Ibrutinib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Ibrutinib is used to treat certain types of non-Hodgkin lymphoma, including mantle cell lymphoma (MCL), Waldenstrom's macroglobulinemia, and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in people with or without 17p deletion.
Ibrutinib is also used to treat marginal cell lymphoma and chronic graft-versus-host disease.
Ibrutinib is sometimes given when other medicines have not been effective.
Ibrutinib was approved to treat mantle cell and marginal lymphomas by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, tumors responded to this medicine. However, it has not been shown that ibrutinib can improve symptoms or lengthen survival time in people with this type of lymphoma.
Ibrutinib may also be used for purposes not listed in this medication guide.
This medicine can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have easy bruising, unusual bleeding, or any bleeding that will not stop. You may also have bleeding on the inside of your body, such as in your stomach or intestines, or in your brain.
Call your doctor at once if you have signs of bleeding inside your body, such as: dizziness, weakness, confusion, headache, speech problems, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds.
You should not use ibrutinib if you are allergic to it.
To make sure ibrutinib is safe for you, tell your doctor if you have ever had:
Using ibrutinib may increase your risk of developing other types of cancer, such as skin cancer. Ask your doctor about your specific risk.
Ibrutinib can harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Ibrutinib use by either parent may cause birth defects.
Keep using birth control for at least 1 month after your last dose of ibrutinib. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ibrutinib.
It is not known whether ibrutinib passes into breast milk or if it could affect a nursing baby. You should not breast-feed while using this medicine.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using ibrutinib and call your doctor at once if you have:
Common side effects may include:
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.