Dexrazoxane Injection

WHY is this medicine prescribed?

Dexrazoxane injection (Totect, Zinecard) is used to prevent or decrease thickening of the heart muscles caused by doxorubicin in women who are taking the medication to treat breast cancer that has spread to other parts of the body. Dexrazoxane injection (Totect, Zinecard) is only given to women who have already received a certain amount of doxorubicin and who will need continued doxorubicin treatment, it is not used to prevent heart damage in women who are starting treatment with doxorubicin. Dexrazoxane injection (Totect) is used to decrease damage to the skin and tissues that may be caused when an anthracycline chemotherapy medication such as daunorubicin (Cerubidine), doxorubicin (Adriamycin, Doxil), epirubicin (Ellence) or idarubicin (Idamycin) leaks out of a vein as it is being injected. Dexrazoxane injection is in classes of medications called cardioprotectants and chemoprotectants. It works by stopping the chemotherapy medications from damaging the heart and the tissues.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Dexrazoxane injection comes as a powder to be mixed with liquid and injected into a vein by a doctor or nurse in a hospital. When dexrazoxane injection is used to prevent heart damage caused by doxorubicin, it is given over 15 minutes just before each dose of doxorubicin. When dexrazoxane injection is used to prevent tissue damage after an anthracycline medication has leaked out of a vein, it is given over 1 to 2 hours once a day for 3 days. The first dose is given as soon as possible within the first 6 hours after the leak occurs, and the second and third doses are given about 24 and 48 hours after the first dose.

What SPECIAL PRECAUTIONS should I follow?

Before receiving dexrazoxane injection,

• tell your doctor and pharmacist if you are allergic to dexrazoxane, any other medications, or any ingredients in dexrazoxane injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention dimethylsulfoxide (DMSO) topical products.

• tell your doctor if you have or have ever had heart, kidney, or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or plan to father a child. You should not become pregnant while you are receiving dexrazoxane injection. If you are receiving dexrazoxane injection (Zinecard), you should use birth control during your treatment. If you are receiving dexrazoxane injection (Totect), you should use birth control during your treatment and for at least 6 months after your final dose. If you are male, you and your female partner should use birth control during your treatment and for 3 months after you stop receiving dexrazoxane injection (Totect). Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while receiving dexrazoxane injection, call your doctor. Dexrazoxane may harm the fetus.

• tell your doctor if you are breast-feeding. You should not breast-feed while you are receiving dexrazoxane (Zinecard) injection. If you are receiving dexrazoxane injection (Totect), you should not breast feed while you are receiving treatment and for 2 weeks after your final dose.

• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of receiving dexrazoxane injection.

• you should know that treatment with dexrazoxane injection decreases but does not eliminate the risk that doxorubicin will damage your heart. Your doctor will still need to monitor you carefully to see how doxorubicin has affected your heart.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Dexrazoxane injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain or swelling in the place where the medication was injected
• nausea
• vomiting
• diarrhea
• constipation
• stomach pain
• loss of appetite
• dizziness
• headache
• excessive tiredness
• difficulty falling asleep or staying asleep
• depression
• swelling of the arms, hands, feet, ankles, or lower legs

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• sore throat, fever, chills, cough, and other signs of infection
• unusual bruising or bleeding
• pale skin
• weakness
• shortness of breath
• rash
• itching
• hives
• difficulty breathing or swallowing
• swelling of the eyes, face, mouth, lips, tongue, or throat
• dizziness
• fainting

Some people who took a medication that is very similar to dexrazoxane injection developed new forms of cancer. There is not enough information to tell if receiving dexrazoxane injection increases the risk that you will develop a new type of cancer. Talk to your doctor about the risks of receiving this medication.

Dexrazoxane injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• sore throat, fever, chills, and other signs of infection
• unusual bruising or bleeding
• pale skin
• shortness of breath
• excessive tiredness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to dexrazoxane injection.

Ask your doctor or pharmacist any questions you have about dexrazoxane injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.