Seladelpar

Pronunciation: sell-a-dell-pah
Generic name: seladelpar
Brand name: Livdelzi
Dosage form: oral capsule
Drug classes: Miscellaneous metabolic agents, Miscellaneous uncategorized agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 25, 2024.

What is seladelpar?

Seladelpar (Brand name Livdelzi) is an oral prescription medicine that may be used to treat primary biliary cholangitis (PBC) in adults. Seladelpar is:

• Taken in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well to UDCA
• Used alone in patients unable to tolerate UDCA.

It is not known if taking seladelpar will improve your chance of survival or prevent liver decompensation.

Seladelpar helps manage PBC by activating specific receptors that control key metabolic and liver disease pathways involved in bile acid synthesis; inflammation; fibrosis; and lipid metabolism, storage, and transport. Seladelpar is beneficial for PBC patients because it reduces bile acid production and helps counteract the liver damage caused by the buildup of bile acids.

Seladelpar gained FDA approval on August 14, 2024, as the brand name Livdelzi, under the accelerated approval designation. Continued approval may be contingent on a continued benefit being shown in clinical trials.

Seladelpar side effects

The most common side effects of seladelpar include:

• headache
• stomach (abdominal) pain
• nausea
• abdominal swelling (distension)
• dizziness.

Serious side effects and warnings

Seladelpar can cause the following serious side effects.

Bone fractures. Taking seladelpar may increase your risk of bone fractures. Tell your healthcare provider about any bone fractures, 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 seladelpar than prescribed. Your healthcare provider will do tests to check your liver before you start and during treatment with seladelpar. Tell your healthcare provider right away if you have any of the following signs or symptoms of worsening liver problems during treatment with seladelpar:

• swelling of your stomach area (abdomen) from a build-up of fluid
• yellowing of your skin or the whites of your eyes
• mental changes such as confusion, being sleepier than usual or harder to wake up,
• pain on the right side of your stomach slurred speech, mood swings, or changes (abdomen) in personality
• black, tarry, or bloody stools
• coughing up or vomiting blood, or your vomit looks like “coffee grounds”.

It is not known if seladelpar is safe and effective in children.

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 seladelpar. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking

Seladelpar is not recommended for use in people who have advanced liver disease (decompensated cirrhosis). Symptoms of advanced liver disease may include:

• Confusion
• Fluid in the stomach area (abdomen)
• Black, tarry, or bloody stools
• Coughing up or vomiting blood, or having vomit that looks like “coffee grounds”.

Before taking seladelpar, tell your healthcare provider about all 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
• are breastfeeding or plan to breastfeed

Pregnancy

It is not known if seladelpar will harm an unborn baby. If you become pregnant while taking seladelpar, tell your healthcare provider right away. There is a pregnancy safety study for women who take seladelpar during pregnancy. Talk to your healthcare provider about providing information about the seladelpar 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.

Breastfeeding

It is not known if seladelpar passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take seladelpar.

How should I take seladelpar?

Take seladelpar exactly as your healthcare provider tells you to. Do not take more seladelpar than your healthcare provider tells you to.

• Take seladelpar by mouth 1 time each day.
• Seladelpar may be taken with or without food.
• If you also take medicines to help lower your cholesterol (bile acid-binding resins), take seladelpar at least 4 hours before or 4 hours after you take the bile acid-binding resin. If this is not possible, space the time between taking seladelpar and your bile acid-binding resin as far apart as possible.

Seladelpar dosage

Usual adult dosage of seladelpar for PBC

• Seladelpar 10 mg 1 time daily.
• Take with or without food.

Related/similar drugs

Ocaliva, ursodiol, Actigall, seladelpar, Iqirvo

What happens if I overdose

If you take too much seladelpar, call your healthcare provider or get emergency medical help right away.

What other drugs will affect seladelpar?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. seladelpar can affect the way certain medicines work. Certain other medicines may affect the way seladelpar works. Especially tell your healthcare provider if you take:

• OAT3 inhibitors, such as probenecid, rifampin, or cabotegravir. Avoid taking together or monitor ALP and bilirubin for rifampin
• Strong CYP2C9 inhibitors, such as cotrimoxazole, fluoxetine, or amiodarone. Avoid taking together
  
  Dual moderate CYP2C9 and moderate to strong CYP3A4 inhibitors, such as fluconazole. Monitor closely for side effects
• CYP2C9 poor metabolizers using moderate to strong CYP3A4 inhibitors: Monitor more frequently for side effects.
• BCRP inhibitors such as rosuvastatin, glyburide, nitrofurantoin, dipyridamole, cimetidine, chlorothiazide, sulfasalazine, and leflunomide. Monitor closely for adverse effects.

Seladelpar should be taken at least 4 hours before or 4 hours after you take medicines to help lower your cholesterol called bile acid-binding resins (examples include cholestyramine or colestipol). If this is not possible, space the time between taking seladelpar and your bile acid-binding resin as far apart as possible.

This is not a complete list of interactions. See the seladelpar Package Insert for a full list.

Storage

Store seladelpar at room temperature between 68°F to 77°F (20°C to 25°C).

Keep out of the reach of children.

Ingredients

Seladelpar is only available unde the brand name Livdelzi. There is not Livdelzi generic.

Active ingredient: seladelpar lysine

Inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, and hard gelatin shells.

Capsule shells contain gelatin, titanium dioxide, black iron oxide, yellow iron oxide, red iron oxide, and the colorant FD&C Blue #2.

Seladelpar is available in 10 mg capsules.

Who makes seladelpar?

Gilead Sciences, Inc. manufactures seladelpar as the brand name Livdelzi.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer