Linerixibat

Linerixibat is used to treat itching in people with primary biliary cholangitis (PBC; a type of liver disease that harms bile ducts). Linerixibat is in a class of medications called ileal bile acid transporter inhibitors. It works by decreasing absorption of bile acids into the body allowing them to be eliminated in feces.

Linerixibat comes as a tablet to take by mouth. Take twice a day at least 30 minutes before any food or drink (except water). Take linerixibat at around the same times every day.

Take linerixibat 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 linerixibat,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• if you are taking cholestyramine, colestipol, or colesevelam, take them 4 hours before or 4 hours after linerixibat.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking linerixibat, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it and at least 30 minutes before a meal. If it more than 6 hours after you were to take your dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• diarrhea
• nausea, indigestion, bloating, abdominal pain
• dizziness
• joint pain

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• thirst, dry mouth, urinating less often, headache
• bleeding
• a broken bone

Linerixibat 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). Keep the desiccant (drying agent) canister in the bottle of medication to keep the tablets dry. Do not eat the desiccant canister.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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.

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

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Lynavoy^®