Ibrutix 140

• Mantle Cell Lymphoma (MCL) - who have received at least one prior therapy
• Chronic Lymphocytic Leukemia (CLL) - who have received at least one prior therapy
• Chronic Lymphocytic Leukemia with 17p deletion
• Waldenström's Macroglobulinemia (WM)
• Marginal Zone Lymphoma (MZL) - who require systemic therapy and have received at least one prior anti-CD20-based therapy

Adult Dose (Oral):

• Mantle Cell Lymphoma (MCL) & Marginal Zone Lymphoma (MZL): 560 mg (four 140 mg capsules) once daily
• Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) & Waldenström Macroglobulinemia (WM): 420 mg (three 140 mg capsules) once daily
• CLL (in combination with bendamustine and rituximab): 420 mg once daily

Hepatic Impairment: Mild (Child Pugh Class A): 140 mg once daily; Moderate-to-severe (Classes B and C): Avoid use

Child Dose: Safety and efficacy not established

Most Common (>10%):

• Diarrhea (51-63%)
• Bruising (30-54%)
• Fatigue (31-41%)
• Nausea (21-31%)
• Rash (25-27%)
• Musculoskeletal pain (27-37%)
• Headache (13-19%)
• Dizziness (14-21%)
• Upper respiratory tract infection (34-48%)
• Hemorrhage (48%)
• Neutropenia (27-29%)
• Thrombocytopenia (10-17%)

Serious: Hemorrhage, Infections, Cytopenias, Atrial Fibrillation, Hypertension, Second Primary Malignancies, Tumor Lysis Syndrome

Precautions:

• Monitor for bleeding
• Monitor patients for fever and infections and evaluate promptly
• Complete blood counts should be checked monthly
• Monitor for atrial fibrillation
• Second primary malignancies (including skin cancers) have occurred
• Monitor patients at risk for Tumor Lysis Syndrome (TLS)
• Embryo-Fetal Toxicity: Can cause fetal harm; advise women to avoid pregnancy