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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® was administered to patients also receiving chemotherapeutic agents for cancer, and the adverse reaction profile reflects the combination of Totect®, underlying disease, and already administered chemotherapy. The adverse reaction data reflect exposure to Totect® 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%
|MedDRA System Organ Class (SOC) and Preferred term||Study 1 and 2 Combined (All causalities)
|Total number of patients with at least one event||68 (85)|
|General disorders and administration site conditions||46 (58)|
|Injection site pain/injection site discomfort||13 (16)|
|Edema peripheral||8 (10)|
|Injection site phlebitis||5 (6)|
|Gastrointestinal disorders||44 (55)|
|Abdominal pain||5 (6)|
|Infections and infestations||24 (30)|
|Postoperative infection||13 (16)|
|Nervous system disorders||19 (24)|
|Skin and subcutaneous disorders||14 (18)|
|Respiratory, thoracic and mediastinal disorders||13 (16)|
|Vascular disorders||12 (15)|
|Blood and lymphatic system disorders||11 (14)|
|Psychiatric disorders||11 (14)|
|Musculoskeletal and connective tissue disorders||10 (13)|
|Metabolism and nutrition disorders||8 (10)|
|Cardiac disorders||4 (5)|
Table 2 summarizes laboratory adverse events from studies 1 and 2.
Table 2: Laboratory Adverse Reactions
|CTCAE version 3 Term||CTC grade 3
|CTC grade 4
|CTC grade 2 to 4
|Decreased hemoglobin||2 (3)||0||34 (43)|
|Decreased WBC||20 (25)||16 (20)||58 (73)|
|Decreased neutrophils||17 (22)||19 (24)||48 (61)|
|Decreased platelets||17 (21)||0||21 (26)|
|Increased bilirubin||1 (2)||0||6 (11)|
|Increased AST||1 (1)||1 (1)||21 (28)|
|Increased ALT||1 (1)||4 (5)||17 (22)|
|Increased alkaline phosphatase||0||0||3 (4)|
|Increased LDH||0||0||1 (5)|
|Increased creatinine||1 (2)||1 (2)||8 (14)|
|Decreased sodium||4 (5)||1 (1)||5 (6)|
|Increased calcium total||1 (2)||1 (2)||4 (7)|
Read the Totect (dexrazoxane for injection, intravenous infusion only) Side Effects Center for a complete guide to possible side effects
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®. 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.
Read the Totect Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 5/14/2013
Additional Totect Information
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