Prescribing Information

COMPOSITION
Ibrutix Capsule: Each capsule contains Ibrutinib INN 140 mg.
CLINICAL PHARMACOLOGY
Ibrutinib is a small-molecule inhibitor of BTK. Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK’s role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that Ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro.

INDICATIONS
Mantle Cell Lymphoma
Ibrutinib is indicated for the treatment of patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy.
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Ibrutinib is indicated for the treatment of patients with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion
Ibrutinib is indicated for the treatment of patients with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) with 17p deletion.
Waldenstrom’s Macroglobulinemia
Ibrutinib is indicated for the treatment of patients with Waldenstrom’s Macroglobulinemia (WM).
Marginal Zone Lymphoma
Ibrutinib is indicated for the treatment of patients with Marginal Zone Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
ADVERSE REACTIONS
The most common adverse reactions (>_20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia, thrombocytopenia, diarrhea, anemia, musculoskeletal pain, rash, nausea, bruising, fatigue, hemorrhage, and pyrexia.

PHARMACEUTICAL INFORMATION
Storage Conditions
Store in a cool and dry place, away from light. Keep out of the reach of children.
Presentation & Packaging
Ibrutix Capsule: Each commercial box contains 120 Capsules in a bottle.