FDA label
What is Imbruvica used for?
Imbruvica contains ibrutinib. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Imbruvica lists 4 uses: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; . 2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion; . 3 Waldenström’s Macroglobulinemia; . 4 Chronic Graft versus Host Disease.
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Imbruvica, tablet, film coated
Indications and Usage, quoted from the label by Pharmacyclics LLC (NDA210563). Cross-references to other label sections are left out.
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
. 2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion
IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion.
. 3 Waldenström’s Macroglobulinemia
IMBRUVICA is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
. 4 Chronic Graft versus Host Disease
IMBRUVICA is indicated for the treatment of adult and pediatric patients age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.
Source: DailyMed label, set id 0dfd0279-ff17-4ea9-89be-9803c71bab44, version 65, effective October 21, 2025. NDC 57962-014, one of 3 listings for this product.
Questions
What is Imbruvica used for?
The FDA label for Imbruvica lists 4 uses: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; . 2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion; . 3 Waldenström’s Macroglobulinemia; . 4 Chronic Graft versus Host Disease.
What drug class is Imbruvica?
FDA lists ibrutinib in the Kinase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.