Dactinomycin


Full Generic Medicine Info
Dosage/Direction for Use

Intravenous
Childhood rhabdomyosarcoma
Adult: 15 mcg/kg daily for 5 days, in combination regimens. Max: 15 mcg/kg or 400-600 mcg/m2 daily for 5 days per 2-wk cycle.
Child: ≥6 mth Same as adult dose.
Reconstitution: Add 1.1 mL of sterile water for inj (w/o preservative), using aseptic precautions to make a soln containing approx 500 mcg/mL. The reconstituted soln can be added to infusion soln of dextrose 5% inj or NaCl inj either directly or to the tubing of a running IV infusion.
Incompatibility: Filgrastim.

Intravenous
Ewing's sarcoma
Adult: 15 mcg/kg daily for 5 days, in combination regimens. Max: 15 mcg/kg or 400-600 mcg/m2 daily for 5 days per 2-wk cycle.
Child: ≥6 mth Same as adult dose.
Reconstitution: Add 1.1 mL of sterile water for inj (w/o preservative), using aseptic precautions to make a soln containing approx 500 mcg/mL. The reconstituted soln can be added to infusion soln of dextrose 5% inj or NaCl inj either directly or to the tubing of a running IV infusion.
Incompatibility: Filgrastim.

Intravenous
Wilm's tumour
Adult: 15 mcg/kg daily for 5 days, in combination regimens. Max: 15 mcg/kg or 400-600 mcg/m2 daily for 5 days per 2-wk cycle.
Child: ≥6 mth Same as adult dose.
Reconstitution: Add 1.1 mL of sterile water for inj (w/o preservative), using aseptic precautions to make a soln containing approx 500 mcg/mL. The reconstituted soln can be added to infusion soln of dextrose 5% inj or NaCl inj either directly or to the tubing of a running IV infusion.
Incompatibility: Filgrastim.

Intravenous
Gestational trophoblastic tumours
Adult: 12 mcg/kg daily for 5 days as a single agent or 500 mcg daily on days 1 and 2 of combination regimens. Max: 15 mcg/kg or 400-600 mcg/m2 daily for 5 days per 2-wk cycle.
Reconstitution: Add 1.1 mL of sterile water for inj (w/o preservative), using aseptic precautions to make a soln containing approx 500 mcg/mL. The reconstituted soln can be added to infusion soln of dextrose 5% inj or NaCl inj either directly or to the tubing of a running IV infusion.
Incompatibility: Filgrastim.

Intravenous
Metastatic nonseminomatous testicular cancer
Adult: 1 mg/m2 on day 1 of combination regimens. Max: 15 mcg/kg or 400-600 mcg/m2 daily for 5 days per 2-wk cycle.
Reconstitution: Add 1.1 mL of sterile water for inj (w/o preservative), using aseptic precautions to make a soln containing approx 500 mcg/mL. The reconstituted soln can be added to infusion soln of dextrose 5% inj or NaCl inj either directly or to the tubing of a running IV infusion.
Incompatibility: Filgrastim.
Contraindications
Hypersensitivity. Patient w/ varicella or herpes zoster infection.
Special Precautions
Patient w/ impaired bone marrow. Renal and hepatic impairment. Pregnancy and lactation. Patient Counselling Avoid inhalation of vapours or contact w/ skin, mucous membrane or eyes. Monitoring Parameters Monitor blood counts, renal, hepatic and bone marrow functions frequently.
Adverse Reactions
Nausea, vomiting, cheilitis, oesophagitis, GI ulceration, proctitis, fever, malaise, hypocalcaemia, myalgia, alopecia, pneumonitis, kidney and liver abnormalities, eruptions, acne, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, severe tissue damage, oedema, neutropenia and febrile neutropenia.
Potentially Fatal: Hepatic failure, hepatic veno-occlusive disease, particularly in childn <4 yr, myelosuppression, sepsis, including neutropenic sepsis.
Overdosage
Symptoms: Nausea, vomiting, diarrhoea, mucositis including stomatitis, GI ulceration, severe skin disorders including skin exfoliation, exanthema, desquamation and epidermolysis, severe haemopoietic depression, veno-occlusive disease, acute renal failure, sepsis (including neutropenic sepsis). Management: Symptomatic and supportive treatment.
Drug Interactions
Combination w/ radiation therapy may result in increased toxicity esp when w/in 2 mth of radiation treatment for right-sided Wilm's tumour. May diminish the therapeutic effect of live vaccines.
Lab Interference
May interfere w/ bioassay procedures for the determination of antibacterial drug levels.
Action
Dactinomycin binds to the guanine portion of DNA forming a complex which interferes w/ DNA and RNA synthesis as well as protein synthesis. It is also immunosuppressive and possesses some hypocalcaemic activity.
Absorption: Poorly absorbed from the GI tract.
Distribution: Rapidly distributed w/ high concentrations in bone marrow and nucleated cells. Crosses the placenta.
Metabolism: Minimal metabolism.
Excretion: Via urine and bile. Terminal plasma half-life: Approx 36 hr.
Storage
Intravenous: Store between 20-25°C. Protect from light and humidity.
CIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DA01 - dactinomycin ; Belongs to the class of cytotoxic antibiotics, actinomycines. Used in the treatment of cancer.
Disclaimer: This information is independently developed by CIMS based on dactinomycin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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