AHFS Class:

90:04.04 Monoclonal Antibodies

Generic Name

• Ublituximab (CAS Registry Number: 1174014-05-1)

Ublituximab-xiiy is available as a 25-mg/mL concentrate for injection in 6-mL preservative-free single-dose vials.³⁹²⁴ Each mL contains ublituximab-xiiy 25 mg with hydrochloric acid 0.4 mg, polysorbate 80 0.7 mg, sodium chloride 9 mg, and sodium citrate 6.4 mg in water for injection.³⁹²⁴ The concentrate for injection must be diluted in sodium chloride 0.9% prior to administration.³⁹²⁴ To prepare a diluted solution for administration, a volume of sodium chloride 0.9% equivalent to the volume of the concentrate for injection to be added (6 or 18 mL, depending on the dose) should be removed from a 250-mL infusion bag before transferring the appropriate volume of ublituximab-xiiy concentrate for injection to the infusion bag.³⁹²⁴ The diluted solution should be mixed by gentle inversion; do not shake.³⁹²⁴

pH

The concentrate for injection has a pH of 6.5.³⁹²⁴

Trade Name(s)

Briumvi

Ublituximab-xiiy is administered by intravenous infusion through a dedicated line, generally over 1 or 4 hours, depending on the dose.³⁹²⁴ Consult product labeling for details on infusion rates.³⁹²⁴ Diluted solutions for infusion should be at room temperature at the time of infusion.³⁹²⁴

Intact vials should be stored at 2 to 8°C in the original carton to protect from light.³⁹²⁴ Do not freeze or shake.³⁹²⁴

Ublituximab-xiiy concentrate for injection is a clear to opalescent, colorless to slightly yellow solution; do not use if the solution is discolored or contains particulate matter.³⁹²⁴

Diluted solutions may be stored at 2 to 8°C for up to 24 hours.³⁹²⁴ Do not freeze.³⁹²⁴ If refrigerated, diluted solutions should be allowed to equilibrate to room temperature (approximately 2 hours) prior to administration.³⁹²⁴ Diluted solutions may be stored at room temperature up to 25°C for an additional 8 hours, including equilibration and infusion time.³⁹²⁴

Sorption

The manufacturer states no incompatibilities between ublituximab-xiiy and polyvinyl chloride (PVC) or polyolefin bags and intravenous administration sets have been observed.³⁹²⁴

Solution Compatibility

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions December 5, 2024. © Copyright, 2025. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.