Dactinomycin

Dactinomycin for injection is an actinomycin indicated for the treatment of: adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with rhabdomyosarcoma, as part of a multiphase, combination chemotherapy regimen. adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion.

Dactinomycin is a cytotoxic actinomycin that binds DNA and inhibits RNA synthesis. The cytotoxic activity of dactinomycin has been demonstrated in animal models of different human cancers.

Wilms Tumor: The recommended dose is 45 mcg/kg intravenously once every 3 to 6 weeks for up to 26 weeks, as part of a multi-agent combination chemotherapy regimen. Rhabdomyosarcoma: The recommended dose is 15 mcg/kg intravenously once daily for 5 days every 3 to 9 weeks for up to 112 weeks, as part of a multi-agent combination chemotherapy regimen. Ewing Sarcoma: The recommended dose is 1250 mcg/m 2 intravenously once every 3 weeks for 51 weeks, as part of a multi-agent combination chemotherapy regimen. Metastatic Nonseminomatous Testicular Cancer: The recommended dose is 1000 mcg/m 2 intravenously every 3 weeks, as part of cisplatin-based, multi-drug chemotherapy regimen.

None. None.

Secondary Malignancy or Leukemia: Increased risk of secondary malignancies following treatment. Veno-occlusive Disease: Can cause severe or fatal VOD. Monitor for elevations in AST, ALT, total bilirubin, hepatomegaly, weight gain, or ascites. Consider delaying next dose. Extravasation: Immediately interrupt the injection or infusion and apply ice. Myelosuppression: Monitor blood cell counts before each cycle. Delay next dose if severe myelosuppression has not improved. Immunizations: Vaccination with live viral vaccines is not recommended before or during treatment. Severe Mucocutaneous Reactions: Discontinue treatment. Renal Toxicity: Monitor creatinine and electrolytes frequently. Hepatotoxicity: Monitor transaminases, alkaline phosphatase and bilirubin prior to and during treatment.

The following serious adverse reactions are described elsewhere in the labeling: • Secondary Malignancy and Leukemia • Veno-occlusive Disease • Extravasation • Myelosuppression • Immunizations • Severe Mucocutaneous Reactions • Renal Toxicity • Hepatotoxicity • Potentiation of Radiation Toxicity and Radiation Recall Common adverse reactions are: infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, and hepatotoxicity. The following adverse reactions have been identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Store at 20º to 25ºC (68º to 77ºF),. Protect from light and humidity.