Mantle Cell Lymphoma : Butinib 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 : Butinib is indicated for the treatment of patients ... Read more Mantle Cell Lymphoma : Butinib 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 : Butinib is indicated for the treatment of patients with chronic lymphocytic leukemia. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion Butinib is indicated for the treatment of patients with chronic lymphocytic leukemia. Waldenstrom Macroglobulinemia (WM) : Butinib is indicated for the treatment of patients with Waldenstrom Macroglobulinemia (WM). Marginal Zone Lymphoma : Butinib is indicated for the reatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD 20-based therapy.
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.
Mantle Cell Lymphoma and Marginal Zone Lymphoma : The recommended dose of Ibrutinib for MCL and MZL is 560 mg (four 140 mg capsules) orally once daily until disease progression or unacceptable toxicity. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenstrom Macroglobulinemia (WM) : The recommended dose of Ibrutinib for CLL/SLL and WM is 420 mg (three 140 mg capsules) orally once daily until disease progression or unacceptable toxicity. The recommended dose of Ibrutinib for CLL/SLL when used in combination with bendamustine and rituximab (administered every 28 days for up to 6 cycles) is 420 mg (three 140 mg capsules) orally once daily until disease progression or unacceptable toxicity.
Always consult a registered doctor before taking any medicine. This information is for general knowledge only.
The following adverse reactions are discussed in more detail in other sections of the labeling: Hemorrhage, Infections, Cytopenias, Atrial Fibrillation, Hypertension, Second Primary Malignancies and Tumor Lysis Syndrome. Additional Important Adverse Reactions: Diarrhea, Visual Disturbance.
Hypersensitivity to the active substance or to any of the excipients.
CYP3A Inhibitors : Co-administration with strong and moderate CYP3A inhibitors should be avoided. If a moderate CYP3A inhibitor must be used, Butinib dose should be reduced CYP3A Inducers : Co-administration with strong CYP3A inducers should be avoided