Adult: As part of a multi-agent combination chemotherapy regimen: 45 mcg/kg once every 3-6 weeks for up to 26 weeks. Alternative dosage regimen in combination with other chemotherapy agents: 15 mcg/kg daily for 5 days. Doses for each 2-week cycle must not exceed 15 mcg/kg daily or 400-600 mcg/m2 daily for 5 days. All doses are given via IV infusion over 10-15 minutes. Calculate dose before each administration and adjust based on patient response, tolerance and other concomitant therapy. Dosage and chemotherapeutic combination regimen may vary between countries or among individual products (refer to specific local treatment protocols). Child: Same as adult dose.
Intravenous Rhabdomyosarcoma
Adult: As part of a multi-agent combination chemotherapy regimen: 15 mcg/kg daily for 5 days every 3-9 weeks for up to 112 weeks. Alternative dosage regimen in combination with other chemotherapy agents: 15 mcg/kg daily for 5 days. Doses for each 2-week cycle must not exceed 15 mcg/kg daily or 400-600 mcg/m2 daily for 5 days. All doses are given via IV infusion over 10-15 minutes. Calculate dose before each administration and adjust based on patient response, tolerance and other concomitant therapy. Dosage and chemotherapeutic combination regimen may vary between countries or among individual products (refer to specific local treatment protocols). Child: Same as adult dose.
Intravenous Ewing's sarcoma
Adult: As part of a multi-agent combination chemotherapy regimen: 1,250 mcg/m2 once every 3 weeks for 51 weeks. Dose for each 2-week cycle must not exceed 15 mcg/kg daily or 400-600 mcg/m2 daily for 5 days. All doses are given via IV infusion over 10-15 minutes. Calculate dose before each administration and adjust based on patient response, tolerance and other concomitant therapy. Dosage and chemotherapeutic combination regimen may vary between countries or among individual products (refer to specific local treatment protocols). Child: Same as adult dose.
Intravenous Metastatic nonseminomatous testicular cancer
Adult: As part of cisplatin-based multi-agent combination chemotherapy regimen: 1,000 mcg/m2 once every 3 weeks for 12 weeks. Doses for each 2-week cycle must not exceed 15 mcg/kg daily or 400-600 mcg/m2 daily for 5 days. All doses are given via IV infusion over 10-15 minutes. Calculate dose before each administration and adjust based on patient response, tolerance and other concomitant therapy. Dosage and chemotherapeutic combination regimen may vary between countries or among individual products (refer to specific local treatment protocols). Child: Same as adult dose.
Intravenous Gestational trophoblastic neoplasia
Adult: As monotherapy in non-metastatic and low-risk metastatic cases: 12 mcg/kg daily for 5 days. As part of a multi-agent combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide and cisplatin (EMA-CO regimen) in high-risk metastatic cases: 500 mcg on Days 1 and 2 every 2 weeks for up to 8 weeks. Doses for each 2-week cycle must not exceed 15 mcg/kg daily or 400-600 mcg/m2 daily for 5 days. All doses are given via IV infusion over 10-15 minutes. Calculate dose before each administration and adjust based on patient response, tolerance and other concomitant therapy. Dosage and chemotherapeutic combination regimen may vary between countries or among individual products (refer to specific local treatment protocols).
Parenteral Solid tumours
Adult: As a component of palliative or adjunctive regional perfusion in patients with locally recurrent or locoregional solid tumours: Usual dose: In combination with melphalan: 50 mcg/kg once (for lower extremities or pelvis) and 35 mcg/kg once (for upper extremities). Doses are given via regional isolation perfusion. Calculate dose before each administration and adjust based on patient response, tolerance and other concomitant therapy. Dosage and treatment recommendations and administration technique may vary between countries and among institutions (refer to specific local treatment protocols).
Special Patient Group
Obese or oedematous patients: Calculate dosage based on ideal body weight.
Concurrent use with chemotherapy or radiation therapy, or in patients who have had prior radiation therapy or other chemotherapy combinations: Reduced dactinomycin dose is required.
Reconstitution
Powder for solution for IV inj: Reconstitute a vial with 1.1 mL of sterile water for inj (preservative-free) to make a 500 mcg/mL concentration, clear and gold-coloured solution. IV infusion: Further dilute the reconstituted solution with dextrose 5% in water or NaCl 0.9% solution to make a final concentration of 10 mcg/mL. Do not use in-line filters with cellulose ester membrane during preparation and administration. Avoid inhaling the powder and direct contact with the skin or mucous membranes.
Incompatibility
May form precipitates with sterile water for inj containing preservatives (e.g. parabens, benzyl alcohol).
Contraindications
Varicella or herpes zoster.
Special Precautions
Patient with hepatobiliary dysfunction. Obese or oedematous patients. Patients who had prior radiation therapy or chemotherapy combinations, and those undergoing concomitant radiation therapy. Administration of antiemetics is recommended to prevent nausea and vomiting. Avoid extravasation. Renal and hepatic impairment. Children and elderly. Pregnancy and lactation. Avoid co-administration with live vaccines before and during therapy.
Adverse Reactions
Significant: Increased risk of radiation-induced skin/buccal/pharyngeal mucosa erythema or vesiculation, gastrointestinal toxicity, and myelosuppression (particularly if in combination with radiation therapy); radiation recall reaction; increased risk of secondary malignancies, including leukaemia; nephrotoxicity, severe mucocutaneous effects (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme); severe local tissue damage, particularly persistent pain, blistering or ulceration (if extravasation occurs); soft tissue damage and oedema (when given via regional perfusion). Blood and lymphatic system disorders: Agranulocytosis, leucopenia, pancytopenia, disseminated intravascular coagulation (DIC). Eye disorders: Optic neuropathy. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, constipation, cheilitis, stomatitis, oesophagitis, gastrointestinal ulcer. General disorders and administration site conditions: Fatigue, fever, malaise. Hepatobiliary disorders: Hepatitis, hepatomegaly. Immune system disorders: Hypersensitivity reactions. Investigations: Abnormal LFTs. Metabolism and nutrition disorders: Anorexia, hypocalcaemia. Musculoskeletal and connective tissue disorders: Myalgia. Nervous system disorders: Peripheral neuropathy. Renal and urinary disorders: Renal impairment or failure. Respiratory, thoracic and mediastinal disorders: Pneumothorax, pneumonitis. Skin and subcutaneous tissue disorders: Rash, alopecia, acne, dermatitis. Vascular disorders: Thrombophlebitis, haemorrhage. Potentially Fatal: Severe myelosuppression, including thrombocytopenia, neutropenia and anaemia; severe hepatic sinusoidal obstruction syndrome (SOS), hepatic failure; sepsis (including neutropenic sepsis).
IV/Parenteral: Z (Not recommended or use only if benefits outweigh potential risks (manufacturer specific).)
Patient Counseling Information
Women of childbearing potential must use proven birth control methods during therapy and for at least 6 months after the last dose. Men with female partners of childbearing potential should use effective contraception during treatment and for at least 3 months after stopping the treatment. Discontinue breastfeeding during and for 14 days after the last dose.
Monitoring Parameters
Confirm pregnancy status prior to therapy initiation in women of childbearing potential. Monitor CBC (before each treatment cycle); LFTs (before and during therapy); kidney function and serum electrolytes (frequently during treatment). Perform Hepatitis B virus screening with HBsAg, hepatitis B core antibody, total Ig or IgG, and antibody to HBsAg before or at the beginning of systemic chemotherapy. Closely monitor the infusion site for extravasation. Assess for signs and symptoms of hepatic SOS, myelosuppression, mucocutaneous reactions, secondary malignancy, and radiation recall.
Management: Symptomatic and supportive treatment. Closely monitor renal, hepatic and bone marrow functions frequently. Assess the integrity of skin and mucous membranes.
Drug Interactions
Concurrent administration with live vaccines may increase the risk of vaccine-associated infections.
Action
Description: Overview: Dactinomycin is a cytotoxic and cell-cycle non-specific antineoplastic antibiotic with immunosuppressant properties. Mechanism of Action: Dactinomycin forms a stable complex with DNA by intercalating with guanine residues and interfering with its template activity, thereby inhibiting DNA synthesis and DNA-dependent RNA synthesis. Synonym(s): Actinomycin D. Pharmacokinetics: Distribution: Concentrated in bone marrow and nucleated cells; does not cross the blood-brain barrier. Metabolism: Minimal metabolism in the liver. Excretion: Via urine and faeces (approx 30%). Elimination half-life: Approx 30-40 hours.
Chemical Structure
Dactinomycin Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 457193, Dactinomycin. https://pubchem.ncbi.nlm.nih.gov/compound/Dactinomycin. Accessed Nov. 26, 2025.
Storage
Intact vial: Store between 20-25°C. Do not freeze. Protect from light and humidity. Diluted solution: Store at room temperature for up to 4 hours from reconstitution. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
L01DA01 - dactinomycin ; Belongs to the class of cytotoxic antibiotics, actinomycines. Used in the treatment of cancer.
References
Brayfield A, Cadart C (eds). Dactinomycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/11/2025.Cosmegen Lyovac 500 micrograms Powder for Solution for Injection (Recordati Rare Diseases). MHRA. https://products.mhra.gov.uk. Accessed 04/11/2025.Dactinomycin Injection, Powder, Lyophilized, for Solution (Eugia US LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/11/2025.Dactinomycin. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 04/11/2025.Dactinomycin. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/11/2025.Dactinomycin. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/11/2025.Paediatric Formulary Committee. Dactinomycin. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 04/11/2025.Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. Cosmegen 500 mg Powder for Injection data sheet 30 July 2025. Medsafe. http://www.medsafe.govt.nz. Accessed 04/11/2025.
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