Totect

Safety Information

ADVERSE REACTIONS

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 two open-label clinical studies, TOTECT® was administered to patients also receiving anthracycline 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
Pyrexia
Injection site pain/injection site discomfort
Fatigue
Edema peripheral
Injection site phlebitis
46 (58)
17 (21)
13 (16)
10 (13)
8 (10)
5 (6)
Gastrointestinal disorders
Nausea
Vomiting
Diarrhea
Abdominal pain
Constipation
44 (55)
34 (43)
15 (19)
9 (11)
5 (6)
5 (6)
Infections and infestations
Postoperative infection
24 (30)
13 (16)
Nervous system disorders
Dizziness
Headache
19 (24)
9 (11)
5 (6)
Skin and subcutaneous disorders
Alopecia
14 (18)
11 (14)
Respiratory, thoracic and mediastinal disorders
Dyspnea
Pneumonia
Cough
13 (16)
6 (8)
5 (6)
4 (5)
Vascular disorders 12 (15)
Blood and lymphatic system disorders
Anemia
11 (14)
5 (6)
Psychiatric disorders
Depression
Insomnia
11 (14)
6 (8)
4 (5)
Musculoskeletal and connective tissue disorders 10 (13)
Metabolism and nutrition disorders
Anorexia
8 (10)
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)

INDICATION: TOTECT® (dexrazoxane) is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.

IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Vial contents must be mixed and diluted with 50 mL of 0.167 M sodium lactate injection solution before use. The TOTECT dose should be reduced by 50% in patients with creatinine clearance
values < 40 mL/min.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS
Myelosuppression: TOTECT is associated with leukopenia, neutropenia, and thrombocytopenia. Perform hematological monitoring.
Use in Pregnancy: Fetal harm can occur when administered to a pregnant woman. Apprise women of potential harm to the fetus.

ADVERSE REACTIONS
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 most common adverse reactions (≥16%) are nausea, fever, injection site pain and vomiting.

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