of influenza virus vaccine trivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.influenza virus vaccine trivalent, adjuvantedSerious - Use Alternative (1)golimumab decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.influenza virus vaccine trivalent, recombinantMonitor Closely (1)golimumab decreases effects of influenza virus vaccine trivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.isavuconazonium sulfateMonitor Closely (1)golimumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.Japanese encephalitis virus vaccineSerious - Use Alternative (1)golimumab decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.leflunomideSerious - Use Alternative (1)golimumab and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.lisocabtagene maraleucelSerious - Use Alternative (1)golimumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.maitakeMonitor Closely (1)golimumab increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.measles (rubeola) vaccineSerious - Use Alternative (1)golimumab decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.measles mumps and rubella vaccine, liveSerious - Use Alternative (1)golimumab decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.measles, mumps, rubella and varicella vaccine, liveSerious - Use Alternative (1)golimumab decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.meningococcal A C Y and W-135 polysaccharide vaccine combinedSerious - Use Alternative (1)golimumab decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.meningococcal group B vaccineMonitor Closely (1)golimumab decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.mercaptopurineMonitor Closely (1)golimumab and mercaptopurine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.methotrexateMinor (1)golimumab, methotrexate. Other (see comment). Minor/Significance Unknown. Comment: Patients receiving immunosuppressives along with golimumab may be at a greater risk of developing an infection.muromonab CD3Serious - Use Alternative (1)golimumab and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.mycophenolateSerious - Use Alternative (1)golimumab and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.ofatumumab SCMonitor Closely (1)ofatumumab SC, golimumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.olaparibMonitor Closely (1)golimumab and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity. pneumococcal vaccine 13-valentSerious - Use Alternative (1)golimumab decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.pneumococcal vaccine heptavalentSerious - Use Alternative (1)golimumab decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.pneumococcal vaccine polyvalentSerious - Use Alternative (1)golimumab decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.poliovirus vaccine inactivatedMonitor Closely (1)golimumab decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .rabies vaccineSerious - Use Alternative (1)golimumab decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.rabies vaccine chick embryo cell derivedSerious - Use Alternative (1)golimumab decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.rilonaceptSerious - Use Alternative (1)golimumab and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.rotavirus oral vaccine, liveSerious - Use Alternative (1)golimumab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.rozanolixizumabMonitor Closely (1)rozanolixizumab will decrease the level or effect of golimumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing rozanolixizumab and using alternative therapies.rubella vaccineSerious - Use Alternative (1)golimumab decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.sipuleucel-TMonitor Closely (1)golimumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.sirolimusSerious - Use Alternative (1)golimumab and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.smallpox (vaccinia) vaccine, liveSerious - Use Alternative (1)golimumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.tacrolimusSerious - Use Alternative (1)golimumab and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.temsirolimusSerious - Use Alternative (1)golimumab and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.tetanus toxoid adsorbed or fluidSerious - Use Alternative (1)golimumab decreases effects of tetanus toxoid adsorbed or fluid by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.tick-borne encephalitis vaccineSerious - Use Alternative (1)golimumab decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.tisagenlecleucelSerious - Use Alternative (1)golimumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.tocilizumabSerious - Use Alternative (1)tocilizumab and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.tongkat aliSerious - Use Alternative (1)golimumab and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.trastuzumabMonitor Closely (1)trastuzumab, golimumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .trastuzumab deruxtecanMonitor Closely (1)trastuzumab deruxtecan, golimumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .travelers diarrhea and cholera vaccine inactivatedSerious - Use Alternative (1)golimumab decreases effects of travelers diarrhea and cholera vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.typhoid polysaccharide vaccineSerious - Use Alternative (1)golimumab decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.typhoid vaccine liveSerious - Use Alternative (1)golimumab decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.ublituximabMonitor Closely (1)ublituximab and golimumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministeredupadacitinibContraindicated (1)golimumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.ustekinumabSerious - Use Alternative (1)golimumab and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.varicella virus vaccine liveSerious - Use Alternative (1)golimumab decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.vedolizumabSerious - Use Alternative (1)vedolizumab and golimumab both increase increasing elimination. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infectionsyellow fever vaccineSerious - Use Alternative (1)golimumab decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.zoster vaccine liveSerious - Use Alternative (1)golimumab decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.zoster vaccine recombinantMonitor Closely (1)golimumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant. >10% Simponi Upper respiratory tract infection (eg, upper respiratory tract infection, nasopharyngitis, pharyngitis, laryngitis, and rhinitis) (16%) Simponi Aria Upper respiratory tract infection (eg, upper respiratory tract infection, nasopharyngitis, pharyngitis, laryngitis, and rhinitis) (12%) 1-10% Simponi Injection site reactions (eg, erythema, urticaria, induration, pain, bruising, pruritus, irritation, paresthesia) (6%) Viral infections (eg, influenza and herpes) (5%) Increased ALT (4%) Increased AST (3%) Dizziness (2%) Paresthesia (2%) Bronchitis (2%) Superficial fungal infections (2%) Sinusitis (2%) Constipation (1%) Simponi Aria Viral infections (eg, influenza and herpes) (3%) Hypertension (2%) Rash (1%) Pyrexia (1%) Bronchitis (1%) Frequency Not Defined Simponi Infections and infestations: Septic shock, atypical mycobacterial infection, pyelonephritis, arthritis bacterial, bursitis infective Neoplasms benign, malignant and unspecified: Leukemia Skin and subcutaneous tissue disorders: Psoriasis (new onset or worsening, palmar/plantar and pustular), vasculitis (cutaneous) Vascular disorders: Vasculitis (systemic) Simponi Aria Infections and infestations: Superficial fungal infection, sinusitis, abscess, lower respiratory tract infection (pneumonia), pyelonephritis Investigations: Alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, neutrophil count decreased Nervous system disorders: Dizziness, paresthesia Gastrointestinal disorders: Constipation Postmarketing Reports Simponi Immune system disorders: Serious systemic hypersensitivity reactions (including anaphylactic reaction), sarcoidosis Respiratory, thoracic and mediastinal disorders: Interstitial lung disease Skin and subcutaneous tissue disorders: Skin exfoliation, rash, bullous skin reactions Simponi Aria General disorders and administration site conditions: Infusion-related reactions Neoplasm benign and malignant: Melanoma, Merkel cell carcinoma Immune system disorders: Serious systemic hypersensitivity reactions (including anaphylactic reaction), sarcoidosis Respiratory, thoracic and mediastinal disorders: Interstitial lung disease Skin and SC tissue disorders: Skin exfoliation, lichenoid reactions, bullous skin reactions Black Box Warnings Serious infection risk Increased risk for developing serious infections resulting in hospitalization or death; most patients were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids) Patients older than 65 years may be at greater risk Discontinue if patient develops serious infection or sepsis Reported infections include: Active TB, including reactivation of latent TB (frequently present with disseminated or extrapulmonary disease); test for latent TB before use and during therapy; treat latent infection prior to use Invasive fungal infections (eg, histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis); may present with disseminated, rather than localized, disease; antigen/antibody testing for histoplasmosis may be negative in some patients with active infection; initiate empiric antifungal therapy if severe systemic illness develops Other bacterial (eg, Legionella, Listeria), mycobacterial (eg, tuberculosis), and viral (eg, hepatitis B) opportunistic pathogens Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers Manufacturer required to report all malignancies to FDA in order for complete and consistent analysis Consider the risks and benefits of treatment prior to initiating therapy in patients with chronic or recurrent infectionContraindications None Cautions Treatment with TNF blockers, 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, therapy should be discontinued Care should be taken when switching from one biological product to another biological product since overlapping biological activity may further increase risk of infection 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 in patients who have or have had significant cytopenias Patients treated with SIMPONI may receive vaccinations, except for live vaccines. In patients receiving anti-TNF therapy, limited data are available on response to live vaccination, or on secondary transmission of infection by live vaccines; use of live vaccines could result in clinical infections, including disseminated infections Other uses of therapeutic infectious agents such as live attenuated bacteria (eg, BCG bladder instillation for treatment of cancer) could result in clinical infections, including disseminated infections; it is recommended that therapeutic infectious agents not be given concurrently with this drug Therapy may not suppress the humoral immune response to the pneumococcal vaccine In postmarketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) reported; some of these reactions occurred after first