Questions about 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.
LIVDELZI is the only treatment for adults with PBC to significantly improve key PBC lab results and itch.
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. Itch was measured using the NRS, a scale from 0 to 10 that measures itch severity, with 0 being no itch and 10 being the worst possible itch.
In a clinical trial, the main trial goal was to improve key PBC lab results by achieving alkaline phosphatase (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. 62% of participants taking LIVDELZI met the key trial goal for PBC treatment compared with 20% of participants taking placebo. A secondary trial goal was to measure itch reduction in participants with Numerical Rating Scale (NRS) scores of 4 or higher. LIVDELZI reduced NRS scores by an average of 3.2 vs 1.7 for placebo at 6 months.
LIVDELZI is designed to target a specific cell receptor in the liver called PPAR-delta. Activation of PPAR-delta is known to help reduce the production of bile acids.
The way LIVDELZI works to treat primary biliary cholangitis (PBC) is not fully understood.
PPAR-delta=peroxisome proliferator-activated receptor delta.
LIVDELZI is used to treat primary biliary cholangitis (PBC) in adults in combination with ursodiol (ursodeoxycholic acid, or UDCA) for people who don’t respond well enough to ursodiol alone. LIVDELZI can also be used by itself in people who are unable to tolerate ursodiol.
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.
The most common side effects of LIVDELZI include headache, stomach (abdominal) pain, nausea, abdominal swelling (distension), and dizziness.
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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Questions about starting treatment with 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.
Other considerations
You may also have other questions you want to ask, such as:
- How can LIVDELZI help my primary biliary cholangitis (PBC)?
- Could LIVDELZI be used to help lower my alkaline phosphatase (ALP)?
- Can LIVDELZI help reduce my PBC itch?
- What are the potential side effects?
The LIVDELZI Conversation Guide can help you have an informed discussion about LIVDELZI during your next appointment.
The Getting Started With LIVDELZI Brochure provides information about how LIVDELZI performed in clinical trials, how to take LIVDELZI, details about financial assistance, and more.
Questions about taking LIVDELZI
LIVDELZI is taken once a day at any time, with or without food.
- Follow your healthcare provider’s instructions in regard to taking LIVDELZI with ursodiol, on its own, and/or with other medications you may be taking
- Do not take more LIVDELZI than your healthcare provider tells you to
- If you take too much LIVDELZI, call your healthcare provider or get emergency medical help right away
It’s important to take LIVDELZI as prescribed by your healthcare provider. If you miss a dose, call your healthcare provider immediately. Missing a dose lowers the amount of medicine in your body.
Questions about financial assistance for LIVDELZI
You may pay as low as a $0 co-pay* with the LIVDELZI Co-pay Coupon Program.
If you have commercial insurance, the LIVDELZI Co-pay Coupon Program may help you save on your prescribed Gilead medication.
If you do not have insurance, the Patient Assistance Program can determine if your financial situation qualifies you to receive your medication free of charge.
*Co-pay coupon support is available for commercially insured eligible patients only. Additional restrictions may apply. Subject to change; for full terms and conditions, visit www.mysupportpath.com/co-pay. This is not health insurance. Only accepted at participating pharmacies.
The Gilead Support Path® Program offers information and resources to help people prescribed LIVDELZI understand their coverage and financial options.
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.