Seladelpar

Seladelpar is used in combination with ursodiol to treat primary biliary cholangitis (PBC; a type of liver disease that destroys bile ducts, which allows bile to stay in the liver and cause damage) in people who cannot take ursodiol or in people who were not treated successfully with ursodiol alone. Seladelpar is in a class of medications called peroxisome proliferator-activated receptor (PPAR)-delta agonists. It works by works by decreasing the production of bile in the liver.

Seladelpar comes as a capsule to take by mouth. It is usually taken with or without food once a day. Take seladelpar at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking seladelpar,

• tell your doctor and pharmacist if you are allergic to seladelpar, any other medications, or any of the ingredients in seladelpar capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking cholestyramine (Locolest, Prevalite), colestipol (Colestid), or colesevelam (Welchol), take them at least 4 hours before or 4 hours after seladelpar.
• tell your doctor if you have advanced liver disease, including liver cirrhosis (a disease which causes scarring of liver tissue). Your doctor may not want you not to take seladelpar.
• tell your doctor if you have or have ever had bile duct obstruction (blockage in the tubes that carry bile from the liver to the gallbladder and small intestine) or other liver problems or osteoporosis.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking seladelpar, call your doctor.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Seladelpar may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• stomach pain
• nausea
• heartburn
• dizziness
• rash
• cough
• hair loss

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• broken bones or fractures
• yellowing of the skin or eyes
• pain or swelling in the upper right part of the stomach
• black, tarry, or bloody stools
• coughing up or vomiting blood or something that looks like coffee grounds
• unusual tiredness
• mental changes such as confusion, slurred speech, or changes in mood or personality

Seladelpar may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• muscle pain

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to seladelpar.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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