Indicated for:

Rheumatoid Arthritis (RA):

• SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

Psoriatic Arthritis (PsA):

• The treatment of active psoriatic arthritis in patients 2 years of age and older.

Ankylosing Spondylitis (AS):

• The treatment of adult patients with active ankylosing spondylitis.

Polyarticular Juvenile Idiopathic Arthritis (pJIA):

• The treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.

For patients with rheumatoid arthritis (RA), SIMPONI ARIA should be given in combination with methotrexate.

The efficacy and safety of switching between intravenous and subcutaneous formulations and routes of administration have not been established.

Do not infuse SIMPONI ARIA concomitantly in the same intravenous line with other agents. No physical biochemical compatibility studies have been conducted to evaluate the use of SIMPONI ARIA with other intravenous agents in the same intravenous line.

Patients treated with SIMPONI ARIA 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.

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.

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.

All patients should be tested for HBV infection before initiating TNF-blocker therapy. For patients who test positive for hepatitis B surface antigen, consultation with a physician with expertise in the treatment of hepatitis B is recommended before initiating TNF-blocker therapy. The risks and benefits of treatment should be considered prior to prescribing TNF-blockers, including SIMPONI ARIA, to patients who are carriers of HBV. Adequate data are not available on whether antiviral therapy can reduce the risk of HBV reactivation in HBV carriers who are treated with TNF-blockers. Patients who are carriers of HBV and require treatment with TNF-blockers should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.

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.

Treatment with SIMPONI ARIA should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection.

Consider the risks and benefits of treatment prior to initiating SIMPONI ARIA in patients:

• with chronic or recurrent infection
• who have been exposed to tuberculosis
• with a history of an opportunistic infection
• who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis
• with underlying conditions that may predispose them to infection

Malignancies in Pediatric Patients:  Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy less than 18 years of age), including golimumab. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression, and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months (range 1 to 84 months) after the first dose of TNF-blocker therapy.

Malignancies in Adult Patients: The risks and benefits of TNF-blocker treatment including SIMPONI ARIA should be considered prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing a TNF-blocker in patients who develop a malignancy. Patients with RA and other chronic inflammatory diseases, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF-blocking therapy. Cases of acute and chronic leukemia have been reported with TNF blocker use, including SIMPONI ARIA, in rheumatoid arthritis and other indications. Even in the absence of TNF-blocker therapy, patients with rheumatoid arthritis may be at a higher risk (approximately 2-fold) than the general population for the development of leukemia.

Rare postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF-blocking agents. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. Nearly all of the reported TNF-blocker associated cases have occurred in patients with Crohn’s disease or ulcerative colitis. The majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine (AZA) or 6-mercaptopurine (6–MP) concomitantly with a TNF-blocker at or prior to diagnosis.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including SIMPONI ARIA. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF-blockers, including SIMPONI ARIA. Some cases had a fatal outcome.

Use of TNF-blockers, including SIMPONI ARIA, has been associated with rare cases of new onset or exacerbation of central nervous system (CNS) demyelinating disorders, including multiple sclerosis (MS), and peripheral demyelinating disorders, including Guillain-Barré syndrome. Cases of central demyelination, MS, optic neuritis, and peripheral demyelinating polyneuropathy have rarely been reported in patients treated with golimumab. Prescribers should exercise caution in considering the use of TNF-blockers, including SIMPONI ARIA, in patients with central or peripheral nervous system demyelinating disorders.

Treatment with TNF blockers, including SIMPONI ARIA, may result in the formation of antinuclear antibodies (ANA).

Rarely, treatment with TNF blockers, may result in the development of a lupus-like  syndrome.

There have been reports of severe hepatic reactions including acute liver failure in patients receiving TNF blockers.

There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia in patients receiving golimumab. Caution should be exercised when using TNF blockers, including SIMPONI ARIA, in patients who have or have had significant cytopenias.

In postmarketing experience, serious systemic hypersensitivity reactions (including anaphylaxis) have been reported following administration of the subcutaneous and intravenous formulations of golimumab including SIMPONI ARIA.

In controlled trials, the concurrent administration of another TNF-blocker and abatacept was associated with a greater proportion of serious infections than the use of a TNF-blocker alone; and the combination therapy, compared to the use of a TNF-blocker alone, has not demonstrated improved clinical benefit in the treatment of RA. Therefore, the combination of TNF-blockers, including SIMPONI ARIA, and abatacept is not recommended.

Concurrent administration of anakinra (an interleukin-1 antagonist) and another TNF-blocker was associated with a greater portion of serious infections and neutropenia and no additional benefits compared with the TNF-blocker alone. Therefore, the combination of anakinra with TNF-blockers, including SIMPONI ARIA, is not recommended.

Care should be taken when switching from one biologic product to another biologic product since overlapping biological activity may further increase the risk of infection.

Avoid live vaccines in patients treated with SIMPONI ARIA. In patients receiving anti-TNF therapy, limited data are available on the response to live vaccination, or on the secondary transmission of infection by live vaccines. Use of live vaccines could result in clinical infections, including disseminated infections.

Administration of live vaccines to infants exposed to SIMPONI ARIA in utero is not recommended for 6 months following the mother’s last SIMPONI ARIA infusion during pregnancy.

Whenever possible update immunizations prior to initiation of treatment with SIMPONI ARIA following current immunization guidelines for patients receiving immunosuppressive agents. Advise patients to discuss with the physician before seeking any immunizations.

Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections. It is recommended that therapeutic infectious agents not be given concurrently with SIMPONI ARIA.

Upon initiation or discontinuation of SIMPONI ARIA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.

There are no adequate and well-controlled trials of SIMPONI ARIA in pregnant women. Monoclonal antibodies, such as golimumab, are transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant.

Golimumab crosses the placenta during pregnancy. Another TNF-blocking monoclonal antibody administered during pregnancy was detected for up to 6 months in the serum of infants. Consequently, these infants may be at increased risk of infection. Administration of live vaccines to infants exposed to SIMPONI ARIA in utero is not recommended for 6 months following the mother’s last SIMPONI ARIA infusion during pregnancy.

There is no information regarding the presence of SIMPONI ARIA in human milk, the effects on breastfed infants, or the effects on milk production. Maternal IgG is known to be present in human milk. If golimumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to golimumab are unknown.

GoToSource

• Use in patients under 2 years of age. GoToSource

• Spondyloarthropatties, inflammatory bowel disease, psoriasis, behçet’s disease, sarcoidosis and noninfectious uveitis. GoToSource

• Beta-cell function in youth with new-onset type 1 diabetes. GoToSource

• COVID-19. GoToSource

• Hidradenitis suppuritiva, pyoderma gangrenosum, dermatomyositis and scleroderma. GoToSource

Upper-respiratory infections, nasopharyngitis, hypertension, tuberculosis, opportunistic infections, lymphoma and immunogenicity (immune response). GoToSource

Leukocytoclastic vasculitis (inflammation of small blood vessels), demyelinating disorders ( disorders resulting in damage to the protective covering that surrounds nerve fibers in brain, optic nerves and spinal cord), congestive heart failure, allergic reactions, alopecia (hair loss), dermatitis (skin inflammation), pruritus (severe itching) and psoriasis. GoToSource

Worsening of ulcerative colitis, non-melanoma skin cancer and hypersensitivity reactions. GoToSource

Autoimmune diseases (including lupus-like syndromes, diabetes mellitus, interstitial lung diseases sarcoidosis, autoimmune hepatitis, uveitis, antiphospholipid syndrome, myositis and myasthenia gravis). GoToSource

Lawsuits filed for fatal fungal infections.