AHFS Class:

10:00 Antineoplastic Agents

Generic Name

• Ipilimumab (CAS Registry Number: 477202-00-9)

Ipilimumab is available as a 5-mg/mL concentrate for injection in 10- and 40-mL preservative-free, single-dose vials.³⁸⁸⁰ Each mL of the concentrate contains ipilimumab 5 mg with pentetic acid 0.04 mg, mannitol 10 mg, polysorbate 80 0.1 mg, sodium chloride 5.85 mg, and tris hydrochloride 3.15 mg in water for injection.³⁸⁸⁰

The concentrate must be diluted prior to administration.³⁸⁸⁰ Prior to use, allow vials to stand at room temperature for approximately 5 minutes.³⁸⁸⁰ To prepare the drug for intravenous infusion, the appropriate dose of the concentrate should be withdrawn from the vial and added to an infusion bag followed by a volume of dextrose 5% or sodium chloride 0.9% to yield a final ipilimumab concentration between 1 and 2 mg/mL.³⁸⁸⁰ The solution should be mixed by gentle inversion.³⁸⁸⁰ Any unused portion remaining in vials should be discarded.³⁸⁸⁰

pH

7.³⁸⁸⁰

Trade Name(s)

Yervoy

Ipilimumab is administered by intravenous infusion over 30 or 90 minutes only after dilution in dextrose 5% or sodium chloride 0.9%.³⁸⁸⁰ Diluted solutions for infusion should be administered through a low protein-binding inline filter.³⁸⁸⁰ The infusion line should be flushed with dextrose 5% or sodium chloride 0.9% after each infusion.³⁸⁸⁰

Other drugs should not be co-administered with ipilimumab through the same infusion line.³⁸⁸⁰

Intact vials of ipilimumab should be stored at 2 to 8°C in the original carton to protect from light and should not be shaken or frozen.³⁸⁸⁰ The concentrate for injection is a clear to slightly opalescent, colorless to pale yellow solution that may contain a small amount of visible translucent to white amorphous particles.³⁸⁸⁰ Vials should be visually inspected for particulate matter and discoloration prior to use; discard the solution if it is discolored, cloudy, or if particulate matter other than translucent to white amorphous particles is present.³⁸⁸⁰

The manufacturer states diluted solutions may be stored for up to 24 hours at room temperature or 2 to 8°C.³⁸⁸⁰

Filtration

Diluted solutions for infusion should be administered through a low protein-binding inline filter.³⁸⁸⁰

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 March 31, 2023. © Copyright, 2025. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.