Interleukin-12 Antagonists

Interleukin-12 Antagonist

Interleukin-23 Antagonists

Interleukin-23 Antagonist

Crohn Disease

Arthritis, Psoriatic

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Ustekinumab, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons.</p><p>STELARA   <span class="Sup">®</span>(ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles with pH of 5.7– 6.3. </p><div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a><p></p><p class="First"><span class="Underline">STELARA     <span class="Sup">®</span>for Subcutaneous Use   </span></p><p>Available as 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex).</p><p>Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg).</p><p>Each 1 mL prefilled syringe delivers 90 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg).</p></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a><p></p><p class="First"><span class="Underline">STELARA     <span class="Sup">®</span>for Intravenous Infusion   </span></p><p>Available as 130 mg of ustekinumab in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper.</p><p>Each 26 mL vial delivers 130 mg ustekinumab, EDTA disodium salt dihydrate (0.52 mg), L-histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), L-methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</p></div></section>

STELARA

0.5 ML ustekinumab 90 MG/ML Injection

0.5 ML ustekinumab 90 MG/ML Injection [Stelara]

26 ML ustekinumab 5 MG/ML Injection

26 ML ustekinumab 5 MG/ML Injection [Stelara]

ustekinumab

0.5 ML ustekinumab 90 MG/ML Prefilled Syringe

Stelara

0.5 ML ustekinumab 90 MG/ML Prefilled Syringe [Stelara]

1 ML ustekinumab 90 MG/ML Prefilled Syringe

1 ML ustekinumab 90 MG/ML Prefilled Syringe [Stelara]

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Stelara is an immunosuppressant medication that targets two inflammatory cytokines, IL-12 and IL-23, which are key contributors to chronic inflammation. For Crohn's disease and ulcerative colitis, Stelara is administered every 8 weeks, and for psoriasis, it is given every 12 weeks. Its most frequently reported side effects are an increased susceptibility to infection, as well as nasopharyngitis, headache, and fatigue.

Stelara is FDA approved for the following indications: Plaque Psoriasis, Psoriatic Arthritis, Crohn’s Disease, and Ulcerative Colitis. 


Report Adverse Event

Prescribing Information

Medication Guide 

Submit MSL Request 

Pharmacy List

Formulary Coverage: Ulcerative Colitis 

Formulary Coverage: Crohn's Disease

Formulary: Psoriatic Arthritis 

Billing & Coding Guide 

Coverage Authorization Request 

Coverage Authorization Appeals

Letter of Medical Necessity 

Letter of Exception: Crohn's Disease 

Letter of Exception: Ulcerative Colitis

Letter of Exception: Plaque Psoriasis

Letter of Exception: Psoriatic Arthritis 

PA Checklist 

PA Checklist - Spanish

Appeals Considerations Checklist

Appeals Considerations Checklist - Spanish

Janssen CarePath Provider Portal

Business Associate Agreement - HCP Office 

Enroll in Patient Savings Program 

Janssen Patient Assistance Program 

Johnson & Johnson Patient Assistance Foundation (JJPAF) Eligibility Check 

Bridge Program 

Gastroenterology Enrollment Form

Dermatology & Rheumatology Enrollment Form

Reimbursement Information

Other HCP Resources: Plaque Psoriasis 

Other HCP Resources: Psoriatic Arthritis

Other HCP Resources (Access): Crohn's Disease 

Other HCP Resources: Crohn's Disease 

Stelara With Me Support Program 

About Stelara: Plaque Psoriasis 

Taking Stelara: Plaque Psoriasis

About Stelara: Pediatric Plaque Psoriasis 

FAQs: Psoriatic Arthritis & Plaque Psoriasis

Doctor Discussion Guide: Plaque Psoriasis

Stelara Start Guide 

About Stelara: Psoriatic Arthritis 

Taking Stelara: Psoriatic Arthritis 

Doctor Discussion Guide: Psoriatic Arthritis 

Patient Resources: Psoriatic Arthritis 

About Stelara: Ulcerative Colitis 

Patient Resources: Ulcerative Colitis 

About Stelara: Crohn's Disease 

Patient Resources: Crohn's Disease

Instructions For Use: Plaque Psoriasis 

Instructions For Use: Psoriatic Arthritis 

Instructions For Use: Ulcerative Colitis 

Instructions For Use: Crohn's Disease 

How To Order Stelara