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Brand Names: Cosmegen

Generic Name: dactinomycin (Pronunciation: DAK tin oh MYE sin)

• What is dactinomycin (Cosmegen)?
• What are the possible side effects of dactinomycin (Cosmegen)?
• What is the most important information I should know about dactinomycin (Cosmegen)?
• What should I discuss with my healthcare provider before using dactinomycin (Cosmegen)?
• How should I use dactinomycin (Cosmegen)?
• What happens if I miss a dose (Cosmegen)?
• What happens if I overdose (Cosmegen)?
• What should I avoid while using dactinomycin (Cosmegen)?
• What other drugs will affect dactinomycin (Cosmegen)?
• Where can I get more information?

What is dactinomycin (Cosmegen)?

Dactinomycin is a cancer (antineoplastic) medication. Dactinomycin interferes with the growth of cancer cells and slows their growth and spread in the body.

Dactinomycin is used to treat Wilm's tumor, childhood rhabdomyosarcoma, Ewing's sarcoma, and testicular cancer. Dactinomycin is also used in the treatment of gestational trophoblastic neoplasia and in the treatment of locally recurrent solid malignancies.

Dactinomycin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of dactinomycin (Cosmegen)?

If you experience any of the following serious side effects from dactinomycin, seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• decreased bone marrow function and blood problems (extreme fatigue; increased susceptibility to infection; slow wound healing; easy bruising or bleeding; or sore throat, fever, chills, or signs of infection);
• abdominal pain or black, bloody, or tarry stools;
• sore mouth (inflamation and sores on the lips or inside the mouth);
• severe nausea, vomiting, diarrhea, or loss of appetite; or
• redness, pain, or swelling at the place of injection or anywhere else on your skin.

In some cases, second malignancies have been reported to occur during and following treatment with dactinomycin. Talk to your doctor about the risks and benefits of this medication.

Other, less serious side effects may be more likely to occur. Continue taking dactinomycin and talk to your doctor if you experience:

• hair loss;
• fatigue;
• mild to moderate nausea, vomiting, or loss of appetite; or
• skin eruptions, acne, or a flare-up of skin redness or increased color of the skin where radiation treatments were done.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dactinomycin (Cosmegen)?

Dactinomycin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of dactinomycin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; increased susceptibility to infection; slow wound healing; easy bruising or bleeding; sore throat, fever, chills, or signs of infection); abdominal pain or black, bloody, or tarry stools; severe nausea, vomiting, diarrhea, and mouth sores; and others. Talk to your doctor about the possible side effects from treatment with dactinomycin.