Generic name: dactinomycin
Drug class: Antibiotics / antineoplastics
Medically reviewed by A Ras MD.
What is Cosmegen?
Cosmegen is a prescription medicine that is used to treat cancer.
Dactinomycin is an actinomycin. Dactinomycin is produced by Streptomyces parvullus. The chemical name is 8-amino-N-(2-amino-4,6-dimethyl-3-oxo-phenoxazin-1-yl)carbonyl-N’-[8-amino-4,6-dimethyl-7-oxo-9-[[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16-tetrazabicyclo[14.3.0]nonadec-11-yl]carbamoyl]phenoxazin-1-yl]carbonyl-4,6-dimethyl-7-oxo-N,N’-bis[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16 tetrazabicyclo[14.3.0]nonadec-11-yl]-1,9-bis[[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16-tetrazabicyclo[14.3.0] nonadec-11-yl]carbamoyl]phenoxazine-1,9-dicarboxamide. The molecular formula is C 62H 86N 12O 16 and the molecular weight is 1255.42 daltons. The structural formula of dactinomycin is shown below:
COSMEGEN (dactinomycin for injection) for intravenous use is a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial. Each vial contains 500 mcg of dactinomycin and 20 mg of mannitol.
Mechanism of Action
COSMEGEN is a cytotoxic actinomycin that binds DNA and inhibits RNA synthesis. The cytotoxic activity of dactinomycin has been demonstrated in animal models of different human cancers.
Before taking Cosmegen, tell your doctor:
- If you are allergic to Cosmegen; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you are breast-feeding. Do not breast-feed while you take Cosmegen and for 2 weeks after your last dose.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Cosmegen with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Cosmegen?
- Tell all of your health care providers that you take Cosmegen. This includes your doctors, nurses, pharmacists, and dentists.
- You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
- You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
- This medicine may add to the chance of getting some types of cancer. Talk with the doctor.
- If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects.
- Very bad blood vessel problems in the liver have happened with Cosmegen. Sometimes, this has been deadly. The chance of these problems is higher in people getting radiation or in children younger than 4 years of age. If you have questions, talk with the doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Talk with your doctor before getting any vaccines. Use of some vaccines with Cosmegen may either raise the chance of an infection or make the vaccine not work as well.
- If you have had or will be having radiation treatment, talk with your doctor. Worse side effects from radiation treatment have happened with Cosmegen.
- Use with care in children. Talk with the doctor.
- If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during treatment and for 3 months after your last dose.
- If you are a man and your sex partner gets pregnant while you take Cosmegen or within 3 months after your last dose, call your doctor right away.
- This medicine may cause harm to the unborn baby if you take it while you are pregnant.
- If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting Cosmegen. Talk with your doctor.
- Use birth control that you can trust to prevent pregnancy while taking Cosmegen and for 6 months after stopping Cosmegen.
- If you get pregnant while taking Cosmegen or within 6 months after your last dose, call your doctor right away.
How is Cosmegen best taken?
Use Cosmegen as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given into a vein for a period of time.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are the side effects of Cosmegen that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Mouth irritation or mouth sores.
- Trouble swallowing.
- This medicine may lower the ability of your bone marrow to make blood cells that your body needs. This can lead to very bad and sometimes deadly bleeding problems or infections. Tell your doctor right away if you have signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, a wound that will not heal; any bruising or bleeding; or if you feel very tired or weak.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.
What are some other side effects of Cosmegen?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Upset stomach or throwing up.
- Feeling tired or weak.
- Hair loss.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Cosmegen?
- If you need to store Cosmegen at home, talk with your doctor, nurse, or pharmacist about how to store it.
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
- NDC 55292-811-55 12 Single Dose VialsCosmegen ® for Injection
(dactinomycin for injection)
500 mcg (0.5 mg)
Store at 20-25ºC (68-77ºF).
See USP controlled room temperature.
Protect from light and humidity.
RECORDATI RARE DISEASES GROUP
R x only
Manufactured by: Baxter Oncology GmbH, 33790 Halle/Westfalen, Germany
For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.
® Trademark of Recordati Rare Diseases Inc.
SRC: NLM .