risankizumab (Rx)

Brand and Other Names:Skyrizi, risankizumab-rzaa
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms and Strengths

injectable solution, single-dose prefilled syringe

  • 75mg/0.83mL

Plaque Psoriasis

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

150 mg (two 75-mg injections) 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

<18 years: Safety and efficacy not established

Next:

Interactions

Interaction Checker

and risankizumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            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)

            Previous
            Next:

            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

            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
            Previous
            Next:

            Pregnancy

            Pregnancy

            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.

            Previous
            Next:

            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

            Previous
            Next:

            Administration

            SC Preparation

            Remove carton from refrigerator and allow to reach room temperature out of direct sunlight (15-30 minutes) without removing prefilled syringes 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

            Inject 2 separate 75-mg single-dose prefilled syringes (150-mg dose)

            Discard prefilled syringes after use; do not reuse

            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 the subcutaneous injection technique

            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

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.