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|Cosmegen

DACTINOMYCIN (Systemic)

Some commonly used brand names are:

In the U.S.—

• Cosmegen

In Canada—

• Cosmegen

Another commonly used name is actinomycin-D .

Category

• Antineoplastic

Description

Dactinomycin (dak-ti-noe-MYE-sin) belongs to the group of medicines known as antineoplastics. It is used to treat some kinds of cancer of the bones and soft tissue, including muscles and tendons; Wilms" tumor (a cancer of the kidney found primarily in children); tumors in the uterus or womb; and cancer of the testicles.

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 good this medicine will do as well as the risks of using it.

Dactinomycin is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:

• Parenteral
• Injection (U.S. and Canada)

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 dactinomycin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to dactinomycin. Also tell your health care professional if you are allergic to any other substances such as foods, preservatives, or dyes.

Pregnancy—There is a chance that this medicine may cause birth defects if either the male or female is receiving it at the time of conception or if it is taken during pregnancy. Studies have shown that dactinomycin causes birth defects in animals. In addition, many cancer medicines may cause sterility which could be permanent. Although sterility has not been reported with this medicine, the possibility should be kept in mind.

Be sure that you have discussed this with your doctor before receiving this medicine. It is best to use some kind of birth control while you are receiving dactinomycin. Tell your doctor right away if you think you have become pregnant while receiving dactinomycin.

Breast-feeding—It is not known whether dactinomycin passes into breast milk. However, because this medicine may cause serious side effects, breast-feeding is generally not recommended while you are receiving it.

Children—Because of increased toxicity, use of dactinomycin in infants less than 6 to 12 months of age is not recommended.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of dactinomycin in the elderly.

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 receiving dactinomycin it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Plicamycin (e.g., Mithramycin) or
• Zidovudine (e.g., AZT, Retrovir) or
• If you have ever been treated with radiation or cancer medicine—Dactinomycin may increase the effects of these medicines or radiation therapy on the blood

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)—Dactinomycin may increase concentrations of uric acid in the blood. Since these medicines are used to lower uric acid levels, they may not be as effective in patients receiving dactinomycin

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

• Cancer treatment, past or
• Radiation treatment, past—Caution should be used

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout (or history of) or
• Kidney stones—Dactinomycin may increase levels of uric acid in the body, which can cause gout or kidney stones

• Infection—Dactinomycin can decrease your body"s ability to fight infection

• Liver disease—Effects of dactinomycin may be increased

• Radiation treatment—If you are taking this medicine for Wilms" tumor and you are having radiation treatment or you have in the past two months, tell your doctor right away.

Proper Use of This Medicine

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 health care professional 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 health care professional 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. Ask your doctor about instructions for handling this medicine, especially if you will be receiving dactinomycin at home. The doctor will have specific instructions for protective clothing to be worn and what to do if you inhale this medicine, or if it comes into contact with your eyes or skin.

Dosing—The dose of dactinomycin will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient"s weight, and whether or not other medicines are also being taken. If you are receiving dactinomycin at home, follow your doctor"s orders or the directions on the label . If you have any questions about the proper dose of dactinomycin, ask your doctor.

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 and to check for unwanted effects.

While you are being treated with dactinomycin, and after you stop treatment with it, do not have any immunizations (vaccinations) 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 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 dactinomycin accidentally seeps out of the vein into which it is injected, it may severely damage some tissues and cause scarring. Tell the health care professional right away if you notice redness, pain, or swelling at the place of injection .

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.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Incidence not known

Other 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:

This medicine often causes a temporary loss of hair, sometimes including the eyebrows. After treatment with dactinomycin has ended, normal hair growth should return.

After you stop receiving dactinomycin, it may still produce some side effects that need attention. During this period of time check with your doctor if you notice any of the following:

Black, tarry stools; blood in urine or stools; cough or hoarseness accompanied by fever or chills; diarrhea; fever or chills; lower back or side pain accompanied by fever or chills; painful or difficult urination accompanied by fever or chills; pinpoint red spots on skin; sores in mouth and on lips; stomach pain; unusual bleeding or bruising; yellow eyes or skin

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

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, dactinomycin is used in certain patients with the following medical conditions:

• Kaposi"s sarcoma (a type of cancer of the skin and mucous membranes)
• Osteosarcoma (a type of bone cancer found primarily in children)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Developed: 05/06/1999
Revised: 01/27/2005

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