Drug Information for Totect Kit (dexrazoxane) for injection, for intravenous infusion onlyInitial U.S. Approval: 2007 (TopoTarget USA): 17 PATIENT COUNSELING INFORMATION

  • See FDA-approved Patient Labeling (17.3)

  • 17.1 Myelosupression

  • Treatment with Totect® is associated with leukopenia, neutropenia, and thrombocytopenia. Perform hematological monitoring. [see Warnings and Precautions (5.1)]

  • 17.2 Pregnancy

  • Women who have potential to become pregnant should be advised that Totect® might cause fetal harm. [see Warnings and Precautions (5.3)]

  • 17.3 FDA-Approved Patient Labeling






    Read the Patient Information that comes with Totect® before you receive treatment. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

    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.

    Totect® has not been studied in children.

    What should I tell my healthcare provider before receiving Totect®?

    Before receiving Totect®:

    • tell your healthcare provider about all your medical conditions including if you have any kidney problems.
    • tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, herbal or dietary supplements. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
    • tell your healthcare provider if you use a topical dimethylsulfoxide (DMSO). Topical DMSO should not be used in combination with Totect® since it may lessen the effect of Totect®.
    • tell your healthcare provider if you are pregnant, could be pregnant, or are planning to become pregnant, or are breast-feeding.It is not known if Totect® passes into your breast milk. You and your doctor should decide if you will receive Totect® or breast feed. You should not do both. Talk to your doctor about the best way to feed your baby if you take Totect®. Do not breast feed while taking Totect®.

    How will I receive Totect®?

    • Totect® is given to you in your healthcare provider's office, clinic or hospital.
    • Totect® is infused into a vein for 1 to 2 hours each day for three days.

    What are the possible side effects of Totect®?

    Totect® can cause serious side effects including:

    • a decrease in white blood cell counts (leukopenia and neutropenia)
    • a decrease in the blood cells which help your blood to clot (thrombocytopenia)

    Blood tests may be needed to monitor for these side effects.

    Common side effects:

    • nausea
    • fever
    • pain at the intravenous site
    • vomiting

    Tell your healthcare provider if you have any side effect that bothers you or does not go away.

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

    Talk to your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at www.fda.gov/medwatch.

    General Information about Totect®

    Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet.

    This Patient Information summarizes the most important information about Totect®. 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.

    For more information, go to www.totect.com or call 1-866-914-2922.

    What are the ingredients in Totect®?

    Active ingredient: dexrazoxane

    Inactive ingredients: hydrochloric acid, sodium lactate, water for injection, sodium hydroxide and lactic acid

    Marketed by:TopoTarget USA Inc.100 Enterprise DriveRockaway, New Jersey 07866USA

    Distributed by:See www.totect.com webpage for the distributors

    Packaged by:Integrated Commercialization SolutionsBrooks, KY 40109USA

    Manufactured by:Ben Venue Laboratories, Inc.Bedford, Ohio 44146USAHameln Pharmaceuticals GmbH31789 HamelnGermany

    Manufactured for:TopoTarget A/SSymbion Science ParkFruebjergvej 3DK-2100 CopenhagenDenmark

    Totect® is a registered trademark of TopoTarget A/S, Copenhagen, Denmark.

    US Patent No 6,727,253 B2

    November 2009


  • Drug Information Provided by National Library of Medicine (NLM).