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warnings and cautions
5 WARNINGS AND PRECAUTIONS Intrathecal administration is fatal ( 5.1 ) Extravasation causes tissue injury ( 5.2 ) Neurologic toxicity: Monitor patients for peripheral motor and sensory, central and autonomic neuropathy, and reduce, interrupt, or discontinue dosing. Patients with preexisting severe neuropathy should be treated with Marqibo only after careful risk-benefit assessment ( 2.2 , 5.3 ) Myelosuppression: Monitor blood counts prior to each dose of Marqibo. Neutropenia, thrombocytopenia, or anemia may occur; consider Marqibo dose reduction or interruption and supportive care measures ( 5.4 ) Tumor lysis syndrome: Anticipate, monitor for, and manage ( 5.5 ) Constipation, bowel obstruction, and/or paralytic ileus: Institute a prophylactic bowel regimen to prevent potential constipation, bowel obstruction, and/or paralytic ileus ( 5.6 ) Fatigue: Severe fatigue can occur ( 5.7 ) Hepatic toxicity: Monitor liver function and modify or interrupt dosing ( 5.8 ) Embryofetal toxicity: Can cause fetal harm. Advise women of potential risk to the fetus ( 5.9 , 8.1 ) 5.1 For Intravenous Use Only Fatal if Given by Other Routes. Death has occurred with intrathecal use. 5.2 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. 5.3 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 (2.2) ]. 5.4 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. 5.5 Tumor Lysis Syndrome Tumor lysis syndrome (TLS) may occur in patients with ALL receiving Marqibo. Anticipate, monitor for, and manage. 5.6 Constipation and Bowel Obstruction Ileus, bowel obstruction, and colonic pseudo-obstruction have occurred. Marqibo can cause constipation [ see Adverse Reactions (6) ]. 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. 5.7 Fatigue Marqibo can cause severe fatigue. Marqibo dose delay, reduction, or discontinuation may be necessary. 5.8 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 toxicity. 5.9 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 pregnant women and there were no reports of pregnancy in any of the clinical studies in the Marqibo clinical development program. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1) ].