Rilzabrutinib

Rilzabrutinib is used in adults to treat recurring or chronic immune thrombocytopenia (ITP).

Rilzabrutinib is given after other treatments did not work or stopped working.

Rilzabrutinib 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.

Rilzabrutinib is usually taken twice per day. Follow your doctor's instructions.

Take with a full glass of water.

You may take rilzabrutinib with or without food, but take it the same way each time.

Take with food if rilzabrutinib upsets your stomach or you experience diarrhea or nausea.

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

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

You will need frequent blood tests to check your liver function, before you start and during treatment.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests and your doctor will check you for signs of infection during your treatment with rilzabrutinib.

Store this medicine in the original package at room temperature away from moisture, heat, and light.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• liver or kidney disease.

Rilzabrutinib may harm an unborn baby. You may need a pregnancy test to ensure you are not pregnant. Use effective birth control while taking rilzabrutinib and for at least 1 week after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while taking rilzabrutinib, and for at least 1 week after your last dose.

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

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

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

Common side effects of rilzabrutinib may include:

• headache;
• diarrhea, stomach pain, nausea; or
• COVID-19 infection.

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 Thrombocytopenia Autoimmune:

400 mg orally twice a dayUse: Treatment of persistent or chronic immune thrombocytopenia in adults who have had an insufficient response to a previous treatment

Take the missed dose as soon as you can on the same day, and wait at least 2 hours between doses. Do not take two doses at once.

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

Grapefruit, Seville oranges, and starfruit may interact with rilzabrutinib and cause side effects. Avoid consuming grapefruit and starfruit products and orange marmalades.

Ask your doctor before taking an antacid, and take only the type your doctor recommends.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medicines work.

Take your rilzabrutinib dose 2 hours before taking any of these other medicines:

• antacids that contain calcium, magnesium, or aluminum; or
• H2 blocker (stomach acid reducer)--such as cimetidine, famotidine, nizatidine, and others.

Tell your doctor about all your current medicines. Many drugs can affect rilzabrutinib, especially:

• proton pump inhibitor (stomach acid reducer)--such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, and others.

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