Stelara Prescribing & Dosing Schedule

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Stelara(ustekinumab)

Stelara 45 MG in 0.5 mL Injection

NO BOXED WARNING

Dosage & Administration

Psoriasis Adult Subcutaneous Recommended Dosage ( 2.1) :

Weight Range (kilograms)	Dose
less than or equal to 100 kg	45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks
greater than 100 kg	90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks

Psoriasis Pediatric Patients (6 to 17 years old) Subcutaneous Recommended Dosage ( 2.1) :

Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.

Weight Range (kilograms)	Dose
less than 60 kg	0.75 mg/kg
60 kg to 100 kg	45 mg
greater than 100 kg	90 mg

Psoriatic Arthritis Adult Subcutaneous Recommended Dosage ( 2.2):

* The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks.
* For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.

Psoriatic Arthritis Pediatric (6 to 17 years old) Subcutaneous Recommended Dosage ( 2.2): Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.

Weight Range (kilograms)	Dose
less than 60 kg	0.75 mg/kg
60 kg or more	45 mg
greater than 100 kg with co-existent moderate-to-severe plaque psoriasis	90 mg

Crohn's Disease and Ulcerative Colitis Initial Adult Intravenous Recommended Dosage ( 2.3) :

A single intravenous infusion using weight-based dosing:

Weight Range (kilograms)	Recommended Dosage
up to 55 kg	260 mg (2 vials)
greater than 55 kg to 85 kg	390 mg (3 vials)
greater than 85 kg	520 mg (4 vials)

Crohn's Disease and Ulcerative Colitis Maintenance Adult Subcutaneous Recommended Dosage ( 2.3) :

A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

Coverage Restrictions

Find Restrictions and Step Therapies for Stelara

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drug label

Stelara Prescribing Information

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prior authorization

Stelara Prior Authorization Resources

Most recent state uniform prior authorization forms

Verified: Jul 26, 2024Arizona - Uniform Prior Authorization Form

Verified: Jul 26, 2024Colorado - Uniform Prior Authorization Form

Verified: Jul 26, 2024Hawaii - Uniform Prior Authorization Form

Verified: Jul 26, 2024Illinois - Uniform Prior Authorization Form

Verified: Jul 26, 2024Indiana - Uniform Prior Authorization Form

Verified: Jul 26, 2024Louisiana - Uniform Prior Authorization Form

Verified: Jul 26, 2024Minnesota - Uniform Prior Authorization Form

Verified: Jul 26, 2024New Hampshire - Uniform Prior Authorization Form

Verified: Jul 26, 2024New Mexico - Uniform Prior Authorization Form

Verified: Jul 26, 2024Oregon - Uniform Prior Authorization Form

Verified: Jul 26, 2024Texas - Uniform Prior Authorization Form

Verified: Jul 07, 2024Washington - Uniform Prior Authorization Form

Verified: Jul 07, 2024Wisconsin - Uniform Prior Authorization Form

Complete Letter of Medical Necessity

Medication Guide

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

Gastroenterology Enrollment Form

Dermatology & Rheumatology Enrollment Form

Benefits investigation

Gastroenterology Enrollment Form

Dermatology & Rheumatology Enrollment Form

Reimbursement help (FRM)

Receive Assistance from an FRM Regarding Reimbursement Information

pharmacy

Stelara Preferred Pharmacy

Pharmacy List

financial assistance

Stelara Financial Assistance Options

Copay savings program

Enroll in Patient Savings Program

Gastroenterology Enrollment Form

Dermatology & Rheumatology Enrollment Form

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Overview

Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)

Patient benefit

A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max

Patient eligibility

Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance

How to sign up

Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form

Bridge program

Bridge Program

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Overview

Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)

Patient benefit

100% free (outside of insurance)

Patient eligibility

HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries

How to sign up

Typically HCP assisted enrollment (via form)

Foundation programs

Janssen Patient Assistance Program

Johnson & Johnson Patient Assistance Foundation (JJPAF) Eligibility Check

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Overview

Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned

Patient benefit

Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and copays) until the grant is exhausted

Patient eligibility

Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.

How to sign up

Patients submit proof of out-of-pocket drug costs to charities for reimbursement

patient education

Stelara Patient Education

Getting started on Stelara

Instructions For Use: Plaque Psoriasis

ASK PATIENT TO:
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Instructions For Use: Psoriatic Arthritis

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Instructions For Use: Ulcerative Colitis

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Instructions For Use: Crohn's Disease

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To share resource; ask patient to:

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2.Open camera

3.Scan QR code with camera

4.Tap link

Patient toolkit

About Stelara: Plaque Psoriasis

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View How to Take Stelara: Plaque Psoriasis

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About Stelara: Pediatric Plaque Psoriasis

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Doctor Discussion Guide: Plaque Psoriasis

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About Stelara: Psoriatic Arthritis

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View How to Take Stelara: Psoriatic Arthritis

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Doctor Discussion Guide: Psoriatic Arthritis

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Patient Resources: Psoriatic Arthritis

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About Stelara: Ulcerative Colitis

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Patient Resources: Ulcerative Colitis

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About Stelara: Crohn's Disease

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Patient Resources: Crohn's Disease

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Stelara FAQs

Is STELARA® safe to use during pregnancy?Limited data on the use of STELARA® in pregnant women are insufficient to inform a drug-associated risk. Animal studies have not shown any adverse effects, but the background risk of major birth defects and miscarriage for the indicated population(s) is unknown. Pregnant women should only use STELARA® if the potential benefits outweigh the risks.

Is it safe to use STELARA® while breastfeeding?There is no data on the presence of ustekinumab in human milk or the effects on milk production or the breastfed infant. Ustekinumab was present in the milk of lactating monkeys administered ustekinumab. Breastfeeding women should only use STELARA® if the potential benefits outweigh the risks.

Can children use STELARA®?STELARA® is approved for the treatment of moderate to severe plaque psoriasis in pediatric patients 6 to 17 years old, and psoriatic arthritis in pediatric patients 6 to 17 years old. Use in patients less than 6 years of age with psoriasis or psoriatic arthritis or in pediatric patients with Crohn’s disease or ulcerative colitis has not been established.

Is STELARA® safe for geriatric patients?Although no overall differences in safety or efficacy were observed between older and younger patients, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients. Geriatric patients using STELARA® may have a higher frequency of serious infection, so caution should be used when treating them.

FAQ Data Source

Dosage & Administration

Dosage & Administration

Coverage Restrictions

Find Restrictions and Step Therapies for Stelara

drug label

Stelara Prescribing Information

prior authorization

Stelara Prior Authorization Resources

Most recent state uniform prior authorization forms

Benefits investigation

Reimbursement help (FRM)

pharmacy

Stelara Preferred Pharmacy

financial assistance

Stelara Financial Assistance Options

Copay savings program

Bridge program

Foundation programs

patient education

Stelara Patient Education

Getting started on Stelara

Patient toolkit

people also ask

Stelara FAQs