Dactinomycin (Intravenous Route)

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)

This product is available in the following dosage forms:

• Powder for Solution

Before Using

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.

Pediatric

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

Geriatric

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

Breastfeeding

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.

Drug Interactions

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

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.

• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Poliovirus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

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, pasta€”Caution should be used

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)a€”Risk of severe disease affecting other parts of the body

• Gout (or history of) or


• Kidney stonesa€”Dactinomycin may increase levels of uric acid in the body, which can cause gout or kidney stones

• Infectiona€”Dactinomycin can decrease your body`s ability to fight infection

• Liver diseasea€”Effects of dactinomycin may be increased

• Radiation treatmenta€”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

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

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

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 .

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