Cosmegen®
for Injection (dactinomycin for injection)

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  • Cosmegen belongs to a group of medicines called actinomycins, a group of antibiotics produced by various species of Streptomyces.
  • Cosmegen is available in vials containing   0.5 mg of dactinomycin.

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Indication
COSMEGEN® (dactinomycin for injection), as part of a combination chemotherapy and/or multi-modality treatment regimen, is indicated for the treatment of Wilms’ tumor, childhood rhabdomyosarcoma, Ewing’s sarcoma and metastatic, nonseminomatous testicular cancer.

COSMEGEN is indicated as a single agent, or as part of a combination chemotherapy regimen, for the treatment of gestational trophoblastic neoplasia.

COSMEGEN, as a component of regional perfusion, is indicated for the palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies.  It is extremely important to observe the patient daily for toxic side effects when combination chemotherapy is employed.

Important Safety Information

COSMEGEN should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.

This drug is HIGHLY TOXIC and both powder and solution must be handled and administered with care. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. 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. Dactinomycin is extremely corrosive to soft tissue. 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.

COSMEGEN is contraindicated in patients who are hypersensitive to any component of this product. COSMEGEN should not be given at or about the time of infection with chicken pox or herpes zoster.  Reports indicate an increased incidence of second primary tumors (including leukemia) following treatment with radiation and antineoplastic agents.  Gastrointestinal toxicity and marrow suppression have been reported when combined therapy including COSMEGEN and radiation have been used.  Renal, hepatic and bone marrow functions should be assessed frequently.  COSMEGEN should be administered to infants only over the age 6 to 12 months. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Common adverse reactions may include any tissue of the body, including the hematopoietic system resulting in myelosuppression.

For more information, please see Full Prescribing Information including Boxed Warning.

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