{"id":"dactinomycin","rwe":[{"pmid":"41834419","year":"2026","title":"Novel Pediatric Aggressive Adipose Tumor With Pathogenic TERT Promoter Variant and an Initial Durable Response to Vincristine and Dactinomycin.","finding":"","journal":"Pediatric blood & cancer","studyType":"Clinical Study"},{"pmid":"41822747","year":"2026","title":"Investigation of antimicrobial synergism of actinomycin derivatives from Streptomyces parvus 35M1 against Escherichia coli ATCC 25922.","finding":"","journal":"Turkish journal of biology = Turk biyoloji dergisi","studyType":"Clinical Study"},{"pmid":"41608667","year":"2026","title":"Primary Embryonal Rhabdomyosarcoma of the Breast: A Case Report and Literature Review.","finding":"","journal":"Case reports in oncology","studyType":"Clinical Study"},{"pmid":"41585198","year":"2026","title":"A scientometric and comparative study of rhabdomyosarcoma research by pediatricians and stomatologists.","finding":"","journal":"Journal of dental sciences","studyType":"Clinical Study"},{"pmid":"41552649","year":"2026","title":"Progressive Metastatic Cutaneous TFCP2::FUS Fusion-Positive Rhabdomyosarcoma: A Case Report.","finding":"","journal":"Case reports in oncology","studyType":"Clinical Study"}],"_fda":{"id":"d9bb02eb-3f9e-4932-bdcd-53b5bd6392b6","set_id":"2aaca42a-3b79-4151-a727-83253556a540","openfda":{"nui":["N0000180850","N0000000233","N0000000150"],"unii":["1CC1JFE158"],"route":["INTRAVENOUS"],"rxcui":["239179"],"spl_id":["d9bb02eb-3f9e-4932-bdcd-53b5bd6392b6"],"brand_name":["Dactinomycin"],"spl_set_id":["2aaca42a-3b79-4151-a727-83253556a540"],"package_ndc":["71288-129-02"],"product_ndc":["71288-129"],"generic_name":["DACTINOMYCIN"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["DACTINOMYCIN"],"pharm_class_epc":["Actinomycin [EPC]"],"pharm_class_moa":["Nucleic Acid Synthesis Inhibitors [MoA]","Protein Synthesis Inhibitors [MoA]"],"manufacturer_name":["Meitheal Pharmaceuticals Inc."],"application_number":["ANDA213463"],"is_original_packager":[true]},"version":"3","pregnancy":["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 ."],"references":["15 REFERENCES 1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html"],"description":["11 DESCRIPTION Dactinomycin is an actinomycin. Dactinomycin is produced by Streptomyces parvullus . The chemical name is 8-amino-N-(2-amino-4,6-dimethyl-3-oxo-phenoxazin-1-yl)carbonyl-N'-[8-amino-4,6-dimethyl-7-oxo-9-[[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16-tetrazabicyclo[14.3.0]nonadec-11-yl]carbamoyl]phenoxazin-1-yl]carbonyl-4,6-dimethyl-7-oxo-N,N'-bis[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16 tetrazabicyclo[14.3.0]nonadec-11-yl]-1,9-bis[[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16-tetrazabicyclo[14.3.0] nonadec-11-yl]carbamoyl]phenoxazine-1,9-dicarboxamide. The molecular formula is C 62 H 86 N 12 O 16 and the molecular weight is 1255.42 daltons. The structural formula of dactinomycin is shown below: Dactinomycin for Injection, USP for intravenous use is a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial. Each vial contains 500 mcg of dactinomycin and 20 mg of mannitol. Structural Formula of Dactinomycin"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Dactinomycin for Injection, USP for intravenous use is an amorphous yellow to orange powder. Each vial contains 500 mcg (0.5 mg) of dactinomycin and 20 mg of mannitol. It is supplied as follows: NDC Dactinomycin for Injection, USP (500 mcg per vial) Package Factor 71288- 129 -02 500 mcg Single-Dose Vial 1 vial per carton Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] 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 [see Dosage and Administration ( 2.7 )] . Dactinomycin for Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Discard unused portion. Lyophilized. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex."],"geriatric_use":["8.5 Geriatric Use Clinical studies of dactinomycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects."],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness of dactinomycin have been established in pediatric patients with Wilms tumor, rhabdomyosarcoma, Ewing sarcoma, and metastatic nonseminomatous testicular cancer. The safety and effectiveness of dactinomycin have been established in post-menarchal pediatric patients with gestational trophoblastic neoplasia. The safety and effectiveness of dactinomycin have not been established in pediatric patients undergoing regional perfusion for locally recurrent or locoregional solid malignancies."],"effective_time":"20201113","pharmacodynamics":["12.2 Pharmacodynamics Dactinomycin exposure-response relationships and the time course of pharmacodynamics response are unknown."],"pharmacokinetics":["12.3 Pharmacokinetics 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. Elimination Excretion Following administration of radiolabeled dactinomycin, approximately 30% was recovered in urine and feces in one week. Specific Populations Pediatric Patients Published studies and population analyses in patients ≤ 21 years of age with cancer report a trend of increasing systemic dactinomycin clearance with increasing body weight. Drug Interaction Studies Published in vitro studies report that dactinomycin may be a substrate of the P-glycoprotein and OATP1B3 transporter systems."],"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 fatal outcome Hematologic : anemia, leukopenia, thrombocytopenia, pancytopenia, reticulocytopenia, neutropenia, febrile neutropenia, disseminated intravascular coagulation Immune system: hypersensitivity Metabolism and nutrition: anorexia, hypocalcemia, tumor lysis syndrome Nervous system: peripheral neuropathy Ocular: optic neuropathy Vascular: thrombophlebitis, hemorrhage Respiratory, thoracic and mediastinal: pneumonitis, pneumothorax Gastrointestinal: nausea, vomiting, abdominal pain, diarrhea, constipation, gastrointestinal ulceration, cheilitis, dysphagia, esophagitis, ulcerative stomatitis, ascites, proctitis, mucositis Hepatobiliary: liver function test abnormalities, hepatomegaly, hepatitis, hepatic failure with reports of death, hepatic veno-occlusive disease Dermatologic: alopecia, rash, dermatitis, acne, erythema multiforme, Stevens Johnson Syndrome, radiation recall, toxic epidermal necrolysis Musculoskeletal and connective tissue: myalgia, growth retardation Renal and urinary: renal impairment, renal failure General: fatigue, fever, malaise Common adverse reactions are: infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, and hepatotoxicity ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["4 CONTRAINDICATIONS None. None. ( 4 )"],"how_supplied_table":["
NDCDactinomycin for Injection, USP (500 mcg per vial)Package Factor
71288-129-02 500 mcg Single-Dose Vial 1 vial per carton
"],"mechanism_of_action":["12.1 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."],"storage_and_handling":["Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] 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 [see Dosage and Administration ( 2.7 )] . Dactinomycin for Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Discard unused portion. Lyophilized. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 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. 12.2 Pharmacodynamics Dactinomycin exposure-response relationships and the time course of pharmacodynamics response are unknown. 12.3 Pharmacokinetics 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. Elimination Excretion Following administration of radiolabeled dactinomycin, approximately 30% was recovered in urine and feces in one week. Specific Populations Pediatric Patients Published studies and population analyses in patients ≤ 21 years of age with cancer report a trend of increasing systemic dactinomycin clearance with increasing body weight. Drug Interaction Studies Published in vitro studies report that dactinomycin may be a substrate of the P-glycoprotein and OATP1B3 transporter systems."],"indications_and_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 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."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS 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. After treatment with dactinomycin, monitor frequently for signs and symptoms of VOD; these include elevations in AST, ALT, total bilirubin, hepatomegaly, weight gain, or ascites. If patients develop VOD, considering delaying next dose of dactinomycin. Resume, reduce dose or permanently discontinue based on severity of reaction and disease being treated. 5.3 Extravasation Extravasation of dactinomycin can result in severe local tissue injury manifesting as blistering, ulcerations and persistent pain requiring wide excision surgery followed by split-thickness skin grafting. If any signs or symptoms of extravasation occur, immediately interrupt the injection or infusion. Apply ice to the site intermittently for 15 minutes, 4 times a day for 3 days [see Dosage and Administration ( 2.7 )] . Observe closely and consult plastic surgery if necessary based on severity of reaction. 5.4 Myelosuppression Severe and fatal myelosuppression, which may include neutropenia, thrombocytopenia and anemia, can occur with dactinomycin. The nadir in neutrophil counts generally occurs 14 to 21 days after administration. Obtain complete blood counts prior to each treatment cycle. Delay next dose of dactinomycin if severe myelosuppression has not improved. Consider dose reduction for patients with prolonged myelosuppression based on severity of reaction and disease being treated. 5.5 Immunizations The safety with live viral vaccines following dactinomycin has not been studied and vaccination with live virus vaccines is not recommended before or during treatment. 5.6 Severe Mucocutaneous Reactions Severe mucocutaneous reactions, such as Steven-Johnson syndrome and Toxic Epidermal Necrolysis (TEN), can occur with dactinomycin. Permanently discontinue dactinomycin in patients who experience a severe mucocutaneous reaction. 5.7 Renal Toxicity Abnormalities of renal function can occur with dactinomycin. Monitor creatinine and electrolytes frequently during dactinomycin therapy. 5.8 Hepatotoxicity Hepatotoxicity can occur with dactinomycin. Monitor AST, ALT, alkaline phosphatase, and bilirubin prior to and during dactinomycin therapy. 5.9 Potentiation of Radiation Toxicity and Radiation Recall Dactinomycin can increase radiation-induced gastrointestinal toxicity, myelosuppression, or erythema and vesiculation of the skin or buccal and pharyngeal mucosa. Reduce the dose of dactinomycin by 50% during concomitant radiation. Radiation recall, affecting previously treated radiation fields, can occur in patients who receive dactinomycin after prior radiation therapy. Although the risk can occur with distant radiation exposure, the risk appears highest when dactinomycin is administered within two months of prior radiation. 5.10 Embryo-Fetal Toxicity 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 recommended human dose. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with dactinomycin and for at least 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with dactinomycin and for 3 months after the final dose [see Use in Specific Populations ( 8.1 , 8.3 )] ."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Dactinomycin is a carcinogen in animals. Local sarcomas were produced in mice and rats after repeated subcutaneous or intraperitoneal injections. Mesenchymal tumors occurred in male rats given intraperitoneal injections of 50 mcg/kg, 2 to 5 times per week, for 18 weeks, at doses (based on body surface area) 0.5 times the clinical dose of 1,250 mcg/m 2 . Dactinomycin was mutagenic in several in vitro and in vivo test systems including human fibroblasts and leukocytes, and HeLa cells. DNA damage and cytogenetic effects have been demonstrated in the mouse and the rat."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Secondary Malignancy or Leukemia Advise patients of the increased risk of secondary malignancies [see Warnings and Precautions ( 5.1 )] . Veno-occlusive Disease Advise patients about the symptoms of VOD and to seek medical attention if they develop new onset jaundice, abdominal distention, or right upper quadrant pain [see Warnings and Precautions ( 5.2 )] . Myelosuppression Advise patients to contact their healthcare provider for any signs or symptoms of myelosuppression or infection [see Warnings and Precautions ( 5.4 )] . Severe Mucocutaneous Reactions Advise patients of the risk of severe mucocutaneous reactions and to contact their health care provided for new skin lesions, mouth sores or oropharyngeal lesions [see Warnings and Precautions ( 5.5 )] . Renal Toxicity or Hepatotoxicity Advise patients of the need for periodic laboratory testing to monitor for renal toxicity and hepatotoxicity [see Warnings and Precautions ( 5.7 , 5.8 )] . Potentiation of Radiation Toxicity and Radiation Recall Advise patients of the risk of increased radiation-induced gastrointestinal, myelosuppression and skin toxicity [see Warnings and Precautions ( 5.9 )] . Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.10 ), Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective contraception during treatment with dactinomycin and for 6 months after final dose [see Use in Specific Populations ( 8.3 )] . Advise male patients with female partners of reproductive potential to use effective contraception during treatment with dactinomycin and for 3 months after final dose [see Use in Specific Populations ( 8.3 )] . Lactation Advise females not to breastfeed during treatment with dactinomycin and for 14 days after the final dose [see Use in Specific Populations ( 8.2 )] . meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2020 Meitheal Pharmaceuticals Inc. August 2020"],"dosage_and_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 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. 2.2 Recommended Dosage for Rhabdomyosarcoma The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, is 15 mcg/kg intravenously once daily for 5 days every 3 to 9 weeks for up to 112 weeks. 2.3 Recommended Dosage for Ewing Sarcoma The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, is 1,250 mcg/m 2 intravenously once every 3 weeks for 51 weeks. 2.4 Recommended Dosage for Metastatic Nonseminomatous Testicular Cancer The recommended dose of dactinomycin for injection, as part of a cisplatin-based, multi-agent combination chemotherapy regimen, is 1,000 mcg/m 2 intravenously once every 3 weeks for 12 weeks. 2.5 Recommended Dosage for Gestational Trophoblastic Neoplasia The recommended dose of dactinomycin for injection for nonmetastatic and low-risk metastatic disease is 12 mcg/kg intravenously daily for five days as a single agent. The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, for high-risk metastatic disease is 500 mcg intravenously on Days 1 and 2 every 2 weeks for up to 8 weeks. 2.6 Recommended Dosage for Regional Perfusion in Locally Recurrent and Locoregional Solid Malignancies The recommended dose of dactinomycin for injection, in combination with melphalan, is 50 mcg/kg once for lower extremity or pelvis. The recommended dose of dactinomycin for injection, in combination with melphalan, is 35 mcg/kg once for upper extremity. Calculate the dose for obese or edematous patients based on ideal body weight. 2.7 Preparation and Administration Dactinomycin for injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Visually inspect the vials for particulate matter and discoloration, whenever solution and container permit. Preparation Reconstitute each vial by adding 1.1 mL of Sterile Water for Injection without preservative using aseptic techniques. The reconstituted product should be a clear, gold-colored solution at a concentration of 500 mcg per mL. Further dilute the reconstituted product with 5% Dextrose Injection or 0.9% Sodium Chloride Injection to yield concentrations greater than 10 mcg/mL. Store at room temperature for no more than 4 hours from reconstitution to completion of injection or infusion. Discard after 4 hours. Dactinomycin for injection does not contain a preservative. Discard any unused portions. Administration Administer the diluted reconstituted product intravenously over 10 to 15 minutes. Do not use in-line filters with a cellulose ester membrane. Management of Extravasation Discontinue dactinomycin for injection for burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation. Manage confirmed or suspected extravasation as follows: Terminate the injection or infusion immediately and restart in another vein. Intermittent application of ice to the site for 15 minutes 4 times daily for 3 days [see Warnings and Precautions ( 5.3 )]."],"spl_product_data_elements":["Dactinomycin Dactinomycin dactinomycin dactinomycin mannitol water"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS For injection: 500 mcg as a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial. For injection: 500 mcg as a lyophilized powder in a single-dose vial. ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 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. Because of the potential for serious adverse reactions in breastfed infants from dactinomycin, advise women not to breastfeed during treatment with dactinomycin and, based on limited published data regarding the dactinomycin half-life, for 14 days after the final dose. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating dactinomycin [see Use in Specific Population ( 8.1 )]. Contraception Dactinomycin can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Females Advise females of reproductive potential to use effective contraception during treatment with dactinomycin and for at least 6 months after the final dose. Males Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with dactinomycin and for 3 months after the final dose [ see Nonclinical Toxicology ( 13.1 )] . 8.4 Pediatric Use The safety and effectiveness of dactinomycin have been established in pediatric patients with Wilms tumor, rhabdomyosarcoma, Ewing sarcoma, and metastatic nonseminomatous testicular cancer. The safety and effectiveness of dactinomycin have been established in post-menarchal pediatric patients with gestational trophoblastic neoplasia. The safety and effectiveness of dactinomycin have not been established in pediatric patients undergoing regional perfusion for locally recurrent or locoregional solid malignancies. 8.5 Geriatric Use Clinical studies of dactinomycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects."],"package_label_principal_display_panel":["Principal Display Panel – Dactinomycin for Injection, USP 500 mcg Vial Label NDC 71288- 129 -02 Rx Only Dactinomycin for Injection, USP 500 mcg (0.5 mg) per vial For Preparation of Intravenous Solutions Caution: Cytotoxic Agent Single-Dose Vial Principal Display Panel – Dactinomycin for Injection, USP 500 mcg Vial Label","Principal Display Panel – Dactinomycin for Injection, USP 500 mcg Carton NDC 71288- 129 -02 Rx Only 1 Single-Dose Vial Dactinomycin for Injection, USP 500 mcg (0.5 mg) per vial For Preparation of Intravenous Solutions Caution: Cytotoxic Agent Principal Display Panel – Dactinomycin for Injection, USP 500 mcg Carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Dactinomycin is a carcinogen in animals. Local sarcomas were produced in mice and rats after repeated subcutaneous or intraperitoneal injections. Mesenchymal tumors occurred in male rats given intraperitoneal injections of 50 mcg/kg, 2 to 5 times per week, for 18 weeks, at doses (based on body surface area) 0.5 times the clinical dose of 1,250 mcg/m 2 . Dactinomycin was mutagenic in several in vitro and in vivo test systems including human fibroblasts and leukocytes, and HeLa cells. DNA damage and cytogenetic effects have been demonstrated in the mouse and the rat."]},"tags":[{"label":"Actinomycin","category":"class"},{"label":"Peptide","category":"modality"},{"label":"Growth factor receptor-bound protein 2","category":"target"},{"label":"GRB2","category":"gene"},{"label":"DDR2","category":"gene"},{"label":"NGLY1","category":"gene"},{"label":"L01DA01","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Ewing's sarcoma","category":"indication"},{"label":"Gestational trophoblastic neoplasia","category":"indication"},{"label":"Malignant tumor of testis","category":"indication"},{"label":"Nephroblastoma","category":"indication"},{"label":"Rhabdomyosarcoma","category":"indication"},{"label":"Recordati Rare","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antibiotics, Antineoplastic","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Nucleic Acid Synthesis Inhibitors","category":"pharmacology"},{"label":"Protein Synthesis Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":521.546,"date":"","count":90,"signal":"Ovarian failure","source":"DrugCentral FAERS","actionTaken":"Reported 90 times (LLR=522)"},{"llr":388.563,"date":"","count":99,"signal":"Maternal exposure before pregnancy","source":"DrugCentral FAERS","actionTaken":"Reported 99 times (LLR=389)"},{"llr":357.985,"date":"","count":104,"signal":"Venoocclusive liver disease","source":"DrugCentral FAERS","actionTaken":"Reported 104 times 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ulceration","drugRate":"reported","severity":"serious"},{"effect":"Hepatotoxicity","drugRate":"reported","severity":"serious"},{"effect":"Anorexia","drugRate":"reported","severity":"mild"},{"effect":"Hypocalcemia","drugRate":"reported","severity":"mild"},{"effect":"Tumor lysis syndrome","drugRate":"reported","severity":"mild"},{"effect":"Optic neuropathy","drugRate":"reported","severity":"mild"},{"effect":"Thrombophlebitis","drugRate":"reported","severity":"mild"},{"effect":"Hemorrhage","drugRate":"reported","severity":"mild"},{"effect":"Nausea","drugRate":"reported","severity":"mild"},{"effect":"Vomiting","drugRate":"reported","severity":"mild"},{"effect":"Abdominal 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infection"],"specialPopulations":{"Lactation":"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. Because of the potential for serious adverse reactions in breastfed infants from COSMEGEN, advise women not to breastfeed during treatment with COSMEGEN and, based on limited published data regarding the dactinomycin half-life, for 14 days after the final dose.","Pregnancy":"Based on findings from animal studies and its mechanism of action, COSMEGEN can cause fetal harm when administered to 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 recommended human dose. Advise pregnant women of the potential risk to fetus.","Geriatric use":"Clinical studies of dactinomycin for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.","Paediatric use":"The safety and effectiveness of dactinomycin have been established in pediatric patients with Wilms tumor, rhabdomyosarcoma, Ewing sarcoma, and metastatic nonseminomatous testicular cancer. The safety and effectiveness of dactinomycin have been established in post-menarchal pediatric patients with gestational trophoblastic neoplasia. The safety and effectiveness of dactinomycin have not been established in pediatric patients undergoing regional perfusion for locally recurrent or"}},"trials":[],"aliases":[],"company":"Recordati","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DACTINOMYCIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:28:01.619837+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T03:28:58.294343+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:28:07.237229+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DACTINOMYCIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:28:07.815879+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:28:00.506182+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:28:00.506218+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:28:52.970888+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:28:00.506225+00:00"},"mechanism.oneSentence":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"12.1 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.","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:28:18.713782+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4748391/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:28:08.530195+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"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 ","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:28:21.343483+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA213463","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:28:00.506231+00:00"}},"allNames":"cosmegen","offLabel":[],"synonyms":["Actinomycin D","dactinomycin","Actactinomycin A IV","Actinomycin 7","Chounghwamycin B","Dactinomycin D","Dilactone actinomycin D acid","Dilactone actinomycindioic D acid","meractinomycin","Oncostatin K"],"timeline":[{"date":"1964-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from RECORDATI RARE to Recordati Rare"},{"date":"1964-12-10","type":"positive","source":"DrugCentral","milestone":"FDA approval (Recordati Rare)"},{"date":"2013-08-23","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 2 manufacturers approved"}],"aiSummary":"Dactinomycin (Cosmegen), marketed by Recordati, is a well-established cytotoxic agent primarily indicated for the treatment of Wilms Tumor. Its key strength lies in its mechanism of action, binding DNA and inhibiting RNA synthesis, which effectively demonstrates cytotoxic activity in cancer models. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.","approvals":[{"date":"1964-12-10","orphan":false,"company":"RECORDATI RARE","regulator":"FDA"}],"brandName":"Cosmegen","ecosystem":[{"indication":"Ewing's sarcoma","otherDrugs":[{"name":"temozolomide","slug":"temozolomide","company":"Merck Sharp Dohme"}],"globalPrevalence":null},{"indication":"Gestational trophoblastic neoplasia","otherDrugs":[{"name":"methotrexate","slug":"methotrexate","company":"Dava Pharms Inc"},{"name":"vinblastine","slug":"vinblastine","company":""}],"globalPrevalence":null},{"indication":"Malignant tumor of testis","otherDrugs":[{"name":"etoposide","slug":"etoposide","company":""},{"name":"etoposide phosphate","slug":"etoposide-phosphate","company":"Bristol Myers Squibb"},{"name":"plicamycin","slug":"plicamycin","company":""},{"name":"vinblastine","slug":"vinblastine","company":""}],"globalPrevalence":null},{"indication":"Nephroblastoma","otherDrugs":[{"name":"doxorubicin","slug":"doxorubicin","company":""},{"name":"vincristine","slug":"vincristine","company":""}],"globalPrevalence":null},{"indication":"Rhabdomyosarcoma","otherDrugs":[{"name":"vincristine","slug":"vincristine","company":""}],"globalPrevalence":null}],"mechanism":{"target":"DNA","targets":[{"gene":"GRB2","source":"DrugCentral","target":"Growth factor receptor-bound protein 2","protein":"Growth factor receptor-bound protein 2"},{"gene":"DDR2","source":"DrugCentral","target":"Discoidin domain-containing receptor 2","protein":"Discoidin domain-containing receptor 2"},{"gene":"NGLY1","source":"DrugCentral","target":"Peptide-N(4)-(N-acetyl-beta-glucosaminyl)asparagine amidase","protein":"Peptide-N(4)-(N-acetyl-beta-glucosaminyl)asparagine amidase"}],"moaClass":"Nucleic Acid Synthesis Inhibitors","modality":"Small molecule","drugClass":"Actinomycin [EPC]","explanation":"Dactinomycin is a cytotoxic agent that works by binding to DNA, which prevents the synthesis of RNA. This inhibition of RNA synthesis leads to cell death, making it effective against various human cancers in animal models.","oneSentence":"Dactinomycin binds DNA and inhibits RNA synthesis, demonstrating cytotoxic activity in cancer models.","technicalDetail":"Dactinomycin binds to DNA and interferes with the transcription process, thereby inhibiting RNA synthesis. This disruption of RNA synthesis results in cytotoxic effects and cell death."},"commercial":{"launchDate":"1964","_launchSource":"DrugCentral (FDA 1964-12-10, RECORDATI RARE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/774","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DACTINOMYCIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DACTINOMYCIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:27:44.795976","_validation":{"fieldsValidated":4,"lastValidatedAt":"2026-04-20T03:28:58.294719+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"genericName":"dactinomycin","indications":{"approved":[{"id":"dactinomycin-wilms-tumor","name":"Wilms Tumor","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adult and pediatric patients with Wilms tumor","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adult and pediatric patients with Wilms tumor","diagnosticRequired":null,"brandNameForIndication":"Cosmegen"},{"id":"dactinomycin-rhabdomyosarcoma","name":"Rhabdomyosarcoma","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adult and pediatric patients with rhabdomyosarcoma","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adult and pediatric patients with rhabdomyosarcoma","diagnosticRequired":null,"brandNameForIndication":"Cosmegen"},{"id":"dactinomycin-ewing-sarcoma","name":"Ewing Sarcoma","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adult and pediatric patients with Ewing sarcoma","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adult and pediatric patients with Ewing sarcoma","diagnosticRequired":null,"brandNameForIndication":"Cosmegen"},{"id":"dactinomycin-metastatic-nonseminomatous-tes","name":"Metastatic Nonseminomatous Testicular Cancer","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adult and pediatric patients with metastatic, nonseminomatous testicular cancer","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adult and pediatric patients with metastatic, nonseminomatous testicular cancer","diagnosticRequired":null,"brandNameForIndication":"Cosmegen"},{"id":"dactinomycin-gestational-trophoblastic-neop","name":"Gestational Trophoblastic Neoplasia","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Post-menarchal patients with gestational trophoblastic neoplasia","pivotalTrial":null,"restrictions":[],"patientPopulation":"Post-menarchal patients with gestational trophoblastic neoplasia","diagnosticRequired":null,"brandNameForIndication":"Cosmegen"},{"id":"dactinomycin-locally-recurrent-or-locoregio","name":"Locally Recurrent or Locoregional Solid Malignancies","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adult patients with locally recurrent or locoregional solid malignancies","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adult patients with locally recurrent or locoregional solid malignancies","diagnosticRequired":null,"brandNameForIndication":"Cosmegen"}],"offLabel":[{"name":"Kaposi's sarcoma","source":"DrugCentral","drugName":"DACTINOMYCIN","evidenceCount":37,"evidenceLevel":"moderate"},{"name":"Ovarian Germ Cell Tumor Carcinoma","source":"DrugCentral","drugName":"DACTINOMYCIN","evidenceCount":53,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Recordati Rare","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT02567435","phase":"PHASE3","title":"Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2016-06-01","conditions":["Alveolar Rhabdomyosarcoma","Botryoid-Type Embryonal Rhabdomyosarcoma","Embryonal Rhabdomyosarcoma","Rhabdomyosarcoma","Sclerosing Rhabdomyosarcoma","Spindle Cell Rhabdomyosarcoma"],"enrollment":325,"completionDate":"2026-10-27"},{"nctId":"NCT00379340","phase":"PHASE3","title":"Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2007-04-30","conditions":["Stage III Kidney Wilms Tumor","Stage IV Kidney Wilms Tumor"],"enrollment":395,"completionDate":"2026-11-18"},{"nctId":"NCT07194044","phase":"PHASE1","title":"Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes","status":"RECRUITING","sponsor":"H. 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