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Cosmegen

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Cosmegen

Cosmegen

Cosmegen Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cosmegen (dactinomycin) For Injection is used to treat different types of cancers that affect the kidneys, uterus, testicles, bones, muscles, joints, and soft tissues. It is also used to treat solid tumors. It is a cancer (antineoplastic) medication. It is available in generic form. Common side effects include nausea or vomiting (may be severe), diarrhea, acne, and pain/redness at the injection site.

The dosage of Cosmegen varies depending on the tolerance of the patient, the size and location of the tumor, and the use of other forms of therapy. Other drugs may interact with Cosmegen. Tell your doctor all medications and supplements you use. Cosmegen is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. To avoid pregnancy, both males and females using this drug should use birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor to discuss birth control. It is unknown if this drug passes into breast milk. It may have undesirable effects on a nursing infant. Breastfeeding while using Cosmegen is not recommended.

Our Cosmegen (dactinomycin) For Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cosmegen in Detail - Patient Information: 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 a serious side effect such as:

  • 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).

Less serious 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.

Read the entire detailed patient monograph for Cosmegen (Dactinomycin for Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cosmegen Overview - Patient Information: Side Effects

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.

Read the entire patient information overview for Cosmegen (Dactinomycin for Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cosmegen FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Toxic effects (excepting nausea and vomiting) usually do not become apparent until two to four days after a course of therapy is stopped, and may not peak until one to two weeks have elapsed. Deaths have been reported. However, adverse reactions are usually reversible on discontinuance of therapy. They include the following:

Miscellaneous: Sepsis (including neutropenic sepsis) with fatal outcome, infection, malaise, fatigue, lethargy, fever, myalgia, proctitis, hypocalcemia and growth retardation.

Oral: cheilitis, dysphagia, esophagitis, ulcerative stomatitis, pharyngitis.

Lung: pneumonitis.

Gastrointestinal: anorexia, nausea, vomiting, abdominal pain, diarrhea, gastrointestinal ulceration. Nausea and vomiting, which occur early during the first few hours after administration, may be alleviated by the administration of anti-emetics.

Hepatic: liver toxicity including liver function test abnormalities, ascites, hepatomegaly, hepatitis, hepatic failure with reports of death, hepatic veno-occlusive disease which may be associated with intravascular clotting disorder and multi-organ failure (see PRECAUTIONS, Veno-occlusive Disease).

Hematologic: anemia, even to the point of aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, reticulocytopenia, neutropenia, febrile neutropenia. Platelet and white cell counts should be performed frequently to detect severe hematopoietic depression. If either count markedly decreases, the drug should be withheld to allow marrow recovery. This often takes up to three weeks.

Dermatologic: alopecia, skin eruptions, acne, erythema multiforme, flare-up of erythema or increased pigmentation of previously irradiated skin. Toxic Epidermal Necrolysis (TEN) and Stevens Johnson Syndrome (SJS) have been observed from postmarketing experience.

Soft tissues: Dactinomycin is extremely corrosive. If extravasation occurs during intravenous use, severe damage to soft tissues will occur. In at least one instance, this has led to contracture of the arms. Epidermolysis, erythema, and edema, at times severe, have been reported with regional limb perfusion.

Laboratory Tests

Many abnormalities of renal, hepatic, and bone marrow function have been reported in patients with neoplastic diseases receiving COSMEGEN. Renal, hepatic, and bone marrow functions should be assessed frequently.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the entire FDA prescribing information for Cosmegen (Dactinomycin for Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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