Ustekinumab

What it is and how it works

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.

Indications

Ustekinumab-aekn is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA) . moderately to severely active Crohn’s disease (CD). moderately to severely active ulcerative colitis. Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO) , who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA) . Plaque Psoriasis (PsO) Ustekinumab-aekn is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Psoriatic Arthritis (PsA) Ustekinumab-aekn is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. Crohn’s Disease (CD) Ustekinumab-aekn is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.

Dosage and administration (summary)

Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage : Weight Range (kilograms) Dosage less than or equal to 100 kg 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks greater than 100 kg 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Subcutaneous Recommended Dosage : Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.

Contraindications

Ustekinumab-aekn is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in Ustekinumab-aekn . Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in Ustekinumab-aekn.

Warnings and precautions

Infections: Serious infections have occurred. Avoid starting Ustekinumab-aekn during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue Ustekinumab-aekn until the infection resolves. Theoretical Risk for Particular Infections : Serious infections from mycobacteria, salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances.

Pregnancy

Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/Mother To Baby Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified an ustekinumab-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes (see Data).

Storage and supply

Ustekinumab-aekn injection, is a sterile, preservative-free, clear and colorless to slightly yellow solution and free of visible particles for subcutaneous use. It is supplied as individually packaged, single-dose prefilled syringes or single-dose vials.

Source: Ustekinumab-Aekn (Ustekinumab-Aekn) — US FDA prescribing information, 2026-07-24, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.