Totect

What is Totect?

• Totect (dexrazoxane hydrochloride) is a cytoprotective agent used to treat the toxic effects of an anticancer drug that leaks from a vein into surrounding tissue and causes tissue damage.

Dexrazoxane Structural Formula V1

What are the uses of this medicine?

Totect is a prescription medicine used:

• to treat anthracycline chemotherapy leaks from your vein into the tissue around the intravenous (IV) site.
• in women with breast cancer that has spread to other parts of the body (metastatic) and are receiving a medicine called doxorubicin. Totect is used to reduce the occurrence and severity of heart muscle problems that may happen with doxorubicin treatment.

Limitations of Use:

• The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established.

How does this medicine work?

• 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.
• It is a type of chemoprotective agent and a type of topoisomerase inhibitor.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Be sure to mention dimethylsulfoxide (DMSO) topical products.

Is this medicine FDA approved?

• Totect was approved for medical use in the United States in 2007.

How should this medicine be used?

Recommended dosage: Recommended Dose for Extravasation:

• The individual dosage is based on calculation of the Body Surface Area (BSA) up to a maximum dose of 2000 mg (each on Day 1 and 2) and 1000 mg (Day 3), corresponding to a BSA of 2 m2.

Recommended Dose for Cardiomyopathy:

• The recommended dosage ratio of Totect to doxorubicin is 10:1 (e.g., 500 mg/m2 Totect to 50 mg/m2 doxorubicin).
• Administer doxorubicin within 30 minutes after the completion of Totect infusion.

• Reduce dose by 50% for patients with creatinine clearance < 40 mL/min.

Administration:

• Dexrazoxane injection comes as a powder to be mixed with liquid and injected into a vein by a doctor or nurse in a hospital.
• When dexrazoxane injection is used to prevent heart damage caused by doxorubicin, it is given over 15 minutes just before each dose of doxorubicin.
• When dexrazoxane injection is used to prevent tissue damage after an anthracycline medication has leaked out of a vein, it is given over 1 to 2 hours once a day for 3 days.
• The first dose is given as soon as possible within the first 6 hours after the leak occurs, and the second and third doses are given about 24 and 48 hours after the first dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 500 mg lyophilized powder in a single dose vial for reconstitution.

This medicine is available in fallowing brand namesː

• Totect

What side effects can this medication cause?

The most common side effects of Totect in people treated for anthracycline chemotherapy leaks include:

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

The most common side effect of Totect in women with metastatic breast cancer to reduce the occurrence and severity of heart muscle problems:

• pain at the intravenous (IV) site

What special precautions should I follow?

• Dexrazoxane is associated with leukopenia, neutropenia, and thrombocytopenia. Dexrazoxane may increase the myelosuppressive effects of chemotherapeutic agents. Perform hematological monitoring.
• Totect may interfere with the antitumor activity of the chemotherapy regimen. Only use Totect in patients who have received a cumulative doxorubicin dose of 300 mg/m2 and are continuing doxorubicin therapy.
• Totect does not completely eliminate the risk of anthracycline-induced cardiac toxicity. For cardiomyopathy, monitor cardiac function before and periodically during therapy to assess left ventricular ejection fraction (LVEF). If deterioration in cardiac function occurs, consider the benefit of continued therapy against the risk of producing irreversible cardiac damage.
• Secondary malignancies such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) have been reported in studies of pediatric patients who have received dexrazoxane in combination with chemotherapy.
• 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. monitor for signs and symptoms. Consider permanent discontinuation for severe hypersensitivity reactions.
• Totect can cause fetal harm. Advise patients of reproductive potential of the risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

Symptoms of overdosage may:

• signs of bone marrow failure
• myelosuppression
• sore throat, fever, chills, and other signs of infection
• unusual bruising or bleeding
• pale skin
• shortness of breath
• excessive tiredness

Treatment of overdosage:

• There is no known antidote for dexrazoxane.
• Instances of suspected overdose should be managed with supportive care until resolution of myelosuppression and related conditions is complete.
• Management of overdose should include treatment of infections, fluid regulation, and maintenance of nutritional requirements.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action, Totect can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of Totect in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: dexrazoxane (as a hydrochloride salt)
• Inactive ingredients: none

Who manufactures and distributes this medicine?

Manufactured for: Clinigen, Inc. Yardley, PA

• Totect® is a registered trademark owned by the Clinigen Group.

What should I know about storage and disposal of this medication?

• Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF).
• Protect from light.
• Keep vial in carton until ready for use.
• Follow special handling and disposal procedures.

• Dailymed label info on Totect
• FDA Totect

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