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FDA Advise-ERR: Lumoxiti has unique preparation instructions!

The US Food and Drug Administration (FDA) approved LUMOXITI (moxetumomab pasudotox-tdfk) injection in September 2018. Lumoxiti is a CD22-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog. The recommended dose is 0.04 mg/kg administered as an intravenous (IV) infusion over 30 minutes on days 1, 3, and 5 of each 28-day cycle. Lumoxiti is available as a 1 mg lyophilized cake or powder in a single-dose vial for reconstitution and further dilution.

It’s important for healthcare professionals to know that the preparation of Lumoxiti requires an intravenous solution stabilizer (IVSS) component that is packaged separately from Lumoxiti. The IVSS component is supplied in a 1 mL vial and is packaged separately because more than one vial of Lumoxiti may be needed for the dose, but only one vial of IVSS should be used per infusion bag. Separate packaging also helps to avoid using an IVSS to dilute Lumoxiti.  

The preparation of Lumoxiti in the pharmacy requires 3 steps:

  1. Calculate the dose: Calculate the dose and number of Lumoxiti vials to be reconstituted based on the patient’s actual metric body weight. Multiple vials of Lumoxiti will likely be needed for each dose. For example, the dose for a 70 kg patient would be 2.8 mg, requiring 3 vials.

  2. Reconstitute: Reconstitute each Lumoxiti vial with 1.1 mL of sterile water for injection to yield a final concentration of 1 mg/mL (each Lumoxiti vial will contain an extractable volume of 1 mL [1 mg]).

  3. Dilute: Add 1 vial (1 mL) of IVSS (packaged separately from Lumoxiti) to a bag containing 50 mL of 0.9% sodium chloride for injection; then add the   required volume/dose of Lumoxiti solution from the reconstituted vial(s) (steps 1 and 2) to the infusion bag.

Consider the following to help prevent preparation errors with Lumoxiti:

  • Review the prescribing information and Healthcare Provider Instructions for Use to obtain important information on dosing, preparing, and administering Lumoxiti. 

  • Ensure the IVSS is present before starting to prepare Lumoxiti, as IVSS is packaged separately from Lumoxiti.

  • Use only 1 vial of IVSS per infusion bag of Lumoxiti, regardless of the number of vials of Lumoxiti needed per dose.

  • Reconstitute each Lumoxiti vial with 1.1 mL of sterile water for injection. Do NOT reconstitute Lumoxiti vials with the IVSS.

  • Refer to full prescribing information, which contains complete, step-by-step instructions for reconstitution, dilution, and administration.

ISMP thanks Casmir Ogbonna, PharmD, MBA, BCPS, BCGP (Safety Evaluator) and Hina Mehta, PharmD (Team Leader) from the FDA Division of Medication Error Prevention and Analysis (DMEPA) for contributing this FDA Advise-ERR.