Indicated for:

Plaque Psoriasis:

• The treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis:

• The treatment of adult patients with active psoriatic arthritis.

TREMFYA may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA and initiate appropriate therapy.

TREMFYA may increase the risk of infection.Treatment with TREMFYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with TREMFYA. Consider anti-TB therapy prior to initiating TREMFYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Do not administer TREMFYA to patients with active TB infection.

Prior to initiating therapy with TREMFYA, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TREMFYA. No data are available on the response to live or inactive vaccines.

As with all therapeutic proteins, there is the potential for immunogenicity with TREMFYA.

Upon initiation of TREMFYA in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and consider dosage adjustment as needed.

There are no available data on TREMFYA 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, TREMFYA may be transmitted from the mother to the developing fetus.

There are no data on the presence of guselkumab in human milk, the effects on the breastfed infant, or the effects on milk production.

GoToSource

• Use in patients under 18 years of age. GoToSource

• Crohn’s disease. GoToSource

• Lupus nephritis. GoToSource

Infections (including fungal skin infections and herpes simplex infections), injection site reactions and joint pain. GoToSource

Hypersensitivity reactions. GoToSource

Gastroenteritis and reactivation of tuberculosis. GoToSource

No major injury lawsuits reported.