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Risankizumab

Medically reviewed by Drugs.com. Last updated on Apr 20, 2019.

Pronunciation

(RIS an KIZ ue mab)

Index Terms

  • Risankizumab-rzaa
  • Skyrizi

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Prefilled Syringe Kit, Subcutaneous [preservative free]:

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

Brand Names: U.S.

  • Skyrizi (150 MG Dose)

Pharmacologic Category

  • Antipsoriatic Agent
  • Interleukin-23 Inhibitor
  • Monoclonal Antibody

Pharmacology

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.

Distribution

Vdss: 11.2 L

Metabolism

Degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG

Time to Peak

3 to 14 days

Half-Life Elimination

~28 days

Special Populations Note

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

Use: Labeled Indications

Plaque psoriasis, moderate to severe: Treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Canadian labeling: Hypersensitivity to risankizumab or any component of the formulation

Dosing: Adult

Plaque psoriasis, moderate to severe: SubQ: Two consecutive injections (75 mg each) for a total dose of 150 mg at weeks 0, 4, and then every 12 weeks thereafter.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Obesity

No dosage adjustment necessary.

Reconstitution

Allow prefilled syringe to reach room temperature (15 to 30 minutes) in original carton before injecting. Intact solution should be colorless to light yellow and clear to slightly opalescent; solution may develop a few translucent to white particles. Discard unused portion of prefilled syringe.

Administration

SubQ: Administer the two consecutive injections subcutaneously at different anatomic locations, such as thighs, abdomen, or back of upper arms. 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).

Storage

Store at 2°C to 8°C (36°F to 46° F) in the original carton; do not freeze. Protect from light. Do not shake.

Drug Interactions

Belimumab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Avoid combination

InFLIXimab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Avoid combination

Vaccines (Live): Risankizumab may enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Adverse Reactions

>10%:

Immunologic: Antibody development (24%; neutralizing: 14%)

Infection: Infection (22%)

Respiratory: Upper respiratory tract infection (13%)

1% to 10%:

Central nervous system: Headache (4%), fatigue (3%)

Dermatologic: Tinea (1%)

Local: Injection site reaction (2%)

Frequency not defined:

Neuromuscular & skeletal: Asthenia

Respiratory: Nasopharyngitis, pneumonia, rhinitis, sinusitis, tonsillitis

<1%, postmarketing, and/or case reports: Cellulitis, folliculitis, herpes zoster infection, osteomyelitis, sepsis, urticaria

Warnings/Precautions

Concerns related to adverse effects:

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

Monitoring Parameters

Tuberculosis screening (prior to initiating and periodically during therapy); signs and symptoms of infection, including tuberculosis (during and after treatment).

Pregnancy Considerations

Risankizumab is a humanized monoclonal antibody (IgG1). Potential placental transfer of human IgG is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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