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Risankizumab-rzaa (Monograph)

Brand name: Skyrizi
Drug class:

Medically reviewed by on Mar 10, 2024. Written by ASHP.


Inhibitor of interleukin-23 (IL-23); a recombinant humanized IgG1 monoclonal antibody that binds specifically to the p19 subunit of IL-23.

Uses for Risankizumab-rzaa

Plaque Psoriasis

Management of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Guidelines generally support use of IL-23 inhibitors as monotherapy for moderate to severe psoriasis.

Recommendations for use and selection of psoriasis therapies vary based on patient age, disease characteristics (e.g., severity, location, presence of psoriatic arthritis), and comorbidities (e.g., inflammatory bowel disease).

Psoriatic Arthritis

Used for the management of active psoriatic arthritis in adults. May be used alone or in combination with nonbiologic disease-modifying antirheumatic drugs (DMARDs).

The American College of Rheumatology and the National Psoriasis Foundation issued a joint guideline for the treatment of psoriatic arthritis in 2018. Risankizumab is not included in these guidelines; however, current evidence suggests that the drug may provide an additional therapeutic option for patients in whom standard therapies are inadequate.

Recommendations for use and selection of disease-modifying therapies in psoriatic arthritis vary based on the presence of certain disease characteristics (e.g., psoriatic spondylitis/axial disease, enthesitis) and comorbidities (e.g., inflammatory bowel disease, diabetes).

Crohn Disease

Treatment of moderately to severely active Crohn disease in adults.

Risankizumab was approved after publication of recent disease state guidelines; however, some experts hypothesize that risankizumab may provide a unique therapeutic option in select patients because of its greater selectivity for IL-23.

Risankizumab-rzaa Dosage and Administration


Pretreatment Screening

Patient Monitoring


Administer by sub-Q injection for treatment of plaque psoriasis and psoriatic arthritis. For treatment of Crohn disease, administer induction dosage by IV infusion and maintenance dosage by sub-Q injection.

Sub-Q Administration

Available as single-use prefilled syringes (containing 75 mg/0.83 mL, 90 mg/mL, or 150 mg/mL), injection pens (containing 150 mg/mL), and prefilled cartridges with an on-body injector (containing 180 mg/1.2 mL or 360 mg/2.4 mL). Should appear as a clear to slightly opalescent, colorless to yellow or slightly yellow (depending on concentration) solution; may contain a few translucent to white particles but should not contain large particulates.

Allow prefilled syringe or injection pen to sit at room temperature inside the carton out of direct sunlight for 15–30 minutes (prefilled syringe) or 30–90 minutes (injection pen) prior to administration. Allow prefilled cartridge with on-body injector to sit at room temperature inside the carton out of direct sunlight for 45–90 minutes prior to administration.

Do not shake the injection.

Administer by sub-Q injection into the upper outer arm, anterior thigh, or abdomen; do not make abdominal injections within 2 inches of the navel. Use thigh or abdomen for self-administration; may use upper arm if administered by a caregiver or clinician. Do not make injections into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.

When using multiple syringes to provide a total dose, sequentially inject the full contents of each syringe at different anatomic sites.

Prefilled pens and syringes are intended for use under the supervision of a clinician, but may be self-administered if the clinician determines that the patient and/or their caregiver is competent to prepare and safely administer the drug after appropriate training. Prefilled cartridges with on-body injector are intended for use under the guidance and supervision of a healthcare professional.

If a dose is missed, administer as soon as possible; thereafter, resume dosing at the regularly scheduled time.

IV Infusion

Available as a 600 mg/10 mL injection that must be further diluted prior to IV infusion.

To prepare, withdraw 10 mL (600 mg) of solution and inject into an infusion bag or glass bottle containing 100, 250, or 500 mL of 5% dextrose for a final concentration of approximately 1.2–6 mg/mL. Discard any remaining solution in the vial. Allow the diluted solution to warm to room temperature prior to infusion. Do not shake the vial or diluted solution. Infuse over a period of at least 1 hour and complete within 8 hours of dilution. Do not administer in the same IV line with other medicinal products.

If not used immediately, store diluted solution at 2–8°C and protect from light for up to 20 hours. Subsequently, the diluted solution can be kept at room temperature up to 25°C and protected from direct and indirect sunlight for 8 hours (cumulative time after preparation including the storage and infusion period).

If a dose is missed, administer as soon as possible; thereafter, resume dosing at the regularly scheduled time.



Plaque Psoriasis

150 mg at 0 and 4 weeks, then every 12 weeks.

If a dose is missed, administer the missed dose as soon as possible and resume dosing at the regularly scheduled interval.

Psoriatic Arthritis

150 mg at 0 and 4 weeks, then every 12 weeks.

If a dose is missed, administer the missed dose as soon as possible and resume dosing at the regularly scheduled interval.

Crohn Disease
IV Infusion

Induction therapy: 600 mg over at least 1 hour at 0, 4, and 8 weeks.


Maintenance therapy: 180 mg or 360 mg at week 12, and every 8 weeks thereafter. Use lowest effective dosage to maintain therapeutic response.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Use

No specific dosage recommendations at this time.

Cautions for Risankizumab-rzaa



Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, reported.

If a serious hypersensitivity reaction occurs, immediately discontinue the drug and initiate appropriate therapy.


May increase risk of infection. In clinical trials in patients with psoriasis, upper respiratory tract infections and tinea infections occurred more frequently with risankizumab-rzaa than with placebo.

Do not initiate risankizumab in patients with any clinically important active infection until infection resolves or is adequately treated. Consider risks and benefits before initiating therapy in patients with chronic infection or history of recurrent infection.

If clinically important infection develops or does not respond to standard therapy, monitor patient closely and discontinue risankizumab until infection resolves.


Evaluate patients for tuberculosis prior to initiation of risankizumab. Do not administer to patients with active tuberculosis. Consider antimycobacterial therapy prior to initiating risankizumab therapy in individuals with a history of latent or active tuberculosis in whom an adequate course of antimycobacterial treatment cannot be confirmed. Closely monitor patients for active tuberculosis during and after risankizumab treatment.

Hepatotoxicity in Treatment of Crohn Disease

Evaluate liver enzymes and bilirubin at baseline and for up to at least 12 weeks during induction and maintenance treatment of Crohn disease. Monitor thereafter according to routine management. Consider alternate treatment in patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until cause of liver enzyme elevation is confirmed. Instruct patients to seek medical attention if they experience symptoms of hepatic dysfunction.

Administration of Vaccines

Administer all age-appropriate vaccines recommended by current immunization guidelines prior to initiating risankizumab.

Avoid live vaccines during therapy.


Antibodies to risankizumab-rzaa, including neutralizing antibodies, reported. High anti-drug antibody titers (detected in approximately 1% of patients receiving risankizumab-rzaa) associated with decreased drug concentrations and decreased efficacy. In clinical studies in psoriatic arthritis, anti-drug antibodies also associated with higher frequency of hypersensitivity and injection-site reactions.

Specific Populations


Data regarding use in pregnant women are inadequate to establish risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Potential for fetal exposure since human IgG crosses the placenta. Consider delaying administration of live vaccines for a minimum of 5 months to infants exposed to risankizumab in utero.

Dose-dependent increase in fetal/infant loss observed in pre- and post-natal developmental study in cynomolgus monkeys; no malformations and no adverse effects on growth and development, immunologic development, or neurobehavioral development observed. Clinical relevance unknown.

Pregnancy registry at 877-302-2161 or [Web].


Not known whether risankizumab distributes into human milk, affects milk production, or affects breast-fed infants. Maternal IgG is present in breast milk.

Because risankizumab is a large protein molecule, absorption by a breast-fed infant is unlikely since the drug will probably be destroyed in the infant's GI tract. Effects of local GI and limited systemic exposure in the breast-fed infant unknown.

Consider benefits of breast-feeding and importance of the drug to the woman; also consider any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

Pediatric Use

Safety and efficacy not established in pediatric patients.

Geriatric Use

No overall differences in safety, efficacy, or drug exposure relative to younger adults; however, insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults. No clinically meaningful differences in pharmacokinetics in geriatric versus younger patients with Crohn disease.

Hepatic Impairment

Pharmacokinetic data in patients with hepatic impairment not available.

Renal Impairment

Pharmacokinetic data in patients with renal impairment not available.

Common Adverse Effects

Adverse reactions (≥1%) in patients with plaque psoriasis and psoriatic arthritis: upper respiratory infection, headache, fatigue, injection site reaction, tinea infection.

Adverse reactions (>3%) in patients receiving induction treatment for Crohn disease: upper respiratory infection, headache, arthralgia.

Adverse reactions (>3%) in patients receiving maintenance treatment for Crohn disease: arthralgia, injection site reaction, abdominal pain, anemia, pyrexia, back pain, arthropathy, urinary tract infection.

Drug Interactions


Avoid live vaccines. No data available regarding response to live or inactivated vaccines in patients receiving risankizumab.

Specific Drugs




No clinically important effect on AUC of caffeine (CYP1A2 substrate)


No clinically important effect on AUC of metoprolol (CYP2D6 substrate)


No clinically important effect on AUC of midazolam (CYP3A4 substrate)


No clinically important effect on AUC of omeprazole (CYP2C19 substrate)


No clinically important effect on AUC of warfarin (CYP2C9 substrate)

Risankizumab-rzaa Pharmacokinetics



Absolute bioavailability is approximately 74-89% following sub-Q administration.

Peak concentration achieved within 3–14 days following a single sub-Q dose; steady-state concentrations attained by week 16 when administered at weeks 0 and 4 and every 12 weeks thereafter.

Concentrations are dose proportional over sub-Q dose range of 18–360 mg and over the IV infusion dose range of 200-1800 mg in healthy individuals.

Special Populations

Plasma concentrations are lower in patients with higher body weight.



Not known whether distributed into human milk.



Metabolic pathway not characterized. Expected to be degraded into small peptides and amino acids via catabolic pathways in similar manner as endogenous IgG.


28 days in patients with plaque psoriasis.

21 days in patients with Crohn disease.

Special Populations

Age does not substantially alter clearance. Drug exposure comparable in patients ≥65 years of age and younger adults with Crohn disease.

Pharmacokinetics not formally studied in renal or hepatic impairment.




Injection, for Sub-Q Use

2–8°C; do not freeze. Store in original carton to protect from light until use.

Injection, for IV Infusion

2–8°C; do not freeze. Store in original carton to protect from light until use.


Advice to Patients

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Risankizumab is available from specialty pharmacies. For information on access and options for insured and uninsured patients, visit [Web].



Dosage Forms


Brand Names



Injection, for subcutaneous use

75 mg/0.83 mL

Skyrizi (available as single-dose prefilled syringes)


90 mg/mL

Skyrizi (available as single-dose prefilled syringes)

150 mg/mL

Skyrizi (available as single-dose prefilled syringes and injection pens)


180 mg/1.2 mL

Skyrizi (available as prefilled cartridges with on-body injector)

360 mg/2.4 mL

Skyrizi (available as prefilled cartridges with on-body injector)

Injection, for IV use

600 mg/10 mL (60 mg/mL)

Skyrizi (available as single-dose vials)

AHFS DI Essentials™. © Copyright 2024, Selected Revisions March 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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