"The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.
Inflectra is biosimilar to"...
(golimumab) for Intravenous Infusion
SERIOUS INFECTIONS AND MALIGNANCY
Patients treated with SIMPONI ARIA are at increased risk for 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.
Discontinue SIMPONI ARIA if a patient develops a serious infection.
Reported infections with TNF blockers, of which SIMPONI ARIA is a member, include:
- Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patients for latent tuberculosis before SIMPONI ARIA use and during therapy. Initiate treatment for latent tuberculosis prior to SIMPONI ARIA use.
- Invasive fungal infections including histoplasmosis, coccidioidomycosis, 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. Consider empiric antifungal therapy 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.
Consider the risks and benefits of treatment with SIMPONI ARIA prior to initiating therapy in patients with chronic or recurrent infection.
Monitor patients closely for the development of signs and symptoms of infection during and after treatment with SIMPONI ARIA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see WARNINGS AND PRECAUTIONS].
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, of which SIMPONI ARIA is a member [see WARNINGS AND PRECAUTIONS].
SIMPONI ARIA (golimumab) is a human IgG1κ monoclonal antibody specific for human tumor necrosis factor alpha (TNFα) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. SIMPONI ARIA was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. SIMPONI ARIA is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses.
The SIMPONI ARIA drug product is a sterile concentrated solution of the golimumab antibody supplied in a 4-mL glass vial for intravenous infusion.
SIMPONI ARIA does not contain preservatives, natural rubber, or latex. The solution is colorless to light yellow with a pH of approximately 5.5. Each 4-mL vial of SIMPONI ARIA contains 50 mg golimumab, 9.5 mM L-histidine, 4.5% (w/v) sorbitol, and 0.015% (w/v) polysorbate 80.
Last reviewed on RxList: 3/3/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Simponi Aria Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options