Uses
What is Livdelzi used for?
Livdelzi (seladelpar) is commonly used to treat primary biliary cholangitis (PBC). PBC is a rare liver disease that occurs when your body’s immune system incorrectly attacks your bile ducts. Bile ducts are tubes that carry bile (a fluid that helps with digestion) out of the liver. Damage to the bile ducts can cause a backup of bile, which can lead to inflammation and damage to the liver.
Livdelzi may also be used for other conditions as determined by your healthcare provider.
How does Livdelzi work (mechanism of action)?
Livdelzi may work by blocking the formation of bile. This may help prevent a backup of bile. Bile buildup can lead to the liver damage that happens with primary biliary cholangitis (PBC).
How is Livdelzi supplied (dosage forms)?
Livdelzi is available as 10 mg oral capsules that are taken by mouth.
How should I store Livdelzi?
Livdelzi should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Side Effects
What are the most common side effects of Livdelzi?
The most common side effects of Livdelzi are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Headache
- Stomach pain
- Nausea
- Swelling of your stomach area
- Dizziness
There may be other side effects of Livdelzi that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Livdelzi?
While less common, the most serious side effects of Livdelzi are described below, along with what to do if they happen.
Severe Allergic Reactions. Livdelzi may cause allergic reactions, which can be serious. Stop taking Livdelzi and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Livdelzi. Call your healthcare provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Coughing up or vomiting blood, or vomit that looks like coffee grounds
- Stomach or belly pain
- Fluid build-up or swelling in your abdomen
- Fever
- Weakness or unusual tiredness
- Confusion, slurred speech, or unusual changes in your mood
- Itching
- Loss of appetite
- Light-colored poop
- Poop that is bloody, black, or looks like tar
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Blocked Bile Duct. Livdelzi should not be used if your bile ducts are blocked, also called biliary obstruction. Call your healthcare provider right away if you have any of the following symptoms of biliary obstruction.
- Pain in your upper stomach area
- Fever
- Stool (poop) that is clay-colored
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Bone Fractures. Livdelzi may increase your risk of having a fracture (broken bone). Tell your healthcare provider if you have new or unusual pain, changes in how well you can move around, or if you break a bone.
Warnings & Precautions
Who should not use Livdelzi?
Allergies to Ingredients. People who are allergic to any of the following should not take Livdelzi.
- Seladelpar
- Livdelzi
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Livdelzi.
Severe Liver Problems. Livdelzi should not be used if you have or develop severe liver disease, such as advanced cirrhosis. Your healthcare provider may do tests to determine if your liver is working well enough to take this medicine. Tell your healthcare provider right away if you have any of the following symptoms of worsening liver problems.
- Swelling in your stomach area from fluid buildup
- Confusion or excessive sleepiness
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
- Vomit with blood that looks like coffee grounds
- Poop that is bloody, black, or looks like tar
- Stomach or belly pain
What should I know about Livdelzi before using it?
Do not take Livdelzi unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Livdelzi with other people, even if they have the same condition as you. It may harm them.
Keep Livdelzi out of the reach of children.
Keep all appointments for blood work to check your liver function before you start Livdelzi and during treatment.
What should I tell my healthcare provider before using Livdelzi?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Livdelzi is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Severe liver problems
- Blockage of the bile ducts in your liver (biliary obstruction)
- Weak bones or have a broken bone
Other Medicines and Supplements. Livdelzi may interact with other medicines and supplements. Before using Livdelzi, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. It is not known if or how Livdelzi could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should use Livdelzi while you are pregnant or trying to get pregnant. If you become pregnant while taking Livdelzi, you can register for a pregnancy safety study by calling 800-445-3235. This study is being conducted to collect safety information about the use of Livdelzi during pregnancy.
Breastfeeding. It is not known if Livdelzi passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Livdelzi while breastfeeding.
How can I get more information about Livdelzi?
For more information about Livdelzi, you can visit the manufacturer’s website at www.livdelzi.com or call them at 800-445-3235.
Interactions
Does Livdelzi interact with foods or drinks?
There are no known interactions between Livdelzi and foods or drinks.
It is unknown if drinking alcohol will affect Livdelzi. The risk of dizziness may be increased if you drink alcohol while taking Livdelzi.
Does Livdelzi interact with other medicines (drug interactions)?
Livdelzi interacts with many other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Livdelzi.
- Probenecid, which is a medicine commonly used for gout
- Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
- A bile acid sequestrant, such as colestipol (Colestid), cholestyramine, or colesevelam (Welchol), which is a medicine to lower cholesterol
- Carbamazepine (Tegretol, Carbatrol, and others), which is a medicine commonly used to treat seizures or nerve pain
- Fluconazole (Diflucan), which is a medicine used for fungal infections
- Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine to suppress your immune system
Many other medicines may alter the blood levels of Livdelzi. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Livdelzi. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Livdelzi?
If you or someone else has used too much Livdelzi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Livdelzi?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.