Ustekinumab — Membership Pricing

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What Ustekinumab is approved for (FDA label)

STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. ( 1.2 ) Moderately to severely active Crohn's disease in adults and pediatric patients 2 years of age and older. ( 1.3 ) Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. ( 1.4 ) 1.1 Plaque Psoriasis (PsO) STELARA 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. 1.2 Psoriatic Arthritis (PsA) STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. 1.3 Crohn's Disease (CD) STELARA is indicated for the treatment of adults and pediatric patients 2 years of age and older with moderately to severely active Crohn's disease. 1.4 Ulcerative Colitis (UC) STELARA is indicated for the treatment of adults and pediatric patients 2 years of age and older with moderately to severely active ulcerative colitis.

Source: Read the full FDA label on DailyMed. Label effective date: September 8, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Ustekinumab (FDA label)

STELARA (ustekinumab) is a colorless to light yellow solution and may contain a few small translucent or white particles. Subcutaneous Injection Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe Injection: 45 mg/0.5 mL solution in a single-dose vial Intravenous Infusion Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial Subcutaneous Injection ( 3 ) Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe Injection: 45 mg/0.5 mL solution in a single-dose vial Intravenous Infusion ( 3 ) Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial

Source: FDA prescribing information (DailyMed). Set ID: c77a9664-e3bb-4023-b400-127aa53bca2b. SPL document ID: 30a2caf3-0c87-47a6-b087-25028ff6f8c0. Label effective date: September 8, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Ustekinumab (FDA label)

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) ] Most common adverse reactions are: Psoriasis and Psoriatic Arthritis (≥3%) : nasopharyngitis, upper respiratory tract infection, headache, and fatigue. ( 6.1 ) Crohn's Disease induction (≥3%): vomiting. ( 6.1 ) maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. ( 6.1 ) Ulcerative Colitis induction (≥3%): nasopharyngitis. ( 6.1 ) maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: c77a9664-e3bb-4023-b400-127aa53bca2b. SPL document ID: 30a2caf3-0c87-47a6-b087-25028ff6f8c0. Label effective date: September 8, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Ustekinumab (FDA label)

STELARA is contraindicated in patients with clinically significant hypersensitivity to any ustekinumab product or to any of the excipients in STELARA [see Warnings and Precautions (5.5) ]. Clinically significant hypersensitivity to any ustekinumab product or to any of the excipients in STELARA. ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: c77a9664-e3bb-4023-b400-127aa53bca2b. SPL document ID: 30a2caf3-0c87-47a6-b087-25028ff6f8c0. Label effective date: September 8, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Ustekinumab (FDA label)

Infections : Serious infections have occurred. Avoid starting STELARA during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue STELARA until the infection resolves. ( 5.1 ) 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. ( 5.2 ) Tuberculosis (TB) : Evaluate patients for TB prior to initiating treatment with STELARA. Initiate treatment of latent TB before administering STELARA. ( 5.3 ) Malignancies : STELARA may increase risk of malignancy.

Source: FDA prescribing information (DailyMed). Set ID: c77a9664-e3bb-4023-b400-127aa53bca2b. SPL document ID: 30a2caf3-0c87-47a6-b087-25028ff6f8c0. Label effective date: September 8, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Ustekinumab (FDA label)

7.1 Concomitant Therapies In trials in subjects with plaque psoriasis the safety of STELARA in combination with immunosuppressive agents or phototherapy has not been evaluated. In trials in subjects with psoriatic arthritis, concomitant MTX use did not appear to influence the safety or efficacy of STELARA. In trials in subjects with Crohn's disease (CD-1 and CD-2) and ulcerative colitis (UC-1), immunomodulators (6-MP, AZA, MTX) were used concomitantly in approximately 30% of subjects and corticosteroids were used concomitantly in approximately 40% and 50% of Crohn's disease and ulcerative colitis subjects, respectively. Use of these concomitant therapies did not appear to influence the overall safety or efficacy of STELARA. 7.2 CYP450 Substrates The formation of CYP450 enzymes can be suppressed by increased levels of certain cytokines (e.g., IL-1, IL-6, TNFα, IFN) during chronic inflammation. Thus, use of STELARA, an antagonist of IL-12 and IL-23, could normalize the formation of CYP450 enzymes.

Source: FDA prescribing information (DailyMed). Set ID: c77a9664-e3bb-4023-b400-127aa53bca2b. SPL document ID: 30a2caf3-0c87-47a6-b087-25028ff6f8c0. Label effective date: September 8, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.