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 knownas antineoplastics. It is used to treat some kinds of cancer of the bonesand soft tissue, including muscles and tendons; Wilms' tumor (a cancer ofthe kidney found primarily in children); tumors in the uterus or womb; andcancer of the testicles.

Dactinomycin interferes with the growth of cancer cells, which are eventuallydestroyed. 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 reportedto your doctor. Other effects, like hair loss, may not be serious but maycause concern. Some effects may not occur for months or years after the medicineis used.

Before you begin treatment with dactinomycin, you and your doctor shouldtalk 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 supervisionof 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 willdo. This is a decision you and your doctor will make. For dactinomycin, thefollowing should be considered:

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

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

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

Breast-feeding?It is not known whether dactinomycin passes intobreast 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 dactinomycinin infants less than 6 to 12 months of age is not recommended.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information about the useof dactinomycin in the elderly.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When receiving dactinomycinit is especially important that your health care professional know if youare 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?Dactinomycinmay increase the effects of these medicines or radiation therapy on the blood

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

Other medical problems?The presence of other medicalproblems may affect the use of dactinomycin. Make sure you tell your doctorif 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 otherparts of the body

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

• Infection?Dactinomycin can decrease your body's ability tofight 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

Dactinomycinis sometimes given together with certain other medicines. If you are receivinga combination of medicines, it is important that you receive each one at theproper time. If you are taking some of these medicines by mouth, ask yourhealth care professional to help you plan a way to remember to take them atthe right times.

This medicine often causes nausea and vomiting. However, it is very importantthat 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 damageto your skin, eyes, nose, throat, or lungs. The medicine must NOT comeinto contact with your skin, eyes, or any other part of your body. Ask yourdoctor about instructions for handling this medicine, especially if you willbe receiving dactinomycin at home. The doctor will have specific instructionsfor 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 differentfor 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 whetheror not other medicines are also being taken. If you arereceiving dactinomycin at home, follow your doctor's orders or the directionson 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 forunwanted effects.

While you are being treated with dactinomycin, and after you stop treatmentwith it, do not have any immunizations (vaccinations)without your doctor's approval. Dactinomycin may lower your body'sresistance, and there is a chance you might get the infection the immunizationis meant to prevent. In addition, other persons living in your household shouldnot take oral polio vaccine since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral polio vaccine withinthe last several months. Do not get close to them, and do not stay in thesame room with them for very long. If you cannot take these precautions, youshould consider wearing a protective face mask that covers the nose and mouth.

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

• If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor 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 ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine 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 yourteeth and gums. Check with your medical doctor before having any dental workdone.
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injurycould 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 mayneed medical attention.

Also, because of the way these medicines act on the body, there is a chancethat they might cause other unwanted effects that may not occur until monthsor years after the medicine is used. These delayed effects may include certaintypes of cancer, such as leukemia. Discuss these possible effects with yourdoctor.

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

More common

Black, tarry stools; blood in urineor stools; cough or hoarseness accompanied by feveror 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; unusualbleeding or bruising

Rare

Pain at place of injection; wheezing

Incidence not known

Abdominal cramps; confusion; convulsions; difficulty in breathing; growth retardation; irregularheartbeats; 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 withyour health care professional as soon as possible if any of the followingside effects occur:

More common

Diarrhea (continuing); difficulty inswallowing; heartburn; sores in mouth and on lips; stomach pain (continuing); unusual tiredness or weakness

Rare

Joint pain; swelling of feet or lowerlegs; yellow eyes or skin

Incidence not known

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. Also, your health care professionalmay be able to tell you about ways to prevent or reduce some of these sideeffects. Check with your health care professional if any of the followingside effects continue or are bothersome or if you have any questions aboutthem:

More common

Darkening of skin; infection; unusual feeling of dullness or sluggishness; general feeling of discomfort or weakness; nauseaand vomiting; redness of skin; skin rash or acne

Thismedicine 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 maystill produce some side effects that need attention. During this period oftime check with your doctor if you notice any of the following:

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

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

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, dactinomycin is used in certain patients with the following medicalconditions:

• 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 additionalinformation relating to proper use, precautions, or side effects for theseuses.