Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (22)
- 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.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of golimumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod 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 efgartigimod and using alternative therapies.
- 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.
- isavuconazonium sulfate
golimumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- 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.
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
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
Consider the risks and benefits of treatment prior to initiating therapy in patients with chronic or recurrent infection
Contraindications
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 administration of therapy; if an anaphylactic or other serious allergic reaction occurs, therapy should be discontinued immediately and appropriate therapy instituted
Infections
- Treated patients are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death
- Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis reported with TNF blockers
- Patients have frequently presented with disseminated rather than localized disease; the concomitant use of a TNF blocker and abatacept or anakinra has been associated with a higher risk of serious infections; the concomitant use with these biologic products not recommended
- Treatment 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 risks and benefits of treatment prior to initiating in following patients with chronic or recurrent infection, who have been exposed to tuberculosis, have a history of an opportunistic infection, have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, or have underlying conditions that may predispose them to infection
- Closely monitor patients for the development of signs and symptoms of infection during and after treatment; discontinue treatment if a patient develops a serious infection, an opportunistic infection, or sepsis; for a patient who develops a new infection during treatment, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, initiate appropriate antimicrobial therapy, and closely monitor them
Tuberculosis
- Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving TNF blockers, including patients who have previously received treatment for latent or active tuberculosis; evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating treatment and periodically during therapy
- Treatment of latent tuberculosis infection prior to therapy with TNF blockers has been shown to reduce the risk of tuberculosis reactivation during therapy; prior to initiating treatment, assess if treatment for latent tuberculosis is needed; an induration of 5 mm or greater is a positive tuberculin skin test, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG)
- Consider anti-tuberculosis therapy prior to initiation of therapy in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection
- Consultation with a physician with expertise in treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient
- Cases of active tuberculosis have occurred in patients treated with golimumab during and after treatment for latent tuberculosis; monitor patients for development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy, patients who are on treatment for latent tuberculosis, or patients who were previously treated for tuberculosis infection
- Consider tuberculosis in the differential diagnosis in patients who develop a new infection during therapy, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis
Fungal infections
- If patients develop a serious systemic illness and they reside or travel in regions where mycoses are endemic, consider invasive fungal infection in the differential diagnosis; consider appropriate empiric antifungal therapy, and take into account both the risk for severe fungal infection and risks of antifungal therapy while a diagnostic workup is being performed; antigen and antibody testing for histoplasmosis may be negative in some patients with active infection; to aid in the management of such patients, consider consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections
Hepatitis B virus reactivation
- The use of TNF blockers has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers (eg, surface antigen positive); in some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal; the majority of these reports have occurred in patients who received concomitant immunosuppressants
- 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 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 to patients who are carriers of HBV; adequate data are not available on whether antiviral therapy can reduce 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
- In patients who develop HBV reactivation, TNF blockers should be stopped and antiviral therapy with appropriate supportive treatment initiated; the safety of resuming TNF blockers after HBV reactivation has been controlled is not known; prescribers should exercise caution when considering resumption of TNF blockers in this situation and monitor patients closely
Malignancies
- 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)
- 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 first dose of TNF-blocker therapy; most of the patients were receiving concomitant immunosuppressants; these cases were reported postmarketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports
- The risks and benefits of TNF-blocker treatment should be considered prior to initiating therapy in patients with a known malignancy other than a successfully treated nonmelanoma skin cancer (NMSC) or when considering continuing a TNF-blocker in patients who develop a malignancy
- Rare postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL) 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 patientstreated with TNF blockers cannot be excluded
- It is not known if the treatment influences 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; in patients with newly diagnosed dysplasia receiving therapy, the risks and benefits to the individual patient must be carefully reviewed and consideration should be given to whether therapy should be continued
- Melanoma and Merkel cell carcinoma reported in patients treated with TNF-blocking agents; periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer
Congestive heart failure
- Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers; some cases had a fatal outcome; in several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality
- Golimumab has not been studied in patients with a history of CHF and should be used with caution in patients with CHF; if a decision is made to administer therapy to patients with CHF, these patients should be closely monitored during therapy, and the drug should be discontinued if new or worsening symptoms of CHF appear
Demyelinating disorders
- Use of TNF blockers 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; casesof central demyelination, MS, optic neuritis, and peripheral demyelinating polyneuropathy reported in patients receiving therapy
- Prescribers should exercise caution in considering the use of TNF blockers in patients with central or peripheral nervous system demyelinating disorders; discontinuation of therapy should be considered if these disorders develop
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
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.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)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Simponi ARIA intravenous - | 12.5 mg/mL vial |  | |
| Simponi subcutaneous - | 100 mg/mL injection |  | |
| Simponi subcutaneous - | 50 mg/0.5 mL injection |  | |
| Simponi subcutaneous - | 100 mg/mL solution |  | |
| Simponi subcutaneous - | 50 mg/0.5 mL solution |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
golimumab intravenous
GOLIMUMAB - INJECTION
(goe-LIM-ue-mab)
COMMON BRAND NAME(S): Simponi Aria
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 treat certain types of arthritis (such as rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis). Golimumab belongs to a class of drugs known as TNF blockers. It works by blocking a protein (tumor necrosis factor - TNF) in your body's immune system that causes joint swelling and damage. Golimumab helps slow joint damage and reduce joint pain/swelling so you can move better.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using golimumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This drug is given by slow injection into a vein by a health care professional, usually over 30 minutes. After the first dose, this medication is usually given again 4 weeks later, then every 8 weeks as directed by your doctor. The dosage is based on your weight. For children, the dosage is based on their body size.You should receive this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose.Tell your doctor if your symptoms do not improve or if they worsen.
SIDE EFFECTS: See also Warning section.Redness, irritation, or pain 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.Golimumab can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash.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 Warning 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, 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. 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.Tell your health care professional that you are using golimumab before having any immunizations/vaccinations. 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 side 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, TB/hepatitis B tests) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
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 December 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.
Formulary
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.
