AHFS Class:

10:00 Antineoplastic Agents

Generic Name

• Tremelimumab (CAS Registry Number: 745013-59-6)

Tremelimumab-actl is available as a 20-mg/mL concentrate for injection in 1.25- and 15-mL preservative-free, single-dose vials containing 25 and 300 mg of the drug, respectively.³⁸⁸⁵ Each mL of the concentrate contains tremelimumab 20 mg with edetate disodium 0.09 mg, histidine 0.68 mg, L-histidine hydrochloride monohydrate 3.3 mg, polysorbate 80 0.2 mg, and trehalose 76 mg in water for injection.³⁸⁸⁵

The concentrate must be diluted prior to administration.³⁸⁸⁵ To prepare the drug for intravenous infusion, the appropriate dose of the concentrate should be withdrawn from the vial and added to an infusion bag containing dextrose 5% or sodium chloride 0.9% to yield a tremelimumab concentration not exceeding 10 mg/mL.³⁸⁸⁵ The solution should be mixed by gentle inversion and should not be shaken.³⁸⁸⁵ Any unused portion remaining in vials should be discarded.³⁸⁸⁵

pH

Approximately 5.5.³⁸⁸⁵

Trade Name(s)

Imjudo

Tremelimumab is administered by intravenous infusion over 60 minutes only after dilution in dextrose 5% or sodium chloride 0.9%.³⁸⁸⁵ Diluted solutions for infusion should be administered through a 0.2- to 0.22-µm low protein-binding filter.³⁸⁸⁵

Other drugs should not be co-administered with tremelimumab through the same infusion line.³⁸⁸⁵

Intact vials of tremelimumab should be stored at 2 to 8°C in the original carton to protect from light and should not be shaken or frozen.³⁸⁸⁵ The concentrate for injection is a clear to slightly opalescent, colorless to slightly yellow solution.³⁸⁸⁵ Vials should be visually inspected for particulate matter and discoloration prior to use; discard the solution if particulate matter is present.³⁸⁸⁵

The manufacturer states diluted solutions may be stored at room temperature or 2 to 8°C for no more than 24 hours from time of preparation to the start of administration.³⁸⁸⁵ Diluted solutions should not be frozen or shaken.³⁸⁸⁵

Filtration

Diluted solutions for infusion should be administered through a 0.2- to 0.22-µm low protein-binding filter.³⁸⁸⁵

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.