Remibrutinib

Remibrutinib is used to treat chronic spontaneous urticaria (CSU; a skin disease where hives appear and stay for longer than 6 weeks without a known trigger). Remibrutinib is in a class of medications called kinase inhibitors. It works by stopping the release of substances in the body that cause hives.

Remibrutinib comes as a tablet to take by mouth. Take twice a day with or without food. Take remibrutinib at around the same times every day.

Take remibrutinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

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 remibrutinib,

• 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.
• some medications should not be taken with remibrutinib. Other medications may cause dosing changes or extra monitoring when taken with remibrutinib. Make sure you have discussed any medications you are currently taking or plan to take before starting remibrutinib with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking remibrutinib, please get the advice of your doctor or pharmacist.
• tell your doctor if you have or have ever had bleeding problems or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking remibrutinib, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking remibrutinib. You may need to stop taking remibrutinib 3-7 days before and after your surgery.
• do not have any vaccinations without talking to your doctor.

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

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

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• runny nose, sore throat
• headache
• nausea, abdominal pain

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

• bleeding; bruising; pink or brown urine; red or black tarry stools
• headache, dizziness, confusion, or feeling weak

Remibrutinib 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 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.

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.

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