Dactinomycin (Cosmegen)

General information

Class/mechanism: Antibiotic oncologic, intercalates between guanine and cytosine DNA base pairs, inhibiting DNA and RNA synthesis.
Route: IV
Extravasation: vesicant

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Endometrial cancer
• Ewing sarcoma
• Gestational trophoblastic neoplasia
• Rhabdomyosarcoma
• Wilms tumor

Diseases for which it was used

• Osteosarcoma
• Testicular cancer

Patient drug information

• Dactinomycin (Cosmegen) package insert
• Dactinomycin (Cosmegen) patient drug information (Chemocare)
• Dactinomycin (Cosmegen) patient drug information (UpToDate)

History of changes in FDA indication

• 1964-12-10: Initial FDA approval
• 2009-03-13 (oldest label available at Drugs @ FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of Wilms tumor. (Based on NWTS-1, NWTS-2, NWTS-3, NWTS-4)
• 2009-03-13 (oldest label available at Drugs @ FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of childhood rhabdomyosarcoma. (Based on IRS-III)
• 2009-03-13 (oldest label available at Drugs @ FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of Ewing sarcoma. (Based on ET-1)
• 2009-03-13 (oldest label available at Drugs @ FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of metastatic, nonseminomatous testicular cancer. (Based on Bosl et al. 1986 & Vugrin et al. 1981)
• 2009-03-13 (oldest label available at Drugs @ FDA): Approved as a single agent, or as part of a combination chemotherapy regimen, for the treatment of gestational trophoblastic neoplasia. (Based on Osathanondh et al. 1975 & Newlands et al. 1991)
• 2009-03-13 (oldest label available at Drugs @ FDA): Approved as a component of regional perfusion for the palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies.

History of changes in EMA indication

• 1963-07-01: EURD

Also known as

• Generic names: AC-DE, actinomycin D
• Brand names: Cosmegen, Dacmozen, Lyovac