When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to dactinomycin, if you are pregnant, or if you have chickenpox or shingles (herpes zoster).

How to Use This Medicine:
Injectable

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Tell your doctor right away if you get this medicine in your eyes or on your skin. This medicine can be very harmful if it touches these areas or if it leaks out of the injection site. Wash your eyes with water, saline, or an irrigating eye solution for at least 15 minutes. Wash the affected skin area with water for at least 15 minutes.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, or any type of infection. Tell your doctor if you have been treated with radiation, or have recently been exposed to chickenpox or herpes.
• This medicine may cause the following problems:
  
  • Liver problems
  • Higher risk of leukemia or other tumors
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Burning, pain, redness, swelling, blistering, or skin changes where the needle is placed
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, and body aches
• Swelling, painful sores, or white patches in your mouth or throat
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, mild nausea or vomiting
• Hair loss
• Mild skin rash or itching
• Trouble swallowing

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088