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:

Hisun Pharmaceuticals USA, Inc.

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 for intravenous use is supplied as a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial. Each Dactinomycin for Injection USP vial (NDC 42658-008-01) contains 0.5 mg of dactinomycin and 20 mg of mannitol. Store at 20 to 25ºC (68 to 77ºF); excursions permitted between 15 to 30ºC (59 to 86ºF) [see USP Controlled Room Temperature]. Protect Dactinomycin for Injection USP from light and humidity. Store the reconstituted Dactinomycin for Injection USP at room temperature for no more than 4 hours from reconstitution to completion of administration [see Dosage and Administration ( 2.7)] . Dactinomycin for Injection USP is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DACTINOMYCIN- DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
HISUN PHARMACEUTICALS USA, INC.
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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
RECENT MAJOR CHANGES
Dosage and Administration, Recommended Dosage for Wilms Tumor ( 2.1)
8/2018
Dosage and Administration, Recommended Dosage for Ewing Sarcoma ( 2.3)
8/2018
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
multi-phase, 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 multi-agent 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 T