Serious Infection Risk; Maliganacy in Children and Adolescents
Risk of Serious Infections
- Patients treated with this drug are at risk of developing serious infections that may lead to hospitalization or death (see Warnings and Precautions). Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
- This drug should be discontinued if a patient develops a serious infection or sepsis.
Reported Infections with TNF Blockers, of which Golimumab is a member, include:
- Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before golimumab use and during therapy. Treatment for latent infection should be initiated prior to golimumab use.
- Invasive fungal infections, including histoplasmosis, coccidiodomycoses, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.
- The risks and benefits of treatment with this drug 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 drug, including the possible development of tuberculosis in patient who have tested negative for latent tuberculosis infection prior to initiating therapy (See Warnings and Precautions and Adverse Reactions sections of product insert).
Malignancy in Children and Adolescents
- Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which golimumab is a member
FDA and Industry Communications
- Initial U.S. Approval: 2009
- FDA Information on TNF Blockers
- Boxed Warning Revision for TNF Blockers: Addition of Risk of Listeria and Legionella Bacterial Infection (Sept 2011)
- Safety Review Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults Receiving TNF Blockers, Azathioprine and/or Mercaptopurine (April 2011)
- Boxed Warning Revision: TNF Blockers (November 2009)
- Revised Boxed Warnings Planned per FDA Safety Review: Increased Risk of Lymphomas and Other Malignancies in Children/Adolescents Treated with TNF Blockers (August 2009)
Patient Counseling Information