Psoriasis

<section class="Section" data-sectioncode="34089-3"><a name="section-8"></a><h1>11 DESCRIPTION</h1>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 75 mg/0.83 mL prefilled syringe for subcutaneous useEach SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 75 mg of risankizumab-rzaa, and the inactive ingredients polysorbate 20 (0.17 mg), sodium succinate (0.53 mg), sorbitol (34 mg), succinic acid (0.049 mg), and Water for Injection, USP. The pH is 6.2.SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous useEach SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2.SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7.SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous useEach SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7.SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7.SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusionSKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial.Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</section>

Skyrizi

0.83 ML risankizumab-rzaa 90.4 MG/ML Prefilled Syringe

0.83 ML risankizumab-rzaa 90.4 MG/ML Prefilled Syringe [Skyrizi]

1 ML risankizumab-rzaa 150 MG/ML Auto-Injector

1 ML risankizumab-rzaa 150 MG/ML Auto-Injector [Skyrizi]

1 ML risankizumab-rzaa 150 MG/ML Prefilled Syringe

1 ML risankizumab-rzaa 150 MG/ML Prefilled Syringe [Skyrizi]

1.2 ML risankizumab-rzaa 150 MG/ML Cartridge

1.2 ML risankizumab-rzaa 150 MG/ML Cartridge [Skyrizi]

10 ML risankizumab-rzaa 60 MG/ML Injection

10 ML risankizumab-rzaa 60 MG/ML Injection [Skyrizi]

2.4 ML risankizumab-rzaa 150 MG/ML Cartridge

2.4 ML risankizumab-rzaa 150 MG/ML Cartridge [Skyrizi]

risankizumab

Interleukin-12 Antagonist

Interleukin-12 Antagonists

Interleukin-23 Antagonist

Interleukin-23 Antagonists

Crohn Disease

Psoriatic Arthritis

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>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.STELARA® (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.<div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>STELARA® for Subcutaneous UseAvailable 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).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).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).</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>STELARA® for Intravenous InfusionAvailable as 130 mg of ustekinumab in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper.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).</div></section>

STELARA

0.5 ML ustekinumab 90 MG/ML Injection

0.5 ML ustekinumab 90 MG/ML Injection [Stelara]

0.5 ML ustekinumab 90 MG/ML Prefilled Syringe

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]

26 ML ustekinumab 5 MG/ML Injection

26 ML ustekinumab 5 MG/ML Injection [Stelara]

Stelara

ustekinumab

Skyrizi, an interleukin inhibitor, is prescribed to alleviate inflammation associated with plaque psoriasis, psoriatic arthritis, or Crohn's disease in adults. The recommended dose is 150mg administered every 12 weeks as two subcutaneous injections of 75mg, which patients can learn to self-administer. The most frequently reported side effects are upper respiratory tract infections, headache, and fatigue.

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


Report Adverse Event 

Prescribing Information

Medication Guide 

Submit MSL Request 

Pharmacy List 

Billing and Coding Guide 

Reimbursement Information 

Formulary Information

Coverage Authorization Request

Coverage Authorization Appeals

Letter of Medical Necessity 

Formulary Exception Letter 

Tiered Exception Letter 

HIPAA Authorization Template

Navigating PA 

Guide To Starting Skyrizi 

Skyrizi Complete Prescription & Enrollment Form: Rheumatology & Dermatology 

Skyrizi Complete Prescription & Enrollment Form: Gastroenterology

Complete by Abbvie {HCP Portal}

Enroll in Patient Savings Program

Enroll in Bridge Program 

Abbvie Patient Assistance Program Application - English 

Abbvie Patient Assistance Program Application - Spanish 

Mechanism of Action (MOA)

Efficacy (PASI): Plaque Psoriasis 

Efficacy (Challenging Body Areas): Plaque Psoriasis 

Efficacy (Before & After): Plaque Psoriasis 

Efficacy (vs Cosentyx): Plaque Psoriasis 

Efficacy (vs Stelara): Plaque Psoriasis 

Efficacy (vs Humira): Plaque Psoriasis 

Efficacy in PsA for Dermatologists 

Dosing: Plaque Psoriasis 

Injection Devices: Plaque Psoriasis  & Psoriatic Arthritis 

Safety Profile: Plaque Psoriasis & Psoriatic Arthritis 

Other HCP Resources: Plaque Psoriasis 

Skyrizi Complete App 

Efficacy (ACR Data): Psoriatic Arthritis 

Efficacy (Enthesitis-Dactylitis): Psoriatic Arthritis 

Efficacy (Disease Control): Psoriatic Arthritis 

Dosing: Psoriatic Arthritis 

Other HCP Resources: Psoriatic Arthritis 

Efficacy: Crohn's Disease

Safety Profile: Crohn's Disease

Dosing & Administration: Crohn's Disease

Other HCP Resources: Crohn's Disease

Patient Brochure: Plaque Psoriasis 

Quick Tips For Self Injecting - 150mg Pen 

Quick Tips For Injecting - 150mg Prefilled Syringe

Skyrizi Complete Support Program 

Nurse Ambassador 

Sharps Container 

About Skyrizi: Plaque Psoriasis 

Taking Skyrizi: Plaque Psoriasis & Psoriatic Arthritis 

Side Effects: Plaque Psoriasis & Psoriatic Arthritis 

Before and After: Plaque Psoriasis 

Patient Stories: Plaque Psoriasis

Doctor Discussion Guide: Plaque Psoriasis & Psoriatic Arthritis 

Prep For Your Appointment: Plaque Psoriasis & Psoriatic Arthritis 

Instructions For Use: Plaque Psoriasis 

Instructions For Use: Psoriatic Arthritis 

About Skyrizi: Psoriatic Arthritis 

About Skyrizi: Crohn's Disease 

Taking Skyrizi: Crohn's Disease 

Side Effects: Crohn's Disease 

Doctor Discussion Guide: Crohn's Disease 

Infusion Support: Crohn's Disease 

Infusion Prep Guide: Crohn's Disease 

On-Body Injector (OBI) Prep Guide: Crohn's Disease

Instructions For Use: Crohn's Disease 

Infusion To On-Body Injector (OBI) Guide 

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. 


Skyrizi®(risankizumab)	Stelara®(ustekinumab)

Prescription Only Skyrizi, an interleukin inhibitor, is prescribed to alleviate inflammation associated with plaque psoriasis, psoriatic arthritis, or Crohn's disease in adults. The recommended...	Prescription Only 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...
Dosage & Administration
Administration
Subcutaneous Injection. Learn more.	Intravenous Infusion or Subcutaneous Injection . Learn more.
Dosing
150 mg at Week 0, Week 4, and every 12 weeks thereafter.. Learn more.	Single intravenous infusion using weight-based dosing: Recommended Dosage up to 55 kg: 260 mg. > 55 kg to 85 kg: 390 mg. > 85 kg: 520 mg. Maintenance dosing: SubQ 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.. Learn more.
Latin Shorthand
150 mg Week 0, 4 then q12w. Learn more.	Single IV infusion w/ weight-based dosing: Up to 55 kg: 260mg 55 to 85 kg: 390mg 85 kg: 520mg. Maintenance dosing: SubQ 90mg 8 wks after initial IV dose, then q8wks thereafter.. Learn more.
Adverse Reactions
Most common adverse reactions are: • Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. • Crohn’s Disease (>3%): o Induction: upper respiratory infections, headache, and arthralgia. o Maintenance: arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection. . Learn more.	Most common adverse reactions are: • Psoriasis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue. • Crohn’s Disease, induction (≥3%): vomiting. • Crohn’s Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. • Ulcerative colitis, induction (≥3%): nasopharyngitis • Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea . Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$5. Learn more.	$5. Learn more.
Annual Cap
$6,000. Learn more.	Learn more.
Assistance Expiration
Learn more.	End of each calendar year (subject to change or discontinuation without notice). Learn more.
Generics
No lower-cost generic available	No lower-cost generic available

Skyrizi® Alternatives