Ustekinumab (Stelara)

Dilution requiredFull monograph review pending

Stelara · Dilution required

Preparation: Adult IV induction for inflammatory bowel disease. Use the 130 mg/26 mL IV vial. For each vial needed, remove 26 mL from a 250 mL bag of 0.9% sodium chloride and replace it with 26 mL of concentrate. Final volume is 250 mL.
Administration and handling: Mix gently and infuse over at least 1 hour using a sterile low protein-binding 0.2 micron in-line filter. Subcutaneous presentations have separate instructions.

Product and source details

Janssen Biotech, Inc. · BLA761044

Product NDC: 57894-054

SPL effective 2026-09-08 | SPL version 49. Checked 2026-11-13.

Source for this summary: U.S. prescribing information. Use the full label for dose selection, contraindications, preparation tables and monitoring.

Applies to

Stelara 130 mg/26 mL vial, adult IV induction.

The cited hospital guide and U.S. product label support the adult statements shown. Use the U.S. label for other methods and populations.

Preparation sources checked 2026-11-13.

Dilution

From a 250 mL bag of 0.9% sodium chloride, remove 26 mL for each full vial to be added. Replace with the same volume of drug.

Sources and exact locations

Claim ID: IVR-72-STELARA-001

Review basis: Separately edited institutional reference

Filter

Use a 0.2 micron in-line filter for the adult IV infusion.

Sources and exact locations

Claim ID: IVR-72-STELARA-002

Review basis: Separately edited institutional reference

Product identifiers and clinical review status

U.S. label preparation available. Full monograph review pending.

Selected product identity

Matched IV presentation for the stated adult preparation steps.

View product identifiers and primary-label provenance

Selected product scope: Stelara 130 mg/26 mL vial, adult IV induction.
Labeler: Janssen Biotech, Inc.
Application number(s): BLA761044
NDC(s): 57894-054
DailyMed Set ID: c77a9664-e3bb-4023-b400-127aa53bca2b
SPL version: 49
Label printed revision date: Not established
SPL effective date: 2026-09-08
Retrieved: 2026-11-13
Downloaded XML SHA-256: 056b81b3f8acddf36b1bc468d41af1852a91e8206c164d0dde244cb99f0017d5

What remains to be completed

Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.