Totect

Efficacy in Treating
Anthracycline Extravasations

TOTECT® (dexrazoxane) for injection demonstrated clinical efficacy in two prospective, multicenter studies1

  • Eliminated the need for surgery in 98% of patients (53/57)
  • Allowed for the majority of patients to continue their next scheduled dose of cancer therapy on time (38/57; 71%)

Table - Clinical Efficacy

TT01 and TT02 study overview: The purpose of these studies were to assess the efficacy and tolerability of i.v. dexrazoxane as acute antidote in biopsy-verified anthracycline extravasation. Patients with fluorescence-positive tissue biopsies were treated with a 3-day schedule of i.v. dexrazoxane (1000, 1000, and 500 mg/m2) starting no later than 6 h after the incident. Patients were assessed for efficacy (the possible need for surgical resection) and toxicity during the treatment period and regularly for the next 3 months.
References:
1. TOTECT® [prescribing information.]. Nashville, TN; Cumberland Pharmaceuticals; February 2018.

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

IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Vial contents must be reconstituted and diluted with 50 mL of 0.167 M sodium lactate injection solution and further mixed and diluted with the recommended dose in 1000 mL 0.9% Sodium Chloride 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 during treatment with TOTECT and cytotoxic chemotherapy as the myelosuppression and cytotoxic potential may be additive to that of chemotherapy alone.

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. Previous history of allergy to dexrazoxane products should be carefully considered prior to administration. Consider permanent discontinuation in patients with severe hypersensitivity reactions.

Embryo-Fetal Toxicity: TOTECT can cause fetal harm when administered to a pregnant woman. Advise patients of potential risk and to use effective contraception during treatment and 6 months following the last dose of TOTECT. Use in patients with hepatic impairment is not recommended.

DRUG INTERACTIONS
TOTECT is not recommended for use with dimethyl sulfoxide (DMSO).

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 (≥15%) are nausea, fever, injection site pain, vomiting, and postoperative infection.

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