Related Pages Drug Information Summaries 1 NCI's drug information summaries provide consumer-friendly information about certain drugs that are approved by the U.S. Food and Drug Administration (FDA) to treat cancer or conditions related to cancer.

Brand name(s): Zinecard®, Totect™

• Approved for treatment of extravasation caused by intravenous anthracycline chemotherapy (Totect)
• Approved for treatment of cardiomyopathy caused by doxorubicin (Zinecard)

Full prescribing information for Totect ² is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

Full prescribing information for Zinecard ³ is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

Treatment of Extravasation Caused by Intravenous Anthracycline Chemotherapy

On September 6, 2007, the FDA approved dexrazoxane hydrochloride for injection (Totect™ made by TopoTarget USA, Inc.), equivalent to 500 mg dexrazoxane, for the treatment of extravasation resulting from intravenous anthracycline chemotherapy. Extravasion occurs when injected drugs leak out of the vein and into the skin.

In two studies, patients who were receiving single-agent anthracycline intravenously (usually as part of combination chemotherapy) and who developed extravasation symptoms of pain, burning, swelling, and redness near the infusion site received dexrazoxane hydrochloride to reduce surgical interventions for tissue injury following anthracycline extravasation. The protocol required extravasation to be confirmed by the presence of fluorescence in tissue biopsies.

The first dexrazoxane hydrochloride dose was given as soon as possible and within six hours following extravasation. After the first dose, treatment was repeated 24 and 48 hours later for a total of three doses. Dexrazoxane hydrochloride was administered as a 1-2 hour IV infusion through a different venous access location. The first and second doses were 1000 mg/m2 and the third dose was 500 mg/m2 up to a maximum daily dose of 2000 mg on days 1 and 2 and 1000 mg on the third day.

Extravasation was confirmed in 57 patients. The anthracyclines most commonly involved were epirubicin (56 percent) and doxorubicin (41 percent). Peripheral sites of extravasation included the forearm in 63 percent, the hand in 21 percent, and the antecubital area in 11 percent; four patients received the anthracycline via a central venous access device (CVAD). Most patients presented with swelling (83 percent), redness (78 percent), and pain (43 percent).

After dexrazoxane hydrochloride treatment, only one of the 57 patients required surgery. Thirteen patients had late adverse effects at the injection site such as pain, fibrosis, atrophy, and local sensory disturbance; all were judged as mild except in the one patient who required surgery. None of the four patients with CVADs required surgical intervention.

Dexrazoxane hydrochloride is a cytotoxic drug. When administered to patients receiving anthracycline-containing cytotoxic therapy, additive cytotoxicity may occur. Treatment with dexrazoxane hydrochloride is associated with leukopenia, neutropenia, and thrombocytopenia. Reversible elevations of liver enzymes may occur. Renal excretion is the primary metabolic pathway. Dimethylsulfoxide (DMSO) should not be used in patients who are receiving dexrazoxane to treat anthracycline-induced extravasation.

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Treatment of Cardiomyopathy Caused by Doxorubicin

In May 1995, the U.S. Food and Drug Administration (FDA) approved dexrazoxane hydrochloride for injection (Zinecard®, made by Pfizer U.S. Pharmaceuticals) as a treatment to reduce the incidence and severity of cardiomyopathy associated with doxorubicin administration in certain breast cancer patients.

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Glossary Terms

A type of antibiotic that comes from certain types of Streptomyces bacteria. Anthracyclines are used to treat many types of cancer. Anthracyclines damage the DNA in cancer cells, causing them to die. Daunorubicin, doxorubicin, and epirubicin are anthracyclines.

The removal of cells or tissues for examination by a pathologist. The pathologist may study the tissue under a microscope or perform other tests on the cells or tissue. There are many different types of biopsy procedures. The most common types include: (1) incisional biopsy, in which only a sample of tissue is removed; (2) excisional biopsy, in which an entire lump or suspicious area is removed; and (3) needle biopsy, in which a sample of tissue or fluid is removed with a needle. When a wide needle is used, the procedure is called a core biopsy. When a thin needle is used, the procedure is called a fine-needle aspiration biopsy.

A tube surgically placed into a blood vessel for the purpose of giving intravenous fluid and drugs. It also can be used to obtain blood samples. This device avoids the need for separate needle insertions for each infusion or blood test. Examples of these devices include Hickman catheters, which require clamps to make sure the valve is closed, and Groshong catheters, which have a valve that opens as fluid is withdrawn or infused and remains closed when not in use.

Treatment with drugs that kill cancer cells.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.

Cell-killing.

The active ingredient in a drug used to treat severe side effects caused by certain anticancer drugs. Under the brand name Totect it is used to treat the toxic effects of an anticancer drug that leaks from a vein into surrounding tissue and causes tissue damage. Under the brand name Zinecard it is used to reduce heart damage in women given doxorubicin for breast cancer that has spread. Dexrazoxane is also being studied in the treatment of cancer. It is a type of cardioprotective agent, a type of chemoprotective agent, and a type of topoisomerase inhibitor.

A drug that is used to treat many types of cancer and is being studied in the treatment of other types of cancer. Doxorubicin comes from the bacterium Streptomyces peucetius. It damages DNA and may kill cancer cells. It is a type of anthracycline antitumor antibiotic. Also called Adriamycin PFS, Adriamycin RDF, doxorubicin hydrochloride, hydroxydaunorubicin, and Rubex.

A drug used together with other drugs to treat early breast cancer that has spread to lymph nodes. It is also being studied in the treatment of other types of cancer. Epirubicin is a type of anthracycline antibiotic. Also called Ellence and epirubicin hydrochloride.

The growth of fibrous tissue.

A method of putting fluids, including drugs, into the bloodstream. Also called intravenous infusion.

Into or within a vein. Intravenous usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein. Also called IV.

A condition in which there is a lower-than-normal number of leukocytes (white blood cells) in the blood.

Having to do with metabolism (the total of all chemical changes that take place in a cell or an organism to produce energy and basic materials needed for important life processes).

A condition in which there is a lower-than-normal number of neutrophils (a type of white blood cell).

A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.

A condition in which there is a lower-than-normal number of platelets in the blood. It may result in easy bruising and excessive bleeding from wounds or bleeding in mucous membranes and other tissues.