esiculation, hyperpigmentation, and tenderness of the skin. Hyperkeratosis, nail changes, alopecia, pruritus, and stomatitis have also been reported. It was necessary to discontinue Bleomycin therapy in 2% of treated patients because of these toxicities.
Scleroderma-like skin changes have been reported.
Skin toxicity is a relatively late manifestation usually developing in the second and third week of treatment after 150 to 200 units of Bleomycin have been administered and appears to be related to the cumulative dose.
Intrapleural administration of Bleomycin has been associated with local pain. Hypotension possibly requiring symptomatic treatment has been reported. Death has been reported in association with Bleomycin pleurodesis in seriously ill patients.
Other
Vascular toxicities coincident with the use of Bleomycin in combination with other antineoplastic agents have been reported. The events are clinically heterogeneous and may include myocardial infarction, cerebrovascular accident, thrombotic microangiopathy (HUS) or cerebral arteritis. Various mechanisms have been proposed for these vascular complications. There are also reports of Raynaud's phenomenon occurring in patients treated with Bleomycin in combination with vinblastine with or without cisplatin or, in a few cases, with Bleomycin as a single agent. It is currently unknown if the cause of Raynaud's phenomenon in these cases is the disease, underlying vascular compromise, Bleomycin, vinblastine, hypomagnesemia, or a combination of any of these factors.
Fever, chills, and vomiting have been reported. Anorexia and weight loss have been reported and may persist long after termination of this medication. Pain at tumor site, phlebitis, and other local reactions have been reported.
Bleomycin Dosage and Administration
BECAUSE OF THE POSSIBILITY OF AN ANAPHYLACTOID REACTION, LYMPHOMA PATIENTS SHOULD BE TREATED WITH 2 UNITS OR LESS FOR THE FIRST TWO DOSES. IF NO ACUTE REACTION OCCURS, THEN THE REGULAR DOSAGE SCHEDULE MAY BE FOLLOWED.
The following dose schedule is recommended:
Squamous cell carcinoma, non-Hodgkin's lymphoma, testicular carcinoma- 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
Hodgkin's Disease - 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly. After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given.
Pulmonary toxicity of Bleomycin appears to be dose related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution.
Note: When Bleomycin is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.
Improvement of Hodgkin's Disease and testicular tumors is prompt and noted within 2 weeks. If no improvement is seen by this time, improvement is unlikely. Squamous cell cancers respond more slowly, sometimes requiring as long as 3 weeks before any improvement is noted.
Malignant Pleural Effusion - 60 units administered as a single dose bolus intrapleural injection (see Administration, Intrapleural).
Use in Patients with Renal Insufficiency
The following dosing reductions are proposed for patients with creatinine clearance (CrCL) values of less than 50 mL/min:
Patient Cr |
