Guselkumab

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

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

Guselkumab 

injectable solution

• prefilled syringe, single-dose

  • 100mg/mL

• one-Press patient-controlled injector, single-dose

  • 100mg/mL