Trade Names:Cosmegen- Lyophilized powder for reconstitution 500 mcg vial with 20 mg of mannitol
Dactinomycin is the principal component of the mixture of actinomycins produced by Streptomyces parvulus . It inhibits messenger RNA synthesis.
Concentrated in nucleated cells. Does not penetrate blood-brain barrier.
Approximately 30% recovered in urine and feces in 1 wk; t ½ approximately 36 h.
Treatment of Wilms tumor, childhood rhabdomyosarcoma, Ewing sarcoma, and metastatic nonseminomatous testicular cancer as part of combination chemotherapy and/or multi-modality treatment regimen; palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies as a component of regional perfusion; treatment of gestational trophoblastic neoplasia as a single agent or as part of a combination chemotherapy regimen.
If given at or about the time of infection with chickenpox or herpes zoster, a severe generalized disease may occur, which could result in death.
IV The dosage varies depending on the tolerance of the patient, the size and location of the neoplasm, and the use of other forms of therapy. The dose intensity per 2-wk cycle for adults and children should not exceed 15 mcg/kg/day or 400 to 600 mcg/m 2 /day for 5 days. Calculate the dosage for obese or edematous patients on the basis of surface area to more closely relate dosage to lean body mass.
Store powder for injection at room temperature (59° to 86°F). Protect from light and humidity. Dactinomycin is stable after reconstitution but does not contain a preservative. Use reconstituted solution as soon as possible. Discard any unused solution. Do not save any unused solution for future use.
No specific drug interactions reported.
Bioassay procedures for the determination of antibacterial drug levels.
Fatigue; lethargy; malaise.
Acne; alopecia; edema; epidermolysis; erythema; extravasation; flare-up of erythema; skin eruptions; increased pigmentation of previously irradiated skin.
Abdominal pain; anorexia; cheilitis; diarrhea; dysphagia; esophagitis; GI ulceration; nausea; ulcerative stomatitis; vomiting.
Hepatomegaly; hepatic veno-occlusive disease; hepatitis; abnormal LFTs; liver toxicity including ascites.
Agranulocytosis; anemia; aplastic anemia; leukopenia; pancytopenia; reticulocytopenia; thrombocytopenia.
Dactinomycin is extremely corrosive to soft tissue. If extravasation occurs during IV use, severe damage to soft tissues will occur. In at least one instance, this has led to contracture of the arms. Avoid use in pregnancy. Dactinomycin is also carcinogenic, mutagenic, and teratogenic.
Ensure liver function (ie, transaminases, bilirubin) and renal function (ie, Scr, BUN) are evaluated before starting therapy and frequently thereafter during treatment. Notify health care provider if abnormalities develop. Ensure CBC with differential and platelet count are evaluated daily. Monitor patient for signs or symptoms of infection or bleeding. Monitor patient closely for toxic adverse reactions of therapy, especially when multiple chemotherapy is being used. Monitor IV injection site for signs or symptoms of extravasation.
Category D .
Toxicity is increased in infants. Avoid use in infants younger than 6 to 12 mo of age.
Use with caution because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.
Do not give at or about the time of infection with chickenpox or herpes zoster; severe generalized disease may occur.
With combined dactinomycin-radiation therapy, the normal skin, as well as the buccal and pharyngeal mucosa, may show early erythema. A smaller than usual x-ray dose, when given with dactinomycin, causes erythema and vesiculation, which progress more rapidly through the tanning and desquamation stages. Erythema from previous x-ray therapy may be reactivated by dactinomycin alone, even when irradiation occurred many months earlier, and especially when the interval between the 2 forms of therapy is brief. When the nasopharynx is irradiated, the combination may produce severe oropharyngeal mucositis. Severe reactions may appear if high doses are used or if the patient is particularly sensitive to such combined therapy.
Note that toxic effects (with exception of nausea and vomiting) usually do not become apparent until 2 to 4 days after a course of therapy is stopped, and may not peak until 1 to 2 wk have elapsed.
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