Indicated for the treatment of adult patients with:

Rheumatoid Arthritis:

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

Psoriatic Arthritis:

• SIMPONI, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis.

Ankylosing Spondylitis:

• SIMPONI is indicated for the treatment of adult patients with active ankylosing spondylitis.

Ulcerative Colitis:

• SIMPONI is indicated in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine for:

• inducing and maintaining clinical response 
• improving endoscopic appearance of the mucosa during induction
• inducing clinical remission
• achieving and sustaining clinical remission in induction responders

Patients treated with SIMPONI 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.

Reported infections with TNF-blockers, of which SIMPONI 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 use and during therapy. Initiate treatment for latent TB prior to SIMPONI use.

Reported infections with TNF blockers, of which SIMPONI is a member, include: 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.

The use of TNF blockers including SIMPONI has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers (i.e., surface antigen positive). In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.

Treatment with SIMPONI 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 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

Incidence of lymphoma was greater than in the general U.S. population. Cases of other malignancies have been observed among patients receiving TNF blockers.

Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), of which SIMPONI is a member. 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.

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. The potential risk with the combination of AZA or 6-MP and SIMPONI should be carefully considered. A risk for the development for hepatosplenic T-cell lymphoma in patients treated with TNF blockers cannot be excluded.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including SIMPONI. 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. Some cases had a fatal outcome.

Use of TNF blockers, of which SIMPONI is a member, 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.

There have been postmarketing reports of pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF blockers.

Treatment with TNF blockers, including SIMPONI, may result in the formation of antinuclear antibodies (ANA) and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with SIMPONI, treatment should be discontinued.

It is not known if SIMPONI treatment influences the risk for developing dysplasia or colon cancer. All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course. This evaluation should include colonoscopy and biopsies per local recommendations. 

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

Live vaccines should not be given concurrently with SIMPONI. Therapeutic infectious agents should not be given concurrently with SIMPONI.

Use of SIMPONI with abatacept or anakinra is not recommended.

Use of SIMPONI with biologics approved to treat RA, PsA, or AS is not recommended because of the possibility of an increased risk of infection.

Infants born to women treated with SIMPONI during their pregnancy may be at increased risk of infection for up to 6 months. Administration of live vaccines to infants exposed to SIMPONI in utero is not recommended for 6 months following the mother’s last SIMPONI injection during pregnancy.

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. 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.

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• Use in patients under the age of 18. GoToSource

• Behçet’s disease, sarcoidosis and non-infectious uveitis. GoToSource

• Hidradenitis suppurativa, cicatricial pemphigoid, pyoderma gangrenosum, multicentric reticulohistiocytosis, aphthous stomatitis, sneddon-wilkinson disease, SAPHO syndrome, pityriasis rubra pilaris, eosinophilic fasciitis, panniculitis, crohn’s disease, necrobiosis lipoidica diabeticorum, dermatomyositis and scleroderma. GoToSource

• Systemic lupus erythematosus. GoToSource

• Refractory diabetic macular edema and neovascular age-related macular degeneration. GoToSource

• Sympathetic ophthalmia, vogt-koyanagi-harada, birdshot chorioretinopathy and serpiginous choroidopathy. GoToSource

• Giant cell arteritis, takayasu arteritis, primary angiitis of the central nervous system and cogan syndrome. GoToSource

• Inflammatory bowel disease. GoToSource

Listeria monocytogenes infection. GoToSource

Takayasu’s arteritis (inflammation that damages the aorta). GoToSource

Non-infectious pulmonary complications including idiopathic pulmonary fibrosis, allergic pneumonitis and pneumonia. GoToSource

Lymphomas, leukemia, melanoma, solid organ cancers, breast cancer, exacerbation of congestive heart failure, reactivation of hepatitis B virus and psoriasis. GoToSource

Tuberculosis, infections including aspergillosis, salmonella, histoplasmosis, coccidioidomycosis and herpes infections. GoToSource

Pelvic inflammatory disease and endometriosis of the appendix, injection-site reactions and elevated liver enzymes. GoToSource

Lawsuits filed for infections including tuberculosis, hepatitis B, legionella, listeria, histoplasmosis and aspergillosis.