Cosmegen

DRUG DESCRIPTION

Dactinomycin is one of the actinomycins, a group of antibiotics produced by various species of Streptomyces. Dactinomycin is the principal component of the mixture of actinomycins produced by Streptomyces parvullus. Unlike other species of Streptomyces, this organism yields an essentially pure substance that contains only traces of similar compounds differing in the amino acid content of the peptide side chains. The empirical formula is C62H86N12O16 and the structural formula is:

COSMEGEN®  (Dactinomycin for Injection)  Structural Formula Illustration

COSMEGEN is a sterile, yellow to orange lyophilized powder for injection by the intravenous route or by regional perfusion after reconstitution. Each vial contains 0.5 mg (500 mcg) of dactinomycin and 20.0 mg of mannitol.

What are the possible side effects of dactinomycin (Cosmegen)?

If you experience any of the following serious side effects from dactinomycin, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; increased susceptibility to infection; slow wound healing; easy bruising or bleeding; or sore throat, fever, chills, or signs of infection);
  • abdominal pain or black,...

Read All Potential Side Effects and See Pictures of Cosmegen »

What are the precautions when taking dactinomycin (Cosmegen)?

Before using dactinomycin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: current infection with chickenpox or herpes zoster (shingles).

Tell your doctor your medical history, especially of: certain virus illnesses (herpes, chickenpox), liver problems, kidney problems, blood disorders (e.g., anemia, clotting problems), previous chemotherapy/radiation treatment.

Do not have immunizations/vaccinations without the consent of your...

Read All Potential Precautions of Cosmegen »


Cosmegen Consumer (continued)

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.

PRECAUTIONS: Before using dactinomycin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: current infection with chickenpox or herpes zoster (shingles).

Tell your doctor your medical history, especially of: certain virus illnesses (herpes, chickenpox), liver problems, kidney problems, blood disorders (e.g., anemia, clotting problems), previous chemotherapy/radiation treatment.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

To lower your chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist that you are using this medication.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effect on blood cell production (myelosuppression).

This drug is not recommended for use during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.

It is not known whether this medication passes into breast milk. However, it may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.


Cosmegen Patient Information Including Side Effects

Brand Names: Cosmegen

Generic Name: dactinomycin (Pronunciation: DAK tin oh MYE sin)

  • What is dactinomycin (Cosmegen)?
  • What are the possible side effects of dactinomycin (Cosmegen)?
  • What is the most important information I should know about dactinomycin (Cosmegen)?
  • What should I discuss with my healthcare provider before using dactinomycin (Cosmegen)?
  • How should I use dactinomycin (Cosmegen)?
  • What happens if I miss a dose (Cosmegen)?
  • What happens if I overdose (Cosmegen)?
  • What should I avoid while using dactinomycin (Cosmegen)?
  • What other drugs will affect dactinomycin (Cosmegen)?
  • Where can I get more information?

What is dactinomycin (Cosmegen)?

Dactinomycin is a cancer (antineoplastic) medication. Dactinomycin interferes with the growth of cancer cells and slows their growth and spread in the body.

Dactinomycin is used to treat Wilm's tumor, childhood rhabdomyosarcoma, Ewing's sarcoma, and testicular cancer. Dactinomycin is also used in the treatment of gestational trophoblastic neoplasia and in the treatment of locally recurrent solid malignancies.

Dactinomycin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of dactinomycin (Cosmegen)?

If you experience any of the following serious side effects from dactinomycin, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; increased susceptibility to infection; slow wound healing; easy bruising or bleeding; or sore throat, fever, chills, or signs of infection);
  • abdominal pain or black, bloody, or tarry stools;
  • sore mouth (inflamation and sores on the lips or inside the mouth);
  • severe nausea, vomiting, diarrhea, or loss of appetite; or
  • redness, pain, or swelling at the place of injection or anywhere else on your skin.

In some cases, second malignancies have been reported to occur during and following treatment with dactinomycin. Talk to your doctor about the risks and benefits of this medication.

Other, less serious side effects may be more likely to occur. Continue taking dactinomycin and talk to your doctor if you experience:

  • hair loss;
  • fatigue;
  • mild to moderate nausea, vomiting, or loss of appetite; or
  • skin eruptions, acne, or a flare-up of skin redness or increased color of the skin where radiation treatments were done.

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. You may report side effects to FDA at 1-800-FDA-1088.

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

Dactinomycin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of dactinomycin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; increased susceptibility to infection; slow wound healing; easy bruising or bleeding; sore throat, fever, chills, or signs of infection); abdominal pain or black, bloody, or tarry stools; severe nausea, vomiting, diarrhea, and mouth sores; and others. Talk to your doctor about the possible side effects from treatment with dactinomycin.

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