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RECONSTITUTION, DOSING
AND ADMINISTRATION
of VELCADE® (bortezomib) 3.5 mg vial for
Subcutaneous (SC) and Intravenous (IV) use
VELCADE® (bortezomib) 3.5 mg powder for solution for injection In order to avoid dosing errors, caution is required when preparing
is available for intravenous (IV) or subcutaneous (SC) administration. VELCADE® as the volume required for reconstitution for the SC route
is lower (1.4 ml) than that used for IV route (3.5 ml) giving a higher
concentration of diluted drug (details are shown in tables 1 and 2).
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Important information regarding
RECONSTITUTION, DOSING
AND ADMINISTRATION
of VELCADE® (bortezomib) 3.5 mg vial for
Subcutaneous (SC) and Intravenous (IV) use
IV
Reconstitution volume is less
than that used for IV giving
SC a more concentrated drug
solution for injection To avoid administration errors, syringes for SC
and IV use should be labelled differently.*
Visual representation
of IV and SC injections
following reconstitution*
Reconstitute the powder with 3.5 ml sodium chloride: inject the sodium The final concentration is 1.0 mg/ml.
chloride solution into the vial containing the lyophilised VELCADE®.
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Important information regarding
RECONSTITUTION, DOSING
AND ADMINISTRATION
of VELCADE® (bortezomib) 3.5 mg vial for
Subcutaneous (SC) and Intravenous (IV) use
BSA: 1.7 m², Dose: 1.3 mg/m² Vial size: 3.5 mg lyophilisate Vial size: 3.5 mg lyophilisate
Intravenous Subcutaneous Diluent volume: 3.5 ml saline Diluent volume: 1.4 ml saline
Sample patient (1.7 m²) Sample patient (1.7 m²)
Final concentration Final concentration
Vial size: 3.5 mg lyophilisate Vial size: 3.5 mg lyophilisate 1 mg/ml 2.5 mg/ml
Diluent volume: 3.5 ml saline Diluent volume: 1.4 ml saline Dose: 1.3 mg/m² Dose: 1.3 mg/m²
Total dose for patient*: Total dose for patient*:
Final concentration Final concentration
2.54 mg 2.54 mg
1 mg/ml 2.5 mg/ml
Dose: 1.3 mg/m² Dose: 1.3 mg/m² Total volume* Total volume*
Total dose for patient: Total dose for patient: applied to the patient: applied to the patient:
2.21 mg 2.21 mg 2.5 ml 1 ml
Injected IV Injected SC
Total volume* Total volume* (3-5 seconds push)
applied to the patient: applied to the patient:
2.2 ml 0.9 ml *Total volume rounded
Injected IV Injected SC NOTE: If the calculated IV volume is used with the SC concentration,
(3-5 seconds push)
the patient will be overdosed.
*Total volume rounded
NOTE: If the calculated IV volume is used with the SC concentration, NOTE: If the calculated SC volume is used with the IV concentration the patient
NOTE: If the calculated SC volume is used with the IV concentration the patient
will be underdosed.
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Important information regarding
RECONSTITUTION, DOSING
AND ADMINISTRATION
of VELCADE® (bortezomib) 3.5 mg vial for
Subcutaneous (SC) and Intravenous (IV) use
Diluent volume: 3.5 ml saline Diluent volume: 1.4 ml saline other protective clothing to prevent skin contact is recommended.
Final concentration Final concentration Please report any adverse event experienced with the administration
1 mg/ml 2.5 mg/ml of VELCADE® immediately.
Dose: 1.0 mg/m² Dose: 1.0 mg/m²
Subcutaneous or Intravenous use only. Do not give by other routes.
Total dose for patient: Total dose for patient:
1.6 mg 1.6 mg Intrathecal administration has resulted in death.
CORRECT ADMINISTRATION
FOR SC & IV VELCADE®
How to administer VELCADE® SC? How to administer VELCADE® IV?
Confirm the dose in the syringe prior to use (check that the syringe is Confirm the dose in the syringe prior to use (check that the syringe is
marked as SC administration). marked for IV administration).
Inject the solution subcutaneously, at a 45-90 °angle. Inject the solution as a 3-5 second bolus intravenous injection
through a peripheral or central intravenous catheter into a vein.
The reconstituted solution should be administered subcutaneously
in the thighs or abdomen and injection sites should be rotated for Flush the peripheral or intravenous catheter with sterile 9 mg/ml
successive injections. (0.9 %) sodium chloride solution.
· Alternate between
- right and left abdomen
(upper or lower quadrant) 8 1 Please report any adverse event experienced with the
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IRE/VEL/2012/0071
Date of Preparation: August 2012