ASH Clinical News December 2014 | Page 9

UP FRONT 2015 Highlights of ASH® in Latin America April 23 – 24, 2015 Cartagena, Colombia 2015 Highlights of ASH® in Asia February 28 – March 1, 2015 Bangkok, Thailand Hear internationally recognized experts analyze the latest updates in hematology research from the ASH Annual meeting. 2015 American Association for Cancer Research Annual Meeting April 18 – 22, 2015 Philadelphia, PA The AACR Annual Meeting 2015 will highlight the latest discoveries in every area of cancer research and will provide a unique opportunity for investigators from all over the world to meet, interact, and share their insights. This year’s meeting theme is “Bringing Cancer Discoveries to Patients.” Extravasation Tissue Injury Only administer through a secure and free-flowing venous access line. If extravasation is suspected, discontinue infusion immediately and consider local treatment measures. Neurologic Toxicity Sensory and motor neuropathies are common and are cumulative. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, hyporeflexia, areflexia, neuralgia, jaw pain, decreased vibratory sense, cranial neuropathy, ileus, burning sensation, arthralgia, myalgia, muscle spasm, or weakness, both before and during treatment. Orthostatic hypotension may occur. The risk of neurologic toxicity is greater if Marqibo is administered to patients with preexisting neuromuscular disorders or when other drugs with risk of neurologic toxicity are being given. In the studies of relapsed and/ or refractory adult ALL patients, Grade ≥3 neuropathy events occurred in 32.5% of patients. Worsening neuropathy requires dose delay, reduction, or discontinuation of Marqibo [see Dosage and Administration]. Myelosuppression Monitor complete blood counts prior to each dose of Marqibo. If Grade 3 or 4 neutropenia, thrombocytopenia, or anemia develops, consider Marqibo dose modification or reduction as well as supportive care measures. Tumor Lysis Syndrome Tumor lysis syndrome (TLS) may occur in patients with ALL receiving Marqibo. Anticipate, monitor for, and manage. Constipation and Bowel Obstruction Ileus, bowel obstruction, and colonic pseudo-obstruction have occurred. Marqibo can cause constipation [see Adverse Reactions]. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction, and/or paralytic ileus, considering adequate dietary fiber intake, hydration, and routine use of stool softeners, such as docusate. Additional treatments, such as senna, bisacodyl, milk of magnesia, magnesium citrate, and lactulose may be considered. Fatigue Marqibo can cause severe fatigue. Marqibo dose delay, reduction, or discontinuation may be necessary. Hepatic Toxicity Fatal liver toxicity and elevated levels of aspartate aminotransferase have occurred. Elevated levels of aspartate aminotransferase of Grade ≥3 occurred in 6-11% of patients in clinical trials. Monitor hepatic function tests. Reduce or interrupt Marqibo for hepatic Print-only toxicity. Embryofetal Toxicity Marqibo can cause fetal harm when administered to a pregnant woman. Vincristine sulfate liposome injection was teratogenic or caused embryo-fetal death in animals. Women of childbearing potential should avoid becoming pregnant while being treated with Marqibo. There are no adequate and well-controlled studies of Marqibo in pregnan