BiCNU Caution For Usage

Administration Precautions: As with other potentially toxic compounds, caution should be exercised in handling BiCNU and preparing the solution of BiCNU. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. Accidental contact of reconstituted BiCNU with the skin has caused transient hyperpigmentation of the affected areas. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing BiCNU. If BiCNU lyophilized material or solution contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.
Reconstituted solution should only be administered by slow intravenous infusion. Administration of BiCNU over a period of less than 2 hours can lead to pain and burning at the site of injection.
Preparation of Intravenous Solutions: First, dissolve BiCNU with 3 mL of the supplied sterile diluent (Dehydrated Alcohol Injection, USP). Second, aseptically add 27 mL Sterile Water for Injection, USP. Each mL of resulting solution contains 3.3 mg of BiCNU in 10% ethanol. Such solutions should be protected from light.
Reconstitution as recommended results in a clear, colorless to yellowish solution which may be further diluted with 5% Dextrose Injection, USP. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Important Note: The lyophilized dosage formulation contains no preservatives and is not intended for use as a multiple dose vial.