Strength: 0.5mg

Pack Size: 1 vial

Drug Class: Cytotoxic agents

Dosage and Administration:

The dosage of Dactinomycin for Injection varies depending on the tolerance of the patient
the size and location of the neoplasm, and the use of other forms of therapy. It may be
necessary to decrease the usual dosages suggested below when additional chemotherapy or radiation therapy is used concomitantly or has been used previously The dosage for Dactinomycin is calculated in micrograms (mcg).
The dose intensity per 2-week cycle for adults or children should not exceed 15 mcg/kg/day or 400-600 McGinty intravenously for five days. Calculation of the dosage for obese or edematous patients
should be performed on the basis of surface area in an effort to more closely relate dosage to
lean body mass A wide variety of single-agent and combination chemotherapy regimens with Dactinomycin
may be employed Because chemotherapeutic regimens are constantly changing dosing
and administration should be performed under the direct supervision of physicians familiar
with current oncologic practices and new advances in therapy. The following suggested
regimens are based upon a review of current literature concerning therapy with Dactinomycin and are on a per-cycle basis

Cold Storage: no

Dactinomycin is one of the actionmycins, a group of antibiotics produced by various species

of Streptomyces. Dactinomycin is the principal component of the mixture of actinomycins produced Streptomyces parvullus.

The empirical formula is CHNO and the structural formula is:

Dactinomycin for Injection 0.5 mg is a yellow to orange colored lyophilized cake or discontinuous powder, aggregates of free flowing powder in 3ml vials.

Dactinomycin for Injection, as part of a combination chemotherapy and/or multi-modality treatment regimen, is indicated for the treatment of Wilms’ tumor, childhood

rhabdomyosarcoma, Ewing’s sarcoma and metastatic, nonseminomatbus testicular cancer. Dactinomycin is indicated as a single agent, or as part of a combination

chemotherapy regimen, for the treatment of gestational trophoblastic neoplasia.

Dactinomycin, as a component of regional perfusion, is indicated for the palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies.

Mechanism Of Action

COSMEGEN 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.


Dactinomycin exposure-response relationships and the time course of pharmacodynamics response are unknown.


Veno-occlusive disease (primarily hepatic) may result in a fatality, particularly in children younger than 48 months.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Dactinomycin has been shown to be mutagenic in a number of test systems in vitro and in vivo including human fibroblasts and leukocytes, and HeLa cells. DNA damage and cytogenetic effects have been demonstrated in the mouse and the rat. Adequate fertility studies have not been reported, although, reports suggest an increased incidence of infertility following treatment with other antineoplastic agents,

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing

infants from Dactinomycin, a decision should be made to discontinuation of nursing and/ or the drug, taking into account the importance of the drug to the mother. The greater frequency of toxic effects of Dactinomycin in infants suggests that this drug’s Pediatric Use should be administered to infants only over the age of 6 to 12 months. 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. Other reported clinical experience has not identified differences in responses between the elderly

Check with your doctor right away if you have diarrhea, nausea or vomiting, or sores or white patches on your lips, mouth, or throat while receiving this medicine. If dactinomycin accidentally seeps out of the vein into which it is injected, it may severely damage some tissues and cause scarring.