DrugindexOnline^{2nd edition}

Generic Name: Dactinomycin (DAK-tin-oh-MYE-sin)
Brand Name: Cosmegen

Cosmegen is very toxic. Do not inhale the dust or vapors of Cosmegen . Do not get Cosmegen in your eyes, nose, mouth, or onto your skin. Do not come into contact with Cosmegen if you are pregnant. Cosmegen is given through a vein. If Cosmegen leaks out of the vein (extravasation), severe damage to the area around the injection site will occur. Tell your doctor or health care provider immediately if you notice any discomfort, pain, or redness at the injection site.

Cosmegen is used for:

Treating certain types of cancer. It may be used alone or with other medicines.

Cosmegen is an antineoplastic. It works by killing certain cancer cells.

Do NOT use Cosmegen if:

• you are allergic to any ingredient in this medicine
• you have chickenpox (varicella infection), or shingles (herpes zoster infection), or if you have had either of these infections recently

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cosmegen :

Some medical conditions may interact with Cosmegen . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have bone marrow problems or an infection, are scheduled to receive a vaccine, or are very overweight
• if you are scheduled to have radiation therapy, have had radiation therapy in the last several months, or are receiving any other cancer therapy

Some MEDICINES MAY INTERACT with Cosmegen . However, no specific interactions with Cosmegen are known at this time.

Ask your health care provider if Cosmegen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cosmegen :

Use Cosmegen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cosmegen is usually given as an injection at your doctor's office, hospital, or clinic. Ask your doctor or pharmacist any questions you may have about Cosmegen .
• If you get Cosmegen in your eyes or on your skin, rinse the area with water for 15 minutes. Remove any contaminated clothing and do not reuse. Contaminated shoes must be cleaned completely before reuse.
• If you miss a dose of Cosmegen , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Cosmegen .

Important safety information:

• If nausea, vomiting, or loss of appetite occurs, ask your doctor about ways to lessen these effects.
• Cosmegen may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Cosmegen may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Cosmegen may increase the risk of developing other cancers (eg, leukemia) when it is used along with radiation therapy. Talk to your doctor if you have questions about your risk of developing other cancers after using Cosmegen .
• Do not receive a live vaccine (eg, measles, mumps) while you are taking Cosmegen . Talk with your doctor before you receive any vaccine.
• Lab tests, including liver function, kidney function, and blood counts, may be performed while you use Cosmegen . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Cosmegen with caution in the ELDERLY; they may be more sensitive to its effects, especially bone marrow problems.
• Cosmegen should be used with extreme caution in CHILDREN younger than 6 months old; they are more sensitive to the serious side effects of Cosmegen .
• Caution is advised when using Cosmegen in CHILDREN; they may be more sensitive to its effects, especially severe liver problems.
• Cosmegen may slow growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Cosmegen .
• PREGNANCY and BREAST-FEEDING: Cosmegen may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cosmegen while you are pregnant. It is not known if Cosmegen is found in breast milk. Do not breast-feed while using Cosmegen .

Possible side effects of Cosmegen :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; hair loss; lack of energy; loss of appetite; mild nausea or vomiting; stomach pain; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; chest pain; dark urine; diarrhea; fever, chills, or sore throat; flushing; leg pain or swelling; muscle pain or aches; pale stools; redness, swelling, pain, or blistering near the injection site; severe or persistent nausea or vomiting; shortness of breath; swelling, sores, or ulcers of the mouth or lips; trouble swallowing; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include decreased amount of urine; mouth pain or swelling; red, swollen, or blistered skin; severe or persistent nausea, vomiting, or diarrhea.

Proper storage of Cosmegen :

Cosmegen is usually handled and stored by a health care provider. If you are using Cosmegen at home, store Cosmegen as directed by your pharmacist or health care provider.

General information:

• If you have any questions about Cosmegen , please talk with your doctor, pharmacist, or other health care provider.
• Cosmegen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Cosmegen . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.