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:

Prasco Laboratories

INN (International Name):

DACTINOMYCIN

Composition:

DACTINOMYCIN 0.5 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dactinomycin is indicated for the treatment of adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. Dactinomycin is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. Dactinomycin is indicated for the treatment of adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. Dactinomycin 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 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 is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion. None. Risk Summary Based on findings from animal studies and its mechanism of action, Dactinomycin can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1)] . In animal reproduction studies, administration of dactinomycin to pregnant animals during the period of organogenesis was teratogenic, resulting in malformations at doses lower than the recommended human dose ( see Data ). Advise pregnant women of the potential risk to a fetus [see Use in Special Populations ( 8.3)] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Dactinomycin was teratogenic in animals. Administration of dactinomycin to pregnant rats, rabbits, and hamsters during the period of organogenesis, increased the incidence of fetal malformations and caused embryotoxicity at doses (based on body surface area) as low as 0.2 times the clinical dose of 1250 mcg/m 2 . Risk Summary There are no data on the presence of dactinomycin or its metabolites in human milk or their effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Dactinomycin, advise women not to breastfeed during treatment with Dactinomycin and, based on limited published data regarding the dactinomycin half-life, for 14 days after the final dose. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating Dactinomycin [see Use in Specific Population ( 8.1)]. Contraception Dactinomycin can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1)]. Females Advise females of reproductive potential to use effective contraception during treatment with Dactinomycin and for at least 6 months after the final dose. Males Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with Dactinomycin and for 3 months after the final dose [see Nonclinical Toxicology ( 13.1)]. The safety and effectiveness of dactinomycin have been established in pediatric patients with Wilms tumor, rhabdomyosarcoma, Ewing sarcoma, and metastatic nonseminomatous testicular cancer. The safety and effectiveness of dactinomycin have been established in post-menarchal pediatric patients with gestational trophoblastic neoplasia. The safety and effectiveness of Dactinomycin have not been established in pediatric patients undergoing regional perfusion for locally recurrent or locoregional solid malignancies. Clinical studies of Dactinomycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Product summary:

Dactinomycin (dactinomycin for injection) for intravenous use is supplied as a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial. Each Dactinomycin vial (NDC 66993-489-35) 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 from light and humidity. Store the reconstituted Dactinomycin at room temperature for no more than 4 hours from reconstitution to completion of administration [see Dosage and Administration ( 2.7)]. Dactinomycin is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DACTINOMYCIN- DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
PRASCO LABORATORIES
----------
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 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 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 Testicular Cancer: The reco