Crohn disease, moderate to severe:
Induction: IV: 600 mg at weeks 0, 4, and 8.
Maintenance: SUBQ: Prefilled cartridge: 180 to 360 mg at week 12 and every 8 weeks thereafter; use lowest effective dosage to maintain therapeutic response.
Plaque psoriasis, moderate to severe: SUBQ: Prefilled syringe and auto-injector: 150 mg at weeks 0, 4, and then every 12 weeks thereafter.
Psoriatic arthritis: SUBQ: Prefilled syringe and auto-injector: 150 mg at weeks 0, 4, and then every 12 weeks thereafter; may be administered alone or in combination with non–biologic disease-modifying antirheumatic drugs.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
No dosage adjustment necessary.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Prefilled Syringe Kit, Subcutaneous [preservative free]:
Skyrizi (150 MG Dose): Risankizumab-rzaa 75 mg/0.83 mL [contains 2 prefilled syringes] (1 ea)
Solution, Intravenous [preservative free]:
Skyrizi: Risankizumab-rzaa 600 mg/10 mL (10 mL) [latex free]
Solution Auto-injector, Subcutaneous [preservative free]:
Skyrizi Pen: Risankizumab-rzaa 150 mg/mL (1 mL) [latex free]
Solution Cartridge, Subcutaneous [preservative free]:
Skyrizi: Risankizumab-rzaa 360 mg/2.4 mL (2.4 mL) [latex free]
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Skyrizi: Risankizumab-rzaa 150 mg/mL (1 mL) [latex free]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Skyrizi: 150 mg/mL (1 ea)
Solution Prefilled Syringe, Subcutaneous:
Skyrizi: 75 mg/0.83 mL (0.83 mL); 150 mg/mL (1 ea)
An FDA-approved patient medication guide, which is available with the product information and at hhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s001lbl.pdf#page=30, must be dispensed with this medication.
IV: Infuse over at least 1 hour (complete infusion within 8 hours of dilution).
SUBQ:
Prefilled syringe kit, auto-injector: Administer SUBQ in thighs, abdomen, or back of upper arms. If 2 consecutive injections are required, administer at different anatomic locations. Do not inject into areas where the skin is tender, bruised, red, hard, or affected by psoriasis. Intended for use under supervision of a health care professional; self-injection may occur after proper training (except back of upper arms).
Prefilled cartridge: Administer on-body injector prefilled cartridge SUBQ in thigh or abdomen. Do not inject into areas where the skin is tender, bruised, red, hard, or affected by any lesions. Intended for use under supervision of a health care professional; self-injection may occur after proper training.
Crohn disease: Treatment of moderately to severely active Crohn disease in adults.
Plaque psoriasis, moderate to severe: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Psoriatic arthritis: Treatment of active psoriatic arthritis in adults.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults with plaque psoriasis unless otherwise indicated.
>10%:
Immunologic: Antibody development (Crohn disease: 3%; plaque psoriasis: 24%, neutralizing: 14%; psoriatic arthritis: 12%)
Infection: Infection (Crohn disease and plaque psoriasis: 22% to 37%; serious infection: Crohn disease: 6%)
Respiratory: Upper respiratory tract infection (Crohn disease and plaque psoriasis: 11% to 13%)
1% to 10%:
Dermatologic: Tinea (1%)
Gastrointestinal: Abdominal pain (Crohn disease: 9%)
Genitourinary: Urinary tract infection (Crohn disease: 4%)
Hematologic & oncologic: Anemia (Crohn disease: 5%)
Hepatic: Increased gamma-glutamyl transferase (psoriatic arthritis: 1%), increased serum aspartate aminotransferase (psoriatic arthritis: 2%)
Hypersensitivity: Hypersensitivity reaction (including severe hypersensitivity reaction; psoriatic arthritis: 2%)
Local: Injection-site reaction (Crohn disease and plaque psoriasis: 2% to 6%)
Nervous system: Fatigue (3%), headache (Crohn disease and plaque psoriasis: 4% to 7%)
Neuromuscular & skeletal: Arthralgia (Crohn disease: 5% to 9%), arthropathy (Crohn disease: 4%), back pain (Crohn disease: 4%)
Miscellaneous: Fever (Crohn disease: 5%)
<1%:
Dermatologic: Folliculitis, urticaria
Hypersensitivity: Anaphylaxis (psoriatic arthritis)
Frequency not defined: Endocrine & metabolic: Hypercholesterolemia (Crohn disease), increased LDL cholesterol (Crohn disease)
Postmarketing (all indications):
Dermatologic: Eczema, skin rash
Hepatic: Hepatic injury
Serious hypersensitivity to risankizumab or any component of the formulation.
Concerns related to adverse effects:
• Antibody formation: Formation of neutralizing anti-drug antibodies may occur with risankizumab and may be associated with loss of efficacy (AAD/NPF [Menter 2019]).
• Hepatotoxicity: Drug-induced liver injury with rash (AST 30 × ULN, ALT 54 × ULN, and total bilirubin 2.2 × ULN) has occurred during treatment for Crohn disease and required hospitalization. Interrupt treatment if drug-induced liver injury is suspected.
• Hypersensitivity reactions: Serious hypersensitivity, including anaphylaxis, has been reported. Discontinue immediately with signs/symptoms of a serious hypersensitivity reaction and treat appropriately, as indicated.
• Infections: Risankizumab may increase the risk of infections; upper respiratory tract and tinea infections have occurred more frequently. Consider the risks versus benefits prior to treatment initiation in patients with a history of chronic or recurrent infection; treatment should not be initiated in patients with clinically important active infections until it is resolved or treated. Monitor for infections; patients should seek medical attention for signs/symptoms of a clinically important infection (acute or chronic). If a serious infection develops or is unresponsive to appropriate therapy for the infection, monitor closely and discontinue risankizumab until the infection resolves.
• Tuberculosis: Patients should be evaluated for tuberculosis (TB) infection prior to initiating therapy. Do not administer to patients with an active TB infection. Treatment for latent TB should be administered prior to administering risankizumab. Consider anti-TB therapy prior to treatment initiation in patients with a history of latent or active TB in whom an adequate course of TB treatment cannon be confirmed. Monitor closely for signs/symptoms of active TB during and after risankizumab treatment.
Other warnings/precautions:
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; there are no data available concerning secondary transmission of infection by live vaccines in patients receiving therapy.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Anifrolumab: Biologic Anti-Psoriasis Agents may enhance the immunosuppressive effect of Anifrolumab. Risk X: Avoid combination
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Belimumab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
InFLIXimab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Risk X: Avoid combination
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
In general, patients who may become pregnant should use effective contraception while using biologic therapy for the treatment of psoriasis (Smith 2020; Yeung 2020)
Risankizumab is a humanized monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Data collection to monitor pregnancy and infant outcomes following exposure to risankizumab is ongoing. Patients with plaque psoriasis exposed to risankizumab while pregnant are encouraged to enroll in the registry (877-302-2161).
It is not known if risankizumab is present in breast milk.
Endogenous IgG is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
CBC with differential (baseline); complete metabolic panel (baseline); liver enzymes and bilirubin (baseline and during induction [at least up to 12 weeks of treatment]); tuberculosis (TB) screening prior to initiating and during therapy (chest X-ray if TB positive); hepatitis B virus (HBV)/hepatitis C virus screening prior to initiating (all patients), HBV carriers (during and for several months following therapy); HIV screening (baseline) (AAD/NPF [Menter 2019]).
Human IgG1 monoclonal antibody which selectively binds to the p19 subunit of interleukin (IL)-23, thereby inhibiting its interaction with the IL-23 receptor, resulting in inhibition of the release of proinflammatory cytokines and chemokines.
Onset of action: Psoriasis: Response best determined after 12 weeks (AAD/NPF [Menter 2019]).
Distribution: Vdss: Plaque psoriasis: 11.2 L; Crohn disease: 7.68 L.
Metabolism: Degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Bioavailability: SUBQ: 74% to 89%.
Half-life elimination: Plaque psoriasis: ~28 days; Crohn disease: ~21 days.
Time to peak: 3 to 14 days.
Body weight: Risankizumab clearance and volume of distribution increase and plasma concentrations decrease as body weight increases.
Prefilled Syringe Kit (Skyrizi (150 MG Dose) Subcutaneous)
75MG/0.83ML (per each): $21,927.35
Solution (Skyrizi Intravenous)
600 mg/10 mL (per mL): $1,096.37
Solution Auto-injector (Skyrizi Pen Subcutaneous)
150 mg/mL (per mL): $21,927.35
Solution Cartridge (Skyrizi Subcutaneous)
360MG/2.4ML (per mL): $9,136.40
Solution Prefilled Syringe (Skyrizi Subcutaneous)
150 mg/mL (per mL): $21,927.35
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