Pronunciation:

dak-tin-oh-MYE-sin

Brand Names:

• Cosmegen

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antibiotic

Uses of This Medicine:

Dactinomycin injection is used to treat certain types of cancer. This includes cancer of the bones and soft tissue, including muscles and tendons, (eg, rhabdomyosarcoma, Ewing sarcoma), Wilms tumor (a cancer of the kidney found primarily in children), tumors in the uterus or womb (gestational trophoblastic neoplasia), and cancer of the testicles that has spread. It is also used to treat solid tumors that have come back (recurrent) to the same site after a previous treatment.

Dactinomycin interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by dactinomycin, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with dactinomycin, you and your doctor should talk about the benefits as well as the risks of using this medicine.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dactinomycin injection in children. However, safety and efficacy have not been established in children to treat solid tumors that have come back to the same site after a previous treatment.

Older adults—

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

• Levoketoconazole
• Methotrexate

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:

• Bone marrow problems or
• Kidney disease or
• Liver disease or
• Veno-occlusive liver disease (blocked veins in the liver)—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infection.

• Radiation treatment—If you are using this medicine for Wilms' tumor and you have received radiation treatment in the past 2 months, tell your doctor right away.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through a needle placed into one of your veins.

Dactinomycin is sometimes given together with certain other medicines. If you are receiving a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your doctor to help you plan a way to remember to take them at the right times.

This medicine often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.

This medicine is very toxic and can cause severe damage to your skin, eyes, nose, throat, or lungs. The medicine must not come into contact with your skin, eyes, or any other part of your body. If any of the medicine does get into the eyes, wash them with water, normal saline, or a balanced salt irrigating eye solution for at least 15 minutes and check with your doctor right away. If any of the medicine does get on your skin, wash the affected part with water or apply ice for at least 15 minutes while removing contaminated clothes and shoes. Check with your doctor right away. The contaminated clothes should be destroyed and shoes must be cleaned thoroughly before using it again.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while receiving this medicine to make sure it is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using 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 effective 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 with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may increase your risk of having other cancer (including leukemia). Talk with your doctor if you have concerns about this.

While you are being treated with dactinomycin, and after you stop treatment with it, do not have any live vaccines without your doctor's approval. Dactinomycin may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Dactinomycin 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 the 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.

Check with your doctor right away if you have diarrhea, nausea or vomiting, or sores or white patches on your lips, mouth, or throat while receiving this medicine.

If dactinomycin accidentally seeps out of the vein into which it is injected, it may severely damage some tissues and cause scarring. Tell your doctor right away if you notice redness, pain, or swelling at the injection site.

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

Black, tarry stools

blood in the urine or stools

chills

cough

diarrhea (continuing)

difficulty with swallowing

fever

heartburn

hoarseness

lower back or side pain

painful or difficult urination

pinpoint red spots on the skin

sores in the mouth and on the lips

stomach pain (continuing)

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Blistering, peeling, or loosening of the skin

body aches or pain

chapped, red, or swollen lips

confusion

congestion

cough

difficulty with breathing

difficulty with moving

difficulty with swallowing

dryness or soreness of the throat

flushing or redness of the skin

irregular heartbeat

joint pain or swelling

muscle ache, pains, or stiffness

muscle cramps in the hands, arms, feet, legs, or face

numbness and tingling around the mouth, fingertips, or feet

pain at the injection site

runny nose

scaling, redness, burning, pain, or other signs of inflammation of the lips

seizures

slow growth

stomach cramps

swelling of the feet or lower legs

tender, swollen glands in the neck

tremor

unusually warm skin

voice changes

yellow eyes or skin

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

Darkening of the skin

general feeling of discomfort or weakness

nausea

skin rash or acne

unusual feeling of dullness or sluggishness

vomiting

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.