Totect

Disclaimer

TOTECT® is an ethical pharmaceutical that has been approved and is regulated by the US Food and Drug Administration (FDA). TOTECT can be obtained only by prescription from a licensed healthcare provider after diligent disclosure by the healthcare provider.

The information provided by this website, directory, accompanying articles, and links to other related websites is provided as a courtesy to site visitors, and all material is intended for information, communication, and education purposes only, and is in no manner an endorsement, recommendation, or approval by anyone of any product or of any treatment. The information presented is not to be considered complete, nor does it contain all medical information that may be relevant, and therefore it is not intended as a substitute for seeking medical treatment and/or appropriate care, nor is the information intended to replace medical advice offered by physicians. It should not be construed as rendering medical advice.

INDICATION: TOTECT® (dexrazoxane) is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.

IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Vial contents must be reconstituted and diluted with 50 mL of 0.167 M sodium lactate injection solution and further mixed and diluted with the recommended dose in 1000 mL 0.9% Sodium Chloride before use. The TOTECT dose should be reduced by 50% in patients with creatinine clearance values < 40 mL/min.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS
Myelosuppression: TOTECT is associated with leukopenia, neutropenia, and thrombocytopenia. Perform hematological monitoring during treatment with TOTECT and cytotoxic chemotherapy as the myelosuppression and cytotoxic potential may be additive to that of chemotherapy alone.

Anaphylactic/Hypersensitivity Reactions: 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. Previous history of allergy to dexrazoxane products should be carefully considered prior to administration. Consider permanent discontinuation in patients with severe hypersensitivity reactions.

Embryo-Fetal Toxicity: TOTECT can cause fetal harm when administered to a pregnant woman. Advise patients of potential risk and to use effective contraception during treatment and 6 months following the last dose of TOTECT. Use in patients with hepatic impairment is not recommended.

DRUG INTERACTIONS
TOTECT is not recommended for use with dimethyl sulfoxide (DMSO).

ADVERSE REACTIONS
In the clinical studies, TOTECT was administered to patients also receiving chemotherapeutic agents for cancer, and the adverse reaction profile reflects the combination of TOTECT, underlying disease, and already administered chemotherapy. The most common adverse reactions (≥15%) are nausea, fever, injection site pain, vomiting, and postoperative infection.

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