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 disease.
Improvement in clinical remission rates in ulcerative colitis.
Assess patient for 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/symptoms of infection (fever, chills, cough, dyspnea, skin infections) periodically during therapy.
Monitor for signs/symptoms of hypersensitivity reactions (fainting; dizziness; feeling light-headed; 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 disease and ulcerative colitis: Assess liver enzymes and bilirubin levels before starting therapy and periodically during induction for ≥12 wk.
Complete all age-appropriate vaccinations as recommended by current immunization guidelines before starting therapy.
Before injecting, remove carton from refrigerator; 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 provider 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.
Intermittent Infusion: Dilution: For Crohn disease: For a dose of 600 mg, add one vial (10 mL) to an IV bag or glass bottle containing 100 mL, 250 mL, or 500 mL of D5W or 0.9% NaCl; For ulcerative colitis: For a dose of 1200 mg, add two vials (20 mL) to an IV bag or glass bottle containing 250 mL or 500 mL of D5W or 0.9% NaCl. Concentration: 1.2–6 mg/mL. Discard any remaining solution in the vial. Do not shake vial or diluted solution. Allow diluted solution to warm to room temperature (if stored refrigerated) prior to administration. Complete infusion within 8 hr of dilution. Solution is stable for 8 hr at room temperature and up to 20 hr if refrigerated and protected from light.
Rate: Infuse over ≥1 hr (600 mg dose) or ≥2 hr (1200 mg dose).
Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Instruct patient and/or caregiver about correct injection technique and disposal of equipment. Administer at Wk 0, Wk 4, and every 12 wk thereafter. If a dose is missed, administer as soon as possible; then resume dosing at the regular scheduled time.
Instruct patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other Rx, OTC, or herbal products.
Advise patient to notify health care provider if signs and symptoms of infection (fever; sweats; chills; cough; shortness of breath; blood in mucus; 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.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Delay live-virus immunizations in infants exposed in utero for ≥5 mo after birth. Inform pregnant patient of registry that monitors outcomes in women who become pregnant while treated with risankizumab. Encourage patient to enroll by calling 1877-302-2161.