ter than 3-times baseline or the upper limit of normal). Resume LUMOXITI uponrecovery to baseline grade or lower [see Warnings and Precautions (5.3)].
2.4 Instructions for Reconstitution, Dilution, and Administration LUMOXITI must be reconstituted and diluted by a healthcare provider using aseptic technique. Refer tothe Healthcare Provider Instructions for Use for LUMOXITI for full reconstitution, dilution, andadministration information.
Step 1: Calculate Dose
Calculate the dose (mg) and the number of LUMOXITI vials (1 mg/vial) to be reconstituted. The finalconcentration of the reconstituted LUMOXITI solution is 1 mg/mL.
∘DO NOT round down for partial vials.
Individualize dosing based on the patient's actual body weight prior to the first dose of the firsttreatment cycle.
∘A change in dose should only be made between cycles when a change in weight of greater than10% is observed from the weight used to calculate the first dose of the first treatment cycle. Nochange in dose should be made during a particular cycle.
Step 2: Reconstitution
Reconstitute LUMOXITI vials with Sterile Water for Injection, USP only.
Reconstitute each LUMOXITI (1 mg/vial) with 1.1 mL Sterile Water for Injection, USP. Theresulting 1 mg/mL solution allows a withdrawal volume of 1 mL.
∘Direct the Sterile Water for Injection, USP along the walls of the vial and not directly at thelyophilized cake or powder.
∘ DO NOT reconstitute LUMOXITI vials with the IV Solution Stabilizer.
Gently swirl the vial until completely dissolved. Invert the vial to ensure all cake or powder in the vialis dissolved. Do not shake.
Visually inspect that the reconstituted solution is clear to slightly opalescent, colorless to slightlyyellow, and free from visible particles. Do not use if solution is cloudy, discolored, or contains anyparticles.
Use reconstituted solution immediately. Do not store reconstituted LUMOXITI vials. See Table 3 forstorage times and conditions for the reconstituted solution.
Step 3: Dilution
Add the IV Solution Stabilizer to the infusion bag prior to adding LUMOXITI solution to theinfusion bag. Vial of IV Solution Stabilizer is packaged separately.
Obtain a 50 mL 0.9% Sodium Chloride Injection, USP infusion bag.
Add 1 mL IV Solution Stabilizer to the infusion bag containing 50 mL 0.9% Sodium ChlorideInjection, USP.
∘Only one vial of IV Solution Stabilizer should be used per administration of LUMOXITI.
∘Gently invert the bag to mix the solution. Do not shake.
Withdraw the required volume (calculated from Step 1) of LUMOXITI solution from thereconstituted vial(s).
∘Inject LUMOXITI into the infusion bag containing 50 mL 0.9% Sodium Chloride Injection, USPand 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 3 for storage times and conditions for the diluted solution.
Step 4: Administration Instructions
For intravenous infusion only.
Administer the diluted 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.
Table 3: Storage Times and Conditions for Recon |
