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.

Stelara Prescribing & Dosing Schedule

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.

Get Your Patient on Stelara

See your patient's specific prior authorization requirements including coverage restrictions and step therapies

Or select your Insurance from the list below:

Stelara Prescribing Information

Contact Medical Science Liaison

Report Adverse Event

Stelara Prior Authorization Resources

Most recent state uniform prior authorization forms

Verified: Sep 24, 2024Arizona - Uniform Prior Authorization Form

Verified: Sep 24, 2024Colorado - Uniform Prior Authorization Form

Verified: Sep 24, 2024Hawaii - Uniform Prior Authorization Form

Verified: Sep 24, 2024Illinois - Uniform Prior Authorization Form

Verified: Sep 24, 2024Indiana - Uniform Prior Authorization Form

Verified: Sep 24, 2024Louisiana - Uniform Prior Authorization Form

Verified: Sep 24, 2024Minnesota - Uniform Prior Authorization Form

Verified: Sep 24, 2024New Hampshire - Uniform Prior Authorization Form

Verified: Sep 24, 2024New Mexico - Uniform Prior Authorization Form

Verified: Sep 24, 2024Oregon - Uniform Prior Authorization Form

Verified: Sep 24, 2024Texas - Uniform Prior Authorization Form

Verified: Oct 05, 2024Washington - Uniform Prior Authorization Form

Verified: Oct 05, 2024Wisconsin - Uniform Prior Authorization Form

Appeals Considerations Checklist

Appeals Considerations Checklist - Spanish

Dermatology & Rheumatology Enrollment Form

Gastroenterology Enrollment Form

Letter of Exception: Crohn's Disease

Letter of Exception: Plaque Psoriasis

Letter of Exception: Psoriatic Arthritis

Letter of Exception: Ulcerative Colitis

Complete Letter of Medical Necessity

Medication Guide

PA Checklist

PA Checklist - Spanish

Benefits investigation

Dermatology & Rheumatology Enrollment Form

Gastroenterology Enrollment Form

Reimbursement help (FRM)

Receive Assistance from an FRM Regarding Reimbursement Information

Stelara Preferred Pharmacy

Pharmacy List

Stelara Financial Assistance Options

Copay savings program

Enroll in Patient Savings Program

Gastroenterology Enrollment Form

Dermatology & Rheumatology Enrollment Form

Learn More

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

Learn More

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

Learn More

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.