Pronunciation:

dak-ti-noe-MYE-sin

Brand Names:

• Cosmegen

Dosage Forms:

• Powder for Solution

Warnings:

Dactinomycin for injection should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.

This drug is highly toxic and both powder and solution must be handled and administered with care. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Avoid exposure during pregnancy. Due to the toxic properties of dactinomycin (e.g., corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently. Dactinomycin is extremely corrosive to soft tissue. If extravasation occurs during intravenous use, severe damage to soft tissues will occur. In at least one instance, this has led to contracture of the arms .

This drug is highly toxic and both powder and solution must be handled and administered with care. Avoid exposure during pregnancy. Due to the toxic properties of dactinomycin (e.g., corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently. If extravasation occurs during intravenous use, severe damage to soft tissues will occur .

Classifications:

Therapeutic—

Antibiotic

Uses of This Medicine:

Dactinomycin 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.

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)

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—

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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

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:

• 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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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.

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

More common

Black, tarry stools

blood in urine or stools

cough or hoarseness accompanied by fever or chills

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

unusual bleeding or bruising

Rare

Pain at place of injection

wheezing

Incidence not known

Abdominal cramps

confusion

convulsions

difficulty in breathing

growth retardation

irregular heartbeats

mood or mental changes

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

numbness and tingling around the mouth, fingertips, or feet

shortness of breath

tremor

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Diarrhea (continuing)

difficulty in swallowing

heartburn

sores in mouth and on lips

stomach pain (continuing)

unusual tiredness or weakness

Rare

Joint pain

swelling of feet or lower legs

yellow eyes or skin

Incidence not known

Blisters

body aches or pain

chapped, red, or swollen lips

congestion

cough

diarrhea

difficulty in moving

difficulty swallowing

dryness or soreness of throat

fever

flushing, redness of skin

hoarseness

joint pain

muscle aching or cramping

muscle pains or stiffness

runny nose

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

swollen joints

tender, swollen glands in neck

trouble in swallowing

unusually warm skin

voice changes

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 skin

infection

unusual feeling of dullness or sluggishness

general feeling of discomfort or weakness

nausea and vomiting

redness of skin

skin rash or acne

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 using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.