Dactinomycin 0.5 mg Vial

Cytotoxic Antibiotic – Antineoplastic Agent / Chemotherapy Adjuvant

ATC Code: L01DA01

WHO Essential Medicines List: ✔️ Yes

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Product Description

Dactinomycin (also known as Actinomycin D) is a cytotoxic polypeptide antibiotic with potent antineoplastic activity. It intercalates into DNA and inhibits RNA polymerase, thereby preventing RNA synthesis. This disruption of transcription leads to impaired protein synthesis and subsequent apoptosis of rapidly dividing cancer cells.

Dactinomycin is derived from Streptomyces species and has been used in oncology for decades, particularly in pediatric tumors and solid malignancies. It is often used in combination regimens and as part of multi-modal protocols in both adult and pediatric oncology.

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Available Presentation

• Strength per vial: 0.5 mg
• Formulation: Lyophilized powder for injection
• Volume: Reconstituted per protocol (usually with 1.1 mL sterile water to yield 0.5 mg/mL)
• Dilution Required: ✔️ Yes – must be reconstituted and further diluted for IV use
• Packaging: Single-use glass vial with flip-off cap, packed in individual carton
• Storage: Store refrigerated between 2°C and 8°C. Protect from light. Do not freeze.

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Indications

• Wilms' tumor
• Rhabdomyosarcoma
• Ewing sarcoma
• Gestational trophoblastic neoplasia (including choriocarcinoma)
• Metastatic testicular cancer
• Kaposi sarcoma (HIV-associated, in some regimens)

Uses

• Primary Use: Oncology – Cytotoxic chemotherapy agent
• Cancer Types: Pediatric solid tumors, germ cell tumors, sarcomas, gestational trophoblastic disease
• Combination Therapy: Often combined with vincristine, cyclophosphamide, methotrexate, and etoposide

Off-label / Investigational Uses

• Retinoblastoma (in intra-arterial delivery)
• Desmoid tumors
• Metastatic or recurrent hepatoblastoma

Pediatric Use

✔️ Extensively used in pediatric oncology. Dosage is body surface area–based (mg/m²). Used under strict supervision with renal and hepatic monitoring.

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Regulatory and Safety Profile

• ATC Code: L01DA01
• WHO Essential Medicines List: ✔️ Yes
• Pharmacologic Class: Antitumor antibiotic / Cytotoxic agent
• Black Box Warning (U.S. FDA): ✔️ Yes
  • Severe myelosuppression
  • Gastrointestinal toxicity
  • Risk of extravasation and tissue necrosis
• Regulatory Status: Registered in multiple jurisdictions as an essential chemotherapy component

Contraindications

• Hypersensitivity to Dactinomycin
• Active infection or significant immunosuppression
• Pregnancy (Category D – teratogenic)

Common Side Effects

• Bone marrow suppression (leukopenia, thrombocytopenia)
• Nausea, vomiting, mucositis
• Alopecia
• Hepatotoxicity
• Risk of infection
• Local necrosis upon extravasation

Monitoring Parameters

• Complete blood count (CBC) with differential
• Liver function tests (ALT, AST, bilirubin)
• Renal function monitoring (especially in pediatric protocols)
• Clinical monitoring for mucositis and GI toxicity
• Vigilance for IV extravasation

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