Class: Chemotherapy

Generic Name: Dactinomycin (ACK-tin-oh-MYE-sin), Actinomycin-D, Actinomycin
Trade Name: Cosmegen®

For which conditions is this drug approved?

Dactinomycin is FDA approved for use in combination with chemotherapy and/or multi-modality treatment for the following cancers:  Wilms’ tumor, childhood rhabdomyosarcoma, Ewing’s sarcoma, and metastatic non-seminomatous testicular cancer. It is also approved as a single agent or as part of combination therapy for the treatment of gestational trophoblastic neoplasia and locally recurrent or locoregional solid malignancies.

It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action?

Dactinomycin is a type of antibiotic that produces its anti-cancer effects by binding to the cell’s genetic structure, DNA, and inhibiting the production of proteins that are necessary to maintain the life of a cell.

How is dactinomycin typically given (administered)?

Dactinomycin is administered intravenously (into a vein) and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used, and the overall health of the patient. It is important for patients to tell their healthcare provider if they feel any stinging or burning, or see any redness or swelling at the site of administration. If dactinomycin leaks outside of the vein during administration, it can cause severe damage to surrounding tissues. Once dactinomycin is administered, it is ultimately cleared from the body through the urine and feces.

How are patients typically monitored?

Patients will usually have scheduled meetings with their healthcare provider while they are being treated with dactinomycin. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

What are the common (occur in 30% or more of patients) side effects of treatment with dactinomycin?

• Low white blood cell levels – increases risk of infection
• Low red blood cell levels- increases risk of anemia
• Low platelet levels – increased risk of bleeding
• Nausea and vomiting
• Sores in the mouth
• Hair loss
• Diarrhea
• Skin reactions – redness, peeling, acne, skin eruptions and sensitivity to sunlight

What are the less common (occur in 10% to 29% of patients) side effects of treatment with dactinomycin?

• Fatigue
• Liver damage
• Loss of appetite
• Fever
• Skin reaction – skin color changes (darkening) or skin sloughing at sites where previous radiation was given
• Sterility – inability to conceive a child

What are possible late side effects of treatment with dactinomycin?

There is risk of developing side effects months or years after treatment has been completed. In uncommon instances, a secondary malignancy may occur as a result of receiving dactinomycin.  A secondary malignancy is a new and unrelated cancer that occurs in an individual as a result of previous treatment with radiation or chemotherapy.  Patients should ask their physician about the possibility of developing a secondary malignancy as a result of their treatment.
Patients receiving dactinomycin should discuss the risk of other late occurring side effects with their physician.

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• For mouth sores, patients should rinse their mouth three times a day with a salt and sod solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.
Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

• Flu or cold-like symptoms: fever, chills, sore throat, cough
• Signs of infection – redness, swelling, pus, tenderness
• Continued nausea or vomiting
• Severe diarrhea
• Ulcers in the mouth or on lips
• Severe fatigue
• Yellow skin or eyes
• Bleeding or bruising
• Severe abdominal pain
• Changes in color or urine or stool

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2010 CancerConnect Last updated 07/10.

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