ial. Patients were required to have cytologically positive pleural effusion, good performance status (0,1,2), lung re-expansion following tube thoracostomy with drainage rates of 100 mL/24 hours or less, no prior intrapleural therapy, no prior systemic Bleomycin therapy, no chest irradiation and no recent change in systemic therapy. Overall survival did not differ between the Bleomycin (n = 44) and tetracycline treatment (n = 41) groups. Of patients eva luated within 30 days of instillation, the recurrence rate was 36% (10/28) with Bleomycin and 67% (18/27) with tetracycline (p = 0.023). Toxicity was similar between groups.
Indications and Usage for Bleomycin
Bleomycin for Injection USP 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.
Bleomycin for injection has also been shown to be useful in the management of:
Malignant Pleural Effusion
Bleomycin for injection is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.
Contraindications
Bleomycin is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to it.
Warnings
Patients receiving Bleomycin must be observed carefully and frequently during and after therapy. It should be used with extreme caution in patients with significant impairment of renal function or compromised pulmonary function.
Pulmonary toxicities occur in 10% of treated patients. In approximately 1%, the nonspecific pneumonitis induced by Bleomycin progresses to pulmonary fibrosis and death. Although this is age and dose related, the toxicity is unpredictable. Frequent roentgenograms are recommended (see ADVERSE REACTIONS, Pulmonary).
A severe idiosyncratic reaction (similar to anaphylaxis) consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported in approximately 1% of lymphoma patients treated with Bleomycin. Since these reactions usually occur after the first or second dose, careful monitoring is essential after these doses (see ADVERSE REACTIONS, Idiosyncratic Reactions).
Renal or hepatic toxicity, beginning as a deterioration in renal or liver function tests, have been reported. These toxicities may occur at any time after initiation of therapy.
Usage in Pregnancy
Pregnancy Category D
Bleomycin can cause fetal harm when administered to a pregnant woman. It has been shown to be teratogenic in rats. Administration of intraperitoneal doses of 1.5 mg/kg/day to rats (about 1.6 times the recommended human dose on a unit/m2 basis) on days 6 to 15 of gestation caused skeletal malformations, shortened innominate artery and hydroureter. Bleomycin is abortifacient but not teratogenic in rabbits at intravenous doses of 1.2 mg/kg/day (about 2.4 times the recommended human dose on a unit/m2 basis) given on gestation days 6 to 18.
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