Benlysta Caution For Usage

Incompatibilities: BENLYSTA is not compatible with 5% dextrose.
BENLYSTA must be prepared and administered only as directed, see Use and Handling as follows.
Instructions for Use/Handling: Reconstitution and dilution: BENLYSTA does not contain a preservative; therefore reconstitution and dilution must be carried out under aseptic conditions.
Allow 10 to 15 minutes for the vial to warm to room temperature.
It is recommended that a 21-25 gauge needle be used when piercing the vial stopper for reconstitution and dilution.
The 120 mg single-use vial of BENLYSTA should be reconstituted with 1.5 mL of sterile Water for Injections to yield a final concentration of 80 mg/mL belimumab. The 400 mg single-use vial of BENLYSTA should be reconstituted with 4.8 mL of sterile Water for Injections to yield a final concentration of 80 mg/mL belimumab.
The stream of sterile water should be directed toward the side of the vial to minimise foaming. Gently swirl the vial for 60 seconds. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 60 seconds every five minutes until the powder is dissolved. Do not shake.
Reconstitution is typically complete within 10 to 15 minutes after the sterile water has been added, but it may take up to 30 minutes. Protect the reconstituted solution from direct sunlight.
If a mechanical reconstitution device is used to reconstitute BENLYSTA it should not exceed 500 rpm and the vial should be swirled for no longer than 30 minutes.
Once reconstitution is complete, the solution should be opalescent and colourless to pale yellow, and without particles. Small air bubbles, however, are expected and acceptable.
The reconstituted product is diluted to 250 mL with 0.9% sodium chloride (normal saline), 0.45% sodium chloride (half normal saline) or Lactated Ringer's solution for intravenous infusion. For patients whose body weight is less than or equal to 40 kg, infusion bags with 100 mL normal saline, half normal saline or Lactated Ringer's solution may be considered providing that the resulting belimumab concentration in the infusion bag does not exceed 4 mg/mL.
5% Dextrose intravenous solutions are incompatible with BENLYSTA and should not be used.
From a 250 mL (or 100 mL) infusion bag or bottle of normal saline, half normal saline, or Lactated Ringer's solution, withdraw and discard a volume equal to the volume of the reconstituted BENLYSTA solution required for the patient's dose. Then add the required volume of the reconstituted BENLYSTA solution into the infusion bag or bottle. Gently invert the bag or bottle to mix the solution. Any unused solution in the vials must be discarded.
Inspect the BENLYSTA solution visually for particulate matter and discoloration prior to administration. Discard the solution if any particulate matter or discoloration is observed.
The reconstituted solution, if not used immediately, should be protected from direct sunlight and stored refrigerated at 2°C to 8°C. Solutions diluted in normal saline, half normal saline, or Lactated Ringer's solution may be stored at 2°C to 8°C or room temperature.
The total time from reconstitution of BENLYSTA to completion of infusion should not exceed eight hours.
Administration: BENLYSTA should be infused over a 1-hour period.
BENLYSTA should not be infused concomitantly in the same intravenous line with other agents. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of BENLYSTA with other agents.
No incompatibilities between BENLYSTA and polyvinylchloride or polyolefin bags have been observed.