Skyrizi risankizumab-rzaa 600 mg/10mL Injection — NDC 0074-5015-01 (Billing 00074-5015-01)
This is a package of Skyrizi risankizumab-rzaa 600 mg/10mL Injection from AbbVie Inc., marketed since Jun 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 083490
- GCN: 52473
- HICL (First Databank): 045699
- AHFS class code: 84:06.28.00
- RxCUI (RxNorm): 797544
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Other antiseptics and disinfectants class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Risankizumab-rzaa injection is used to treat plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin) Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) Risankizumab-rzaa is in a class of medications called monoclonal antibodies. It works by stopping the acti...
Read the full MedlinePlus article ↗- Skyrizi is approved for four conditions: moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely...
- That depends on what you're treating. For psoriasis or psoriatic arthritis, you get a subcutaneous (under-the-skin) injection at weeks 0 and 4, and then roughly every 12 weeks afte...
- How often do I need to take Skyrizi, and do I have to go to a clinic every time?
- The most common ones are upper respiratory infections (like colds or sinus infections), headache, fatigue, and reactions at the injection site like redness or soreness. Fungal skin...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Risankizumab-Rzaa — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $856.88 | $856.88 / 1 vial |
| Medicare drug plans payPart D · Q2 2026 | $23,080.61 | $23,080.61 / 1 vial |
| Medicare Part B allowsASP · J2327 | $14.531 / J2327 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00074-5015-01 You're viewing this Main listing | 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE | 2022-06-16 | — | Active |
| 00074-5015-02 0074-5015-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE Sample | 2022-06-16 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Skyrizi risankizumab-rzaa 600 mg/10mL Injection?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Skyrizi 600 mg/10mLthis 00074-5015-01 | AbbVie | 1 vial | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Sep 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Jun 16, 2034 |
Is there a biosimilar for SKYRIZI 600 MG/10 ML VIAL?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Sep 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.54 mg / 10 mL
UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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2 mg / 10 mL
UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
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7.5 mg / 10 mL
UNII 4550K0SC9B
Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
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633.3 mg / 10 mL
UNII B8WCK70T7I
Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis in adults and pediatric patients 6 years of age and older. ( 1.2 ) moderately to severely active Crohn's disease in adults.
( 1.3 ) moderately to severely active ulcerative colitis in adults. ( 1.4 )
1.1Plaque Psoriasis SKYRIZI ® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy.
1.2Psoriatic Arthritis SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults and pediatric patients 6 years of age and older.
1.3Crohn’s Disease SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.
1.4Ulcerative Colitis SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For the treatment of moderately to severely active Crohn’s disease and ulcerative colitis: Obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI. ( 2.1 , 5.4 ) Complete all age-appropriate vaccinations as recommended by current immunization guidelines ( 2.1 , 5.5 ) Recommended Dosage Moderate-to-Severe Plaque Psoriasis: Adults : 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.3 ) Pediatric P atients 6 Years of Age and Older : Patients weighing less than 40 kg: 55 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
( 2.3 ) Patients weighing 40 kg or greater: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.3 ) Active Psoriatic Arthritis: Adults: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.4 ) Pediatric Patients 6 Y ears of Age and Older: Patients weighing less than 40 kg: 55 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
( 2.4 ) Patients weighing 40 kg or greater: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.4 ) SKYRIZI may be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). ( 2.4 ) Moderately to Severely Active 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. ( 2.6 ) Moderately to Severely Active 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. ( 2.7 )
2.1Procedures Prior to Treatment Initiation For the treatment of moderately to severely active Crohn’s disease and ulcerative colitis, obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI [see Warnings and Precautions ( 5.4 )] . Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI [see Warnings and Precautions ( 5.3 )] . Complete all age-appropriate vaccinations as recommended by current immunization guidelines [see Warnings and Precautions ( 5.5 )] .
2.2General Considerations for Administration • Visually inspect SKYRIZI for particulate matter and discoloration prior to administration. The solution may contain a few translucent to white particles. ○ SKYRIZI 55 mg/0.37 mL prefilled syringe, 150 mg/mL prefilled pen or prefilled syringe, 180 mg/1.2 mL prefilled syringe or prefilled cartridge, and 360 mg/2.4 mL prefilled cartridge: a colorless to yellow, and clear to slightly opalescent solution. ○ SKYRIZI 90 mg/mL prefilled syringe and 600 mg/10 mL vial: a colorless to slightly yellow, and clear to slightly opalescent solution. ○ Do not use if the solution contains large particles or is cloudy or discolored. • Discard after use.
Do not reuse. 2. 3 Recommended Dosage for Moderate-to-Severe Plaque Psoriasis Adults The recommended dosage for adults is 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
Pediatric Patients 6 Years of Age and Older The recommended dosage for pediatric patients 6 years of age and older is based on body weight (see Table 1 ) and administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. Table 1. Recommended Dose of SKYRIZI for Pediatric Patients 6 Years of Age and Older with Moderate-to-Severe Plaque Pso… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Subcutaneous Injection SKYRIZI Pen Injection: 150 mg/mL as a colorless to yellow and clear to slightly opalescent solution in each single-dose prefilled pen. SKYRIZI Prefilled Syringe Injection: 55 mg/0.37 mL as a colorless to yellow and clear to slightly opalescent solution in each single-dose prefilled syringe. Injection: 90 mg/mL as a colorless to slightly yellow and clear to slightly opalescent solution in each single-dose prefilled syringe.
Injection: 150 mg/mL as a colorless to yellow and clear to slightly opalescent solution in each single-dose prefilled syringe. Injection: 180 mg/1.2 mL (150 mg/mL) as a colorless to yellow and clear to slightly opalescent solution in each single-dose prefilled syringe. SKYRIZI Prefilled Cartridge with Supplied On-Body Injector Injection: 180 mg/1.2 mL (150 mg/mL) as a colorless to yellow, and clear to slightly opalescent solution in each single-dose prefilled cartridge for use with the on-body injector.
Injection: 360 mg/2.4 mL (150 mg/mL) as a colorless to yellow, and clear to slightly opalescent solution in each single-dose prefilled cartridge for use with the on-body injector. Intravenous Infusion SKYRIZI Vial Injection: 600 mg/10 mL (60 mg/mL) as a colorless to slightly yellow, and clear to slightly opalescent solution in each single-dose vial. Subcutaneous injection ( 3 ) Injection: 150 mg/mL in each single-dose prefilled pen.
Injection: 55 mg/0.37 mL in each single-dose prefilled syringe. Injection: 90 mg/mL in each single-dose prefilled syringe. Injection: 150 mg/mL in each single-dose prefilled syringe.
Injection: 180 mg/1.2 mL (150 mg/mL) in each single-dose prefilled syringe. Injection: 180 mg/1.2 mL (150 mg/mL) in each single-dose prefilled cartridge. Injection: 360 mg/2.4 mL (150 mg/mL) in each single-dose prefilled cartridge.
Intravenous infusion ( 3 ) Injection: 600 mg/10 mL (60 mg/mL) in each single-dose vial.
⛔ Contraindications ▾
4 CONTRAINDICATIONS SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients [see Warnings and Precautions ( 5.1 )] . SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur. ( 5.1 ) Infections: SKYRIZI may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur.
If such an infection develops, do not administer SKYRIZI until the infection resolves. ( 5.2 ) Tuberculosis (TB): Evaluate for TB prior to initiating treatment with SKYRIZI. ( 5.3 ) Hepatotoxicity: Drug-induced liver injury during induction treatment of inflammatory bowel disease has been reported.
Monitor liver enzymes and bilirubin levels at baseline and, during induction, up to at least 12 weeks of treatment. Monitor thereafter according to routine patient management. ( 5.4 ) Immunizations: Avoid use of live vaccines.
( 5.5 )
5.1Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately [see Adverse Reactions ( 6.1 )]. 5.
2 Infections SKYRIZI may increase the risk of infections [see Adverse Reactions ( 6.1 )] . Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI.
Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer SKYRIZI until the infection resolves. 5.
3 Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI. Across the Phase 3 psoriasis clinical studies, of the 72 subjects with latent TB who were concurrently treated with SKYRIZI and appropriate TB prophylaxis during the studies, none developed active TB during the mean follow-up of 61 weeks on SKYRIZI. Two subjects taking isoniazid for treatment of latent TB discontinued treatment due to liver injury.
Of the 31 subjects from the PsO-3 study with latent TB who did not receive prophylaxis during the study, none developed active TB during the mean follow-up of 55 weeks on SKYRIZI. Consider anti-TB therapy prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment.
Do not administer SKYRIZI to patients with active TB. 5. 4 Hepatotoxicity A serious adverse reaction of drug-induced liver injury in conjunction with a rash that required hospitalization was reported in a patient with Crohn’s disease (ALT 54x ULN, AST 30x ULN, and total bilirubin 2.2x ULN) following two 600 mg intravenous doses of SKYRIZI.
The liver test abnormalities resolved following administration of steroids. SKYRIZI was subsequently discontinued. For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline, and during induction at least up to 12 weeks of treatment.
Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury.
Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
5.5Immunizations Avoid use of live vaccines in patients treated with SKYRIZI. Drugs that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Tuberculosis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Most common adverse reactions are: Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. ( 6.1 ) Crohn’s Disease (>3%): ◦ Induction : upper respiratory infections, headache, and arthralgia.
( 6.1 ) ◦ Maintenance : arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection. ( 6.1 ) Ulcerative Colitis (≥3%): ◦ Induction : arthralgia. ( 6.1 ) ◦ Maintenance : arthralgia, pyrexia, injection site reactions, and rash.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Plaque Psoriasis A total of 2234 subjects were treated with SKYRIZI in clinical development trials in plaque psoriasis. Of these, 1208 subjects with psoriasis were exposed to SKYRIZI for at least one year.
Data from placebo- and active-controlled trials were pooled to evaluate the safety of SKYRIZI for up to 16 weeks. In total, 1306 subjects were evaluated in the SKYRIZI 150 mg group. Table 4 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the SKYRIZI group than the placebo group during the 16-week controlled period of pooled clinical trials.
Table 4. Adverse Reactions Occurring in ≥ 1% of Adults with Plaque Psoriasis on SKYRIZI through Week 16 Adverse Drug Reactions SKYRIZI N = 1306 n (%) Placebo N = 300 n (%) Upper respiratory infections a 170 (13) 29 (9.7) Headache b 46 (3.5) 6 (2) Fatigue c 33 (2.5) 3 (1) Injection site reactions d 19 (1.5) 3 (1) Tinea infections e 15 (1.1) 1 (0.3) a Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis b Includes: headache, tension headache, sinus headache, cervicogenic headache c Includes: fatigue, asthenia d Includes: injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, warmth e Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, tinea infection, onychomycosis Adverse reactions that occurred in < 1% but > 0.1% of subjects in the SKYRIZI group and at a higher rate than in the placebo group through Week 16 were folliculitis and urticaria.
Specific Adverse Reactions Infections: In the first 16 weeks, infections occurred in 22.1% of the SKYRIZI group (90.8 events per 100 patient-years) compared with 14.7% of the placebo group (56.5 events per 100 patient-years) and did not lead to discontinuation of SKYRIZI. The rates of serious infections for the SKYRIZI group and the placebo group were ≤0.4%. Serious infections in the SKYRIZI group included cellulitis, osteomyelitis, sepsis, and herpes zoster.
In Trials PsO-1 and PsO-2, through Week 52, the rate of infections (73.9 events per 100 patient-years) was similar to the rate observed during the first 16 weeks of treatment. Safety T hrough Week 52 Through Week 52, no new adverse reactions were identified, and the rates of the adverse reactions were similar to those observed during the first 16 weeks of treatment. During this period, serious infections that led to trial discontinuation included pneumonia.
Plaque Psoriasis of the Sca… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while treated with SKYRIZI. Patients should be encouraged to enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com. Risk Summary Available pharmacovigilance and clinical trial data with 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.
Although there are no data on risankizumab-rzaa, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero - exposed infant . There are adverse pregnancy outcomes in women with inflammatory bowel disease (see Clinical Considerations) . In an enhanced pre- and post-natal developmental toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of 5 or 50 mg/kg risankizumab-rzaa once weekly during the period of organogenesis up to parturition.
Increased fetal/infant loss was noted in pregnant monkeys at the 50 mg/kg dose (see Data) . The 50 mg/kg dose in pregnant monkeys resulted in approximately 5 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 32 times the exposure (AUC) to the maximum recommended maintenance dose (360 mg). No risankizumab-rzaa-related effects on functional or immunological development were observed in infant monkeys from birth through 6 months of age.
The clinical significance of these findings for humans is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown.
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. Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth.
Fetal/Neonatal adverse reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, SKYRIZI may be present in infants exposed in utero . The potential clinical impact of risankizumab exposure in infants exposed in utero should be considered.
Data Animal Data An enhanced pre- and post-natal developmental toxicity study was conducted in cynomolgus monkeys. Pregnant cynomolgus monkeys were administered weekly subcutaneous doses of risankizumab-rzaa of 5 or 50 mg/kg from gestation day 20 to parturition, and the cynomolgus monkeys (mother and infants) were monitored for 6 months after delivery. No maternal toxicity was noted in this study.
There were no treatment-related effects on growth and development, malformations, developmental immunotoxicology, or neurobehavioral development. However, a dose-dependent increase in fetal/infant loss was noted in the risankizumab-rzaa-treated groups (32% and 43% in the 5 mg/kg and 50 mg/kg groups, respectively) compared with the vehicle control group (19%). The increased fetal/infant loss in the 50 mg/kg group was considered to be related to risankizumab-rzaa treatment.
The no-observed adverse effect level (NOAEL) for maternal toxicity was identified as 50 mg/kg, and the NOAEL for developmental toxicity was identified as 5 mg/kg. The 5 mg/kg dose in pregnant monkeys resulted in approximately 0.6 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 5 times the exposure (AUC) in humans administered the… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while treated with SKYRIZI. Patients should be encouraged to enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com. Risk Summary Available pharmacovigilance and clinical trial data with 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.
Although there are no data on risankizumab-rzaa, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero - exposed infant . There are adverse pregnancy outcomes in women with inflammatory bowel disease (see Clinical Considerations) . In an enhanced pre- and post-natal developmental toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of 5 or 50 mg/kg risankizumab-rzaa once weekly during the period of organogenesis up to parturition.
Increased fetal/infant loss was noted in pregnant monkeys at the 50 mg/kg dose (see Data) . The 50 mg/kg dose in pregnant monkeys resulted in approximately 5 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 32 times the exposure (AUC) to the maximum recommended maintenance dose (360 mg). No risankizumab-rzaa-related effects on functional or immunological development were observed in infant monkeys from birth through 6 months of age.
The clinical significance of these findings for humans is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown.
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. Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth.
Fetal/Neonatal adverse reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, SKYRIZI may be present in infants exposed in utero . The potential clinical impact of risankizumab exposure in infants exposed in utero should be considered.
Data Animal Data An enhanced pre- and post-natal developmental toxicity study was conducted in cynomolgus monkeys. Pregnant cynomolgus monkeys were administered weekly subcutaneous doses of risankizumab-rzaa of 5 or 50 mg/kg from gestation day 20 to parturition, and the cynomolgus monkeys (mother and infants) were monitored for 6 months after delivery. No maternal toxicity was noted in this study.
There were no treatment-related effects on growth and development, malformations, developmental immunotoxicology, or neurobehavioral development. However, a dose-dependent increase in fetal/infant loss was noted in the risankizumab-rzaa-treated groups (32% and 43% in the 5 mg/kg and 50 mg/kg groups, respectively) compared with the vehicle control group (19%). The increased fetal/infant loss in the 50 mg/kg group was considered to be related to risankizumab-rzaa treatment.
The no-observed adverse effect level (NOAEL) for maternal toxicity was identified as 50 mg/kg, and the NOAEL for developmental toxicity was identified as 5 mg/kg. The 5 mg/kg dose in pregnant monkeys resulted in approximately 0.6 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 5 times the exposure (AUC) in humans administered the maximum recommended maintenan… [Excerpted — this section continues on DailyMed.]
🧒 Pediatric Use ▾
8.4Pediatric Use Moderate-to-Severe Plaque Psoriasis The safety and effectiveness of SKYRIZI for the treatment of moderate-to-severe plaque psoriasis have been established in pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. Use of SKYRIZI for this indication is supported by evidence from a four-part trial in a total of 137 pediatric subjects 6 years of age and older with moderate-to-severe plaque psoriasis. In addition to two lead-in pharmacokinetic cohorts, the trial also included a randomized, efficacy assessor-blinded, active treatment-controlled cohort that enrolled 82 pediatric subjects 12 years of age and older and a single-arm, open-label cohort that enrolled 30 pediatric subjects 6 to less than 12 years of age [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.1 )] .
The safety and effectiveness of SKYRIZI have not been established in pediatric patients younger than 6 years of age with moderate-to-severe plaque psoriasis. Active Psoriatic Arthritis The safety and effectiveness of SKYRIZI for the treatment of psoriatic arthritis have been established in pediatric patients 6 years of age and older. Use of SKYRIZI for this indication is supported by evidence from well-controlled studies of SKYRIZI in adults with psoriatic arthritis, pharmacokinetic data from adult patients with psoriatic arthritis or plaque psoriasis, and pharmacokinetic, safety, and immunogenicity data from pediatric patients with moderate-to-severe plaque psoriasis [see A dverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 , 12.6 ), and Clinical Studies ( 14.2 ) ] .
Risankizumab exposures in pediatric patients with psoriatic arthritis at the recommended dosage are predicted to be comparable to those observed in adults with psoriatic arthritis based on population pharmacokinetic modeling and simulation . The safety and effectiveness of SKYRIZI have not been established in pediatric patients younger than 6 years of age with psoriatic arthritis. Crohn’s Disease and Ulcerative Colitis The safety and effectiveness of SKYRIZI have not been established in pediatric patients with Crohn’s disease or ulcerative colitis.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 6,862 subjects exposed to SKYRIZI, a total of 664 were 65 years and older (243 subjects with plaque psoriasis, 246 subjects with psoriatic arthritis, 72 subjects with Crohn’s disease and 103 subjects with ulcerative colitis), and 71 subjects were 75 years and older. Clinical studies of SKYRIZI, within each indication, did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects. No clinically meaningful differences in the pharmacokinetics of risankizumab-rzaa were observed based on age [see Clinical Pharmacology ( 12.3 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Risankizumab-rzaa is a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Risankizumab-rzaa inhibits the release of pro-inflammatory cytokines and chemokines.
12.2Pharmacodynamics No formal pharmacodynamics studies have been conducted with risankizumab-rzaa.
12.3Pharmacokinetics Risankizumab-rzaa plasma concentrations, after single dose administration increased dose proportionally from 18 mg to 360 mg when administered subcutaneously (0.12 to 2.4 times the lowest recommended dose and 0.05 to 1 times the highest recommended dose) and from 200 mg to 1,800 mg when administered as an up to 3-hour intravenous infusion (0.2 to 3 times the recommended dose) in healthy subjects. In subjects with plaque psoriasis treated with 150 mg subcutaneously at Weeks 0, 4, and every 12 weeks thereafter, steady-state peak concentration (C max ) and trough concentration (C trough ) are estimated to be 12 mcg/mL and 2 mcg/mL, respectively.
With the same subcutaneous dosing regimen, the pharmacokinetics of risankizumab-rzaa in subjects with psoriatic arthritis were similar to that in subjects with plaque psoriasis. In subjects with Crohn’s disease treated with 600 mg intravenous induction dose at Weeks 0, 4, and 8, followed by 180 mg or 360 mg subcutaneous maintenance dose at Week 12 and every 8 weeks thereafter, the median C max and C trough are estimated to be 156 mcg/mL and 38.8 mcg/mL, respectively, during Weeks 8-12; and the steady state median C max and C trough are estimated to be 14 mcg/mL and 4.1 mcg/mL, respectively for 180 mg or 28 mcg/mL and 8.1 mcg/mL, respectively, for 360 mg, during Weeks 40-48.
In subjects with ulcerative colitis treated with 1,200 mg intravenous induction dose at Weeks 0, 4, and 8, followed by 180 mg or 360 mg subcutaneous maintenance dose at Week 12 and every 8 weeks thereafter, the median C max and C trough are estimated to be 350 and 87.7 mcg/mL, respectively, during the induction period (Weeks 8-12); and the steady state median C max and C trough are estimated to be 19.6 and 4.64 µg/mL, respectively, for 180 mg or 39.2 mcg/mL and 9.29 mcg/mL, respectively, for 360 mg, during the maintenance period (Weeks 40-48).
Based on population pharmacokinetic analyses, the pharmacokinetics of risankizumab-rzaa in subjects with ulcerative colitis was generally similar to that in subjects with Crohn’s disease. Absorption The absolute bioavailability of risankizumab-rzaa was estimated to be 74 to 89% following subcutaneous injection. In healthy subjects, following administration of a single subcutaneous dose, C max was reached by 3 to 14 days.
Distribution The estimated steady-state volume of distribution (inter-subject CV%) was
11.2 L (34%) in subjects with plaque psoriasis, and
7.68L (64%) in subjects with Crohn’s disease. Elimination The estimated systemic clearance (inter-subject CV%) was
0.31 L/day (24%) and
0.30L/day (34%) and terminal elimination half-life was approximately 28 days and 21 days in subjects with plaque psoriasis and Crohn’s disease, respectively. Metabolism The metabolic pathway of risankizumab-rzaa has not been characterized. As a humanized IgG1 monoclonal antibody, risankizumab-rzaa is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.
Specific Populations Pediatric Patients Plaque Psoriasis: Risankizumab-rzaa exposures in pediatric subjects 6 years of age and older with plaque psoriasis receiving weight-based dosing regimens were consistent with those in adults. At the recommended dosing regimens evaluated in these subjects, estimated median steady-state peak and trough plasma concentrations were 15.7 and 2.3 mcg/mL, respectively, in subjects weighing less than 40 kg, and 11.1 and 1.6… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Risankizumab-rzaa is a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Risankizumab-rzaa inhibits the release of pro-inflammatory cytokines and chemokines.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied SKYRIZI (risankizumab-rzaa) injection is supplied in the following strengths and packaging units: Strength Packaging Unit NDC Subcutaneous Injection 150 mg/mL single-dose pen Carton of 1 0074-2100-01 55 mg/0.37 mL single-dose prefilled syringe Carton of 1 0074-4059-01 90 mg/mL single-dose prefilled syringe Carton of 2 0074-7040-02 Carton of 4 0074-7042-04 180 mg/1.2 mL (150 mg/mL) single-dose prefilled syringe Carton of 1 0074-8300-01 Carton of 2 0074-8350-01 150 mg/mL single-dose prefilled syringe Carton of 1 0074-1050-01 180 mg/1.2 mL (150 mg/mL) single-dose prefilled cartridge with on-body injector Kit 0074-1065-01 360 mg/2.4 mL (150 mg/mL) single-dose prefilled cartridge with on-body injector Kit 0074-1070-01 Intravenous Infusion 600 mg/10 mL (60 mg/mL) single-dose vial Carton of 1 0074-5015-01 Subcutaneous Injection SKYRIZI 55 mg/0.37 mL prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution.
Each prefilled syringe consists of a 1 mL glass syringe with a fixed 27-gauge ½ inch needle with needle guard. SKYRIZI 150 mg/mL prefilled syringe or prefilled pen contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each prefilled syringe or prefilled pen consists of a 1 mL glass syringe with a fixed 27-gauge ½ inch needle with needle guard.
SKYRIZI 90 mg/mL prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow and clear to slightly opalescent solution. Each prefilled syringe consists of a 1 mL glass syringe with a fixed 29-gauge ½ inch needle with needle guard. SKYRIZI 180 mg/1.2 mL (150 mg/mL) prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution.
Each prefilled syringe consists of a 2.25 mL glass syringe with a fixed 27-gauge ½ inch needle with needle guard. SKYRIZI 180 mg/1.2 mL (150 mg/mL) cyclic olefin polymer prefilled cartridge with a septum and cap contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution for use with supplied on-body injector administration device. SKYRIZI 360 mg/2.4 mL (150 mg/mL) cyclic olefin polymer prefilled cartridge with a septum and cap contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution for use with supplied on-body injector administration device.
Intravenous Infusion SKYRIZI 600 mg/10 mL (60 mg/mL) vial contains a sterile and preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each glass vial is closed with a stopper and blue flip cap. Storage and Handling Store in a refrigerator at 36°F to 46° F (2°C to 8°C).
Do not freeze. Do not shake. Keep in the original cartons to protect from light.
Not made with natural rubber latex.
📋 Description ▾
11 DESCRIPTION Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/ 0.37 mL prefilled syringe for subcutaneous use Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution.
Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution.
Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution.
Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution.
Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/ 1.2 mL (150 mg/ mL ) prefilled cartridge for use with supplied on-body-injector for subcutaneous use Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution.
Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied o n- b ody i njector for subcutaneous use Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution.
Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial.
Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients and/or caregivers to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Hypersensitivity Reactions Advise patients to discontinue SKYRIZI and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions ( 5.1 )]. Infections Inform patients that SKYRIZI may lower the ability of their immune system to fight infections.
Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions ( 5.2 )] . Hepatotoxicity Inform patients that SKYRIZI may cause liver injury, especially during the initial 12 weeks of treatment. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of liver dysfunction (e.g., unexplained rash, nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine) [see Warnings and Precautions ( 5.4 )] .
Immunizations Advise patients that vaccination with live vaccines is not recommended during SKYRIZI treatment and immediately prior to or after SKYRIZI treatment. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Instruct patients to inform the healthcare practitioner that they are taking SKYRIZI prior to a potential vaccination [see Warnings and Precautions ( 5.5 ) ] .
Administration Instruction Instruct patients or caregivers to perform the first self-injected dose under the supervision and guidance of a qualified healthcare professional for training in preparation and administration of SKYRIZI, including choosing anatomical sites for administration, and proper subcutaneous injection technique [see Dosage and Administration ( 2.5 )] . For pediatric patients, inform patients and caregivers that for pediatric patients 10 years of age and older, it is recommended that SKYRIZI be administered by or under supervision of an adult.
For pediatric patients 6 to less than 10 years of age, SKYRIZI should be administered by an adult [see Dosage and Administration ( 2.5 )] . If using SKYRIZI 90 mg/mL, instruct patients or caregivers to administer two 90 mg single-dose syringes to achieve the full 180 mg maintenance dose or four 90 mg single-dose syringes to achieve the full 360 mg maintenance dose of SKYRIZI for Crohn’s disease or ulcerative colitis [see Instructions for Use ] . If using SKYRIZI 180 mg/1.2 mL, instruct patients or caregivers to administer one 180 mg single-dose syringe to achieve the full 180 mg maintenance dose or two 180 mg single-dose syringes to achieve the full 360 mg maintenance dose of SKYRIZI for Crohn’s disease or ulcerative colitis [see Instructions for Use ] .
Instruct patients or caregivers in the technique of pen or syringe disposal [see Instructions for Use ] . Pregnancy Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to SKYRIZI during pregnancy [see Use in Specific Populations ( 8.1 ) ] . Manufactured by: AbbVie Inc.
North Chicago, IL 60064, USA US License Number 1889 SKYRIZI and its design are trademarks of AbbVie Biotechnology Ltd. © 2026 AbbVie. All rights reserved. 20101630 6/2026
💬 Medication Guide ▾
Medication Guide SKYRIZI ® (sky-RIZZ-ee) (risankizumab-rzaa) injection, for subcutaneous or intravenous use What is the most important information I should know about SKYRIZI? SKYRIZI may cause serious side effects, including: Serious allergic reactions. Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: ● fainting, dizziness, feeling lightheaded (low blood pressure) ● chest tightness ● swelling of your face, eyelids, lips, mouth, tongue, or throat ● skin rash, hives ● trouble breathing or throat tightness ● itching Infections.
SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.
Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: ● fever, sweats, or chills ● muscle aches ● weight loss ● cough ● warm, red, or painful skin or sores on your body different from your psoriasis ● diarrhea or stomach pain ● shortness of breath ● burning when you urinate or urinating more often than normal ● blood in your mucus (phlegm) See “What are the possible side effects of SKYRIZI?” for more information about side effects. What is SKYRIZI? SKYRIZI is a prescription medicine used to treat: moderate to severe plaque psoriasis in adults and children 6 years of age and older who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). active psoriatic arthritis in adults and children 6 years of age and older. moderate to severe Crohn’s disease in adults. moderate to severe ulcerative colitis in adults.
It is not known if SKYRIZI is safe and effective in children under 6 years of age with moderate to severe plaque psoriasis or active psoriatic arthritis. It is not known if SKYRIZI is safe and effective in children with Crohn’s disease or ulcerative colitis. Who should not use SKYRIZI?
Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the end of this Medication Guide for a complete list of ingredients in SKYRIZI. Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section “What is the most important information I should know about SKYRIZI?” have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine).
Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine. are pregnant or plan to become pregnant.
It is not known if SKYRIZI can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk. If you become pregnant while taking SKYRIZI, you are encouraged to enroll in the Pregnancy Registry.
The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use SKYRIZI? See the detailed “Instructions for Use” that comes with SKYRIZI for information on how to pr… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Risankizumab-rzaa plasma concentrations, after single dose administration increased dose proportionally from 18 mg to 360 mg when administered subcutaneously (0.12 to 2.4 times the lowest recommended dose and 0.05 to 1 times the highest recommended dose) and from 200 mg to 1,800 mg when administered as an up to 3-hour intravenous infusion (0.2 to 3 times the recommended dose) in healthy subjects. In subjects with plaque psoriasis treated with 150 mg subcutaneously at Weeks 0, 4, and every 12 weeks thereafter, steady-state peak concentration (C max ) and trough concentration (C trough ) are estimated to be 12 mcg/mL and 2 mcg/mL, respectively.
With the same subcutaneous dosing regimen, the pharmacokinetics of risankizumab-rzaa in subjects with psoriatic arthritis were similar to that in subjects with plaque psoriasis. In subjects with Crohn’s disease treated with 600 mg intravenous induction dose at Weeks 0, 4, and 8, followed by 180 mg or 360 mg subcutaneous maintenance dose at Week 12 and every 8 weeks thereafter, the median C max and C trough are estimated to be 156 mcg/mL and 38.8 mcg/mL, respectively, during Weeks 8-12; and the steady state median C max and C trough are estimated to be 14 mcg/mL and 4.1 mcg/mL, respectively for 180 mg or 28 mcg/mL and 8.1 mcg/mL, respectively, for 360 mg, during Weeks 40-48.
In subjects with ulcerative colitis treated with 1,200 mg intravenous induction dose at Weeks 0, 4, and 8, followed by 180 mg or 360 mg subcutaneous maintenance dose at Week 12 and every 8 weeks thereafter, the median C max and C trough are estimated to be 350 and 87.7 mcg/mL, respectively, during the induction period (Weeks 8-12); and the steady state median C max and C trough are estimated to be 19.6 and 4.64 µg/mL, respectively, for 180 mg or 39.2 mcg/mL and 9.29 mcg/mL, respectively, for 360 mg, during the maintenance period (Weeks 40-48).
Based on population pharmacokinetic analyses, the pharmacokinetics of risankizumab-rzaa in subjects with ulcerative colitis was generally similar to that in subjects with Crohn’s disease. Absorption The absolute bioavailability of risankizumab-rzaa was estimated to be 74 to 89% following subcutaneous injection. In healthy subjects, following administration of a single subcutaneous dose, C max was reached by 3 to 14 days.
Distribution The estimated steady-state volume of distribution (inter-subject CV%) was
11.2 L (34%) in subjects with plaque psoriasis, and
7.68L (64%) in subjects with Crohn’s disease. Elimination The estimated systemic clearance (inter-subject CV%) was
0.31 L/day (24%) and
0.30L/day (34%) and terminal elimination half-life was approximately 28 days and 21 days in subjects with plaque psoriasis and Crohn’s disease, respectively. Metabolism The metabolic pathway of risankizumab-rzaa has not been characterized. As a humanized IgG1 monoclonal antibody, risankizumab-rzaa is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.
Specific Populations Pediatric Patients Plaque Psoriasis: Risankizumab-rzaa exposures in pediatric subjects 6 years of age and older with plaque psoriasis receiving weight-based dosing regimens were consistent with those in adults. At the recommended dosing regimens evaluated in these subjects, estimated median steady-state peak and trough plasma concentrations were 15.7 and 2.3 mcg/mL, respectively, in subjects weighing less than 40 kg, and 11.1 and 1.6 mcg/mL, respectively, in subjects weighing 40 kg or greater. Psoriatic Arthritis: Risankizumab exposures in patients 6 years of age and older with active psoriatic arthritis at the recommended pediatric dosage are predicted to be comparable to those observed in adult patients with psoriatic arthritis based on population pharmacokinetic modeling simulation.
Geriatric Patients Risankizumab-rzaa exposures (C trough ) in geriatric patients (≥65 years) are comparable to those in younger adult patients within… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics No formal pharmacodynamics studies have been conducted with risankizumab-rzaa.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Figure 1. Percent of Adult Subjects with Active Psoriatic Arthritis Achieving ACR20 Responses in Trial PsA-1 through Week 24
14.1Clinical Trials in Subjects with Moderate-to-Severe Plaque Psoriasis Adults with Moderate-to-Severe Plaque Psoriasis Four multicenter, randomized, double-blind trials [PsO-1 (NCT02684370), PsO-2 (NCT02684357), PsO-3 (NCT02672852), and PsO-4 (NCT02694523)] enrolled 2,109 subjects 18 years of age and older with moderate-to-severe plaque psoriasis who had a body surface area (BSA) involvement of ≥10%, a static Physician’s Global Assessment (sPGA) score of ≥3 (“moderate”) in the overall assessment (plaque thickness/induration, erythema, and scaling) of psoriasis on a severity scale of 0 to 4, and a Psoriasis Area and Severity Index (PASI) score ≥12.
Overall, subjects had a median baseline PASI score of 17.8 and a median BSA of 20%. Baseline sPGA score was 4 (“severe”) in 19% of subjects. A total of 10% of trial subjects had a history of diagnosed psoriatic arthritis.
Across all trials, 38% of subjects had received prior phototherapy, 48% had received prior non-biologic systemic therapy, and 42% had received prior biologic therapy for the treatment of psoriasis. Trials PsO-1 and PsO-2 In trials PsO-1 and PsO-2, 997 subjects were enrolled (including 598 subjects randomized to the SKYRIZI 150 mg group, 200 subjects randomized to the placebo group, and 199 to the biologic active control group). Subjects received treatment at Weeks 0, 4, and every 12 weeks thereafter.
Both trials assessed the responses at Week 16 compared with placebo for the two co-primary endpoints: the proportion of subjects who achieved an sPGA score of 0 (“clear”) or 1 (“almost clear”) the proportion of subjects who achieved at least a 90% reduction from baseline PASI (PASI 90) Secondary endpoints included the proportion of subjects who achieved PASI 100, sPGA 0, and Psoriasis Symptom Scale (PSS) 0 at Week 16. The results are presented in Table 8. Table 8.
Efficacy Results at Week 16 in Adults with Moderate-to-Severe Plaque Psoriasis in PsO-1 and PsO-2 PsO-1 PsO-2 SKYRIZI (N=304) n (%) Placebo (N=102) n (%) SKYRIZI (N=294) n (%) Placebo (N=98) n (%) sPGA 0 or 1 (“clear or almost clear”) a 267 (88) 8 (8) 246 (84) 5 (5) PASI 90 a 229 (75) 5 (5) 220 (75) 2 (2) sPGA 0 (“clear”) 112 (37) 2 (2) 150 (51) 3 (3) PASI 100 109 (36) 0 (0) 149 (51) 2 (2) a Co-primary endpoints Examination of age, gender, race, body weight, baseline PASI score and previous treatment with systemic or biologic agents did not identify differences in response to SKYRIZI among these subgroups at Week 16.
In PsO-1 and PsO-2 at Week 52, subjects receiving SKYRIZI achieved sPGA 0 (58% and 60%, respectively), PASI 90 (82% and 81%, respectively), and PASI 100 (56% and 60%, respectively). Patient Reported Outcomes Improvements in signs and symptoms related to pain, redness, itching and burning at Week 16 compared to placebo were observed in both trials as assessed by the PSS. In PsO-1 and PsO-2, about 30% of the subjects who received SKYRIZI achieved PSS 0 (“none”) at Week 16 compared to 1% of the subjects who received placebo.
Trial PsO-3 Trial PsO-3 enrolled 507 subjects (407 randomized to SKYRIZI 150 mg and 100 to placebo). Subjects received treatment at Weeks 0, 4, and every 12 weeks thereafter. At Week 16, SKYRIZI was superior to placebo on the co-primary endpoints of sPGA 0 or 1 (84% SKYRIZI and 7% placebo) and PASI 90 (73% SKYRIZI and 2% placebo).
The respective response rates for SKYRIZI and placebo at Week 16 were: sPGA 0 (46% SKYRIZI and 1% placebo); PASI 100 (47% SKYRIZI and 1% placebo); and PASI 75 (89% SKYRIZI and 8% placebo). Maintenance and Durability of Response In PsO-1 and PsO-2, among the subjects who received SKYRIZI and had PASI 100 at Week 16, 80% (206/258) of the subjects who continued on SKYRIZI had PASI 100 at Week 52. For PASI 90 responders at Week 16, 88% (398/450) of the subjects had PASI 90 at Week 52.
In PsO-3, subjects who were… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and mutagenicity studies have not been conducted with SKYRIZI. No effects on male fertility parameters were observed in sexually mature male cynomolgus monkeys dosed weekly for 26 weeks with 50 mg/kg risankizumab-rzaa at 4 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 39 times the exposure in humans administered the maximum recommended maintenance dose (360 mg).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and mutagenicity studies have not been conducted with SKYRIZI. No effects on male fertility parameters were observed in sexually mature male cynomolgus monkeys dosed weekly for 26 weeks with 50 mg/kg risankizumab-rzaa at 4 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 39 times the exposure in humans administered the maximum recommended maintenance dose (360 mg).
📖 Instructions for Use ▾
I NSTRUCTIONS FOR USE SKYRIZI ® (sky-RIZZ-ee) Pen (risankizumab-rzaa) injection, for subcutaneous use single-dose prefilled pen 150 mg/mL Read Before First Use Refer to the Medication Guide for product information. Read complete Instructions for Use before using SKYRIZI Pen (risankizumab-rzaa) injection. Before using SKYRIZI, you should receive training from your healthcare provider on how to inject SKYRIZI Pen .
In children 10 years of age and older, it is recommended that SKYRIZI Pen be given by an adult or with an adult watching (supervision). In children 6 years to less than 10 years of age, SKYRIZI should be given by an adult. SKYRIZI Pen Important Information You Need to Know Before Injecting SKYRIZI Pen Store SKYRIZI Pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
Keep SKYRIZI Pen in the original carton to protect from light until you are ready to use. Before injecting, take the SKYRIZI Pen carton out of the refrigerator. Leave the carton at room temperature and out of direct sunlight for 30 to 90 minutes.
The liquid in the inspection window should look clear to yellow and may contain tiny white or clear particles. Do not use SKYRIZI Pen if the liquid is discolored , cloudy or contains flakes or large particles . Do not use SKYRIZI Pen if the expiration date (EXP) has passed.
Do not use SKYRIZI Pen if the liquid has been frozen, even if it has been thawed. Do not shake SKYRIZI Pen. Do not use if the SKYRIZI Pen has been dropped or damaged.
Do not use SKYRIZI Pen if carton perforations are broken. Return product to pharmacy. Do not remove the dark gray cap until right before injection.
SKYRIZI Pen is not made with natural rubber latex. Prepare SKYRIZI Pen injection Take the SKYRIZI Pen carton out of the refrigerator. Leave the carton at room temperature and out of direct sunlight for 30 to 90 minutes before injecting.
Do not remove the SKYRIZI Pen from the carton while allowing SKYRIZI to reach room temperature. Do not warm SKYRIZI Pen in any other way. For example, do not warm it in a microwave or in hot water.
Do not use the SKYRIZI Pen if the liquid has been frozen, even if it has been thawed. Check expiration date (EXP). Do not use the SKYRIZI Pen if expiration date has passed.
Gather and Place the following on a clean, flat surface: 1 single-dose SKYRIZI Pen (included) 1 alcohol swab (not included) 1 cotton ball or gauze pad (not included) Sharps disposal container (not included). See “ Used SKYRIZI Pen Disposal ” for information on how to throw away (dispose of) used SKYRIZI Pens. Wash and dry your hands.
Choose an injection site: on the front of your left thigh or right thigh or your abdomen (belly) at least 2 inches from your navel (belly button) W ipe the injection site in a circular motion with the alcohol swab and let it dry. Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting.
Do not inject through clothes. Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis. Hold the SKYRIZI Pen with the dark gray cap pointing up.
Pull the dark gray cap straight off. Throw the dark gray cap away. Check the liquid through the inspection window.
It is normal to see 1 or more bubbles in the liquid. The liquid should look clear to yellow and may contain tiny white or clear particles. Do not use if the liquid is discolored , cloudy or contains flakes or large particles .
Give SKYRIZI Pen injection Hold the SKYRIZI Pen with your fingers on the gray hand grips. Turn the SKYRIZI Pen so that the white needle sleeve points toward the injection site and you can see the green activator button. Pinch the skin at your injection site to make a raised area and hold it firmly.
Place the white needle sleeve straight (90-degree angle) against the raised injection site. Hold the SKYRIZI Pen so that you can see the green activator button and inspection window. Push and keep pressing the SKYRIZI Pen down firmly against the raise… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Indications and Usage ( 1.1 , 1.2 ) 6/2026 Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 , 2.8 ) 6/2026
📄 Package Label / Principal Display Panel ▾
NDC 0074-2100-01 One 1 mL Single-Dose Prefilled Pen Skyriz i ® PEN 150 mg/mL risankizumab-rzaa Injection FOR SUBCUTANEOUS USE ONLY Return to pharmacy if carton perforations are broken. ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide. The entire carton is to be dispensed as a unit. www.SKYRIZI.com Rx only abbvie NDC 0074-2100-01 One 1 mL Single-Dose Prefilled Pen Skyrizi® PEN 150 mg/mL risankizumab-rzaa Injection FOR SUBCUTANEOUS USE ONLY Return to pharmacy if carton perforations are broken.
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide. This entire carton is dispensed as a unit. www.SKYRIZI.com Rx only abbvie
NDC 0074-1050-01 One 1 mL Single-Dose Prefilled Syringe Skyriz i ® 150 mg/mL risankizumab-rzaa injection FOR SUBCUTANEOUS USE ONLY AREA FOR PHARMACY LABEL www.SKYRIZI.com Rx only A bbvie NDC 0074-1050-01 One 1 mL Single-Dose Prefilled Syringe Skyrizi® 150 mg/mL risankizumab-rzaa injection FOR SUBCUTANEOUS USE ONLY Return to pharmacy if carton perforations are broken. This entire carton is dispensed as a unit. AREA FOR PHARMACY LABEL www.SKYRIZI.com Rx only Abbvie
NDC 0074-1070-01 1 x 2.4 mL P refilled Cartridge 1 On-Body Injector Skyriz i ® risankizumab-rzaa Injection 3 60 mg/ 2.4 mL (150 mg/mL) FOR SUBCUTANEOUS USE ONLY Single-Dose SKYRIZI.com Rx only abbvie NDC 0074-1070-01 1 x 2.4 mL Prefilled Cartridge 1 On-Body Injector Skyrizi® risankizumab-rzaa Injection 360 mg/2.4 mL (150 mg/mL) FOR SUBCUTANEOUS USE ONLY Single-Dose SKYRIZI.com Rx only abbvie
NDC 0074-5015-01 Skyriz i ® risankizumab-rzaa Injection 600 mg/ 10 mL (60 mg/mL) FOR INTR A VENOUS USE ONLY Must be diluted prior to use One 10 mL Single-Dose Vial- Discard Unused Portion ATTENTION: Dispense the enclosed Medication Guide to each patient. Rx only abbvie NDC 0074-5015-01 Skyrizi® risankizumab-rzaa Injection 600 mg/10 mL (60 mg/mL) FOR INTRAVENOUS USE ONLY Must be diluted prior to use One 10 mL Single-Dose Vial- Discard Unused Portion ATTENTION: Dispense the enclosed Medication Guide to each patient. Rx only abbvie
NDC 0074-1069-01 Skyrizi ® risankizumab-rzaa Injection 360 mg/2.4 mL (150 mg/mL) FOR SUBCUTANEOUS USE ONLY Single-Dose Rx Only NDC 0074-1069-01 Skyrizi® risankizumab-rzaa Injection 360 mg/2.4 mL (150 mg/mL) FOR SUBCUTANEOUS USE ONLY Single-Dose Rx Only
NDC 0074-1069-02 NOT FOR SALE Skyrizi ® risankizumab-rzaa Injection 360 mg/2.4 mL (150 mg/mL) FOR SUBCUTANEOUS USE ONLY Single-Dose Rx Only NDC 0074-7032-90 One 1 mL Single-Dose Prefilled Syringe Skyrizi® risankizumab-rzaa Injection 90 mg/mL FOR SUBCUTANEOUS USE ONLY FOR HEALTHCARE PROVIDER ADMINISTRATION ONLY www. SKYRIZI.com Rx Only abbvie
NDC 0074-1065-01 1 x 1.2 mL Prefilled Cartridge 1 On-Body Injector Skyrizi ® risankizumab-rzaa Injection 180 mg/1.2 mL (150 mg/mL) FOR SUBCUTANEOUS USE ONLY Single-Dose SKYRIZI.com Rx only abbvie NDC 0074-1065-01 1 x 1.2 mL Prefilled Cartridge 1 On-Body Injector Skyrizi® risankizumab-rzaa Injection 180 mg/1.2 mL (150 mg/mL) FOR SUBCUTANEOUS USE ONLY Single-Dose SKYRIZI.com Rx only abbvie
NDC 0074-1066-01 Skyrizi ® risankizumab-rzaa Injection 180 mg/1.2 mL (150 mg/mL) FOR SUBCUTANEOUS USE ONLY Single-Dose Rx Only NDC 0074-1066-01 Skyrizi® risankizumab-rzaa Injection 180 mg/1.2 mL (150 mg/mL) FOR SUBCUTANEOUS USE ONLY Single-Dose Rx Only
NDC 0074-1066-02 NOT FOR SALE Skyrizi ® risankizumab-rzaa Injection 180 mg/1.2 mL (150 mg/mL) FOR SUBCUTANEOUS USE ONLY Single-Dose Rx Only NDC 0074-1066-02 NOT FOR SALE Skyrizi® risankizumab-rzaa Injection 180 mg/1.2 mL (150 mg/mL) FOR SUBCUTANEOUS USE ONLY Single-Dose Rx Only
NDC 0074-7034-02 2 x 1 mL Prefilled Syringes Skyriz i ® risankizumab-rzaa Injection 90 mg/mL per syringe 2 x 90 mg/mL. Single-Dose Prefilled Syringes for a total 180 mg/2 mL dose FOR SUBCUTANEOUS USE ONLY FOR HEALTHCARE PROVIDER ADMINISTRATION ONLY www. SKYRIZI.com Rx Only abbvie NDC 0074-7034-02 2 x 1 mL Prefilled Syringes Skyrizi® risankizumab-rzaa Injection 90 mg/mL pe… [Excerpted — this section continues on DailyMed.]
Medicaid utilization & spend
Medicaid utilization by pack size
Medicare Part D spend CMS · PART D · 2026 (Q1)
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |