risankizumab (Rx)

Brand and Other Names:Skyrizi, risankizumab-rzaa
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Dosing & Uses

AdultPediatric

Dosage Forms and Strengths

injectable solution

  • 75mg/0.83mL (single-dose prefilled syringe)
  • 150mg/mL (single-dose prefilled syringe or pen)
  • Each syringe/pen has affixed 27-gauge 0.5-inch needle

Plaque Psoriasis

Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

150 mg SC at Week 0, Week 4, and q12Weeks thereafter

Dosage Modifications

Renal and hepatic impairment: No studies conducted

Dosing Considerations

Evaluate for tuberculosis (TB) before initiating treatment

Complete all age-appropriate vaccinations as recommended by current immunization guidelines

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and risankizumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (11)

              • adenovirus types 4 and 7 live, oral

                risankizumab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.

              • BCG vaccine live

                risankizumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.

              • influenza virus vaccine quadrivalent, intranasal

                risankizumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.

              • measles mumps and rubella vaccine, live

                risankizumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.

              • measles, mumps, rubella and varicella vaccine, live

                risankizumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.

              • rotavirus oral vaccine, live

                risankizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.

              • smallpox (vaccinia) vaccine, live

                risankizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.

              • typhoid vaccine live

                risankizumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.

              • varicella virus vaccine live

                risankizumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.

              • yellow fever vaccine

                risankizumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.

              • zoster vaccine live

                risankizumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.

              Monitor Closely (2)

              • dengue vaccine

                risankizumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • isavuconazonium sulfate

                risankizumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

              Minor (0)

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                Adverse Effects

                >10%

                Upper respiratory tract infections (13%)

                1-10%

                Headache (3.5%)

                Fatigue (2.5%)

                Injection site reactions (1.5%)

                Tinea infections (1.1%)

                <1%

                Serious infections (eg, cellulitis, osteomyelitis, sepsis, herpes zoster)

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                Warnings

                Contraindications

                None

                Cautions

                In Phase 3 clinical studies, patients with latent TB were concurrently treated with risankizumab and appropriate TB prophylaxis during the studies, none developed active TB; consider antitubercular therapy before initiating treatment in patients with history of latent or active TB in whom course of treatment cannot be confirmed; monitor for signs and symptoms of active TB during and after treatment; do not administer to patients with active TB

                Before initiating therapy, consider completion of all age-appropriate immunizations according to current immunization guidelines; avoid use of live vaccines in treated patients; no data available on response to live or inactive vaccines

                Administration of vaccines

                • Avoid use of live vaccines in patients receiving therapy; medications that interact with immune system may increase risk of infection following administration of live vaccines
                • Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines; no data are available on response to live or inactive vaccines

                Infections

                • In clinical studies, infections occurred more frequently in the risankizumab-treated patients compared with placebo
                • Consider risks and benefits of risankizumab in patients with chronic infection or history of recurrent infection
                • If infection develops or is not responding to standard therapy, closely monitor and withhold risankizumab until the infection resolves
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                Pregnancy & Lactation

                Pregnancy

                There is a pregnancy exposure registry that monitors outcomes in women with plaque psoriasis who become pregnant while receiving therapy; patients should be encouraged to enroll by calling 1- 877-302-2161

                Limited available data with use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome

                Human IgG is known to cross the placental barrier; therefore, risankizumab is transmitted from mother to developing fetus

                Animal data

                • In an enhanced prenatal and postnatal developmental toxicity study, pregnant cynomolgus monkeys were administered SC doses of 5 and 50 mg/kg risankizumab-rzaa qWeek during organogenesis up to parturition
                • At 50 mg/kg dose (20x the maximum recommended human dose [MRHD]; 2.5 mg/kg based on administration of a 150-mg dose to a 60-kg individual), increased fetal/infant loss was noted in pregnant monkeys
                • Clinical significance of these findings for humans is unknown

                Lactation

                There are no data on the presence of risankizumab-rzaa in human milk, the effects on the breastfed infant, or the effects on milk production

                Maternal IgG is known to be present in human milk

                Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of human interleukin 23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor

                IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses

                Risankizumab-rzaa inhibits the release of proinflammatory cytokines and chemokines

                Absorption

                Peak plasma concentration: ~12 mcg/mL (reached by 3-14 days)

                Bioavailability: 89%

                Steady-state achieved at Week 16

                Distribution

                Vd: 11.2 L

                Metabolism

                Expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG

                Elimination

                Clearance: 0.31 L/day

                Half-life: ~28 days

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                Administration

                SC Preparation

                Remove carton from refrigerator and allow to reach room temperature out of direct sunlight (30-90 minutes for prefilled pen and 15-30 minutes for prefilled syringe[s]) without removing pen/syringe(s) from the carton

                Visually inspect for particulate matter and discoloration prior to administration

                Injectable solution is colorless to slightly yellow and clear to slightly opalescent; may contain a few translucent-to-white particles

                Do not use if solution contains large particles or is cloudy or discolored

                SC Administration

                SC administration only

                If injecting 2 separate 75-mg single-dose prefilled syringes (150-mg dose), inject 1 syringe after the other in different anatomic locations

                Self-injections: Administer injections at different anatomic locations (eg, thighs, abdomen), and avoid areas where skin is tender, bruised, erythematous, indurated, or affected by psoriasis

                Administration in the upper, outer arm may only be performed by a healthcare professional or caregiver

                Drug is intended for use under the guidance and supervision of a healthcare professional, who may train patient and caregivers to self-inject using SC injection technique

                Discard prefilled syringes after use; do not reuse

                Missed dose

                • If a dose is missed, administer dose as soon as possible; resume dosing at the regular scheduled time

                Storage

                Refrigerate at 2-8°C (36-46°F)

                Do not freeze; do not shake

                Keep prefilled syringes in the outer carton to protect from light

                Not made from natural rubber latex

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                Images

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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.