Dexrazoxane for Injection, Intravenous Infusion Only

Totect® (dexrazoxane for injection) is a sterile, pyrogen-free lyophilizate intended for intravenous (IV) administration. Totect® is packaged as an urgent treatment kit for single patient use. Each kit contains 1 or 4 vials of Totect® (dexrazoxane for injection) 500 mg and 1 or 4 vials of 50 mL diluent. Up to 10 vials each may be needed to complete three days of treatment.

Chemically, dexrazoxane is 2,6-piperazinedione,4,4'-(1-methyl-1,2ethanediyl)bis-,(S)- or (S)-(+)-1,2-bis(3,5-dioxopiperazin-1-yl)propane. The following diagram shows the chemical structure:

The molecular formula is C11H16N4O4; the molecular weight is 268.3. Dexrazoxane is a white to off-white powder, with a melting point of 194 ± 3 °C. It is soluble in dioxane and 0.1 N HCl, sparingly soluble in water, tetrahydrofuran, citrate buffer at pH 4.0, phosphate buffer at pH 7.0, and borate-potassium chloride sodium hydroxide buffer at pH 9.0. The acid dissociation constants, pKa, are 2.5 (for the tertiary piperazine nitrogen) and 9.7 (for the nitrogen imide). Log P is -2.135.

The finished product is supplied in a sterile form for intravenous infusion only following mixing and diluting.

Each kit contains 2 or 8 50 mL Type I glass vials. One or 4 vials each contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane and 1 or 4 vials each contains diluent (0.167M Sodium Lactate Injection, USP). Each vial of dexrazoxane for injection is closed with an aluminum flip-off cap covered with a dark red overcap. Each vial of diluent is closed with an aluminum flip-off cap covered with a white overcap.

When reconstituted as directed, the admixture contains dexrazoxane and the following excipients: hydrochloric acid, sodium lactate, water for injection, sodium hydroxide and lactic acid [see DOSAGE AND ADMINISTRATION]. The admixture should be further diluted in 0.9 % NaCl prior to administration to patients.

Totect® is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.

Included as part of the PRECAUTIONS section.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.