ent 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.
CONTRAINDICATIONS
BLENOXANE is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to it.
WARNINGS
Patients receiving BLENOXANE 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 BLENOXANE 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 BLENOXANE. 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
BLENOXANE 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. BLENOXANE 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.
There have been no studies in pregnant women. If BLENOXANE is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with BLENOXANE.
PRECAUTIONS
General
Patients with creatinine clearance values of less than 50 mL/min should be treated with caution and their renal function should be carefully monitored during the administration of bleomycin. Lower doses of BLENOXANE may be required in these patients than those with normal renal function (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of BLENOXANE in humans is unknown. A study in F344-type male rats demonstrated an increased incidenc |
