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COSMEGEN® 500 MCG

Description

Powder for solution for injection

Cosmegen is brand innovator for Actinomycin D  (known as Dactinomycin) FDA approved

A polypeptide antibiotic isolated from the Streptomyces parvullus bacterium.

Indicatedion

  • Wilms’ tumour
  • Childhood rhabdomyosarcoma
  • Ewing’s sarcoma
  • Metastatic non-seminomatous testicular cancer
  • Gestational trophoblastic neoplasia
  • locoregionally metastatic melanoma.

Dosage and route of administration

The dosage of ‘Cosmegen’ is calculated in micrograms. The dose intensity per-two-week cycle for adults or children should not exceed 15 micrograms per kg per day or 400-600 micrograms per square meter of body surface daily, intravenously, for five days.

Calculation of the dosage for obese or oedematous patients should be on the basis of surface area in an effort to relate dosage to lean body mass.

As there is a greater frequency of toxic effects of ‘Cosmegen’ in infants, ‘Cosmegen’ should only be given to infants under the age of 12 months, when the benefit outweighs the risk.

The following suggested regimens are based upon a review of current literature concerning therapy with ‘Cosmegen’ and are on a per-cycle basis.

Wilms’s Tumor

Regimens of 45 micrograms per kg intravenously administered in various combinations and schedules with other chemotherapeutic agents.

 

Rhabdomyosarcoma

Regimens of 15 micrograms per kg intravenously daily for five days administered in various combinations and schedules with other chemotherapeutic agents.

 

Ewing’s Sarcoma

Regimens of 1.25 milligrams per m2 intravenously administered in various combinations and schedules with other chemotherapeutic agents.

 

Testicular carcinoma

1,000 micrograms per m2 intravenously on Day 1 as part of a combination regimen with cyclophosphamide, bleomycin, vinblastine, and cisplatin.

 

Gestational trophoblastic neoplasia

12 micrograms per kg intravenously daily for five days as a single agent.

500 micrograms intravenously on Days 1 and 2 as part of a combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide and cisplatin.

 

Regional perfusion in locally recurrent and locoregionally metastatic melanoma

The dosage schedules and the technique itself vary from one investigator to another, and the published literature should, therefore, be consulted for details. In general the following doses are suggested:

For a lower extremity or pelvis – 50 micrograms per kg bodyweight.

For an upper extremity – 35 micrograms per kg bodyweight.

It may be advisable to use lower doses in obese patients, or when previous chemotherapy or radiation therapy has been employed.

Elderly patients: The general considerations already outlined also apply to elderly patients. Administration of ‘Cosmegen’ to elderly patients may be associated with an increased risk of myelosuppression compared to younger patients