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Cosmegen

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, or 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 Cosmegen
  • you have chickenpox (varicella infection) or shingles (herpes zoster infection), or if you have had either of these infections recently
  • you have taken or will be taking palifermin within 24 hours before or after using Cosmegen

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

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

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. Tell your health care provider if you are taking any other medicines, especially any of the following: Palifermin because if mouth or tongue sores develop, they may be more severe or last longer

This may not be a complete list of all interactions that may occur. 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.
  • When mixed, Cosmegen is a clear, gold-colored solution. Do not use it if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • 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.
  • Tell your doctor or dentist that you take Cosmegen before you receive any medical or dental care, emergency care, or surgery.
  • Cosmegen may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Cosmegen.
  • 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, vomiting, or stomach pain; sluggishness; 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; diarrhea; fever, chills, or sore throat; flushing; leg pain or swelling; muscle pain or aches; red, swollen, blistering, or peeling skin; 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, tongue, or lips; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe stomach pain, yellowing of the skin or eyes); trouble swallowing; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased amount of urine produced; diarrhea; red, swollen, blistered, or peeling skin; severe or persistent nausea or vomiting; swelling, sores, or ulcers of the mouth, tongue, or lips; symptoms of infection (eg, fever, chills, sore throat); unusual bruising or bleeding; unusual tiredness or weakness.

Proper storage of Cosmegen:

Cosmegen is usually handled and stored by a health care provider. Keep Cosmegen out of the reach of children and away from pets.

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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Cosmegen or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Cosmegen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Cosmegen. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Cosmegen.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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