Ustekinumab-Srlf (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INTRAVENOUS.
Brand Names
- IMULDOSA
Contraindications
IMULDOSA is contraindicated in patients with clinically significant hypersensitivity to Ustekinumab products or to any of the excipients in IMULDOSA [ see Warnings and Precautions ( 5.5) ].
Adverse Reactions
The following serious adverse reactions are discussed elsewhere in the label: Infections [see Warnings and Precautions ( 5.1)] Malignancies [see Warnings and Precautions ( 5.4)] Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.5)] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions ( 5.6)] Noninfectious Pneumonia [see Warnings and Precautions ( 5.8)]
Mechanism of Action
Ustekinumab products are human IgG1κ monoclonal antibodies that bind with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. In in vitro models, ustekinumab products were shown to disrupt IL-12 and IL-23 mediated signaling and cytokine cascades by disrupting the interaction of these cytokines with a shared cell-surface receptor chain, IL-12Rβ1. The cytokines IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn’s disease and ulcerative colitis. In animal models of colitis, genetic absence or antibody blockade of the p40 subunit of IL-12 and IL-23, the target of ustekinumab products, was shown to be protective.