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Guselkumab

    Brands

    DEA Class; Rx

    Common Brand Names; Tremfya

    • Antipsoriatics, Systemic; 
    • Interleukin Inhibitors; 
    • Monoclonal Antibodies

    Subcutaneous interleukin-23 (IL-23) blocker
    Used to treat moderate-to-severe plaque psoriasis and psoriatic arthritis in adults
    May increase the risk for infections; evaluate patients for tuberculosis before use

    Indicated for the treatment of moderate to severe plaque psoriasis in those patients who are candidates for phototherapy or systemic therapy.

    For the treatment of active psoriatic arthritis.

    History of serious hypersensitivity reaction to guselkumab or to any of the excipients

    • Infections (23%)
    • Upper respiratory tract infections (14.3%)
    • 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%)

    May increase infection risk; consider risks and benefits in patients with a chronic infection or history of recurrent infection; discontinue drug if patient develops serious infection or is not responding to therapy; treatment should not be initiated in patients with any clinically important active infection until infection resolves or is adequately treated

    Serious hypersensitivity reactions, including anaphylaxis, reported with postmarket use; some cases required hospitalization; if a serious hypersensitivity reaction occurs, discontinue drug and initiate appropriate therapy

    Do not initiate in patients with clinically important active infection until infection resolves or is adequately treated

    Screen for tuberculosis (TB) before initiating treatment; initiate treatment for latent TB prior to administering guselkumab; monitor patients for signs and symptoms of active TB during and after treatment

    Consider completion of all age-appropriate immunizations before initiating guselkumab; avoid live vaccines

    No available data on use in pregnant women to inform a drug-associated risk of adverse developmental outcomes

    Unknown if distributed in human breast milk; maternal IgG is known to be present in human milk

    Adults

    100 mg/dose subcutaneously.

    Geriatric

    100 mg/dose subcutaneously.

    Adolescents

    Safety and efficacy not established.

    Children

    Safety and efficacy not established.

    Infants

    Safety and efficacy not established.

    Neonates

    Safety and efficacy not established.

    Guselkumab 

    injectable solution

    • prefilled syringe, single-dose
      • 100mg/mL
    • one-Press patient-controlled injector, single-dose
      • 100mg/mL