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What is IMBRUVICA^® (ibrutinib)?

IMBRUVICA^® (ibrutinib) is a prescription medicine used to treat adults with:

Mantle cell lymphoma (MCL) who have received at least one prior treatment
Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion
Waldenström’s macroglobulinemia (WM)
Marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment
Chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy

It is not known if IMBRUVICA^® is safe and effective in children.

DOSAGE AND ADMINISTRATION

1.MCL and MZL: 560 mg taken orally once daily (four 140 mg capsules once daily)

2.CLL/SLL, WM, and cGVHD: 420 mg taken orally once daily (three 140 mg capsules once daily).

Capsules should be taken orally with a glass of water. Do not open, break, or chew the capsules

IMPORTANT SIDE EFFECT INFORMATION

Before taking IMBRUVICA^®, tell your healthcare provider about all of your medical conditions, including if you:

have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA^® for any planned medical, surgical, or dental procedure
have bleeding problems
have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes
have an infection
have liver problems
are pregnant or plan to become pregnant. IMBRUVICA^® can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA^®
- Females should not become pregnant during treatment and for 1 month after the last dose of IMBRUVICA^®
- Males should avoid getting female partners pregnant during treatment and for 1 month after the last dose of IMBRUVICA^®
are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take IMBRUVICA^® or breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA^® with certain other medicines may affect how IMBRUVICA^® works and can cause side effects.

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