Guselkumab

Indications

Guselkumab is used for: Moderate to severe, plaque psoriasis, in adults who are candidates for systemic therapy.

Adult Dose

Plaque Psoriasis Indicated for moderate-to-severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy 100 mg SC at Week 0, Week 4, and q8Weeks thereafter

Child Dose

<18 years: Safety and efficacy not established

Renal Dose

Administration

SC Preparation Remove from refrigerator; allow syringe to reach room temperature (~30 min) before removing syringe cap Preservative free; visually inspect syringe for any particulates or discoloration prior to administration SC Administration For SC use only; inject full amount (1 mL) Do not inject areas where skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis

Contra Indications

Serious hypersensitivity. Clinically important active infections (eg, active TB).

Precautions

Discontinue use in case of serious hypersensitivity reactions. Increased risk of infection. Evaluate for TB prior to treatment initiation. Monitor for signs & symptoms of active TB during & after treatment. Concurrent use w/ live vaccines. Withhold treatment for at least 12 wk after last dose prior to live viral or bacterial vaccination; treatment can be resumed 2 wk after vaccination. Women of childbearing potential should use effective methods of contraception during & for at least 12 wk after treatment. Pregnancy & lactation. Elderly >65 yr. Childn & adolescent <18 yr.

Pregnancy-Lactation

Pregnancy No available data on use in pregnant women to inform a drug-associated risk of adverse developmental outcomes Human IgG antibodies are known to cross the placental barrier; therefore, guselkumab may be transmitted from the mother to the developing fetus Animal studies In a combined embryofetal development and prenatal and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after SC administration during organogenesis through parturition at doses up to 30 times the maximum recommended human dose (MRHD) Neonatal deaths were observed at 6-to 30-times the MRHD Lactation Unknown if distributed in human breast milk; maternal IgG is known to be present in human milk Guselkumab was not detected in the milk of lactating cynomolgus monkeys 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

Concomitant use w/ immunosuppresants (eg, biologics) or phototherapy.

Adverse Effects

Side effects of Guselkumab : >10% Infections (23%) Upper respiratory tract infections (14.3%) 1-10% Headache (4.6%) Injection site reactions (4.5%) Arthralgia (2.7%) Elevated liver enzymes (2.6%) Diarrhea (1.6%) Gastroenteritis (1.3%) Tinea infections (1.1%) Herpes simplex infections (1.1%)

Mechanism of Action

Monoclonal antibody (IgG1-lambda) that inhibits IL-23 by selectively binding to p19 subunit of IL-23; IL-23 is a natural cytokine associated with inflammatory and immune responses; guselkumab inhibits the proinflammatory actions of IL-23, thereby decreasing cytokine and chemokine release.