Dactinomycin

What it is and how it works

Mechanism of Action 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.

Mechanism class: Nucleic Acid Synthesis Inhibitors · Protein Synthesis Inhibitors

Indications

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 multi-phase, 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. 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.

Dosage and administration (summary)

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 1,250 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 1,000 mcg/m 2 intravenously every 3 weeks, as part of cisplatin-based, multi-drug chemotherapy regimen.

Contraindications

None. None.

Warnings and precautions

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. ( 2.7 , 5.3 ) 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.

Pregnancy

Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, dactinomycin can cause fetal harm when administered to a pregnant woman . In animal reproduction studies, administration of dactinomycin to pregnant animals during the period of organogenesis was teratogenic, resulting in malformations at doses lower than the …

Storage and supply

Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Protect from light and humidity. Store the reconstituted Dactinomycin for Injection, USP at room temperature for no more than 4 hours from reconstitution to completion of administration .

Source: Dactinomycin (Dactinomycin) — US FDA prescribing information, 2020-11-13, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.