Totect Side Effects
Generic Name: dexrazoxane
Please note - some side effects for Totect may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Totect Side Effects - for the Professional
Totect
Overview
Dexrazoxane has been studied previously as a cytotoxic agent. Adverse reactions of nausea/vomiting, diarrhea, stomatitis, bone marrow suppression (neutropenia, thrombocytopenia), altered liver function (increased AST/ALT), and infusion site burning have been observed. These adverse reactions have been reversible.
Discussion of Adverse Reaction Information
Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice.
In the two 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 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 reaction occurring with ≥ 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 | 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 reactions from studies 1 and 2 combined.
| CTCAE version 3 Term |
CTC grade 3 |
CTC grade 4 |
CTC grade 2 to 4 |
| N (%) | N (%) | 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) |
Side Effects by Body System
Gastrointestinal
Gastrointestinal side effects including nausea (43%), vomiting (19%), diarrhea (11%), abdominal pain (6%), and constipation (6%) have been reported.
General
General side effects including pyrexia (21%), postoperative infection (16%), fatigue (13%), peripheral edema (10%), chest pain, chest discomfort, decreased drug effect, hyperpyrexia, and decreased therapeutic response have been reported.
Local
Local side effects including injection site pain (16%) and injection site phlebitis (6%) have been reported.
Cardiovascular
Cardiovascular side effects including vascular disorders (15%) and cardiac disorders (5%) have been reported.
Dermatologic
Dermatologic side effects including alopecia (14%) have been reported.
Musculoskeletal
Musculoskeletal side effects including "musculoskeletal and connective tissue disorders" (13%) have been reported.
Nervous system
Nervous system side effects including dizziness (11%) and headache (6%) have been reported.
Respiratory
Respiratory side effects including dyspnea (8%), pneumonia (6%), and cough (5%) have been reported.
Psychiatric
Psychiatric side effects including depression (8%), anorexia (5%), and insomnia (5%) have been reported.
Hematologic
Hematologic side effects including anemia (6%), decreased WBC, decreased neutrophils, and decreased platelets have been reported.
Hepatic
Hepatic side effects including increased bilirubin, increased AST, increased ALT, increased alkaline phosphatase, and increased LDH have been reported
Metabolic
Metabolic side effects including increased creatinine, decreased sodium, and increased total calcium have been reported.
TopMore resources:
Dexrazoxane - Includes detailed dosage instructions.
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