s coincident with the use of BLENOXANE 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 BLENOXANE in combination with vinblastine with or without cisplatin or, in a few cases, with BLENOXANE as a single agent. It is currently unknown if the cause of Raynaud’s phenomenon in these cases is the disease, underlying vascular compromise, BLENOXANE, 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.
Malaise has been reported.
DOSAGE AND ADMINISTRATION
Because of the possibility of an anaphylactoid reaction, lymphoma patients should be treated with 2 units or less for the first 2 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 BLENOXANE 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 BLENOXANE 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 CrCL
(mL/min) BLENOXANE
Dose (%)
50 and above 100
40-50 70
30-40 60
20-30 55
10-20 45
5-10 40
CrCL can be estimated from the individual patient’s measured serum creatinine (Scr) values using the Cockcroft and Gault formula:
Males CrCL = [weight × (140 – Age)]/(72 × Scr)
Females CrCL = 0.85 × [weight × (140 – Age)]/(72 × Scr)
Where CrCL in mL/min/1.73m2, weight in kg, age in years, and Scr in mg/dL.
Administration
BLENOXANE may be given by the intramuscular, intravenous, subcutaneous, or intrapleural routes.
Administration Precautions
Caution should be exercised when handling BLENOXANE for injection. Procedures for proper handling and disposal |
