DACTINOMYCIN injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DACTINOMYCIN (UNII: 1CC1JFE158) (DACTINOMYCIN - UNII:1CC1JFE158)

Available from:

AuroMedics Pharma LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. Dactinomycin for injection is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. Dactinomycin for injection is indicated for the treatment of adult patients with locally recurrent or locoregional s

Product summary:

Dactinomycin for injection, USP is a lyophilized powder. In the dry form the compound is an amorphous yellow to orange powder. The solution is clear, gold or yellow to orange colored and essentially free from visible particles. Dactinomycin for injection, USP is supplied in vials containing 0.5 mg (500 micrograms) of dactinomycin USP and 20.0 mg of mannitol. NDC 55150-928-02: 0.5 mg/vial in 2 mL single-dose vial; individually boxed Storage: Store at 20º to 25ºC (68º to 77ºF); [see USP Controlled Room Temperature]. Protect from light and humidity. Special Handling: Animal studies have shown dactinomycin to be corrosive to skin, irritating to the eyes and mucous membranes of the respiratory tract and highly toxic by the oral route. It has also been shown to be carcinogenic, mutagenic, embryotoxic and teratogenic. Due to the drug’s toxic properties, appropriate precautions including the use of appropriate safety equipment are recommended for the preparation of dactinomycin for injection for parenteral administration. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Avoid exposure during pregnancy. The National Institutes of Health presently recommends that the preparation of injectable antineoplastic drugs should be performed in a Class II laminar flow biological safety cabinet. Personnel preparing drugs of this class should wear chemical resistant, impervious gloves, safety goggles, outer garments and shoe covers. Additional body garments should be used based upon the task being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces and inhalation of vapors and dust. Appropriate techniques should be used to remove potentially contaminated clothing. Several other guidelines for proper handling and disposal of antineoplastic drugs have been published and should be considered.1-4 Accidental Contact Measures: Should accidental eye contact occur, copious irrigation for at least 15 minutes with water, normal saline or a balanced salt ophthalmic irrigating solution should be instituted immediately, followed by prompt ophthalmologic consultation. Should accidental skin contact occur, the affected part must be irrigated immediately with copious amounts of water for at least 15 minutes while removing contaminated clothing and shoes. Medical attention should be sought immediately. Contaminated clothing should be destroyed and shoes cleaned thoroughly before reuse (see PRECAUTIONS, General and DOSAGE AND ADMINISTRATION, Preparation of Solution for Intravenous Administration). The vial stopper is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DACTINOMYCIN - DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
AUROMEDICS PHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DACTINOMYCIN FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DACTINOMYCIN FOR
INJECTION.
DACTINOMYCIN FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1964
INDICATIONS AND USAGE
Dactinomycin for injection is an actinomycin indicated for the
treatment of:
adult and pediatric patients with Wilms tumor, as part of a
multi-phase, combination chemotherapy
regimen. (1.1)
adult and pediatric patients with rhabdomyosarcoma, as part of a
multiphase, combination
chemotherapy regimen. (1.2)
adult and pediatric patients with Ewing sarcoma, as part of a
multi-phase, combination chemotherapy
regimen. (1.3)
adult and pediatric patients with metastatic, nonseminomatous
testicular cancer, as part of a multi-
phase, combination chemotherapy regimen. (1.4)
post-menarchal patients with gestational trophoblastic neoplasia, as a
single agent or as part of a
combination chemotherapy regimen. (1.5)
adult patients with locally recurrent or locoregional solid
malignancies, as a component of palliative or
adjunctive regional perfusion. (1.6)
DOSAGE AND ADMINISTRATION
Wilms Tumor: The recommended dose is 45 mcg/kg intravenously once
every 3 to 6 weeks for up to 26
weeks, as part of a multi-agent combination chemotherapy regimen.
(2.1)
Rhabdomyosarcoma: The recommended dose is 15 mcg/kg intravenously once
daily for 5 days every 3
to 9 weeks for up to 112 weeks, as part of a multiagent combination
chemotherapy regimen. (2.2)
Ewing Sarcoma: The recommended dose is 1250 mcg/m intravenously once
every 3 weeks for 51
weeks, as part of a multi-agent combination chemotherapy regimen.
(2.3)
Metastatic Nonseminomatous Testicular Cancer: The recommended dose is
1000 mcg/m
intravenously every 3 weeks, as part of cisplatin-based, multi-drug
chemotherapy regimen. (2.4)
Gestational Trophoblastic Neoplasia:
O Non-m