To Report Suspected Adverse Reactions:
Contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
For Professional Medical Information:
For all questions concerning adverse events associated with the use of this product, please contact Cumberland Pharmaceuticals by phone at 1-877-484-2700.
For Ordering Information:
Contact your wholesaler or our customer service center to order TOTECT®.
Customer Service Center:
INDICATION: TOTECT® (dexrazoxane) is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.
IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Vial contents must be mixed and diluted with 50 mL of 0.167 M sodium lactate injection solution before use. The TOTECT dose should be reduced by 50% in patients with creatinine clearance
values < 40 mL/min.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Myelosuppression: TOTECT is associated with leukopenia, neutropenia, and thrombocytopenia. Perform hematological monitoring.
Use in Pregnancy: Fetal harm can occur when administered to a pregnant woman. Apprise women of potential harm to the fetus.
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 (≥16%) are nausea, fever, injection site pain and vomiting.
Click here to view Full Prescribing Information