pharmacopeia
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/api/v1/drug/dactinomycin

Mechanism of action

Sourced from openFDA

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.

Nucleic Acid SynthesisProtein Synthesis

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

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 Extremity or Pelvis: The recommend dose is 50 mcg/kg once with melphalan. ( 2.6 ) Upper Extremity: The recommended dose is 35 mcg/kg once with melphalan. ( 2.6 ) 2.1 Recommended Dosage for Wilms Tumor The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, is 45 mcg/kg intravenously once every 3 to 6 weeks for up to 26 weeks.

Warnings & precautions

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Secondary Malignancy or Leukemia: Increased risk of secondary malignancies following treatment. ( 5.1 ) 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. ( 5.2 ) 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. ( 5.4 ) Immunizations: Vaccination with live viral vaccines is not recommended before or during treatment. ( 5.5 ) Severe Mucocutaneous Reactions: Discontinue treatment ( 5.6 ) Renal Toxicity: Monitor creatinine and electrolytes frequently. ( 5.7 ) Hepatotoxicity: Monitor transaminases, alkaline phosphatase and bilirubin prior to and during treatment. ( 5.8 ) Potentiation of Radiation Toxicity and Radiation Recall: Reduce dose by 50% during concomitant radiation. Use caution when administering within two months of radiation. ( 5.9 ) Embryo-fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.10 , 8.1 , 8.3 ) 5.1 Secondary Malignancy or Leukemia The risk of developing secondary malignancies, including leukemia, is increased following treatment with dactinomycin. 5.2 Veno-occlusive Disease Severe and fatal hepatic veno-occlusive disease (VOD) can occur with dactinomycin. Risk factors for the development of VOD include age younger than 4 years or concomitant radiotherapy.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 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 [see Clinical Pharmacology ( 12.1 )] . 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 recommended human dose (see Data ) . Advise pregnant women of the potential risk to a fetus [see Use in Special Populations ( 8.3 )] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Dactinomycin was teratogenic in animals. Administration of dactinomycin to pregnant rats, rabbits, and hamsters during the period of organogenesis, increased the incidence of fetal malformations and caused embryotoxicity at doses (based on body surface area) as low as 0.2 times the clinical dose of 1,250 mcg/m 2 . 8.2 Lactation Risk Summary There are no data on the presence of dactinomycin or its metabolites in human milk or their effects on the breastfed infant or on milk production.

Pharmacokinetics

Sourced from openFDA
Metabolism
The distribution and excretion of radiolabeled dactinomycin ( 3 H actinomycin D) were assessed in three adult patients with malignant melanoma. Distribution 3 H actinomycin D is concentrated in nucleated cells and does not penetrate the blood-brain barrier.

Approval history

Sourced from openFDA
  • Nov 9, 2017ANDAANDA203385Eugia Pharma
  • May 20, 2019ANDAANDA203999Xgen Pharms
  • Jul 16, 2019ANDAANDA207232Hisun Pharm Hangzhou
  • Nov 13, 2020ANDAANDA213463Meitheal

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,171 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use27813%
  2. 2Febrile Neutropenia1918.8%
  3. 3Product Use In Unapproved Indication1316.0%
  4. 4Neutropenia1265.8%
  5. 5Drug Ineffective1155.3%
  6. 6Thrombocytopenia1044.8%
  7. 7Vomiting1034.7%
  8. 8Anaemia874.0%
  9. 9Pyrexia864.0%
  10. 10Disease Progression843.9%
  11. 11Venoocclusive Liver Disease753.5%
  12. 12Venoocclusive Disease733.4%
  13. 13Acute Myeloid Leukaemia713.3%
  14. 14Stomatitis713.3%
  15. 15Nausea703.2%

Literature

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Recent PubMed references pinned to Dactinomycin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 73 ClinicalTrials.gov registrations naming Dactinomycin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Dactinomycin work?
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.
What is Dactinomycin used for?
According to FDA labeling, Dactinomycin carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dactinomycin?
Dactinomycin is classified as Actinomycines, Actinomycin, Nucleic Acid Synthesis Inhibitors, Protein Synthesis Inhibitors, Decreased DNA Integrity, Decreased Protein Synthesis, Decreased RNA Integrity.
What are the brand names for Dactinomycin?
Dactinomycin is marketed under brand names including Cosmegen.
What are the contraindications for Dactinomycin?
Dactinomycin labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for dactinomycin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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