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Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.

In the clinical studies, Totect (dexrazoxane for injection, intravenous infusion only ) ® was administered to patients also receiving chemotherapeutic agents for cancer, and the adverse reaction profile reflects the combination of Totect (dexrazoxane for injection, intravenous infusion only ) ®, underlying disease, and already administered chemotherapy. The adverse reaction data reflect exposure to Totect (dexrazoxane for injection, intravenous infusion only ) ® in 80 patients who received the first dose, 72 patients who received two doses, and 69 patients who received all three doses. Table 1 summarizes adverse reactions occurring with ≥ 5% frequency.

Table 1: Adverse Reactions Occurring at ≥ 5% Frequency

Neutropenia and febrile neutropenia each occurred in 2.5% of patients.

Table 2 summarizes laboratory adverse events from studies 1 and 2.

Table2: Laboratory Adverse Reactions

No drug interactions have been identified [see CLINICAL PHARMACOLOGY].

• Dimethylsulfoxide: Based on anecdotal reports concurrent use of topical dimethyl sulfoxide (DMSO) at the site of tissue injury may reduce the benefit of Totect (dexrazoxane for injection, intravenous infusion only ) ®. Additionally, nonclinical studies using a mouse model that simulates extravasation of anthracyclines has shown that concomitant treatment with topical DMSO decreases the efficacy of systemic dexrazoxane.

Last reviewed on RxList: 9/30/2009
This monograph has been modified to include the generic and brand name in many instances.