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Bleomycin for Injection, USP:
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15 units per single-dose vial (SDV)
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30 units per single-dose vial (SDV)
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INDICATIONS AND USAGE
Bleomycin for Injection 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 bleomycin 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.
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WARNING
It is recommended that Bleomycin for Injection 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 Bleomycin for Injection.
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
Bleomycin for Injection.
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Please refer to full prescribing information.
Important Safety Information
Common side effects include erythema, rash, striae, hyperpigmentation and vesiculation of the skin. Fever, chills, vomiting, anorexia and weight loss are also frequent. In approximately 1% of the lymphoma patients treated with Bleomycin for Injection, an idiosyncratic reaction, similar to anaphylaxis clinically, has been reported. The reaction may be immediate or delayed for several hours, and usually occurs after the first or second dose. It consists of hypotension, mental confusion, fever, chills and wheezing. Treatment is symptomatic including volume expansion, pressor agents, antihistamines, and corticosteroids.
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