golimumab (Rx)

Brand and Other Names:Simponi, Simponi Aria
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

SC solution (single-dose prefilled syringe/autoinjector)

  • 50mg/0.5mL (Simponi)
  • 100mg/1mL (Simponi)

IV solution (single-dose vial)

  • 50mg/4mL (Simponi Aria)

Rheumatoid Arthritis

Indicated for moderately-to-severely active rheumatoid arthritis in combination with methotrexate

Simponi

  • 50 mg SC qMonth

Simponi Aria

  • 2 mg/kg IV at weeks 0 and 4, then q8Weeks

  • Give in combination with methotrexate

Psoriatic Arthritis

Indicated for moderately-to-severely active psoriatic arthritis alone or in combination with methotrexate

Simponi

  • 50 mg SC qMonth

Simponi Aria

  • 2 mg/kg IV at weeks 0 and 4, then q8Weeks

  • Corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment

Ankylosing Spondylitis

Indicated for active ankylosing spondylitis with or without methotrexate

Simponi

  • 50 mg SC qMonth

Simponi Aria

  • 2 mg/kg IV at weeks 0 and 4, then q8Weeks

  • Corticosteroids, NSAIDs, and/or analgesics may be continued during treatment

Ulcerative Colitis

Simponi

  • Indicated in adults with moderate to severe active ulcerative colitis who demonstrate corticosteroid dependence or who have 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
  • Initial: 200 mg SC at Week 0, followed by 100 mg SC at Week 2, THEN
  • Maintenance: 100 mg SC q4Weeks

Dosage Modifications

Renal and hepatic impairment

  • No formal trial of the effect of renal or hepatic impairment on pharmacokinetics was conducted

Dosing Considerations

Safety and efficacy of switching between IV and SC formulations and routes of administration not established

Monitoring parameters

  • Evaluate patients for active tuberculosis and test for latent infection before initiating and periodically during therapy
  • Test for hepatitis B viral infection before initiating

Dosage Forms & Strengths

IV solution (single-dose vial)

  • 50mg/4mL (Simponi Aria)

Psoriatic Arthritis

Indicated for active psoriatic arthritis (PsA) in patients aged ≥2 years

80 mg/m2 IV at weeks 0 and 4, and q8Weeks thereafter

Polyarticular Juvenile Idiopathic Arthritis

Indicated for active polyarticular juvenile idiopathic arthritis (pJIA) in patients aged ≥2 years

80 mg/m2 IV at weeks 0 and 4, and q8Weeks thereafter

Dosage Modifications

Renal and hepatic impairment

  • No formal trial of the effect of renal or hepatic impairment on pharmacokinetics was conducted

Dosing Considerations

Monitoring parameters

  • Evaluate patients for active tuberculosis and test for latent infection before initiating and periodically during therapy
  • Test for hepatitis B viral infection before initiating
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Interactions

Interaction Checker

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (65)

              • adalimumab

                adalimumab and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • alefacept

                alefacept and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • anakinra

                anakinra and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • anthrax vaccine

                golimumab decreases effects of anthrax vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • antithymocyte globulin equine

                antithymocyte globulin equine and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • antithymocyte globulin rabbit

                antithymocyte globulin rabbit and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • azathioprine

                azathioprine and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • baricitinib

                baricitinib, golimumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.

              • basiliximab

                basiliximab and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • BCG vaccine live

                golimumab decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • canakinumab

                canakinumab and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • certolizumab pegol

                golimumab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

              • cyclosporine

                cyclosporine and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • diphtheria & tetanus toxoids

                golimumab decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • diphtheria & tetanus toxoids/ acellular pertussis vaccine

                golimumab decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine

                golimumab decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • etanercept

                etanercept and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • everolimus

                everolimus and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • glatiramer

                glatiramer and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • hepatitis A vaccine inactivated

                golimumab decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • hepatitis a/b vaccine

                golimumab decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • hepatitis a/typhoid vaccine

                golimumab decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • hepatitis b vaccine

                golimumab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • human papillomavirus vaccine, nonavalent

                golimumab decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • human papillomavirus vaccine, quadrivalent

                golimumab decreases effects of human papillomavirus vaccine, quadrivalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • hydroxychloroquine sulfate

                golimumab and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • infliximab

                golimumab and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • influenza virus vaccine quadrivalent

                golimumab decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • influenza virus vaccine quadrivalent, adjuvanted

                golimumab decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine quadrivalent, cell-cultured

                golimumab decreases effects of influenza virus vaccine quadrivalent, cell-cultured by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • influenza virus vaccine quadrivalent, intranasal

                golimumab decreases effects of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • influenza virus vaccine trivalent

                golimumab decreases effects of influenza virus vaccine trivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • influenza virus vaccine trivalent, adjuvanted

                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.

              • Japanese encephalitis virus vaccine

                golimumab decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • leflunomide

                golimumab and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • measles (rubeola) vaccine

                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, live

                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, live

                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 combined

                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.

              • muromonab CD3

                golimumab and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • mycophenolate

                golimumab and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • pneumococcal vaccine 13-valent

                golimumab decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • pneumococcal vaccine heptavalent

                golimumab decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • pneumococcal vaccine polyvalent

                golimumab decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • rabies vaccine

                golimumab decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.

              • rabies vaccine chick embryo cell derived

                golimumab decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • rilonacept

                golimumab and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • rotavirus oral vaccine, live

                golimumab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • rubella vaccine

                golimumab decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • sirolimus

                golimumab and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • smallpox (vaccinia) vaccine, live

                golimumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • tacrolimus

                golimumab and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • temsirolimus

                golimumab and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tetanus toxoid adsorbed or fluid

                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 vaccine

                golimumab decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • tocilizumab

                tocilizumab and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tongkat ali

                golimumab and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • travelers diarrhea and cholera vaccine inactivated

                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 vaccine

                golimumab decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • typhoid vaccine live

                golimumab decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • ustekinumab

                golimumab and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • varicella virus vaccine live

                golimumab decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • vedolizumab

                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 infections

              • yellow fever vaccine

                golimumab decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • zoster vaccine live

                golimumab decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              Monitor Closely (20)

              • astragalus

                golimumab increases and astragalus decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • belatacept

                belatacept and golimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • dengue vaccine

                golimumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • denosumab

                golimumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • echinacea

                golimumab increases and echinacea decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • fingolimod

                golimumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • haemophilus influenzae type b vaccine

                golimumab decreases effects of haemophilus influenzae type b vaccine 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.

              • hydroxyurea

                hydroxyurea, golimumab. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.

              • influenza virus vaccine quadrivalent, recombinant

                golimumab decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

              • influenza virus vaccine trivalent, recombinant

                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.

              • maitake

                golimumab increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • meningococcal group B vaccine

                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.

              • mercaptopurine

                golimumab and mercaptopurine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • ofatumumab SC

                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.

              • olaparib

                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.

              • poliovirus vaccine inactivated

                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. .

              • sipuleucel-T

                golimumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • trastuzumab

                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 deruxtecan

                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. .

              • zoster vaccine recombinant

                golimumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.

              Minor (1)

              • methotrexate

                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.

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              Adverse Effects

              >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
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              Warnings

              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

              Contraindications

              None

              Cautions

              Risk of infections, reactivation of latent hepatitis/TB; interrupt if serious infection develops (eg, bacterial sepsis, severe invasive fungal infections, opportunistic infections)

              Risk of exacerbation of or new onset heart failure; discontinue therapy if worsening symptoms occur; fatal outcomes reported in patients with congestive heart failure

              Pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia may occur; exercise caution when using TNF-blockers in patients who have or have had significant cytopenias

              Use of TNF-blockers, including golimumab, has been associated with rare cases of new onset or exacerbation of central nervous system (CNS) demyelinating disorders (eg, multiple sclerosis [MS]) and peripheral demyelinating disorders (eg, Guillain Barre syndrome)

              Treatment with TNF blockers, including golimumab, may result in the formation of antinuclear antibodies (ANA); rarely, treatment with TNF blockers, may result in the development of a lupus-like syndrome; if a patient develops symptoms suggestive of a lupus-like syndrome following treatment, discontinue treatment

              Serious systemic hypersensitivity reactions including anaphylaxis may occur

              Severe hepatic reactions including acute liver failure in patients receiving TNF blockers reported

              Malignancies

              • Increased risk of lymphoma and other cancers reported in children and adolescents
              • Occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers
              • Skin cancer (melanoma, Merkel cell carcinoma) reported with TNF blockers; perform periodic skin examination for all patients, particularly those with risk factors for skin cancer
              • Hepatosplenic T-cell lymphomas (HSTCL)
                • Rare postmarketing cases reported primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with TNF blockers
                • Reports have also included a patient being treated for psoriasis and 2 patients being treated for rheumatoid arthritis
                • HSTCL is an aggressive, rare type of T-cell lymphoma (usually fatal)
                • Most reported cases with TNF blockers have occurred with concomitant treatment with azathioprine or 6-mercaptopurine, although there have been cases reported receiving azathioprine or mercaptopurine alone

              Drug interactions overview

              • Infection risk increases when coadministered with abatacept, anakinra, abatacept, or rituximab; combination 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
              • Increased risk of serious infections seen in clinical RA studies of other TNF-blockers used in combination with no added benefit
              • May decrease humoral response to live-virus vaccines (eg, MMR)
              • Whenever possible update immunizations prior to initiation of treatment, following current immunization guidelines for patients receiving immunosuppressive agents; advise patients to discuss with physician before seeking any immunizations
              • Limited data are available on response to live vaccination, or on secondary transmission of infection by live vaccines for patients receiving anti-TNF therapy
              • Administration of live virus vaccines and therapeutic agents (eg, BCG bladder instillation) may result in disseminated infections; avoid live vaccines
              • Formation of CYP450 enzymes may be suppressed by increased levels of cytokines (eg, TNF-alpha) during chronic inflammation; molecules (eg, golimumab) that antagonizes cytokine activity may normalize the formation of CYP450 enzymes; upon initiation or discontinuation of treatment in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effects (eg, warfarin) or drug concentrations (eg, cyclosporine or theophylline) is recommended and adjusting individual doses of the drug products as needed
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              Pregnancy & Lactation

              Pregnancy

              There are no adequate and well-controlled trials in pregnant women; monoclonal antibodies are transported across the placenta during the third trimester and may affect immune response in the in utero exposed infant

              Use during pregnancy only if clearly needed

              Clinical considerations

              • Golimumab crosses the placenta during pregnancy; another TNF-blocking monoclonal antibody administered during pregnancy detected for up to 6 months in serum of infants; consequently, infants may be at increased risk of infection
              • Live vaccines administration to infants exposed to golimumab in utero is not recommended for 6 months following the mother’s last dose during pregnancy

              Lactation

              There is no information regarding the presence in human milk, the effects on breastfed infants, or the effects on milk production

              Maternal IgG is known to be present in human milk; the effects of local exposure in gastrointestinal tract and potential limited systemic exposure in the infant to golimumab are unknown; developmental and health benefits of breast-feeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breast-fed infants or from the underlying maternal condition

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Human anti-TNF-alpha monoclonal antibody, binds to both soluble and transmembrane bioactive forms of human TNFα; prevents binding of TNF-alpha to its receptors, thereby inhibiting biological activity of TNFα (a cytokine protein)

              Absorption

              Bioavailability: ~53%

              Peak plasma concentration

              • Simponi Aria: 44.4 mcg/mL
              • Simponi: 3.2 mcg/mL.

              Peak plasma time

              • Simponi: 2-6 days (RA)

              Distribution

              Vd

              • Simponi Aria: 115 mL/kg (healthy patients); 151 mL/kg (RA)
              • Simponi: 58-126 mL/kg

              Metabolism

              Exact metabolic pathway unknown

              Elimination

              Clearance

              • Simponi Aria: 6.9 mL/day/kg (healthy patients); 7.6 mL/day/kg (RA)

              Half-life

              • Simponi Aria: 12 days (healthy patients); 14 days (RA)
              • Simponi: 14 days (healthy patients and patients with active RA, PsA, or AS)
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              Administration

              IV Preparation

              Simponi Aria only

              Inspect vial; solution is colorless to light yellow and opalescent

              Do not use if opaque particles, discoloration or other foreign particles are present

              Dilute calculated dose volume with 0.9% NaCl to a final volume of 100 mL; alternatively, 0.45% NaCl Injection, USP can also be used; gently mix (DO NOT SHAKE)

              Discard any unused drug remaining in the vials

              IV Administration

              Simponi Aria only

              Use only an infusion set with an in-line, sterile, nonpyrogenic, low protein-binding filter (pore size 0.22 micrometer or less)

              Do not administer concomitantly in same IV line with other agents

              Infuse over 30 minutes

              SC Administration

              Simponi only

              Warm by sitting at room temperature for 30 min; do NOT heat or microwave

              If multiple injections required, administer at different site on the body

              Injection sites: Front of thighs (recommended), lower abdomen (except for a 2-inch area right around the navel); back of the upper arms (only if someone else is administering it)

              Rotate injection sites for each administration

              Do not administer in area where the skin is tender, bruised, red, or hard

              Storage

              Refrigerate unopened IV and SC products at 2-8ºC (36-46ºF); do not freeze

              Keep the product in the original carton to protect from light until the time of use

              Once diluted, IV infusion solution may be stored for 4 hr at room temperature

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Simponi subcutaneous
              -
              100 mg/mL injection
              Simponi subcutaneous
              -
              100 mg/mL solution
              Simponi subcutaneous
              -
              50 mg/0.5 mL injection
              Simponi subcutaneous
              -
              50 mg/0.5 mL solution
              Simponi ARIA intravenous
              -
              12.5 mg/mL vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Education
              golimumab subcutaneous

              GOLIMUMAB - SUBCUTANEOUS INJECTION

              (goe-LIM-ue-mab)

              COMMON BRAND NAME(S): Simponi

              WARNING: This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). Tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States.Your doctor will test you for tuberculosis (TB) infection before and during treatment with this drug. If you are diagnosed with TB, your doctor will first prescribe treatment for this to prevent a serious TB infection while using golimumab.Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin cancer) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as unusual lumps/growths, swollen glands, unexplained weight loss, persistent fever, or night sweats.

              USES: This medication is used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, and ankylosing spondylitis). It works by blocking a protein (tumor necrosis factor or TNF) found in the body's immune system that causes joint swelling and damage. By reducing joint swelling, the medication helps to reduce further joint damage and preserve joint function. Depending on the type of arthritis that is being treated, this drug may be used alone or in combination with another drug called methotrexate.This medication is also used to treat a certain bowel condition (ulcerative colitis). It is used to help lessen symptoms of moderate to severe ulcerative colitis (such as abdominal pain/cramping, diarrhea, bloody stools).

              HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using golimumab and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Use this medication exactly as prescribed. This drug is given by injection under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once a month. If you are using this medication to treat ulcerative colitis, your doctor may prescribe a different schedule/higher dose at the start of your treatment. Carefully follow your doctor's directions for using this medication. Learn all preparation and usage instructions in the product package. Never shake this product. Doing so may decrease the effectiveness of the drug.Remove this medication from the refrigerator and leave it at room temperature for at least 30 minutes before injecting. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water.Before using, check this product visually for particles or discoloration. The liquid is usually colorless to pale yellow and may contain tiny particles that are white or that you can see through. If the liquid is any darker than pale yellow, if it is discolored in any other way, if it is cloudy, or if it contains large particles, do not use the liquid.Before injecting each dose, clean the injection site with rubbing alcohol.It is important to change the injection site with each dose. Do not inject into any areas of skin that are sore, bruised, red, scaly, or hard.If using an autoinjector, remove the cap before injecting this medication.Use this medication regularly to get the most benefit from it. To help you remember, mark the day on the calendar when you need to receive the medication.Learn how to store and discard needles and medical supplies safely. Never reuse syringes or needles. Consult your pharmacist.Tell your doctor if your condition persists or worsens.

              SIDE EFFECTS: See also Warning section.Redness, itching, pain, or swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, numbness/tingling of the hands/feet, unsteadiness, unexplained muscle weakness, vision changes, muscle/joint pain, butterfly-shaped rash on the nose and cheeks, symptoms of heart failure (including shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), signs of infection (such as fever/chills/cough/persistent sore throat, unusual sweating), symptoms of liver damage (including dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellow eyes/skin).Get medical help right away if you have any very serious side effects, including: chest pain, seizures.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: See also Warnings section.Before using golimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow problems (such as low red/white blood cells and platelets), certain brain/nerve disorders (such as multiple sclerosis, Guillain-Barre syndrome), cancer, current/recent/repeated infections (including fungal, hepatitis B, tuberculosis), heart disease (especially congestive heart failure), lupus, seizures.Golimumab can make you more likely to get infections or may worsen any current infections. Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the effects of this drug, especially the risk of infections.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Mothers who have used this medication during pregnancy should ask a doctor about immunizations/vaccinations for their newborn babies.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other TNF-blockers (such as adalimumab, certolizumab, etanercept, infliximab), other drugs that weaken the immune system (such as abatacept, anakinra, cyclosporine).Avoid treatments that contain live bacteria or viruses (such as BCG, flu vaccine inhaled through the nose) since they may increase your risk for serious infections while you are using golimumab.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as complete blood counts, liver function, skin exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

              MISSED DOSE: If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

              STORAGE: Store in the original carton in the refrigerator away from light. Do not freeze. Discard any unused portion of this medication. This medication may also be stored in the original carton at room temperature for up to 30 days. If stored at room temperature, do not return drug to refrigerator and discard drug after 30 days if not used. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.