Application Nr Approved Date Route Status External Links
NDA050682 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dactinomycin Is An Actinomycin Indicated For The Treatment Of: Adult And Pediatric Patients With Wilms Tumor, As Part Of A Multi-Phase, Combination Chemotherapy Regimen. ( 1.1 ) Adult And Pediatric Patients With Rhabdomyosarcoma, As Part Of A Multiphase, Combination Chemotherapy Regimen. ( 1.2 ) Adult And Pediatric Patients With Ewing Sarcoma, As Part Of A Multi-Phase, Combination Chemotherapy Regimen. ( 1.3 ) Adult And Pediatric Patients With Metastatic, Nonseminomatous Testicular Cancer, As Part Of A Multi-Phase, Combination Chemotherapy Regimen. ( 1.4 ) Post-Menarchal Patients With Gestational Trophoblastic Neoplasia, As A Single Agent Or As Part Of A Combination Chemotherapy Regimen. ( 1.5 ) Adult Patients With Locally Recurrent Or Locoregional Solid Malignancies, As A Component Of Palliative Or Adjunctive Regional Perfusion. ( 1.6 ) 1.1 Wilms Tumor Dactinomycin Is Indicated For The Treatment Of Adult And Pediatric Patients With Wilms Tumor, As Part Of A Multi-Phase, Combination Chemotherapy Regimen. 1.2 Rhabdomyosarcoma Dactinomycin Is Indicated For The Treatment Of Adult And Pediatric Patients With Rhabdomyosarcoma, As Part Of A Multi-Phase, Combination Chemotherapy Regimen. 1.3 Ewing Sarcoma Dactinomycin Is Indicated For The Treatment Of Adult And Pediatric Patients With Ewing Sarcoma, As Part Of A Multi-Phase, Combination Chemotherapy Regimen. 1.4 Metastatic Nonseminomatous Testicular Cancer Dactinomycin Is Indicated For The Treatment Of Adult And Pediatric Patients With Metastatic, Nonseminomatous Testicular Cancer, As Part Of A Multi-Phase, Combination Chemotherapy Regimen. 1.5 Gestational Trophoblastic Neoplasia Dactinomycin Is Indicated For The Treatment Of Post-Menarchal Patients With Gestational Trophoblastic Neoplasia, As A Single Agent Or As Part Of A Combination Chemotherapy Regimen. 1.6 Regional Perfusion In Locally Recurrent And Locoregional Solid Malignancies Dactinomycin Is Indicated For The Treatment Of Adult Patients With Locally Recurrent Or Locoregional Solid Malignancies, As A Component Of Palliative Or Adjunctive Regional Perfusion.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dactinomycin

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