weight used to calculate the first dose of the
first treatment cycle. No change in dose should be made during a particular cycle.
Do not round down the dose for partial vials.
Step 2: Gather Supplies
LUMOXITI 1 mg/vial (number of vials to be reconstituted are based on Step 1)
1 vial of IV Solution Stabilizer (packaged separately)alcohol swabs
1 infusion bag containing 50 mL or 100 mL 0.9% Sodium Chloride Injection, USPSterile Water for Injection, USP
syringes and needles
Step 3: Reconstitution
Reconstitute each LUMOXITI vial with 1.1 mL Sterile Water for Injection, USP using aseptic
technique.
22 Reference ID: 4320135
Direct the Sterile Water for Injection, USP slowly along the walls of the LUMOXITI vialand not directly at the lyophilized cake or powder (see figure below).
Do not reconstitute LUMOXITI vials with the IV Solution Stabilizer.
Gently swirl the vial until completely dissolved. Invert the vial to ensure all cake orpowder in the vial is dissolved. Do not shake.
Visually inspect that the reconstituted solution is clear to slightly opalescent, colorless to slightly yellow, and free from visible particles.
Do not use if solution is cloudy, discolored, or contains any particles.
The resulting 1 mg/mL solution allows a withdrawal volume of 1 mL.
Use reconstituted solution immediately. Do not store reconstituted LUMOXITI vials. See Table 1
for storage times and conditions for the reconstituted solution.
Step 4: Preparation of Infusion Bag with IV Solution Stabilizer Obtain a 50 mL 0.9% Sodium Chloride Injection, USP infusion bag.
Only one vial of IV Solution Stabilizer is needed per administration of LUMOXITI, regardless of the number of vials of LUMOXITI used to prepare the infusion.
Add 1 mL IV Solution Stabilizer to the infusion bag containing 50 mL 0.9% SodiumChloride Injection, USP.
Gently invert the bag to mix the solution. Do not shake.
Step 5: Dilution
Slowly withdraw the required volume of reconstituted LUMOXITI solution needed from each vial,
per the calculated dose based on the patient’s actual body weight (kg).
Inject LUMOXITI into the infusion bag containing 50 mL 0.9% Sodium Chloride Injection,USP and 1 mL IV Solution Stabilizer.
Gently invert the bag to mix the solution. Do not shake.
Discard any partially used or empty vials of LUMOXITI and IV Solution Stabilizer.
See Table 1 for storage times and conditions for the diluted solution.
Step 6: Intravenous Hydration and Pre-infusion Medications Administer intravenous hydration and premedication to the patient.
Intravenously administer 1 L of isotonic solution (e.g. 5% Dextrose Injection, USP and 0.45% or 0.9% Sodium Chloride Injection, USP) over 2 to 4 hours before each LUMOXITI infusion. Administer 0.5 L to patients under 50 kg.
Premedicate 30 to 90 minutes prior to each LUMOXITI infusion with anantihistamine(e.g. hydroxyzine or diphenhydramine), acetaminophen, and a histamine-2 receptor antagonist (e.g. ranitidine, famotidine, or cimetidine).
Step 7: Administration Infuse the diluted LUMOXITI solution intravenously over 30 minutes.
Do not mix LUMOXITI, or administer as an infusion with other medicinal products.
After the infusion, flush the intravenous administration line with of 0.9% Sodium Chloride Injection, USP at the same rate as the infusion. This ensures that the full LUMOXITI dose is delivered.
Step 8: Post-infusion Medications Administer post-inf
