risankizumab

REMS

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

Contraind./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.

Adv. Reactions/Side Effects ⬆ ⬇

GI: hepatotoxicity(in Crohn's disease)

Local: injection site reactions

Neuro: fatigue, headache

Misc: infection, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

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

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

Route/Dosage ⬆ ⬇

Plaque Psoriasis and Psoriatic Arthritis

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

US Brand Names ⬆ ⬇

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 effects:

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.

Classifications ⬆ ⬇

Therapeutic Classification: antipsoriatics

Pharmacologic Classification: interleukin antagonists, monoclonal antibodies

Pharmacokinetics ⬆ ⬇

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

Distribution: Well distributed to tissues.

Metabolism/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)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	3–14 days	12 wk
IV	unknown	unknown	unknown

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.

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Indications ⬇