Pronunciation:

dex-ray-ZOX-ane

Brand Names:

• Totect
• Zinecard

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Cardioprotective Agent

Uses of This Medicine:

Dexrazoxane is used to help prevent heart problems (eg, cardiomyopathy) in women receiving doxorubicin for breast cancer.

Dexrazoxane injection is used to treat tissue damage caused by the leakage of certain cancer medicines from the injection site.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of dexrazoxane injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dexrazoxane injection in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving dexrazoxane injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dimethyl Sulfoxide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood disorder or bleeding problem (eg, leukopenia, neutropenia, thrombocytopenia)—May make this condition worse.

• Kidney disease—The effects may be increased because of slower removal of the medicine from the body.

• Liver disease—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. It must also be given slowly, so the needle will have to stay in place for 1 to 2 hours. If you are also taking doxorubicin: You will receive this medicine over 15 minutes before your doxorubicin treatment.

This medicine must be injected right away and within 6 hours after tissue damage caused by the leakage of certain cancer medicines. It is usually given once a day for 3 days.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you are using an ice pack or any other cooling procedure at the affected area, you may have to remove it at least 15 minutes before receiving this medicine.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 3 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using this medicine. Some men receiving this medicine have become infertile (unable to have children).

Dexrazoxane can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

If you are also taking doxorubicin: This medicine may not protect your heart completely. It is important to tell your doctor if you have any symptoms of heart problems, including trouble breathing, chest pain, lightheadedness, dizziness, or a fast or uneven heartbeat.

This medicine may increase your risk for certain cancers, including acute myeloid leukemia and myelodysplastic syndrome. Talk to your doctor if you have questions or concerns.

This medicine may cause a serious allergic reaction, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bluish color

changes in skin color

chest pain or tightness

chills

cold hands and feet

cough

fever

hoarseness

lower back or side pain

pain, redness, or swelling in the arm or leg

painful or difficult urination

pale skin

sneezing

sore throat

swelling of the hands, ankles, feet, or lower legs

tenderness

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Black, tarry stools

chest discomfort

fast, irregular, or pounding heartbeat

pain at the injection site

ulcers, sores, or white spots in the mouth

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blurred or double vision

diarrhea

difficulty having a bowel movement

difficulty in swallowing

difficulty in walking

discouragement

dizziness

drooping eyelids

fainting

feeling sad or empty

hair loss

headache

heartburn

irritability

jaw pain

lack or loss of appetite

lightheadedness

loss of interest or pleasure

muscle pain, spasms, cramps, or stiffness

nausea

numbness or tingling in the fingers and toes

pain in the fingers and toes

pain in the testicles

pain or burning in the throat

pain or redness at the site of injection

pale skin at the site of injection

rapid, shallow breathing

stomach pain

swelling or inflammation of the mouth

thinning of the hair

trouble concentrating

trouble sleeping

vomiting

weight loss

Less common

Hives, welts, itching

redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.