treatment compared with 20% of people taking placebo.
ALP: A secondary trial goal was to measure ALP normalization at 1 year. LIVDELZI lowered ALP to normal in 25% of people compared with 0% of people taking placebo.
Itch: Another secondary trial goal was to measure itch reduction in people with Numerical Rating Scale (NRS) scores of 4 or higher at 6 months. The average NRS score at the start of the trial was 6.1 for LIVDELZI (49 people) and 6.6 for placebo (23 people). The NRS is a scale from 0 to 10 that measures itch severity, with 0 being no itch and 10 being the worst possible itch. LIVDELZI reduced NRS scores by an average of 3.2 vs 1.7 for placebo at 6 months.
LIVDELZI safety and tolerability
The most common side effects for LIVDELZI in the clinical trial include headache, stomach (abdominal) pain, nausea, abdominal swelling (distension), and dizziness.
LIVDELZI has an established safety profile and a lower discontinuation rate (3.1%) due to side effects vs placebo (4.6%).
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LIVDELZI and your treatment goals
Decisions about your health are personal, and there may be
certain considerations that are important to you when picking a treatment option:
- Wanting to improve your PBC itch
- Taking your other conditions or treatments into account
- Reducing your key PBC levels (like ALP)
- Finding a treatment that fits with your daily routine
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If any of the reasons above match your current mindset, it may be time to have a conversation with your healthcare team to see if LIVDELZI could help
Talking to your healthcare team about LIVDELZI
If you’re ready to talk to your healthcare provider about LIVDELZI, doing a little planning before your next appointment may be helpful. You’ll want to make sure you say everything you want to say and get all of your questions answered. Taking some simple steps to be prepared can help make that happen.
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Preparing for your appointment
Before your appointment, write down what you want to talk about,
such as:
- Any concerns you’re having with your current treatment, including any symptoms or side effects you’ve been experiencing
- Reasons why you want to talk about adjusting your treatment plan
- Questions you have about your current treatment or LIVDELZI
Bring your list to your next appointment so you can go over it with your healthcare provider. This is a way to feel empowered sharing your goals and concerns for treatment and have a more informed conversation.
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Starting the conversation
Sometimes starting the conversation is the hardest part. To get the conversation going, you can say something as simple as:
“I read about LIVDELZI, and I’d like to know if it might work for my treatment plan.”
You can also bring up LIVDELZI when you and your healthcare provider are already discussing other things related to your PBC, such as the results of a FibroScan, your latest PBC lab levels, or your symptoms. For example, you could ask:
- Can LIVDELZI help treat my PBC?
- Could LIVDELZI be used to help lower my ALP?
- Can LIVDELZI help reduce my PBC itch?
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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.