STELARA® is a human IgG1κ monoclonal antibody against
the p40 subunit of the IL-12 and IL-23 cytokines. Using DNA recombinant
technology, STELARA® is produced in a well characterized recombinant cell line
and is purified using standard bio-processing technology. The manufacturing
process contains steps for the clearance of viruses. STELARA® is comprised of
1326 amino acids and has an estimated molecular mass that ranges from 148,079
to 149,690 Daltons.
STELARA® is available as: 45 mg of ustekinumab in 0.5 mL and
90 mg of ustekinumab in 1 mL. STELARA® is supplied as a sterile solution in a
single-use prefilled syringe with a 27 gauge fixed ½ inch needle, or a
single-use 2 mL Type I glass vial with a coated stopper. The syringe is fitted
with a passive needle guard and a needle cover that is manufactured using a dry
natural rubber (a derivative of latex).
Each 45 mg ustekinumab prefilled syringe also contains:
L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate
80 (0.02 mg), and sucrose (38 mg) to fill to a final volume of 0.5 mL.
Each 90 mg ustekinumab prefilled syringe also contains:
L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate
80 (0.04 mg), and sucrose (76 mg) to fill to a final volume of 1 mL.
Each 45 mg ustekinumab vial also contains: L-histidine and
L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg),
and sucrose (38 mg) to fill to a final volume of 0.5 mL.
Each 90 mg ustekinumab vial also contains: L-histidine and
L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and
sucrose (76 mg) to fill to a final volume of 1 mL.
The STELARA® solution is colorless to slightly yellow in
appearance and has a Ph of 5.7-6.3. STELARA® does not contain preservatives.
Last reviewed on RxList: 4/20/2012
This monograph has been modified to include the generic and brand name in many instances.