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Blenoxane (Bleomycin Sulfate) - Summary

 

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WARNING

It is recommended that BLENOXANE be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

Pulmonary fibrosis is the most severe toxicity associated with BLENOXANE. The most frequent presentation is pneumonitis occasionally progressing to pulmonary fibrosis. Its occurrence is higher in elderly patients and in those receiving greater than 400 units total dose, but pulmonary toxicity has been observed in young patients and those treated with low doses.

A severe idiosyncratic reaction consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported in approximately 1% of lymphoma patients treated with BLENOXANE.

 

BLENOXANE SUMMARY

BLENOXANE®
(bleomycin sulfate for injection, USP)

BLENOXANE® (bleomycin sulfate for injection, USP) is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus. It is freely soluble in water. Note: A unit of bleomycin is equal to the formerly used milligram activity. The term milligram activity is a misnomer and was changed to units to be more precise.

BLENOXANE (bleomycin) is indicated for the following:

BLENOXANE should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents:

Squamous Cell Carcinoma

Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to BLENOXANE is poorer in patients with previously irradiated head and neck cancer.

Lymphomas

Hodgkin’s Disease, non-Hodgkin’s lymphoma.

Testicular Carcinoma

Embryonal cell, choriocarcinoma, and teratocarcinoma.

BLENOXANE has also been shown to be useful in the management of:

Malignant Pleural Effusion

BLENOXANE is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.

BLENOXANE NEWS HIGHLIGHTS

Published Studies Related to Blenoxane (Bleomycin)

Randomized trial comparing bleomycin/etoposide/cisplatin with alternating cisplatin/cyclophosphamide/doxorubicin and vinblastine/bleomycin regimens of chemotherapy for patients with intermediate- and poor-risk metastatic nonseminomatous germ cell tumors: Genito-Urinary Group of the French Federation of Cancer Centers Trial T93MP. [2008.01.20]

Two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine plus extended-field radiotherapy is superior to radiotherapy alone in early favorable Hodgkin's lymphoma: final results of the GHSG HD7 trial. [2007.08.10]

Patterns of failure in patients with locally advanced head and neck cancer treated postoperatively with irradiation or concomitant irradiation with Mitomycin C and Bleomycin. [2007.03.01]

Bleomycin tattooing as a promising therapeutic modality in large keloids and hypertrophic scars. [2006.08]

Randomized trial of dacarbazine versus bleomycin, vincristine, lomustine and dacarbazine (BOLD) chemotherapy combined with natural or recombinant interferon-alpha in patients with advanced melanoma. [2005.08]

more>>

Clinical Trials Related to Blenoxane (Bleomycin)

Medpulser Electroporation With Bleomycin Study to Treat Posterior Head and Neck Squamous Cell Carcinoma [Suspended]

Study Using the Medpulser Electroporation System With Bleomycin to Treat Head and Neck Cancer [Active, not recruiting]

Medpulser Electroporation With Bleomycin Study to Treat Anterior Head and Neck Squamous Cell Carcinoma [Suspended]

Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS [Completed]

Bleomycin, Doxycycline, or Talc in Treating Patients With Malignant Pleural Effusions [Active, not recruiting]

more>>

Page last updated: 2008-03-26

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