Administer only under the supervision of a physician experienced in the use of chemotherapeutic agents. This drug is highly toxic and both powder and solution must be handled and administered with care. Avoid exposure during pregnancy. Due to the toxic properties of dactinomycin (e.g., corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently. If extravasation occurs during intravenous use, severe damage to soft tissues will occur .
Dactinomycin injection is used to treat certain types of cancer. This includes cancer of the bones and soft tissue (including muscles and tendons), Wilms' tumor (a cancer of the kidney found primarily in children), tumors in the uterus or womb, and cancer of the testicles.
Dactinomycin interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by dactinomycin, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.
Before you begin treatment with dactinomycin, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it.
This medicine is to be administered only by or under the immediate supervision of your doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, dactinomycin is used in certain patients with the following medical conditions:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dactinomycin injection in children older than 12 months of age. However, safety and efficacy have not been established in infants younger than 12 months of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dactinomycin injection in the elderly. However, elderly patients are more likely to have bone marrow problems, which may require caution and an adjustment in the dose for patients receiving dactinomycin injection.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you or your child this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.
Dactinomycin is sometimes given together with certain other medicines. If you are receiving a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your doctor to help you plan a way to remember to take them at the right times.
This medicine often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.
This medicine is very toxic and can cause severe damage to your skin, eyes, nose, throat, or lungs. The medicine must not come into contact with your skin, eyes, or any other part of your body. If any of the medicine does get in the eyes, wash the eyes with water, normal saline, or a balanced salt irrigating eye solution for at least 15 minutes and check with your doctor right away. If any of the medicine does get in your skin, wash the affected part with water for at least 15 minutes while removing contaminated clothes and shoes. Check with your doctor right away. The contaminated clothes should be destroyed and shoes must be cleaned thoroughly before using it again.
It is very important that your doctor check you closely while you or your child are receiving this medicine. This is to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may increase your risk of having other tumors (including leukemia). Talk with your doctor if you have concerns about this.
While you are being treated with dactinomycin, and after you stop treatment with it, do not have any live vaccines without your doctor's approval. Dactinomycin may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Dactinomycin can temporarily lower the number of white blood cells in your blood increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
Check with your doctor right away if you have diarrhea, nausea or vomiting, or sores or white patches on your lips, mouth, or throat while receiving this medicine.
If dactinomycin accidentally seeps out of the vein into which it is injected, it may severely damage some tissues and cause scarring. Tell your doctor right away if you notice redness, pain, or swelling at the injection site.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.