DACTINOMYCIN .5 mg/mL
DACTINOMYCIN · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Eugia US LLC
DACTINOMYCIN is a injection, powder, lyophilized, for solution containing dactinomycin at .5 mg/mL, taken intravenous. Manufactured by Eugia US LLC.
Key Facts
- Brand Name
- DACTINOMYCIN
- Generic Name
- DACTINOMYCIN
- NDC Code (Product)
55150-928- Manufacturer
- Eugia US LLC
- Strength
- .5 mg/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA203385
- Drug Class
- Actinomycin [EPC]
- Marketing Start
- 03/15/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1.1 ) adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, 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 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 rhabdomyosa…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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. ( 2.1 ) 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. ( 2.2 ) Ewing Sarcoma: The recommended dose is 1,250 mcg/m 2 intravenously once every 3 weeks for 51 weeks, as part of a multi-agent combination chemotherapy regimen. ( 2.3 ) Metastatic Nonseminomatous Testicular Cancer: The recommended dose is 1,000 mcg/m 2 intravenously every 3 weeks, as part of cisplatin-based, multi-drug chemotherapy regimen. ( 2.4 ) Gestational Trophoblastic Neoplasia: Non-metastatic and Low-risk Metastatic Disease: The recommended dose is 12 mcg/kg intravenously daily for 5 days, as a single agent. ( 2.5 ) High-risk Metastatic Disease: The recommended dose is 500 mcg intravenously on Days 1 and 2 every 2 weeks for up to 8 weeks, as part of a multi-agent combination chemotherapy regimen. ( 2.5 ) Regional Perfusion in Locally Recurrent and Locoregional Solid Malignancies: Lower Ext…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Secondary Malignancy and Leukemia [see Warnings and Precautions ( 5.1 )] Veno-occlusive Disease [see Warnings and Precautions ( 5.2 )] Extravasation [see Warnings and Precautions ( 5.3 )] Myelosuppression [see Warnings and Precautions ( 5.4 )] Immunizations [see Warning and Precautions ( 5.5 )] Severe Mucocutaneous Reactions [see Warnings and Precautions ( 5.6 )] Renal Toxicity [see Warnings and Precautions ( 5.7 )] Hepatotoxicity [see Warnings and Precautions ( 5.8 )] Potentiation of Radiation Toxicity and Radiation Recall [see Warnings and Precautions ( 5.9 )] 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. Infections: infections including sepsis with fat…
Frequently Asked Questions
What is DACTINOMYCIN used for?
DACTINOMYCIN contains DACTINOMYCIN. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is DACTINOMYCIN a controlled substance?
DACTINOMYCIN is not classified as a controlled substance by the DEA.
What is the generic name for DACTINOMYCIN?
The generic name for DACTINOMYCIN is DACTINOMYCIN. There are 3 other brand versions of DACTINOMYCIN.
What is the NDC code for DACTINOMYCIN .5 mg/mL?
The NDC (National Drug Code) for DACTINOMYCIN .5 mg/mL is 55150-928, listed by Eugia US LLC.