Dosing & Uses
Dosage Forms and Strengths
SC injectable solution
- 75mg/0.83mL (single-dose prefilled syringe)
- 150mg/mL (single-dose prefilled syringe or pen)
- 360 mg/2.4 mL (150 mg/mL) in each single-dose prefilled cartridge (for Crohn disease)
- Each syringe/pen has affixed 27-gauge 0.5-inch needle
IV injectable solution
- 600mg/10mL (single-dose vial)
Plaque Psoriasis
Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
150 mg SC at Week 0, Week 4, and q12Weeks thereafter
Psoriatic Arthritis
Indicated for the treatment of active psoriatic arthritis
150 mg SC at Week 0, Week 4, and q12Weeks thereafter
May be administered alone or in combination with nonbiologic disease-modifying antirheumatic drugs (DMARDs)
Crohn Disease
Indicated for moderately-to-severely active Crohn disease
Induction: 600 mg IV infused over at least 1 hr at Week 0, Week 4, and Week 8; THEN
Maintenance: 360 mg SC at Week 12, and every 8 weeks thereafter
Dosage Modifications
Renal and hepatic impairment: No studies conducted
Dosing Considerations
Before initiating
- Evaluate for tuberculosis (TB)
- Complete all age-appropriate vaccinations as recommended by current immunization guidelines
- Crohn disease: Obtain liver enzymes and bilirubin levels
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (18)
- adenovirus types 4 and 7 live, oral
risankizumab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
- axicabtagene ciloleucel
risankizumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- BCG vaccine live
risankizumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
- brexucabtagene autoleucel
risankizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
risankizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
risankizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent, intranasal
risankizumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
- lisocabtagene maraleucel
risankizumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles mumps and rubella vaccine, live
risankizumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
- measles, mumps, rubella and varicella vaccine, live
risankizumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
- rotavirus oral vaccine, live
risankizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
- smallpox (vaccinia) vaccine, live
risankizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
- tisagenlecleucel
risankizumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- typhoid vaccine live
risankizumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
- upadacitinib
risankizumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
- varicella virus vaccine live
risankizumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
- yellow fever vaccine
risankizumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
- zoster vaccine live
risankizumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
Monitor Closely (4)
- dengue vaccine
risankizumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of risankizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- isavuconazonium sulfate
risankizumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ublituximab
ublituximab and risankizumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
Adverse Effects
>10%
Plaque psoriasis
- Upper respiratory tract infections (13%)
Crohn disease
- Upper respiratory tract infections (10.6%)
1-10%
Plaque psoriasis
- Headache (3.5%)
- Fatigue (2.5%)
- Injection site reactions (1.5%)
- Tinea infections (1.1%)
Crohn disease
- Arthralgia (5-9.2%)
- Abdominal pain (8.5%)
- Headache (6.6%)
- Injection site reactions (5.6%)
- Anemia (4.9%)
- Pyrexia (4.9%)
- Back pain (4.2%)
- Arthropathy (3.5%)
- Urinary tract infection (3.5%)
<1%
Serious infections (eg, cellulitis, osteomyelitis, sepsis, herpes zoster)
Postmarketing Reports
Skin and subcutaneous tissue disorders: Eczema and rash
Hepatotoxicity (Crohn disease)
Warnings
Contraindications
History of serious hypersensitivity reactions to risankizumab or any product excipients
Cautions
Serious hypersensitivity reactions, including anaphylaxis, reported; if a serious hypersensitivity reaction occurs, discontinue treatment and initiate appropriate therapy immediately
Before initiating therapy, consider completion of all age-appropriate immunizations according to current immunization guidelines; avoid use of live vaccines in treated patients; no data available on response to live or inactive vaccines
Tuberculosis
- Evaluate for TB infection before initiating
- In Phase 3 clinical studies, patients with latent TB were concurrently treated with risankizumab and appropriate TB prophylaxis during the studies, none developed active TB
- Consider antitubercular therapy before initiating in patients with history of latent or active TB in whom course of treatment cannot be confirmed
- Monitor for signs and symptoms of active TB during and after treatment; do not administer to patients with active TB
Administration of vaccines
- Avoid use of live vaccines in patients receiving therapy; medications that interact with immune system may increase risk of infection following administration of live vaccines
- Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines; no data are available on response to live or inactive vaccines
Infections
- Infections occurred more frequently in treated patients compared to placebo
- Consider risks and benefits of risankizumab in patients with chronic infection or history of recurrent infection
- If infection develops or is not responding to standard therapy, closely monitor and withhold risankizumab until the infection resolves
Hepatotoxicity
- Drug-induced liver injury was reported in a patient with Crohn disease (ALT 54x ULN, AST 30x ULN, and total bilirubin 2.2x ULN) following two IV 600-mg doses along with a rash that required hospitalization
- Liver test abnormalities resolved following administration of steroids
- For Crohn disease, 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; promptly rule out the cause of liver enzyme elevation
- 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
Pregnancy & Lactation
Pregnancy
There is a pregnancy exposure registry that monitors outcomes in women with plaque psoriasis who become pregnant while receiving therapy; patients should be encouraged to enroll by calling 1- 877-302-2161 or visiting http://glowpregnancyregistry.com
Available pharmacovigilance and clinical trial data with 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 this drug, monoclonal antibodies can be actively transported across placenta, and the drug may cause immunosuppression in the in the utero-exposed infant; there are adverse pregnancy outcomes in women with inflammatory bowel disease
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 2500 g) in infants, and small for gestational age at birth
Transport of endogenous IgG antibodies across placenta increases as pregnancy progresses, and peaks during third trimesterl because risankizumab may interfere with immune response to infections, risks and benefits should be considered prior to administer live vaccines to infants exposed to the drug in utero; there are insufficient data regarding infant serum levels of the drug at birth and duration of persistence of the drug in infant serum after birth; although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, a minimum of 5 months after birth should be considered because of the half-life of the product
Animal data
- In an enhanced prenatal and postnatal developmental toxicity study, pregnant cynomolgus monkeys were administered SC doses of 5 and 50 mg/kg risankizumab-rzaa qWeek during organogenesis up to parturition
- At 50 mg/kg dose (20x the maximum recommended human dose [MRHD]; 2.5 mg/kg based on administration of a 150-mg dose to a 60-kg individual), increased fetal/infant loss was noted in pregnant monkeys
- Clinical significance of these findings for humans is unknown
Lactation
There are no data on presence of the drug in human milk, effects on breastfed infant, or on milk production; endogenous maternal IgG and monoclonal antibodies are transferred in human milk; effects of local gastrointestinal exposure and limited systemic exposure in breastfed infant to this drug are unknown
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of human interleukin 23 (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 proinflammatory cytokines and chemokines
Absorption
Peak plasma concentration: ~12 mcg/mL (reached by 3-14 days)
Bioavailability: 89%
Steady-state achieved at Week 16
Distribution
Vd: 11.2 L
Metabolism
Expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG
Elimination
Clearance: 0.31 L/day
Half-life: ~28 days
Administration
SC Preparation
Remove carton from refrigerator and allow to reach room temperature out of direct sunlight (30-90 minutes for prefilled pen and 15-30 minutes for prefilled syringe[s]) without removing pen/syringe(s) from the carton
Visually inspect for particulate matter and discoloration prior to administration
Injectable solution is colorless to slightly yellow and clear to slightly opalescent; may contain a few translucent-to-white particles
Do not use if solution contains large particles or is cloudy or discolored
SC Administration
SC administration only
If injecting 2 separate 75-mg single-dose prefilled syringes (150-mg dose), inject 1 syringe after the other in different anatomic locations
Self-injections: Administer injections at different anatomic locations (eg, thighs, abdomen), and avoid areas where skin is tender, bruised, erythematous, indurated, or affected by psoriasis
Administration in the upper, outer arm may only be performed by a healthcare professional or caregiver
Drug is intended for use under the guidance and supervision of a healthcare professional, who may train patient and caregivers to self-inject using SC injection technique
Discard prefilled syringes after use; do not reuse
Missed dose: Administer dose as soon as possible; resume dosing at the regular scheduled time
IV Preparation
Use proper aseptic technique when administering
Withdraw 10 mL of drug from vial and inject into an IV infusion bag or glass bottle containing D5W (600 mg/10 mL in 100 mL, or 250 mL, or 500 mL); final concentration is 1.2-6 mg/mL
Discard any remaining solution in vial
Do not shake vial or diluted solution in the infusion bag or glass bottle
IV Administration
Allow diluted solution to warm to room temperature (if stored refrigerated) administering
Infuse IV over at least 1 hr
Complete infusion within 8 hr of dilution
Do not administer diluted solution concomitantly in the same IV line with other medicinal products
Storage
SC prefilled syringes or cartridges
- Refrigerate at 2-8ºC (36-46ºF)
- Do not freeze; do not shake
- Not made from natural rubber latex
Unopened vials
- Refrigerate at 2-8ºC (36-46ºF)
- Do not freeze; do not shake
- Protect from light
- Not made from natural rubber latex
Diluted solution
- Protect from light
- If not used immediately, refrigerate at 2-8ºC (36-46ºF); do NOT freeze
- Subsequently, may store at room temperature at up to 25ºC (77°ºF) after dilution (cumulative time after preparation including the storage and the infusion period) for up to 8 hrs
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Skyrizi subcutaneous - | 150 mg/mL injection |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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