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Totect Generic Name & Formulations
Legal Class
Rx
General Description
Dexrazoxane 500mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Cytoprotective agent.
How Supplied
Single-dose vial—1
Manufacturer
Totect Indications
Indications
To treat extravasation resulting from IV anthracycline chemotherapy. To reduce incidence and severity of cardiomyopathy associated with doxorubicin
administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300mg/m2 and will continue to receive doxorubicin therapy to maintain tumor control.
Totect Dosage and Administration
Adult
Extravasation: give once daily for 3 consecutive days by IV infusion over 1–2hrs. Initiate 1st dose as soon as possible and within 1st 6hrs after extravasation. Days 1 and 2: 1000mg/m2; max 2000mg. Day 3: 500mg/m2; max 1000mg. Cardiomyopathy: give by IV infusion over 15mins. Initiate prior to and until discontinuation of doxorubicin. Dose ratio: 10:1 (eg, Totect 500mg/m2 to doxorubicin 50mg/m2). May administer doxorubicin within 30mins after completing Totect infusion. Renal impairment (CrCl <40mL/min): reduce dose by 50%. Hepatic impairment (extravasation): not recommended; (cardiomyopathy): reduce Totect dose proportionately to doxorubicin (maintaining 10:1 ratio).
Children
Not established.
Totect Contraindications
Not Applicable
Totect Boxed Warnings
Not Applicable
Totect Warnings/Precautions
Warnings/Precautions
Myelosuppression. Obtain CBCs prior to each course of therapy (for cardiomyopathy). Monitor cardiac function prior to and during therapy (eg, LVEF). Renal impairment: monitor for hematological toxicity. Hepatic impairment (see Adult dose). Elderly. Embryo-fetal toxicity. Use effective contraception during treatment and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to chemotherapy initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Totect Pharmacokinetics
See Literature
Totect Interactions
Interactions
Avoid with chemotherapy initiation; may interfere with antitumor activity of the chemo regimen. Increased risk of secondary malignancies concomitant with chemotherapy. Extravasation: concomitant topical dimethylsulfoxide (DMSO); not recommended.
Totect Adverse Reactions
Adverse Reactions
Inj site pain/discomfort, nausea, vomiting, pyrexia, post-op infection; leukopenia, neutropenia, thrombocytopenia, lab abnormalities, cardiac toxicity, hypersensitivity reactions (if severe, consider permanent discontinuation).
Totect Clinical Trials
See Literature
Totect Note
Not Applicable
Totect Patient Counseling
See Literature
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