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Totect™ Package Insert
Totect™
500 mg*
dexrazoxane for injection
*Each vial of dexrazoxane for injection contains 589 mg dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane
DESCRIPTION
Totect™ (dexrazoxane for injection) is a sterile, pyrogen-free lyophilizate intended for intravenous (IV) administration. Totect™ is provided in a carton consisting of 10 vials of Totect™ and 10 vials of diluent.
Chemically, dexrazoxane is 2,6-piperazinedione,4,4'-(1-methyl-1,2-ethanediyl) 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). The log P is -2.135.
The finished product is supplied in a sterile form for intravenous infusion only following mixing and diluting.
Each carton contains twenty 50 mL Type I glass vials. Ten vials contain dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. The other 10 vials contain 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.
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