Totect

Generic name: dexrazoxane
Drug class: Miscellaneous uncategorized agents

Medically reviewed by  A Ras MD.

What is Totect?

Totect is a prescription medicine used to treat people when anthracycline chemotherapy leaks from your vein into the tissue around the intravenous (IV) site.

It is not known if Totect is safe and effective in children.

Description

Totect (dexrazoxane for injection) is a sterile, pyrogen-free lyophilized powder intended for intravenous (IV) administration. Each Totect carton contains 1 single dose vial of Totect (dexrazoxane for injection) 500 mg.

Chemically, dexrazoxane a cytoprotective agent, 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:

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 carton contains one 50 mL Type I glass vial. Each vial contains 568 mg dexrazoxane hydrochloride, equivalent to 500 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 50 mL of Sterile Water for injection, USP, each mL contains 10 mg dexrazoxane and the pH of the resultant solution is 1.0 to 3.0.

Mechanism of Action

The mechanism by which dexrazoxane reduces tissue damage caused by anthracycline-related cardiomyopathy or following anthracycline extravasation is not fully understood. Dexrazoxane is a cyclic derivative of EDTA that penetrates cell membranes. Results of laboratory studies suggest that dexrazoxane is converted intracellularly to a ring-opened chelating agent that interferes with iron-mediated free radical generation. Some evidence suggests that dexrazoxane inhibits topoisomerase II reversibly.

What should I tell my healthcare provider before using Totect?

Before you receive Totect, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems.
  • have liver problems.
  • have ever had an allergic reaction to products that contain dexrazoxane.
  • are pregnant or plan to become pregnant. Totect can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with Totect.
    • Females who can become pregnant should use effective birth control during treatment with Totect and for 6 months after the final dose.
    • Males who have female partners who can become pregnant should use effective birth control during treatment with Totect and for 3 months after the final dose.
  • are breastfeeding or plan to breastfeed. It is not known if Totect passes into your breast milk. Do not breastfeed during treatment with Totect and for 2 weeks after the final dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal or dietary supplements.

Especially tell your healthcare provider if you use a medicine on the skin (topical) called dimethyl sulfoxide (DMSO). Using a topical DMSO during treatment with Totect may affect how well Totect works.

How should I use Totect?

  • Totect is given to you by your healthcare provider.
  • Totect is injected into your vein (intravenous or IV infusion) over 1 to 2 hours each day for three days.

What are the possible side effects of Totect?

Totect can cause serious side effects, including:

  • Low blood cell counts. Low blood cell counts, including a decrease in white blood cell counts (leukopenia and neutropenia) and a decrease in the blood cells which help your blood to clot (thrombocytopenia), have happened with Totect. Your healthcare provider will do blood tests to check your blood cell counts during treatment with Totect and certain other chemotherapy medicines. You should check your temperature often during treatment with Totect and tell your healthcare provider if you have a fever.
  • Serious allergic reactions. Totect can cause allergic reactions that can be severe and may lead to death. Get medical help right away if you get any of the following symptoms of an allergic reaction:
    • trouble breathing
    • dizziness or lightheadedness
    • swelling of your face, lips, tongue or throat
    • faint or pass out
    • raised bumps (hives)

The most common side effects of Totect include:

  • nausea
  • fever
  • blood vessel problems
  • pain at the intravenous (IV) site
  • vomiting
  • infection after surgery

Totect may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Totect. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Totect

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Totect that is written for health professionals.

Label

PRINCIPAL DISPLAY PANEL – BOTTLE LABEL

 

  • NDC 76310-110-01
  • Rx Only
  • Totect®
  • (dexrazoxane) for injection
  • 500 mg/vial
  • For Intravenous Infusion Only.
  • Important: Please see Prescribing Information for instructions for reconstitution and final dilution.
  • Single Dose Vial; Discard Unused Portion.

 

Totect

 

PRINCIPAL DISPLAY PANEL – CARTON LABEL

  • NDC 76310-110-01
  • Rx Only
  • Totect®
  • (dexrazoxane) for injection
  • 500 mg/vial
  • For Intravenous Infusion Only.
  • Important: Please see Prescribing Information for instructions for reconstitution and final dilution.
  • Single Dose Vial; Discard Unused Portion.

 

Carton Label

What are the ingredients in Totect?

Active ingredient: dexrazoxane (as a hydrochloride salt).

Inactive ingredients: none

SRC: NLM .

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