Interleukin-17A Antagonist

Interleukin-17A Antagonists

Psoriasis

<section class="Section" data-sectioncode="34089-3"><a name="s53"></a><a name="section-8"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each, and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule.</p><p>TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab.</p><p>Each mL is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2.</p></section>

TALTZ

1 ML ixekizumab 80 MG/ML Auto-Injector

1 ML ixekizumab 80 MG/ML Auto-Injector [Taltz]

1 ML ixekizumab 80 MG/ML Prefilled Syringe

1 ML ixekizumab 80 MG/ML Prefilled Syringe [Taltz]

Taltz

ixekizumab

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><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]

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

Taltz, a monoclonal antibody, has anti-inflammatory properties and can potentially alleviate symptoms of psoriasis, psoriatic arthritis, or ankylosing spondylitis. Its administration involves subcutaneous injection, and the most common side effects include injection site reactions and an elevated susceptibility to infections.

Taltz is FDA approved for the following indications: Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-Radiographic Axial Spondylarthritis. 


Report Adverse Event

Prescribing Information

Medication Guide

Submit MSL Request 

Pharmacy List 

Reimbursement Information

Coverage Authorization Request

Coverage Authorization Appeals

Letter of Medical Necessity 

Taltz Together Enrollment & Prescription Form - Adult Dermatology

Taltz Together Enrollment & Prescription Form - Pediatric Dermatology

Taltz Together Enrollment & Prescription Form - Adult Rheumatology

Enroll in Patient Savings Program

Lilly Cares Patient Assistance Program Eligibility Check 

Mechanism of Action (MOA)

Efficacy: Plaque Psoriasis 

Efficacy (Head-to-Head Data): Plaque Psoriasis 

Efficacy (Challenging Body Areas): Plaque Psoriasis

Efficacy & Safety (Pediatric Data): Plaque Psoriasis 

Safety Profile: Plaque Psoriasis 

Dosing (Adult & Pediatric): Plaque Psoriasis 

Efficacy: Psoriatic Arthritis 

Efficacy (H2H vs Humira): Psoriatic Arthritis 

Safety Profile: Psoriatic Arthritis 

Efficacy: Ankylosing Spondylitis (AS)

Efficacy: Non-radiographic Axial Spondyloarthritis (nr-axSpA)

Safety Profile: Ankylosing Spondylitis (AS) & Non-radiographic Axial Spondyloarthritis (nr-axSpA)

Dosing: Psoriatic Arthritis, AS & nr-axSpA

About Taltz: Plaque Psoriasis 

Patient Stories: Plaque Psoriasis

Before & After: Plaque Psoriasis

Genital Plaque Psoriasis 

About Taltz (Pediatric): Plaque Psoriasis

Before & After (Pediatric): Plaque Psoriasis

About Taltz: Psoriatic Arthritis 

Patient Stories: Psoriatic Arthritis

About Taltz: Ankylosing Spondylitis (AS) & Non-radiographic Axial Spondyloarthritis (nr-axSpA)

Taking Taltz: Plaque Psoriasis

Taking Taltz (Pediatrics): Plaque Psoriasis 

Taking Taltz: Psoriatic Arthritis 

Taking Taltz: Ankylosing Spondylitis (AS)

Taking Taltz: Non-radiographic Axial Spondyloarthritis (nr-axSpA)

App Download 

Taltz Cost Information

Sharps Disposal

Taltz Together Program 

Instructions For Use: Psoriasis 

Instructions For Use: Psoriatic Arthritis 

Instructions For Use: Ankylosing Spondylitis 

Instructions For Use: Non-radiographic Axial Spondyloarthritis (nr-axSpA)

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 

Medication Guide 

How To Order Stelara

Formulary Coverage: Ulcerative Colitis 

Formulary Coverage: Crohn's Disease

Formulary: Psoriatic Arthritis 

Billing & Coding Guide 

Coverage Authorization Request 

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 

Mechanism of Action (MOA): Plaque Psoriasis 

Efficacy: Plaque Psoriasis

Dosing: Plaque Psoriasis 

Efficacy, Safety & Dosing: Pediatric Plaque Psoriasis 

Other HCP Resources: Plaque Psoriasis 

Mechanism of Action (MOA): Psoriatic Arthritis 

Dosing: Psoriatic Arthritis 

Other HCP Resources: Psoriatic Arthritis

Efficacy: Crohn's Disease 

Safety Profile: Crohn's Disease

Dosing: Crohn's Disease

Other HCP Resources (Access): Crohn's Disease 

Other HCP Resources: Crohn's Disease 

Efficacy: Ulcerative Colitis

Safety Profile: Ulcerative Colitis 

Dosing: Ulcerative Colitis 

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 Brochure: Ulcerative Colitis & Crohn's Disease 

Patient Resources: Ulcerative Colitis 

About Stelara: Crohn's Disease 

Patient Resources: Crohn's Disease

Instructions For Use: Plaque Psoriasis 

Instructions For Use: Ulcerative Colitis 

Instructions For Use: Crohn's Disease 

Skyrizi

Cosentyx

Tremfya

Taltz®(ixekizumab)	Stelara®(ustekinumab)

Prescription Only Taltz, a monoclonal antibody, has anti-inflammatory properties and can potentially alleviate symptoms of psoriasis, psoriatic arthritis, or ankylosing spondylitis. Its...	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
Recommended dosage is 80 mg by subcutaneous injection every 4 weeks.. 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
80mg SC inj. Q4W. 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 (≥1%) adverse reactions associated with TALTZ treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.. 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
$9,100. Learn more.	Learn more.
Assistance Expiration
12/31/2025 or 36 months from qualification, whichever comes first (with prior authorization and appeal process as required). 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

Taltz® Alternatives