Remibrutinib

Remibrutinib is used in adults to treat chronic spontaneous urticaria (hives) when other treatments have not worked or have stopped working. Remibrutinib is not used to treat other types of urticaria.

Remibrutinib may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not change your dose or stop taking this medicine without your doctor's advice.

Remibrutinib is usually taken twice per day.

You may take remibrutinib with or without food.

Swallow the tablet whole with water and do not crush, chew, or break it.

If you need surgery, tell the surgeon ahead of time that you are using remibrutinib. You may need to stop using the medicine for a short time before and after surgery.

You may bleed more easily. Call your doctor if you have unusual bleeding.

Store this medicine in the original container at room temperature away from moisture and heat.

You may have an increased risk of bleeding. Contact your doctor if you notice any unusual bleeding.

Tell your doctor if you have or have ever had:

• recent surgery or plan to have surgery;
• bleeding problems or are using a blood thinner;
• if you recently received or are scheduled to receive a vaccine; or
• liver disease.

Make sure you are up to date on all vaccines before you start using remibrutinib.

If you are pregnant, your name may be listed on a pregnancy registry to monitor the effects of remibrutinib on the baby.

It is not known if remibrutinib will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using remibrutinib.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Remibrutinib may cause serious side effects. Call your doctor right away if you have:

• any bleeding that will not stop;
• easy bruising or bleeding (nosebleeds, bleeding gums);
• pinpoint purple or red spots under your skin;
• pink or brown urine, bloody or tarry stools; or
• severe headache, dizziness, confusion, weakness.

Common side effects of remibrutinib may include:

• headache;
• cold symptoms such as stuffy or runny nose, sore throat;
• bleeding;
• nausea; or
• stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Chronic Idiopathic Urticaria:

25 mg orally twice a dayComments:-Limitations of Use: This drug is not indicated for other forms of urticaria.-Interrupt therapy for 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.Use: For the treatment of chronic spontaneous urticaria in adult patients who remain symptomatic despite H1 antihistamine treatment

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while you are being treated with remibrutinib. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.

Sometimes, using certain medicines together can be unsafe. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines work less effectively.

Tell your doctor about all your other medicines, especially:

• a blood thinner—warfarin, Coumadin, Jantoven; or
• medicine used to prevent blood clots—alteplase, clopidogrel, dipyridamole, ticlopidine, and others.

This list is not complete. Other drugs may affect remibrutinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.