Risk of Serious Infections

• Patients treated with tocilizumab are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
• If a serious infection develops, interrupt therapy with this agent until the infection is controlled
• Reported infections include:
  
  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before tocilizumab use and during therapy. Treatment for latent infection should be initiated prior to tocilizumab use.
  • Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized disease.
  • Bacterial, viral, and other infections due to opportunistic pathogens.
• The risks and benefits of treatment with this agent should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
• Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with this agent, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.