Is there a pregnancy exposure registry for SKYRIZI?

Yes, there is a pregnancy exposure registry for SKYRIZI that monitors outcomes in women who become pregnant while treated with the medication. Patients can enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com.

What is the background risk of birth defects and miscarriage in the general population?

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Is SKYRIZI detected in human milk?

There is no data on the presence of risankizumab in human milk. However, maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SKYRIZI and any potential adverse effects on the breastfed infant from the medication or from the underlying maternal condition.

Is SKYRIZI safe and effective in pediatric patients?

The safety and efficacy of SKYRIZI in pediatric patients (less than 18 years of age) have not been established.

Skyrizi Prescribing & Dosing Schedule

Dosage & Administration

* For the treatment of Crohn’s disease and ulcerative colitis: Obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI.

* Complete all age-appropriate vaccinations as recommended by current immunization guidelines

Recommended Dosage

Plaque Psoriasis and Psoriatic Arthritis:

* 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.

* In patients with psoriatic arthritis SKYRIZI can be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs).

Crohn’s Disease:

* The recommended induction dosage is 600 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain therapeutic response.

Ulcerative Colitis:

* The recommended induction dosage is 1,200 mg administered by intravenous infusion over at least two hours at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain therapeutic response.

Get Your Patient on Skyrizi

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

Or select your Insurance from the list below:

Skyrizi Prescribing Information

Contact Medical Science Liaison

Report Adverse Event

Skyrizi 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

Coverage Authorization Appeals

Formulary Exception Letter

Complete Letter of Medical Necessity

Tiered Exception Letter

Benefits investigation

Skyrizi Complete Prescription & Enrollment Form: Gastroenterology

Skyrizi Complete Prescription & Enrollment Form: Rheumatology & Dermatology

Reimbursement help (FRM)

Receive Assistance from an FRM Regarding Reimbursement Information

Skyrizi Preferred Pharmacy

Pharmacy List

Skyrizi Financial Assistance Options

Copay savings program

Skyrizi Complete Prescription & Enrollment Form: Rheumatology & Dermatology

Skyrizi Complete Prescription & Enrollment Form: Gastroenterology

Enroll in Patient Savings Program

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

Enroll in 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)

Skyrizi PubMed™ News

Skyrizi Patient Education

Getting started on Skyrizi

Instructions For Use: Plaque Psoriasis

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Instructions For Use: Psoriatic Arthritis

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Instructions For Use: Crohn's Disease

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

To share resource; ask patient to:

1.Pull out phone

2.Open camera

3.Scan QR code with camera

4.Tap link

Patient toolkit

Patient Brochure: Plaque Psoriasis

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Quick Tips For Self Injecting - 150mg Pen

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Quick Tips For Injecting - 150mg Prefilled Syringe

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

About Skyrizi: Plaque Psoriasis

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

View How to Take Skyrizi: Plaque Psoriasis & Psoriatic Arthritis

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Side Effects: Plaque Psoriasis & Psoriatic Arthritis

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Before and After: Plaque Psoriasis

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Patient Stories: Plaque Psoriasis

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Scan QR Code & Tap Link

Doctor Discussion Guide: Plaque Psoriasis & Psoriatic Arthritis

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Open Camera on Phone
Scan QR Code & Tap Link

Prep For Your Appointment: Plaque Psoriasis & Psoriatic Arthritis

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

About Skyrizi: Psoriatic Arthritis

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

About Skyrizi: Crohn's Disease

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

View How to Take Skyrizi: Crohn's Disease

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Side Effects: Crohn's Disease

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Doctor Discussion Guide: Crohn's Disease

ASK PATIENT TO:
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Infusion Support: Crohn's Disease

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Infusion Prep Guide: Crohn's Disease

ASK PATIENT TO:
Open Camera on Phone
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On-Body Injector (OBI) Prep Guide: Crohn's Disease

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Infusion To On-Body Injector (OBI) Guide

ASK PATIENT TO:
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Other resources

Skyrizi Complete App

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Sharps Container

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Skyrizi FAQs

Available data on risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. However, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero-exposed infant. Additionally, there are adverse pregnancy outcomes in women with inflammatory bowel disease.

Of the subjects with plaque psoriasis or psoriatic arthritis exposed to SKYRIZI, a total of 185 subjects were 65 years or older, and 13 subjects were 75 years or older. No overall differences in safety or effectiveness were observed between older and younger subjects who received SKYRIZI. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.