Dactinomycin (Cosmegen)

==General information==
Class/mechanism: Antibiotic oncologic, intercalates between guanine and cytosine DNA base pairs, inhibiting DNA and RNA synthesis.Dactinomycin (Cosmegen) package insert Dactinomycin (Cosmegen) package insert (locally hosted backup)
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 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 (Chemocare)
*Dactinomycin (Cosmegen) patient drug information (UpToDate)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
==References==
Category:Drugs
Category:Intravenous medications
Category:Vesicant
Category:Antitumor antibiotics
Category:Human DNA synthesis inhibitors
Category:Endometrial cancer medications
Category:Ewing sarcoma medications
Category:Gestational trophoblastic neoplasia medications
Category:Rhabdomyosarcoma medications
Category:Wilms tumor medications
Category:Osteosarcoma medications (historic)
Category:Testicular cancer medications (historic) 
Category:FDA approved in 1964
Category:EMA approved in 1963
Category:WHO Essential Cancer Medicine