Testing generic 2

<p>Mantle Cell Lymphoma<br /> Indicated for mantle cell lymphoma (MCL) in patients who have received &gt;1 prior therapy</p>

<p>Mantle Cell Lymphoma<br /> Indicated for mantle cell lymphoma (MCL) in patients who have received &gt;1 prior therapy</p> <p>100 mg PO every twelve hours</p> <p>Continue until disease progression or unacceptable toxicity</p> <p>Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma<br /> Indicated for treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)</p> <p>Monotherapy<br /> 100 mg PO every twelve hours<br /> Continue until disease progression or unacceptable toxicity</p> <p>Combination with obinutuzumab<br /> Indicated for patients with previously untreated CLL or SLL<br /> Start acalabrutinib at Cycle 1 (each cycle is 28 days)<br /> Start obinutuzumab at Cycle 2 for a total of 6 cycles<br /> Refer to obinutuzumab for infusion rates<br /> Cycle 1<br /> Days 1-28: Acalabrutinib 100 mg PO q12hr</p> <p>Cycle 2<br /> Days 1-28: Acalabrutinib 100 mg PO q12hr<br /> Day 1: Obinutuzumab 100 mg IV infusion<br /> Day 2: Obinutuzumab 900 mg IV infusion<br /> Days 8 and 15: Obinutuzumab 1000 mg IV infusion</p> <p>Cycles 3-7<br /> Day 1-28: Acalabrutinib 100 mg PO q12hr<br /> Day 1: Obinutuzumab 1000 mg IV infusion<br /> Cycle 8 and subsequent cycles<br /> Day 1-28: Acalabrutinib 100 mg PO q12hr<br /> Continue until disease progression or unacceptable toxicity</p>

<p>Serious hemorrhagic events, including fatal events, reported; the mechanism for the bleeding events is not well understood; acalabrutinib may further increase hemorrhage risk in patients receiving antiplatelet or anticoagulant therapies, and patients should be monitored for signs of bleeding; consider the benefit-risk of withholding acalabrutinib for 3-7 days presurgery and postsurgery depending on the type of surgery and the risk of bleeding</p> <p>Serious infections (bacterial, viral, or fungal), including fatal events and opportunistic infections, reported; monitor for infection and consider prophylaxis in patients who are at increased risk for opportunistic infections</p> <p>Cytopenias reported, including neutropenia, anemia, and thrombocytopenia; assess complete blood cell counts monthly during treatment</p> <p>Second primary malignancies, including nonskin carcinomas, have occurred in patients with hematologic malignancies treated with acalabrutinib; the most frequent was skin cancer; advise patients regarding need for protection from sun exposure</p> <p>Atrial fibrillation and flutter occurred (rare) during clinical trials; monitor patients and manage as appropriate</p> <p>Monitoring Parameter<br /> Monitor complete blood cell counts monthly during treatment<br /> Monitor for symptoms of arrhythmia (eg, palpitations, dizziness, syncope, dyspnea)<br /> Evaluate bilirubin and transaminases at baseline and throughout treatment; for patients who develop abnormal liver tests, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity.</p>

<p>&nbsp;&gt;10%<br /> All grades<br /> Decreased hemoglobin (46%)<br /> Decreased platelets (44%)<br /> Headache (39%)<br /> Decreased neutrophils (36%)<br /> Diarrhea (31%)<br /> Fatigue (28%)<br /> Myalgia (21%)<br /> Bruising (21%)<br /> Nausea (19%)<br /> Rash (18%)<br /> Abdominal pain (15%)<br /> Constipation (15%)<br /> Vomiting (13%)</p> <p>Grade &gt;3<br /> Decreased neutrophils (15%)<br /> Decreased platelets (12%)</p> <p>1-10%<br /> Increased creatinine, 1.5-3X ULN (4.8%)</p> <p>All grades<br /> Hemorrhage/hematoma (8%)<br /> Epistaxis (6%)</p> <p>Grade &gt;3<br /> Decreased hemoglobin (10%)<br /> Diarrhea (3.2%)<br /> Abdominal pain (1.6%)<br /> Headache (1.6%)<br /> Vomiting (1.6%)</p>