Dexrazoxane

Dexrazoxane is used to protect the heart and other tissues from harmful side effects caused by certain cancer medications.

The Totect brand of dexrazoxane is used in men or women to treat a condition called extravasation (es-TRA-va-ZAY-shun). Extravasation happens when an injected medicine escapes from the blood vessels and spreads into tissues in the body. Serious tissue damage can occur when extravasation happens during the injection of certain cancer medications.

Dexrazoxane is also used to help prevent chemotherapy-related heart problems in women who are receiving doxorubicin for metastatic breast cancer. dexrazoxane is given only after you have received enough doxorubicin infusions to reach a specific total dose.

Dexrazoxane may also be used for purposes not listed in this medication guide.

Dexrazoxane is given through an infusion into a vein. A healthcare provider will give you this injection.

Totect is usually started within 6 hours after extravasation and is continued once daily for 3 days.

Dexrazoxane is usually started 15 minutes before you receive your doxorubicin infusion. Dexrazoxane is not given with your first dose of doxorubicin, but only after you have received prior doxorubicin doses up to a certain total amount.

Dexrazoxane can increase bone marrow suppression caused by chemotherapy. You may become more susceptible to infections, including serious or fatal infections. Your doctor will need to examine you regularly.

Dexrazoxane can harm an unborn baby or cause birth defects if the mother or father is using dexrazoxane. Tell your caregivers if you are pregnant, or if you are a man and your sex partner can become pregnant.

You should not receive Zinecard if your chemotherapy does not include doxorubicin or a similar medication (such as daunorubicin, epirubicin, idarubicin, or mitoxantrone).

Tell your doctor right away if you have signs of infection such as fever, chills, sore throat, easy bruising or bleeding, skin sores, or warmth and redness of any surgical incision.

You should not receive Zinecard if your chemotherapy does not include doxorubicin or a similar medication such as:

• daunorubicin (Cerubidine, Daunoxome);
• epirubicin (Ellence);
• idarubicin (Idamycin); or
• mitoxantrone (Novantrone).

Tell your doctor if you have ever had:

• heart problems;
• liver disease; or
• kidney disease.

Dexrazoxane can harm an unborn baby or cause birth defects if the mother or the father is receiving this medicine. Women should use effective birth control to prevent pregnancy while receiving dexrazoxane and for at least 6 months after the last dose. Men should use birth control during treatment and for at least 3 months after the last dose. Tell your doctor right away if a pregnancy occurs during this time.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because dexrazoxane may harm the baby if a pregnancy does occur.

You should not breastfeed while you are using dexrazoxane. Women receiving Totect should continue to not breastfeed for at least 2 weeks after the last dose.

Get emergency medical help if you notice any signs of an allergic reaction: hives; trouble breathing; feeling faint; swelling of your face, lips, tongue, or throat.

Dexrazoxane may lead to serious side effects. Contact your doctor immediately if you experience:

• fever, chills, fatigue, mouth sores, skin sores;
• easy bruising, unusual bleeding;
• sore throat, cough, difficulty breathing; or
• bruising, swelling, warmth, redness, oozing, or bleeding from any surgical incision.

Common side effects of dexrazoxane may include:

• nausea, vomiting;
• fever;
• infection after surgery; or
• pain at the injection site.

This is not a complete list of side effects, and others may happen. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Cardiomyopathy Prophylaxis:

Zinecard (R):Dosage ratio of dexrazoxane to doxorubicin is 10:1 (e.g. 500 mg/m2 dexrazoxane to 50 mg/m2 doxorubicin)-Administer via IV infusion over 15 minutes.-DO NOT administer via IV push.-Administer doxorubicin within 30 minutes of completion of dexrazoxane infusion; do not administer doxorubicin before dexrazoxane.Comments:-Do not use with the initiation of doxorubicin therapy.Use(s): Reducing incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin.

Usual Adult Dose for Extravasation:

Totect (R):Recommended doses:Day one: 1000 mg/m2 IV over 1 to 2 hoursDay two: 1000 mg/m2 IV over 1 to 2 hoursDay three: 500 mg/m2 IV over 1 to 2 hoursMaximum doses:Day one: 2000 mgDay two: 2000 mgDay three: 1000 mgComments:-Product must be diluted with 50 mL of 0.167 M sodium lactate injection solution prior to administration.-Initiate first infusion as soon as possible and within the first 6 hours of extravasation.-Start day 2 and 3 treatments at the same hour as the first day (give or take 3 hours).-Remove cooling features such as ice packs (if used) at least 15 minutes before administration to allow sufficient blood flow to extravasation area.Use(s): Extravasation resulting from intravenous anthracycline chemotherapy

Since dexrazoxane is administered by a healthcare professional as part of your chemotherapy treatment, it is unlikely that you will miss a dose.

Call your doctor for instructions if you miss your chemotherapy appointment.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid close contact with people who are sick or have infections. Tell your doctor immediately if you notice any signs of infection.

Tell your doctor about all your other medicines, especially:

• other cancer medications; or
• dimethyl sulfoxide (DMSO).

This list does not cover everything. Other drugs may interact with dexrazoxane, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are included here.