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Cosmegen (Dactinomycin) - Summary

 

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WARNING

COSMEGEN Registered trademark of MERCK & CO., Inc. COPYRIGHT © 1983, 2000 MERCK & CO., Inc. All rights reserved (Dactinomycin for Injection) should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.

This drug is HIGHLY TOXIC and both powder and solution must be handled and administered with care. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Avoid exposure during pregnancy. Due to the toxic properties of dactinomycin (e.g., corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently. Dactinomycin is extremely corrosive to soft tissue. If extravasation occurs during intravenous use, severe damage to soft tissues will occur. In at least one instance, this has led to contracture of the arms.

 

COSMEGEN SUMMARY

COSMEGEN ®
FOR INJECTION
(DACTINOMYCIN FOR INJECTION)
(Actinomycin D)

Dactinomycin is one of the actinomycins, a group of antibiotics produced by various species of Streptomyces. Dactinomycin is the principal component of the mixture of actinomycins produced by Streptomyces parvullus. Unlike other species of Streptomyces, this organism yields an essentially pure substance that contains only traces of similar compounds differing in the amino acid content of the peptide side chains.

COSMEGEN, as part of a combination chemotherapy and/or multi-modality treatment regimen, is indicated for the treatment of Wilms' tumor, childhood rhabdomyosarcoma, Ewing's sarcoma and metastatic, nonseminomatous testicular cancer.

COSMEGEN is indicated as a single agent, or as part of a combination chemotherapy regimen, for the treatment of gestational trophoblastic neoplasia.

COSMEGEN, as a component of regional perfusion, is indicated for the palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies.

COSMEGEN NEWS HIGHLIGHTS

Published Studies Related to Cosmegen (Dactinomycin)

Comparison of pulse methotrexate and pulse dactinomycin in the treatment of low-risk gestational trophoblastic neoplasia. [2005.04]

Randomized controlled trial of doxorubicin versus dactinomycin in a multiagent protocol for treatment of dogs with malignant lymphoma. [1998.10.01]

Comparison between single-dose and divided-dose administration of dactinomycin and doxorubicin for patients with Wilms' tumor: a report from the National Wilms' Tumor Study Group. [1998.01]

A randomized clinical trial of single-dose versus fractionated-dose dactinomycin in the treatment of Wilms' tumor. Results after extended follow-up. Brazilian Wilms' Tumor Study Group. [1994.06.15]

Single-dose versus fractionated-dose dactinomycin in the treatment of Wilms' tumor. Preliminary results of a clinical trial. The Brazilian Wilms' Tumor Study Group. [1991.06.15]

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Clinical Trials Related to Cosmegen (Dactinomycin)

Evaluating Dactinomycin and Vincristine in Young Patients With Cancer [Recruiting]

A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer [Recruiting]

Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia [Active, not recruiting]

Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia [Completed]

Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma [Recruiting]

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Page last updated: 2006-01-31

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