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Prescreening: Prior to every Novantrone infusion, all patients should have a complete blood count including platelet and liver function tests; all female patients should be tested for pregnancy.
Neutrophil count: Novantrone should not be administered to patients with a baseline neutrophil count of <1500 cells/mm3. Frequent peripheral blood cell counts are recommended for all patients.
Cardiac toxicity: A patient's baseline left ventricular ejection fraction (LVEF) should be evaluated by echo contrast or a multiple gated acquisition (MUGA) scan and should be >50%. Patients should be questioned about symptoms of congestive heart failure prior to treatment. Regular evaluation of a patient's LVEF prior to each dose is imperative due to the risk of myocardial toxicity. If the LVEF decreases below 50%, therapy must be discontinued. In a clinical trial, LVEF decreased to <50% in 2 of 127 patients (2%) receiving Novantrone.
Hepatic impairment: Novantrone clearance is reduced by hepatic impairment. MS patients with hepatic impairment should ordinarily not be treated with Novantrone.
Pregnancy: MS patients must be on effective birth control before starting Novantrone therapy and must test negative for pregnancy prior to each infusion. Pregnant women, or women who wish to become pregnant, should not use Novantrone. In a clinical trial, secondary amenorrhea persisted for longer than 1 year in 20% of women taking Novantrone for MS.
Lifetime dosing: Novantrone should not ordinarily be administered to MS patients who have already received a cumulative lifetime dose of greater than 140 mg/m2 of Novantrone. Multiple sclerosis patients with a baseline LVEF <50% should not be treated with NOVANTRONE®. LVEF should be reevaluated by echocardiogram or MUGA prior to each dose administered to patients with multiple sclerosis. Additional doses of NOVANTRONE® should not be administered to multiple sclerosis patients who have experienced either a drop in LVEF to below 50% or a clinically significant reduction in LVEF during NOVANTRONE® therapy. Prior use of radiation or chemotherapy, as well as cardiotoxic drugs, further limits permissible exposure to Novantrone. Cardiac toxicity with NOVANTRONE® may occur whether or not cardiac risk factors are present. For additional information, see WARNINGS, Cardiac Effects, and DOSAGE AND ADMINISTRATION.
Secondary leukemia: Secondary acute myelogenous leukemia (AML) has been reported in MS and cancer patients treated with Novantrone. In a cohort of mitoxantrone treated MS patients followed for varying period of time, an elevated leukemia risk of 0.25% (2/802) has been observed. Post-marketing cases of secondary AML have also been reported.
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