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February 9, 2012
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dactinomycin - injection, Cosmegen

GENERIC NAME: DACTINOMYCIN - INJECTION (dack-tin-oh-MY-sin)

BRAND NAME(S): Cosmegen

Warning | Medication Uses | How To Use | Side Effects | Precautions | Drug Interactions | Overdose | Notes | Missed Dose | Storage

WARNING: If this medication accidentally leaks into surrounding tissue when being given, the skin and/or muscle may be severely damaged. Tell your doctor immediately if you feel pain or irritation at the injection site.

Be very careful when handling/giving this medication. This medication may be very harmful to your skin, eyes, or mucous membranes. To avoid touching this medication or inhaling its dust or vapors, wear protective clothing (e.g., gown, mask, gloves). If this medication gets in your eye, open the eyelids and flush with water, saline, or an eyewash solution for 15 minutes, then seek immediate medical attention. If this medication touches your skin, nose, mouth, or other area, immediately wash the area well with water for 15 minutes, then seek immediate medical attention. Remove and discard any contaminated clothing.

Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the powder.

USES: Dactinomycin is used alone or with other anti-cancer drugs to treat cancer. It works by slowing or stopping the growth of cancer cells.

HOW TO USE: This medication is given by injection into a vein over a few minutes by a health care professional, usually once daily for 1 to 5 days or as directed by your doctor. Do not give into a muscle or under the skin. Tell your doctor or nurse immediately if you experience pain, burning, or redness at the injection site.Dosage is based on your medical condition, body size, and response to treatment. Your doctor will order lab tests to make sure you can receive your next dose. Keep all medical/lab appointments.

SIDE EFFECTS: Nausea, vomiting, diarrhea, acne, and pain/redness at the injection site may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.Temporary hair loss is another common side effect. Normal hair growth should return after treatment has ended.Many people using this medication may have serious side effects. However, your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. To lower your risk of serious side effects, your doctor will follow your condition closely and order lab tests. Serious side effects may not happen until days to weeks after your treatment.Pain/sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods. Tell your doctor immediately if these effects persist/worsen or if you have trouble swallowing.Tell your doctor right away if you have any serious side effects, including: unusual weakness/tiredness, muscle/joint pain, stomach pain, swelling hands/ankles/feet (edema), pain/redness/swelling of arms/legs, coughing up blood, vomit that looks like coffee grounds, unusual bleeding/bruising, bloody/black/tarry stools, severe abdominal pain, lower back/side (flank) pain, yellowing skin/eyes, red/pinkish/dark urine, painful/difficult urination, change in the amount of urine.This medication may cause certain severe blood and bone marrow problems (low red blood cells/white blood cells/platelets). These problems can affect your body's ability to stop bleeding or fight infection. Tell your doctor immediately if you develop easy bleeding/bruising or signs of infection (e.g., fever, chills, persistent sore throat).When dactinomycin is given after radiation treatment, it can sometimes cause a serious skin reaction that looks likes a severe sunburn (radiation recall). The reaction usually develops within days to months after treatment on the skin area previously treated with radiation. Throat problems can also be part of radiation recall with dactinomycin. Tell your doctor immediately if you develop skin redness/tenderness/swelling/peeling/blisters or painful/difficult swallowing. If you develop a skin reaction, avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.A very serious allergic reaction to this drug is unlikely. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.




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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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Cancer is the uncontrolled growth of abnormal cells anywhere in a body. The abnormal cells are termed cancer cells, malignant cells, or tumor cells. Many cancers and the abnormal cells that compose the cancer tissue are further identified by the name of the tissue that the abnormal cells originated from (for example, breast cancer, lung cancer, colon cancer). Cancer is not confined to humans; animals and other living organisms can get cancer. Below is a schematic that shows normal cell division and how when a cell is damaged or altered without repair to its system, the cell usually dies. Also shown is what can occur when such damaged or unrepaired cells do not die and become cancer cells and proliferate with uncontrolled growth; a mass of cancer cells develop. Frequently, cancer cells can break away from this original mass of cells, travel through the blood and lymph systems, and lodge in other organs where they can again repeat the ...

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