ted by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-151 85; U.S. License No. 2059
For more information, go to www.LUMOXITI.com or call 1-800-236-9933.
LUMOXITI™ (moxetumomab pasudotox-tdfk)for injection Healthcare Provider Instructions for Use Important Information Read the following instructions before reconstitution, dilution, and administration of LUMOXITI.
LUMOXITI must be prepared by a healthcare professional using proper aseptictechnique.
Do not freeze or shake LUMOXITI or IV Solution Stabilizer.
Provide each patient the Medication Guide packaged with LUMOXITI prior to each treatment cycle to inform them of the risks and benefits of LUMOXITI.
See Full Prescribing Information for more information on LUMOXITI.
For questions, call AstraZeneca at 1-800-236-9933.
How Supplied
LUMOXITI and IV Solution Stabilizer are packaged separately.
Prior to preparation, LUMOXITI and IV Solution Stabilizer should be stored at 2°C to 8°C(36°F to 46°F) in original cartons to protect from light.
LUMOXITI (moxetumomab pasudotox-tdfk)
Each single-dose vial supplies LUMOXITI 1 mg/vial(moxetumomab pasudotox-tdfk) for injection as a lyophilized cake or powder for reconstitution and dilution
prior to intravenous infusion.
Multiple vials of LUMOXITI may be required to administer a single dose (See Step 1: Calculate Dose).
Reconstitute LUMOXITI vials with Sterile Water for Injection, USP only (not supplied).
IV Solution Stabilizer
Each single-dose vial contains 1 mL IV Solution Stabilizer.
Only one vial of IV Solution Stabilizer is needed peradministration of LUMOXITI, regardless of the number of vials of LUMOXITI used to prepare the infusion.
Do not use IV Solution Stabilizer to reconstitute LUMOXITI.
Do not flush IV lines with IV Solution Stabilizer.
Storage and Handling of Reconstituted and Diluted LUMOXITI
Table 1. Storage Times and Conditions for Reconstituted and Diluted LUMOXITI Solution Reconstituted Solution Diluted LUMOXITI Solution in Infusion Bag
After Dilution Administration
LUMOXITI does not
contain bacteriostatic
preservatives.
Use reconstituted
solution immediately.
DO NOT STORE
reconstituted LUMOXITI
vials.
Use diluted solution
immediately or after storage
at room temperature (20°C
to 25°C; 68°F to 77°F) for up
to 4 hours or store
refrigerated at 2°C to 8°C
(36°F to 46°F) for up to 24
hours.
PROTECT FROM LIGHT.
DO NOT FREEZE.
DO NOT SHAKE.
If the diluted solution is
refrigerated (2°C to 8°C; 36°F to
46°F), allow it to equilibrate at
room temperature (20°C to 25°C;
68°F to 77°F) for no more than 4
hours prior to administration.
Administer diluted solution within
24 hours of reconstitution as a 30-
minute infusion.
PROTECT FROM LIGHT.
Step 1: Calculate Dose
Calculate the dose (mg) and the number of LUMOXITI vials (1 mg/vial) to be reconstituted.
Thefinal concentration of the reconstituted LUMOXITI solution is 1 mg/mL.
Individualize dosing based on the patient's actual body weight prior to the first dose ofthe first treatment cycle.
oA change in dose should only be made between cycles when a change in weight of
greater than 10% is observed from the |
