Interleukin-23 Antagonist

Interleukin-23 Antagonists

Psoriasis

<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">Guselkumab, an interleukin-23 blocker, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. Guselkumab is produced in a mammalian cell line using recombinant DNA technology.</p><p>TREMFYA (guselkumab) injection is a sterile, preservative free, clear, colorless to light yellow solution that may contain small translucent particles. TREMFYA is supplied as a single-dose solution in a 1 mL glass syringe with a 27G, half inch fixed needle assembled in a passive needle guard delivery system or One-Press patient-controlled injector for subcutaneous use.</p><p>Each TREMFYA 1 mL prefilled syringe or One-Press patient-controlled injector contains 100 mg guselkumab, L-histidine (0.6 mg), L-histidine monohydrochloride monohydrate (1.5 mg), polysorbate 80 (0.5 mg), sucrose (79 mg) and water for injection at pH 5.8.</p></section>

Tremfya

1 ML guselkumab 100 MG/ML Auto-Injector

1 ML guselkumab 100 MG/ML Auto-Injector [Tremfya]

1 ML guselkumab 100 MG/ML Prefilled Syringe

1 ML guselkumab 100 MG/ML Prefilled Syringe [Tremfya]

guselkumab

Interleukin-12 Antagonist

Interleukin-12 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

Tremfya, an interleukin inhibitor, is indicated for the treatment of plaque psoriasis or psoriatic arthritis in adults. Patients can learn to self-administer Tremfya subcutaneously every eight weeks, and the most common side effects are injection site reactions and an elevated risk of infection.

Tremfya is FDA approved for the following indications: Plaque Psoriasis and Psoriatic Arthritis. 


Report Adverse Event 

Prescribing Information

Prescribing Information - Spanish

Medication Guide 

Submit MSL Request 

Pharmacy List 

Formulary Coverage: Plaque Psoriasis

Formulary Coverage: Psoriatic Arthritis 

Biling & Coding Guide 

Coverage Authorization Request 

Coverage Authorization Appeals

Letter of Medical Necessity 

Letter of Medical Necessity (Reverification)

PA Checklist 

PA Checklist - Spanish

Formulary Exceptions Checklist 

Formulary Exceptions Checklist - Spanish

Formulary Exception Letter 

Appeals Checklist 

Appeals Checklist - Spanish

Janssen CarePath Provider Portal

Business Associate Agreement - HCP Office 

Patient Authorization Form - To be Signed by Patient if HCP Office has no BAA with Janssen 

Tremfya With Me Enrollment & Prescription Form 

Enroll in Patient Savings Program 

Bridge Program 

Rebate Form (If Pharmacy Unable to Process Savings Card)

Johnson & Johnson Patient Assistance Foundation (JJPAF) Eligibility Check 

Mechanism of Action (MOA): Plaque Psoriasis 

Efficacy (Skin Clearance Data): Plaque Psoriasis 

Efficacy (Durability Data): Plaque Psoriasis 

Efficacy (Difficult To Treat): Plaque Psoriasis 

Efficacy (vs Cosentyx): Plaque Psoriasis 

Efficacy (vs Stelara): Plaque Psoriasis 

Safety Profile: Plaque Psoriasis 

Dosing: Plaque Psoriasis 

Other HCP Resources: Plaque Psoriasis 

Efficacy in PsA for Dermatologists 

Mechanism of Action (MOA): Psoriatic Arthritis 

Efficacy (ACR Response): Psoriatic Arthritis 

Efficacy (Skin Data & More): Psoriatic Arthritis 

Efficacy (Additional Data ): Psoriatic Arthritis 

Safety Profile: Psoriatic Arthritis 

Dosing: Psoriatic Arthritis 

Patient Brochure: Psoriatic Arthritis 

Other HCP Resources: Psoriatic Arthritis 

Sharps Container 

Tremfya With Me Support Program 

About Tremfya: Plaque Psoriasis 

Taking Tremfya: Plaque Psoriasis 

Instructions For Use: Plaque Psoriasis 

About Tremfya: Psoriatic Arthritis 

Taking Tremfya: Psoriatic Arthritis 

Instructions For Use: Psoriatic Arthritis 

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. 


How To Order Stelara

Formulary Coverage: Ulcerative Colitis 

Formulary Coverage: Crohn's Disease

Formulary: Psoriatic Arthritis 

Billing & Coding Guide 

Letter of Exception: Crohn's Disease 

Letter of Exception: Ulcerative Colitis

Letter of Exception: Plaque Psoriasis

Letter of Exception: Psoriatic Arthritis 

Appeals Considerations Checklist

Appeals Considerations Checklist - Spanish

Janssen Patient Assistance Program 

Gastroenterology Enrollment Form 

Dermatology & Rheumatology Enrollment Form 

Reimbursement Information

Efficacy: Plaque Psoriasis

Efficacy, Safety & Dosing: Pediatric Plaque Psoriasis 

Efficacy: 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: Ulcerative Colitis 

Instructions For Use: Crohn's Disease 

Taltz

Skyrizi

Cosentyx

Tremfya®(guselkumab)	Stelara®(ustekinumab)

Prescription Only Tremfya, an interleukin inhibitor, is indicated for the treatment of plaque psoriasis or psoriatic arthritis in adults. Patients can learn to self-administer Tremfya...	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
100 mg at Week 0, Week 4, and every 8 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
100 mg Week 0, 4, q8w. 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 TREMFYA include upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex 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
$6,000. Learn more.	Learn more.
Assistance Expiration
End of each calendar year (subject to change or end without notice). 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

Tremfya® Alternatives