Adult Dosing
Wilms' tumor, childhood rhabdomyosarcoma, and Ewing’s sarcoma
- 15 mcg/kg/day IV x 5 days, administered in various combinations and schedules with other chemotherapeutic agents
Metastatic nonseminomatous testicular cancer
- 1000 mcg/m2 IV on day 1 as part of a combination regimen with cyclophosphamide, bleomycin, vinblastine, and cisplatin
Gestational trophoblastic neoplasia
- 12 mcg/kg/day IV x 5 days as a single agent
- 500 mcg IV on days 1 and 2 as part of a combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide, and cisplatin
Regional perfusion in locally recurrent and locoregional solid malignancies
- 50 mcg/kg IV for lower extremity or pelvis
- 35 mcg/kg IV for upper extremity
- Use lower doses in obese patients, or when previous chemotherapy or radiation therapy has been employed
Note:
- Max: 15 mcg/kg/day IV per 2-wk cycle or 400-600 mcg/m2/day IV x 5 days
- Dose calculation 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
Pediatric Dosing
- Safety and efficacy in pediatric patients below 6-12 months of age have not been established
Wilms' tumor, childhood rhabdomyosarcoma, and Ewing’s sarcoma
- 15 mcg/kg/day IV x 5 days, administered in various combinations and schedules with other chemotherapeutic agents
Note:
- Max: 15 mcg/kg/day IV per 2-wk cycle or 400-600 mcg/m2/day IV x 5 days
- Dose calculation 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
[Outline]
- Increased incidence of second primary tumors including leukemia following treatment with radiation and dactinomycin
- Therapy may cause fetal harm when administered to a pregnant woman. Caution patients about the potential hazard to the fetus if used during pregnancy or if the patient becomes pregnant while on therapy
- Because dactinomycin is highly corrosive to soft tissue, it is intended for intravenous use
- Avoid inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes [US Black Box Warning]
- Care should be taken while handling dactinomycin. In case of accidental eye or skin contact, copious irrigation of the affected part for at least 15 minutes with water, normal saline or a balanced salt ophthalmic irrigating solution should be instituted immediately, followed by prompt medical consultation
- Fatalities related to veno-occlusive disease (primarily hepatic), particularly in children younger than 48 months may occur during therapy
- Increased incidence of severe oropharyngeal mucositis, gastrointestinal toxicity, marrow suppression, early erythema of the normal skin, as well as the buccal and pharyngeal mucosa may occur with combined therapy involving dactinomycin and radiation. Smaller radiation dose given in combination with dactinomycin causes erythema and vesiculation, which progress rapidly through the tanning and desquamation stages
- Reactivation of erythema from previous x-ray therapy may occur with dactinomycin alone, especially with brief intervals between the two forms of therapy
- Severe reactions may occur if high doses of both dactinomycin and radiation are used or if the patient is sensitive to such combined therapy
- Regional perfusion therapy with dactinomycin may cause certain complications such as hematopoietic depression, absorption of toxic products from massive destruction of neoplastic tissue, increased susceptibility to infection, impaired wound healing, superficial ulceration of the gastric mucosa, damage to soft tissues of the perfused area, and venous thrombosis
- Patients receiving therapy have reported abnormalities of renal, hepatic, and bone marrow function
- Carefully observe patients daily for toxic adverse effects, especially with combination chemotherapy such as stomatitis, diarrhea, or severe hematopoietic depression during therapy; if such reactions occur, discontinue treatment until the patient recovers
- Avoid concomitant administration of dactinomycin with radiotherapy in the treatment of Wilms’ tumor unless the benefit outweighs the risk
Cautions: Use cautiously in
- Hepatic impairment
- Renal impairment
- Elderly patients
- Recent radiation therapy
Pregnancy Category:D
Breastfeeding: Unsafe. According to the manufacturer's data, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
