Infliximab, Infliximab-dyyb

Warning

Serious Infections

• Increased risk of serious infections that may require hospitalization or result in death, particularly in patients receiving other immunosuppressive agents concomitantly; tuberculosis (frequently disseminated or extrapulmonary), invasive fungal infections (may be disseminated), bacterial (e.g., legionellosis, listeriosis) and viral infections, and other opportunistic infections reported. (See Infectious Complications under Cautions.)

• Carefully consider risks and benefits prior to initiating therapy with infliximab products in patients with chronic or recurring infections.

• Evaluate patients for latent tuberculosis infection prior to and periodically during therapy with infliximab products; if indicated, initiate appropriate antimycobacterial regimen prior to initiating infliximab products.

• Closely monitor patients for infection, including active tuberculosis in those with a negative tuberculin skin test, during and after treatment. Discontinue infliximab product if serious infection or sepsis occurs. Consider empiric antifungal therapy if serious systemic illness occurs in a patient at risk for invasive fungal infections. Serologic tests for histoplasmosis may be negative.

Malignancy

• Lymphoma and other malignancies (some fatal) reported in children and adolescents receiving TNF blocking agents. (See Malignancies and Lymphoproliferative Disorders under Cautions.)

• Aggressive, usually fatal hepatosplenic T-cell lymphoma reported mainly in adolescent and young adult males with Crohn's disease or ulcerative colitis receiving TNF blocking agents, including infliximab products. Most of the patients received a combination of immunosuppressive agents, including TNF blocking agents and thio