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dactinomycin

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

What is dactinomycin?

Dactinomycin is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Dactinomycin is used to treat different types of cancers that affect the kidneys, uterus, testicles, bones, muscles, joints, and soft tissues. Dactinomycin is also used to treat solid tumors.

Dactinomycin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about dactinomycin?

Dactinomycin is a cancer medication that interferes with the growth and spread of cancer cells in the body.

You should not receive dactinomycin if you have recently had chickenpox or herpes zoster (shingles).

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

Dactinomycin can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

What should I discuss with my healthcare provider before receiving dactinomycin?

You should not receive dactinomycin if you are allergic to it, or if you have recently had chickenpox or herpes zoster (shingles).

To make sure you can safely take dactinomycin, tell your doctor if you have recently received radiation treatment for Wilms' tumor.

Using dactinomycin may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk.

FDA pregnancy category D. Do not use dactinomycin if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether dactinomycin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using dactinomycin.

How should I use dactinomycin?

Dactinomycin is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Dactinomycin is usually given only on certain days during a treatment cycle. How often you receive this medication depends on the condition being treated.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when dactinomycin is injected.

Dactinomycin can be harmful if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, rinse with plain water for at least 15 minutes.

Dactinomycin can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your dactinomycin injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using dactinomycin?

Avoid getting this medicine on your clothes. Destroy any clothing the medicine has leaked onto if an accidental spill occurs.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Do not receive a "live" vaccine while using dactinomycin, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Dactinomycin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pain, swelling, burning, irritation, or skin changes where the injection was given;

  • fever, chills, body aches, diarrhea, flu symptoms, sores in your mouth and throat;

  • swelling or tenderness in your upper stomach, weight gain, dark urine, jaundice (yellowing of the skin or eyes);

  • feeling short of breath, urinating less than usual or not at all;

  • chest pain, dry cough, wheezing;

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • any wound that will not heal; or

  • redness or your skin or the inside of your mouth and throat (if you are also receiving radiation treatment).

Common side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite;

  • tired feeling, muscle pain;

  • rectal pain or bleeding;

  • numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;

  • hair loss;

  • dry or cracked skin, chapped lips; or

  • acne, mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Dactinomycin dosing information

Usual Adult Dose for Wilms' Tumor:

15 mcg/kg/day or 400 to 600 mcg/m2/day intravenously for 5 days as a part of a combination regimen. Dosage for obese or edematous adult patients may be calculated on the basis of body surface area to relate dosage to lean body mass. Dosage may be repeated every 3 to 6 weeks.

Usual Adult Dose for Ewing's Sarcoma:

15 mcg/kg/day or 400 to 600 mcg/m2/day intravenously for 5 days as a part of a combination regimen. Dosage for obese or edematous adult patients may be calculated on the basis of body surface area to relate dosage to lean body mass. Dosage may be repeated every 3 to 6 weeks.

Usual Adult Dose for Rhabdomyosarcoma:

15 mcg/kg/day or 400 to 600 mcg/m2/day intravenously for 5 days as a part of a combination regimen. Dosage for obese or edematous adult patients may be calculated on the basis of body surface area to relate dosage to lean body mass. Dosage may be repeated every 3 to 6 weeks.

Usual Adult Dose for Testicular Cancer:

For use in the treatment of metastatic nonseminomatous testicular cancer:

1000 mcg/m2 intravenously on day 1 as part of a combination regimen with cyclophosphamide, bleomycin, vinblastine, and cisplatin.

Usual Adult Dose for Trophoblastic Disease:

For use in the treatment of gestational trophoblastic neoplasia:

12 mcg/kg intravenously daily for five days as a single agent.

or

500 mcg intravenously on days 1 and 2 as part of a combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide and cisplatin.

Usual Adult Dose for Malignant Disease:

For use as a component of regional perfusion in the palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies:

50 mcg/kg for lower extremity or pelvis

or

35 mcg/kg for upper extremity.

(Please note that the dosage schedules and the technique itself vary from one investigator to another. Please consult the published literature for details.)

Usual Adult Dose for Osteosarcoma:

600 mcg/m2/day on days 1, 2, and 3 as part of a combination chemotherapy regimen

Usual Adult Dose for Ovarian Cancer:

For use in the treatment of ovarian (germ cell) tumor:

500 mcg/day for 5 days every 4 weeks

or

300 mcg/m2/day for 5 days every 4 weeks

Usual Pediatric Dose for Wilms' Tumor:

Greater than 6 months:

15 mcg/kg/day or 400-600 mcg/m2/day intravenously for 5 days (in various combination regimens and schedules). Dosage may be repeated every 3 to 6 weeks.

Usual Pediatric Dose for Ewing's Sarcoma:

Greater than 6 months:

15 mcg/kg/day or 400-600 mcg/m2/day intravenously for 5 days (in various combination regimens and schedules). Dosage may be repeated every 3 to 6 weeks.

Usual Pediatric Dose for Rhabdomyosarcoma:

Greater than 6 months:

15 mcg/kg/day or 400-600 mcg/m2/day intravenously for 5 days (in various combination regimens and schedules). Dosage may be repeated every 3 to 6 weeks.

Usual Pediatric Dose for Testicular Cancer:

For use in the treatment of metastatic nonseminomatous testicular cancer:

1000 mcg/m2 intravenously on day 1 as part of a combination regimen with cyclophosphamide, bleomycin, vinblastine, and cisplatin.

Usual Pediatric Dose for Trophoblastic Disease:

For use in the treatment of gestational trophoblastic neoplasia:

12 mcg/kg intravenously daily for five days as a single agent.

or

500 mcg intravenously on days 1 and 2 as part of a combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide and cisplatin.

Usual Pediatric Dose for Malignant Disease:

For use as a component of regional perfusion in the palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies:

50 mcg/kg for lower extremity or pelvis

or

35 mcg/kg for upper extremity.

(Please note that the dosage schedules and the technique itself vary from one investigator to another. Please consult the published literature for details.)

Usual Pediatric Dose for Osteosarcoma:

600 mcg/m2/day on days 1, 2, and 3 as part of a combination chemotherapy regimen

What other drugs will affect dactinomycin?

Other drugs may interact with dactinomycin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about dactinomycin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02. Revision Date: 2013-07-01, 2:39:58 PM.

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