ures 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 BLENOXANE for injection. If BLENOXANE 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 BLENOXANE 15 units vial should be reconstituted with 1 to 5 mL of Sterile Water for Injection, USP, Sodium Chloride for Injection, 0.9%, USP, or Sterile Bacteriostatic Water for Injection, USP. The BLENOXANE 30 units vial should be reconstituted 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
Sixty units of BLENOXANE 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 BLENOXANE. 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, BLENOXANE 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 BLENOXANE 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 SUPPLIED
BLENOXANE® (bleomycin sulfate for injection, USP) is available as follows:
NDC 0015-3010-20, 15 units per vial as bleomycin sulfate for injection, USP.
NDC 0015-3063-01, 30 units per vial as bleomycin sulfate for injection, USP.
Stability
The sterile powder is stable under refrigeration 2°C (36°F) to 8°C (46°F) and should not be used after the expiration date is reached.
BLENOXANE should not be reconstituted or diluted with D5W or other dextrose containing diluents. When reconstituted in D5W and analyzed by HPLC, BLENOXANE demonstrates a loss of A2 and B2 potency that does not occur when BLENOXANE is reconstituted in Sodium Chloride for Injection, 0.9%, USP.
BLENOXANE is stable for 24 hours at room temperature in Sodium Chloride.
REFERENCES
|
