Ibrucent

Ibrutinib ·Incepta Pharmaceuticals Ltd.·Capsule

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Administration

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.

Effects

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.

There is no specific experience in the management of Ibrutinib over dose in patients. One healthy subject experienced reversible Grade 4 hepatic enzyme increases (AST and ALT) after a dose of 1680 mg. Closely monitor patients who ingest more than the recommended dosage and provide appropriate supportive treatment.

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. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion Ibrutinib is indicated for the treatment of patients with chronic lymphocytic leukemia.

Waldenstrom Macroglobulinemia (WM): Ibrutinib is indicated for the treatment of patients with Waldenstrom Macroglobulinemia (WM).

Marginal Zone Lymphoma: Ibrutinib 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.

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.