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Totect

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Totect

Totect

SIDE EFFECTS

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% Frequency

MedDRA System Organ Class (SOC) and Preferred term Study 1 and 2 Combined (All causalities)
N=80 (%)
Total number of patients with at least one event 68 (85)
General disorders and administration site conditions 46 (58)
  Pyrexia 17 (21)
  Injection site pain/injection site discomfort 13 (16)
  Fatigue 10 (13)
  Edema peripheral 8 (10)
  Injection site phlebitis 5 (6)
Gastrointestinal disorders 44 (55)
  Nausea 34 (43)
  Vomiting 15 (19)
  Diarrhea 9 (11)
  Abdominal pain 5 (6)
  Constipation 5 (6)
Infections and infestations 24 (30)
  Postoperative infection 13 (16)
Nervous system disorders 19 (24)
  Dizziness 9 (11)
  Headache 5 (6)
Skin and subcutaneous disorders 14 (18)
  Alopecia 11 (14)
Respiratory, thoracic and mediastinal disorders 13 (16)
  Dyspnea 6 (8)
  Pneumonia 5 (6)
  Cough 4(5)
Vascular disorders 12 (15)
Blood and lymphatic system disorders 11 (14)
  Anemia 5 (6)
Psychiatric disorders 11 (14)
  Depression 6 (8)
  Insomnia 4 (5)
Musculoskeletal and connective tissue disorders 10 (13)
Metabolism and nutrition disorders 8 (10)
  Anorexia 4 (5)
Cardiac disorders 4 (5)

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

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

Table 2: Laboratory Adverse Reactions

CTCAE version 3 Term CTC grade 3
N (%)
CTC grade 4
N (%)
CTC grade 2 to 4
N (%)
Hematologic:
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)
Hepatic:
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)
Metabolic:
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

DRUG INTERACTIONS

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
This monograph has been modified to include the generic and brand name in many instances.

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