is an actinomycin indicated for the treatment of: adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen.
The drug formulation includes dactinomycin
, a well-understood cancer drug, incorporated into a proprietary ANA-conjugated nanoemulsion.
Standard treatment according to the IRSG/STS COG trials in North America consists of a combination of vincristine, dactinomycin
and cyclophosphamide (VAC).
Chemical name Trademarker Class Source Actinomycin-D Dactinomycin
Non-alkaloid Streptomyces spp.
Bigmar intends to formulate and market a number of generic oncology drugs in IV bags, including, Fluorouracil, Doxorubicin, Methotrexate, Dacarbazine, Carboplatin, Aclarubicin, Ganciclovir, Azathioprine, Cyclophosphamide, Ifosfamide, Melphalan, Vincristinsulphate, Cisplatin, Amsakrine, Etoposide, Vinblastin and Dactinomycin
. In this regard, Bigmar plans to apply for ANDA approvals in the United States as well as various approvals from European regulatory authorities for the above-mentioned generic oncology drugs in IV bags during the first half of 2000.
There has been no acceptable antidote reported in the literature for a dactinomycin
infiltrate (Dorr, 1994).
The drug combination VAC (vincristine, dactinomycin
, and cyclophosphamide) has been widely studied and found to be effective against this disease.
The patient then was administered combined chemotherapy, including vincristine (2 mg/[m.sup.2], day 1), doxorubicin (75 mg/[m.sup.2], day 1), cyclophosphamide plus mesna (1200 mg/[m.sup.2], day 1), dactinomycin
(1.25 mg/[m.sup.2], day 1), ifosfamide plus mesna (1800 mg/[m.sup.2] daily, days 1-5) and etoposide (100 mg/[m.sup.2] daily, days 1-5).
* combination chemotherapy (adriamycin, vinblastine, bleomycin, dactinomycin
, vincristine, dacarbazine)
Other important products acquired in the acquisition are NeoProfen (ibuprofen lysine injection) and Indocin IV (indomethacin injection), which is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants, and Cosmegen (dactinomycin
for injection), used mainly in the treatment of three rare cancers.
Alternative drug, dactinomycin
(0.5 mg), is recommended to infuse into uterine artery of the literature .
Bedford Laboratories, a division of Ben Venue Laboratories Inc., has added dactinomycin
for injection USP 500 mcg (0.5 mg) to its line of generic oncology products.