General

Pronunciation:
ris-an-kiz-ue-mab

Trade Name(s)

• Skyrizi

Ther. Class.

antipsoriatics

Pharm. Class.

interleukin antagonists

monoclonal antibodies

Indications

• Moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy.
• Active psoriatic arthritis (as monotherapy or in combination with non-biologic disease-modifying antirheumatic drugs [DMARDs]).
• Moderately to severely active Crohn's disease

Action

Binds to the p19 protein subunit of the interleukin (IL)-23 cytokine to prevent its interaction with the IL-23 receptor. This cytokine is normally involved in inflammatory and immune responses. Binding to interleukins antagonizes their effects, inhibiting the release of proinflammatory cytokines and chemokines.

Therapeutic Effect(s):

• Decrease in area and severity of psoriatic lesions.
• Improvement in clinical and symptomatic parameters of psoriatic arthritis.
• Improvement in clinical and endoscopic remission rates in Crohn's disease.

Pharmacokinetics

Absorption: 89% absorbed following SUBQ administration. IV administration results in complete bioavailability.

Distribution: Well distributed to tissues.

Metabolism and Excretion: Broken down by catabolic processes into peptides and amino acids.

Half-life: Plaque psoriasis:  28 days;  Crohn's disease:  21 days.

TIME/ACTION PROFILE (plasma concentrations)

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity;
• Active, untreated infection.

Use Cautiously in:

• History of tuberculosis (possibility of reactivation);
• Cirrhosis (for Crohn's disease only);
• OB:  Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
• Lactation: Safety not established in breastfeeding;
• Pedi:   Safety and effectiveness not established in children.

Exercise Extreme Caution in:

Chronic infection or history of recurrent infection.

Adverse Reactions/Side Effects

GI: hepatotoxicity (in crohn's disease)

Local: injection site reactions

Neuro: fatigue, headache

Misc: infection, HYPERSENSITIVITY REACTIONS (including anaphylaxis)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

May ↓ antibody response to and ↑ risk of adverse reactions from  live vaccines ; avoid use during therapy.

Route/Dosage

Plaque Psoriasis and Psoriatic Arthritis

SUBQ (Adults): 150 mg initially and 4 wk later, then 150 mg every 12 wk.

Crohn's Disease

IV (Adults): Induction:  600 mg initially and then at Week 4 and Week 8. At Week 12, begin Maintenance therapy (SUBQ) (see below).

SUBQ (Adults): Maintenance:  180 mg or 360 mg at Week 12, and then every 8 wk.

Availability

Solution for SUBQ injection (prefilled pens): 150 mg/mL

Solution for SUBQ injection (prefilled syringes): 75 mg/0.83 mL, 150 mg/mL

Solution for SUBQ injection (prefilled cartridge with on-body injector): 360 mg/2.4 mL

Solution for IV injection: 60 mg/mL

Assessment

• Assess patient for tuberculosis (TB) before starting, during, and after therapy. Do not administer risankizumab to patient with active TB. Consider anti-TB therapy before starting therapy in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
• Assess skin lesions before and periodically during therapy.
• Monitor for signs and symptoms of infection (fever, chills, cough, dyspnea, skin infections) periodically during therapy.
• Monitor for signs and symptoms of hypersensitivity reactions (fainting; dizziness; feeling lightheaded; chest tightness; swelling of face, eyelids, lips, mouth, tongue, or throat; skin rash; hives; trouble breathing or throat tightness; itching) during therapy.

Lab Test Considerations:

For Crohn's disease:  assess liver enzymes and bilirubin levels prior to starting therapy and periodically for at least 12 wk.

Implementation

• Complete all age-appropriate vaccinations as recommended by current immunization guidelines before starting therapy.
• Before injecting, remove carton from refrigerator and without removing prefilled pen or prefilled syringe(s) from the carton, allow risankizumab to reach room temperature out of direct sunlight: 30–90 min for prefilled pen and 15–30 min for the prefilled syringe(s). Solution is colorless to slightly yellow and clear to slightly opalescent; may contain a few translucent to white particles. Do not use if solution is cloudy, discolored, or contains large particles. Do not freeze or shake.
• May use pen, prefilled syringe, or prefilled cartridge with supplied on-body injector for SUBQ injections. Follow manufacturer's  Instructions for Use  for each method.
• SUBQ Inject into abdomen or thigh; may inject in upper, outer arm if administered by health care professional or caregiver. Do not inject into areas where skin is tender, bruised, erythematous, indurated or affected by psoriasis. If using 75 mg/0.83 mL syringes, 150 mg dose requires two syringes. Inject in different locations.

• Y-Site Incompatibility: Do not administer with other medications or solutions.

Patient/Family Teaching

• Instruct patient caregiver in correct injection technique and disposal of equipment. Administer at Week 0, Week 4, and every 12 wk thereafter. If a dose is missed, administer as soon as possible, then resume dosing at the regular scheduled time.
• Advise patient to notify health care professional if signs and symptoms of infection (fever, sweats, chills, cough, shortness of breath, blood in mucus [phlegm], muscle aches, warm, red, or painful skin or sores different from psoriasis, weight loss, diarrhea or stomach pain, burning on urination, urinating more often than usual) occur.
• Advise patient to avoid live vaccines during therapy.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
• Rep:  Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Delay live virus immunizations in infants exposed in utero for a minimum of 5 mo after birth. Inform patient of pregnancy exposure registry that monitors outcomes in women who become pregnant while treated with risankizumab. Encourage patient to enroll by calling 1­877-302-2161.

Evaluation/Desired Outcomes

• Decrease in area and severity of psoriatic lesions.
• Improvement in clinical and symptomatic parameters of psoriatic arthritis.
• Improvement in clinical and endoscopic remission rates in Crohn's disease.