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warnings and cautions
5 WARNINGS AND PRECAUTIONS Myelosuppression: Dexrazoxane is associated with leukopenia, neutropenia, and thrombocytopenia. Perform hematological monitoring. ( 5.1 ) Anaphylactic/Hypersensitivity Reactions: Monitor for signs and symptoms. Permanent treatment discontinuation should be considered for severe hypersensitivity reactions. ( 5.2 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the risk to a fetus and to use effective contraception ( 5.3 , 8.1 , 8.3 ) 5.1 Myelosuppression Treatment with Totect is associated with leukopenia, neutropenia, and thrombocytopenia. Grade 2-4 decreased white blood cells (73%), decreased neutrophils (61%), and decreased platelets (26%) occurred in patients treated with Totect and cytotoxic chemotherapy in clinical trials. Febrile neutropenia occurred in 2.5% of patients [see Adverse Reactions ( 6.1 )] . Monitor complete blood counts during treatment with Totect and cytotoxic chemotherapy. The myelosuppression and cytotoxic potential of Totect and cytotoxic chemotherapy (with a nadir occurring on days 10-12) may be additive to that of the chemotherapy administered alone. 5.2 Anaphylactic/Hypersensitivity Reactions Hypersensitivity reactions including anaphylactic reaction, angioedema, skin reactions, bronchospasm, respiratory distress, hypotension and loss of consciousness have occurred in patients treated with dexrazoxane products and anthracyclines [see Adverse Reactions ( 6 )] . Previous history of allergy to dexrazoxane products should be carefully considered prior to administration. Consider permanent discontinuation in patients with severe hypersensitivity reactions. 5.3 Embryo-Fetal Toxicity Totect can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. In animal reproduction studies, intravenous administration of dexrazoxane to pregnant rats and rabbits during organogenesis resulted in teratogenicity at maternal doses approximately 0.1 and 0.2 times, respectively, the human dose of 1000 mg/m 2 . Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Totect. Advise males with female partners of reproductive potential to use effective contraception during treatment with Totect and for 3 months after the last dose [see Use in Specific Populations ( 8.1 , 8.3 ) and Clinical Pharmacology ( 12.1 )] .
6 ADVERSE REACTIONS The most common adverse reactions (≥15%) are nausea, pyrexia, injection site pain, vomiting, and postoperative infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 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 and laboratory abnormalities presented in Tables 1 and 2 reflect the combination of Totect, underlying disease, and already administered chemotherapy. The adverse reaction data reflect exposure to Totect from two clinical studies 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 System Organ Class (SOC) and Adverse Reaction Study 1 and 2 Combined (All causalities) % (N=80) Total number of patients with at least one event 85 General disorders and administration site conditions 58 Pyrexia 21 Injection site pain/injection site discomfort 16 Fatigue 13 Edema peripheral 10 Injection site phlebitis 6 Gastrointestinal disorders 55 Nausea 43 Vomiting 19 Diarrhea 11 Abdominal pain 6 Constipation 6 Infections and infestations 30 Postoperative infection 16 Nervous system disorders 24 Dizziness 11 Headache 6 Skin and subcutaneous disorders 18 Alopecia 14 Respiratory, thoracic and mediastinal disorders 16 Dyspnea 8 Pneumonia Cough 6 5 Vascular disorders 15 Blood and lymphatic system disorders 14 Anemia 6 Psychiatric disorders 14 Depression Insomnia 8 5 Musculoskeletal and connective tissue disorders 13 Metabolism and nutrition disorders Anorexia 10 5 Cardiac disorders 5 Table 2 summarizes laboratory abnormalities from studies 1 and 2. Table 2: Laboratory Abnormalities Laboratory Abnormality Grade 3 Grade 4 Grade 2 to 4 % % % Hematologic: Decreased hemoglobin 3 0 43 Decreased WBC 25 20 73 Decreased neutrophils 22 24 61 Decreased platelets 21 0 26 Hepatic: Increased bilirubin 2 0 11 Increased AST 1 1 28 Increased ALT 1 5 22 Increased alkaline phosphatase 0 0 4 Increased LDH 0 0 5 Metabolic: Increased creatinine 2 2 14 Decreased sodium 5 1 6 Increased calcium total 2 2 7