What is the generic name?

DACTINOMYCIN

What is the Trade Name for DACTINOMYCIN?

Dactinomycin

What are the Indications for DACTINOMYCIN?

• 1 INDICATIONS AND USAGE Dactinomycin for injection is an actinomycin indicated for the treatment of: ‚Ä¢ adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. ( 1.1 ) ‚Ä¢ adult and pediatric patients with rhabdomyosarcoma, as part of a multiphase, combination chemotherapy regimen. ( 1.2 ) ‚Ä¢ adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. ( 1.3 ) ‚Ä¢ adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. ( 1.4 ) ‚Ä¢ post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. ( 1.5 ) ‚Ä¢ 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 for injection 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 for injection 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 for injection 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 for injection 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 for injection 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 for injection is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion.

References: https://open.fda.gov/