Totect

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

Totect 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 circulates into tissues in the body. Serious tissue damage can occur when extravasation happens during injection of certain cancer medications.

Totect is also used to help prevent chemotherapy-related heart problems in women who are receiving doxorubicin for metastatic breast cancer. This medicine is given only after you have received enough doxorubicin infusions to amount to a certain total dose.

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

For extravasation, Totect is given via intravenous infusion over 1 to 2 hours once daily for 3 consecutive days and is usually started within 6 hours after extravasation.

For cardiomyopathy, Totect is given via intravenous infusion over 15 minutes before you receive your doxorubicin infusion. This medicine is not given with your first dose of doxorubicin, but only after you've received prior doxorubicin doses up to a certain total amount.

You should not receive Totect if you are pregnant. Dexrazoxane can harm an unborn baby or cause birth defects if the mother or father is using this medicine. Tell your caregivers if you are pregnant, or if you are a man and your partner is able to get pregnant.

Tell your doctor at once 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.

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows that you have received Totect.

Tell your doctor if you have ever had:

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

Totect 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 Totect 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 have signs of an allergic reaction to Totect: hives; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

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

Common Totect side effects may include:

• nausea, vomiting;
• fever;
• infection after a surgery; or
• pain where the medicine was injected.

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

Usual Adult Dose for Cardiomyopathy Prophylaxis:

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:

Recommended doses: Day one: 1000 mg/m2 IV over 1 to 2 hours Day two: 1000 mg/m2 IV over 1 to 2 hours Day three: 500 mg/m2 IV over 1 to 2 hours Maximum doses: Day one: 2000 mg Day two: 2000 mg Day three: 1000 mg Comments: -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 Totect is given by a healthcare professional, you are not likely to miss a dose.

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

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Tell your doctor about all your other medicines, especially:

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

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