CL
(mL/min) Bleomycin for Injection, USP
Dose (%)
50 and above 100
40 to 50 70
30 to 40 60
20 to 30 55
10 to 20 45
5 to 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 x (140 – Age)]/(72 x Scr)
Females CrCL = 0.85 x [weight x (140 – Age)]/(72 x Scr)
Where CrCL in mL/min/1.73m2, weight in kg, age in years, and Scr in mg/dL.
Administration
Bleomycin for injection may be given by the intramuscular, intravenous, subcutaneous, or intrapleural routes.
Administration Precautions
Caution should be exercised when handling Bleomycin for injection. Procedures for proper handling and disposal of anticancer drugs should be utilized. Several guidelines on this subject have been published.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing Bleomycin for injection. If Bleomycin for injection contacts the skin, immediately wash the skin thoroughly with soap and water. If contact with mucous membranes occurs, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.
Intramuscular or Subcutaneous
The Bleomycin for injection USP 15 units vial should be reconstituted and dissolved with 1 to 5 mL of sterile water for injection, USP, sodium chloride injection, 0.9%, USP, or bacteriostatic water for injection, USP. The Bleomycin for injection USP 30 units vial should be reconstituted and dissolved with 2 to 10 mL of the above diluents.
Intravenous
The contents of the 15 units or 30 units vial should be dissolved in 5 mL or 10 mL, respectively, of Sodium Chloride for Injection, 0.9%, USP, and administered slowly over a period of 10 minutes.
Intrapleural
60 units of Bleomycin are dissolved in 50 to 100 mL Sodium Chloride for Injection, 0.9%, USP and administered through a thoracostomy tube following drainage of excess pleural fluid and confirmation of complete lung expansion. The literature suggests that successful pleurodesis is, in part, dependent upon complete drainage of the pleural fluid and reestablishment of negative intrapleural pressure prior to instillation of a sclerosing agent. Therefore, the amount of drainage from the chest tube should be as minimal as possible prior to instillation of Bleomycin. Although there is no conclusive evidence to support this contention, it is generally accepted that chest tube drainage should be less than 100 mL in a 24-hour period prior to sclerosis. However, Bleomycin instillation may be appropriate when drainage is between 100 to 300 mL under clinical conditions that necessitate sclerosis therapy. The thoracostomy tube is clamped after Bleomycin instillation. The patient is moved from the supine to the left and right lateral positions several times during the next four hours. The clamp is then removed and suction reestablished. The amount of time the chest tube remains in place following sclerosis is dictated by the clinical situation.
The intrapleural injection of topical anesthetics or systemic narcotic analgesia is generally not required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
How is Bleomycin Supplied
Bleomycin for Injection USP contains sterile Bleomycin sulfate equivalent to 15 units or 30 units of Bl |
