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Risankizumab: Drug information

Risankizumab: Drug information
(For additional information see "Risankizumab: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (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.

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic 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%)

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: Tinea (1%; including tinea pedis, tinea cruris, tinea versicolor, tinea manuum, onychomycosis)

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 and plaque psoriasis: 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: 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

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 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 (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): $1,176.71

Solution Auto-injector (Skyrizi Pen Subcutaneous)

150 mg/mL (per mL): $25,220.83

Solution Cartridge (Skyrizi Subcutaneous)

180 mg/1.2 mL (per mL): $21,017.36

360MG/2.4ML (per mL): $10,508.68

Solution Prefilled Syringe (Skyrizi Subcutaneous)

150 mg/mL (per mL): $25,220.83

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.

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 (0.83 mL); Risankizumab-rzaa 150 mg/mL (1 ea)

Administration: Adult

IV: Infuse over at least 1 hour.

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.

Medication Guide and/or Vaccine Information Statement (VIS)

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.

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.

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 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

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

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. 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 diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

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

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

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

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

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- 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 Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

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

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

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

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

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

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): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). 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

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 2020]). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.

• Labs: CBC with differential; complete metabolic panel; 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 2020]).

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 2020]).

• Labs: CBC and LFTs every 3 to 6 months or as clinically indicated, 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 2020]); 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;
  • (EE) Estonia: Skyrizi;
  • (ES) Spain: Skyrizi;
  • (FI) Finland: Skyrizi;
  • (FR) France: Skyrizi;
  • (GB) United Kingdom: Skyrizi;
  • (GR) Greece: 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;
  • (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, Smith C, Spuls PI, et al. EuroGuiDerm guideline on the systemic treatment of Psoriasis vulgaris - part 1: treatment and monitoring recommendations. J Eur Acad Dermatol Venereol. 2020;34(11):2461-2498. doi:10.1111/jdv.16915 [PubMed 33349983]
  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; January 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]
Topic 121112 Version 138.0

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