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تعداد آیتم قابل مشاهده باقیمانده : -5 مورد

Risankizumab: Drug information

Risankizumab: Drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Risankizumab: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Skyrizi;
  • Skyrizi (150 MG Dose) [DSC];
  • Skyrizi Pen
Brand Names: Canada
  • Skyrizi
Pharmacologic Category
  • Antipsoriatic Agent;
  • Interleukin-23 Inhibitor;
  • Monoclonal Antibody
Dosing: Adult

Dosage guidance:

Safety: Prior to initiation, certain assessments (clinical and laboratory) are required with documentation and ensure age-appropriate vaccinations are up to date. In general, live vaccines should not be administered within 4 weeks prior to starting therapy (Ref). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.

Crohn disease, moderate to severe

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

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

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.

Ulcerative colitis, moderate to severe

Ulcerative colitis, moderate to severe:

Induction: IV: 1,200 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.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Obesity: Adult

No dosage adjustment necessary.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

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%; ulcerative colitis: 4% to 9%, neutralizing: 2% to 7%)

Infection: Infection (Crohn disease and plaque psoriasis: 22% to 37%; serious infection: Crohn disease: 3% to 6%)

Respiratory: Upper respiratory tract infection (Crohn disease and plaque psoriasis: 11% to 13%)

1% to 10%:

Dermatologic: Skin rash (ulcerative colitis: 4%), tinea (1%; including onychomycosis, tinea cruris, tinea manuum, tinea pedis, tinea versicolor)

Gastrointestinal: Abdominal pain (Crohn disease: 6% to 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, plaque psoriasis, and ulcerative colitis: 2% to 6%; including bleeding at injection site, bruising at injection site, erythema at injection site, hematoma at injection site, hypersensitivity reaction at injection site, inflammation at injection site, injection-site infection, injection-site pruritus, irritation at injection site, pain at injection site, rash at injection site, swelling at injection site, urticaria at injection site, warm sensation at injection site)

Nervous system: Fatigue (3%), headache (Crohn disease and plaque psoriasis: 4% to 7%)

Neuromuscular & skeletal: Arthralgia (Crohn disease and ulcerative colitis: 3% to 10%), arthropathy (Crohn disease: 4%), back pain (Crohn disease: 4%)

Miscellaneous: Fever (Crohn disease and ulcerative colitis: 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

Hepatic: Hepatic injury

Contraindications

Serious hypersensitivity to risankizumab or any component of the formulation.

Warnings/Precautions

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 inflammatory bowel 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 (latent TB) prior to initiating therapy. Do not administer to patients with TB disease (active TB). Treatment for TB infection should be administered prior to administering risankizumab. Consider anti-TB therapy prior to treatment initiation in patients with a history of TB infection or disease in whom an adequate course of TB treatment cannon be confirmed. Monitor closely for signs/symptoms of TB disease 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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Prefilled Syringe Kit, Subcutaneous [preservative free]:

Skyrizi (150 MG Dose): Risankizumab-rzaa 75 mg/0.83 mL [contains 2 prefilled syringes] (1 ea [DSC])

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]

Skyrizi: Risankizumab-rzaa 180 mg/1.2 mL (1.2 mL)

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Skyrizi: Risankizumab-rzaa 150 mg/mL (1 mL) [latex free]

Generic Equivalent Available: US

No

Pricing: US

Solution (Skyrizi Intravenous)

600 mg/10 mL (per mL): $1,244.72

Solution Auto-injector (Skyrizi Pen Subcutaneous)

150 mg/mL (per mL): $26,860.19

Solution Cartridge (Skyrizi Subcutaneous)

180 mg/1.2 mL (per mL): $22,383.49

360MG/2.4ML (per mL): $11,191.75

Solution Prefilled Syringe (Skyrizi Subcutaneous)

150 mg/mL (per mL): $26,860.19

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Skyrizi: Risankizumab-rzaa 600 mg/10 mL (10 mL)

Solution Auto-injector, Subcutaneous:

Skyrizi: Risankizumab-rzaa 150 mg/mL (1 ea)

Solution Cartridge, Subcutaneous:

Skyrizi: Risankizumab-rzaa 360 mg/2.4 mL (2.4 mL)

Solution Prefilled Syringe, Subcutaneous:

Skyrizi: 75 mg/0.83 mL ([DSC]); Risankizumab-rzaa 150 mg/mL (1 ea)

Administration: Adult

IV: Infuse over at least 1 hour (600 mg dose) or 2 hours (1,200 mg dose).

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; start injection within 5 minutes after preparation. 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.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s027,761262s008lbl.pdf#page=31, must be dispensed with this medication.

Use: Labeled Indications

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.

Ulcerative colitis: Treatment of moderately to severely active ulcerative colitis in adults.

Metabolism/Transport Effects

None known.

Drug Interactions

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Anifrolumab: Biologic Anti-Psoriasis Agents may increase immunosuppressive effects of Anifrolumab. Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Belimumab: May increase immunosuppressive effects of Biologic Anti-Psoriasis Agents. Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider Therapy Modification

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. 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 (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects 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 decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects 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 increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

InFLIXimab: May increase immunosuppressive effects of Biologic Anti-Psoriasis Agents. Risk X: Avoid

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects 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 increase immunosuppressive effects 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

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of 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 decrease therapeutic effects 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

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects 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 Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects 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

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects 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

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

In general, patients who may become pregnant should use effective contraception while using biologic therapy for the treatment of psoriasis (Smith 2020; Yeung 2020)

Pregnancy Considerations

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).

Breastfeeding Considerations

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.

Monitoring Parameters

Prior to therapy start:

• Evaluate for malignancy (especially skin cancer), current or latent infection lymphadenopathy, ensure age-appropriate vaccinations are up to date, signs and, in general, no live vaccines are administered within 4 weeks of starting therapy (AAD [Menter 2019]; EuroGuiDerm [Nast 2024]). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.

• Labs: CBC with differential; complete metabolic panel; LFTs and bilirubin (inflammatory bowel disease); testing for tuberculosis (TB) infection (latent TB) (eg, Quantiferon Gold) or interferon gamma release assay for TB in patients who have had Bacillus Calmette-Guérin (BCG) vaccine; chest radiograph if testing for TB infection is positive; serologic testing for hepatitis B virus (hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody), hepatitis C virus antibody, HIV; pregnancy test, C-reactive protein (AAD [Menter 2019]; EuroGuiDerm [Nast 2024]).

During therapy:

• Evaluate for infection, malignancy (specifically skin cancer screening, especially for patients who have a history of skin cancer or UV phototherapy), infusion/injection site reactions (AAD [Menter 2019]; EuroGuiDerm [Nast 2024]).

• Labs: CBC and LFTs every 3 to 6 months or as clinically indicated; bilirubin at least up to 12 weeks and routinely thereafter; pregnancy test as needed; yearly testing/chest radiograph for TB in high-risk patients (eg, contact with individuals with TB disease [active TB]) (AAD [Menter 2019]; EuroGuiDerm [Nast 2024]); hepatitis B carriers should be periodically evaluated for signs/symptoms of active hepatitis B infection (AAD [Menter 2019]).

After therapy:

• Periodically evaluate patients who are hepatitis B carriers for signs/symptoms of active hepatitis B infection (AAD [Menter 2019]).

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

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.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Body weight: Risankizumab clearance and volume of distribution increase and plasma concentrations decrease as body weight increases.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Skyrizi;
  • (AR) Argentina: Skyrizi;
  • (AT) Austria: Skyrizi;
  • (AU) Australia: Skyrizi;
  • (BE) Belgium: Skyrizi;
  • (BG) Bulgaria: Skyrizi;
  • (BR) Brazil: Skyrizi;
  • (CH) Switzerland: Skyrizi;
  • (CL) Chile: Skyrizi;
  • (CO) Colombia: Skyrizi;
  • (CZ) Czech Republic: Skyrizi;
  • (DE) Germany: Skyrizi;
  • (EC) Ecuador: Skyrizi;
  • (EE) Estonia: Skyrizi;
  • (ES) Spain: Skyrizi;
  • (FI) Finland: Skyrizi;
  • (FR) France: Skyrizi;
  • (GB) United Kingdom: Skyrizi;
  • (GR) Greece: Skyrizi;
  • (HK) Hong Kong: Skyrizi;
  • (HR) Croatia: Skyrizi;
  • (HU) Hungary: Skyrizi;
  • (IE) Ireland: Skyrizi;
  • (IT) Italy: Skyrizi;
  • (JP) Japan: Skyrizi;
  • (KR) Korea, Republic of: Skyrizi;
  • (KW) Kuwait: Skyrizi;
  • (LB) Lebanon: Skyrizi;
  • (LT) Lithuania: Skyrizi;
  • (LU) Luxembourg: Skyrizi;
  • (LV) Latvia: Skyrizi;
  • (MX) Mexico: Skyrizi;
  • (MY) Malaysia: Skyrizi;
  • (NL) Netherlands: Skyrizi;
  • (NO) Norway: Skyrizi;
  • (NZ) New Zealand: Skyrizi;
  • (PE) Peru: Skyrizi;
  • (PL) Poland: Skyrizi;
  • (PR) Puerto Rico: Skyrizi;
  • (PT) Portugal: Skyrizi;
  • (QA) Qatar: Skyrizi | Skyrizi (150 mg Dose);
  • (RO) Romania: Skyrizi;
  • (SA) Saudi Arabia: Skyrizi;
  • (SE) Sweden: Skyrizi;
  • (SG) Singapore: Skyrizi;
  • (SI) Slovenia: Skyrizi;
  • (SK) Slovakia: Skyrizi;
  • (TR) Turkey: Skyrizi;
  • (TW) Taiwan: Skyrizi
  1. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. doi:10.1016/j.jaad.2018.11.057 [PubMed 30772098]
  2. Nast A, Spuls PI, Dressler C, et al; European Dermatology Forum, European Centre for Guidelines Development. EuroGuiDerm guideline for the systemic treatment of psoriasis vulgaris. https://www.guidelines.edf.one/guidelines/psoriasis-guideline. Updated March 2024. Accessed October 24, 2024.
  3. Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi:10.1155/2012/985646 [PubMed 22235228]
  4. Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi:10.1002/bdrb.20201 [PubMed 19626656]
  5. Skyrizi (risankizumab-rzaa) [prescribing information]. North Chicago, IL: AbbVie Inc; June 2024.
  6. Smith CH, Yiu ZZN, Bale T, et al; British Association of Dermatologists’ Clinical Standards Unit. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update. Br J Dermatol. 2020;183(4):628-637. doi:10.1111/bjd.19039 [PubMed 32189327]
  7. Yeung J, Gooderham MJ, Grewal P, et al. Management of plaque psoriasis with biologic therapies in women of child-bearing potential consensus paper. J Cutan Med Surg. 2020;24(1 suppl):S3-S14. doi:10.1177/1203475420928376 [PubMed 32500730]
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