If you’re starting LIVDELZI, consider your treatment goals such as improving your PBC lab results, lowering your alkaline phosphatase (ALP), and improving itch.
PBC is chronic, meaning long-lasting, and progressive, meaning it can become worse over time. The good news is that PBC can be managed—but it’s important to follow your treatment plan exactly as your healthcare provider tells you to throughout your PBC treatment journey.
Follow some of these tips to help you stay on track with your treatment plan.
Set your goals
Setting goals from the start of your treatment can help you stay on track and celebrate your wins, from little achievements to big moments.
What motivates you?
First, focus on what’s important to you. Keeping your priorities in mind can help you stay motivated.
In life, roadblocks are sometimes unavoidable. The same goes for PBC treatment. When challenges come up, try responding to them as quickly as you can to help stay on track with your treatment. For example:
| Challenge | Response |
| Missing a dose or getting off track with taking LIVDELZI | Talk to your healthcare provider and examine your routines to see if a new approach is needed to help remind you to take LIVDELZI each day. |
| Experiencing side effects | Tell your healthcare provider about any side effect that bothers you or does not go away. Ask if there are ways to address the side effects that you are experiencing. |
| Feeling “stuck” or like you’re not making enough progress | Talk to your healthcare provider about your progress and treatment concerns. Reflect on how far you’ve come since you started treatment and how this progress may be supporting your treatment goals.
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It takes time and repetition to create a positive habit. But once you do, you may find that it makes progress easier and more consistent.
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.