Risankizumab
Indications
Risankizumab is used for:
Plaque Psoriasis
Adult Dose
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
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
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
Contra Indications
Precautions
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
Pregnancy-Lactation
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
Interactions
Adverse Effects
Side effects of Risankizumab :
>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)
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