Special precautions for disposal and other handling: General precautions: Bortezomib is a cytotoxic agent. Therefore, caution should be used during handling and preparation of bortezomib. Use of gloves and other protective clothing to prevent skin contact is recommended.
Aseptic technique must be strictly observed throughout the handling of bortezomib, since it contains no preservative.
There have been fatal cases of inadvertent intrathecal administration of bortezomib. Bortezomib 1 mg powder for solution for injection is for intravenous use only, while bortezomib 3.5 mg powder for solution for injection is for intravenous or subcutaneous use. Bortezomib should not be administered intrathecally.
Instructions for reconstitution: Bortezomib must be reconstituted by a healthcare professional.
Intravenous injection: Each 10 ml vial of bortezomib must be reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection. Dissolution of the lyophilized powder is completed in less than 2 minutes.
After reconstitution, each ml solution contains 1 mg bortezomib. The reconstituted solution is clear and colorless, with a final pH of 4 to 7.
The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration. If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Subcutaneous injection: Each 10 ml vial of bortezomib should be reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection. Dissolution of the lyophilized powder is completed in less than 2 minutes.
After reconstitution, each ml solution contains 2.5 mg bortezomib. The reconstituted solution is clear and colorless, with a final pH of 4 to 7. The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration. If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Disposal: Bortezomib is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.