Medically reviewed by Drugs.com. Last updated on Sep 14, 2020.
(goe LIM ue mab)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Simponi Aria: 50 mg/4 mL (4 mL) [latex free; contains polysorbate 80]
Solution Auto-injector, Subcutaneous [preservative free]:
Simponi: 50 mg/0.5 mL (0.5 mL); 100 mg/mL (1 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Simponi: 50 mg/0.5 mL (0.5 mL); 100 mg/mL (1 mL) [contains polysorbate 80]
Brand Names: U.S.
- Simponi Aria
- Antipsoriatic Agent
- Antirheumatic, Disease Modifying
- Monoclonal Antibody
- Tumor Necrosis Factor (TNF) Blocking Agent
Human monoclonal antibody that binds to human tumor necrosis factor alpha (TNFα), thereby interfering with endogenous TNFα activity. Biological activities of TNFα include the induction of proinflammatory cytokines (interleukin [IL]-6, IL-8, Granulocyte-colony stimulating factor, granulocyte-macrophage colony stimulating factor), expression of adhesion molecules (E-selectin, vascular cell adhesion molecule [VCAM]-1, intercellular adhesion molecule [ICAM]-1) necessary for leukocyte infiltration, activation of neutrophils and eosinophils.
Children ≥6 years and Adolescents ≤17 years (Xu 2019): SubQ:
<30 kg: Median: 6.05 L.
30 to <45 kg: Median: 7.52 L.
≥45 kg: Median: 12 L.
Adults: IV: 151 ± 61 mL/kg (distributed primarily to circulatory system with limited extravascular distribution).
Time to Peak
SubQ: 2 to 6 days.
Children ≥6 years and Adolescents ≤17 years (Xu 2019):
<45 kg: Median: 7.53 days.
≥45 kg: Median: 11.9 days.
Adults: ~2 weeks.
Special Populations Note
Body weight: Following IV administration, patients with higher body weights tend to have higher serum golimumab concentrations (compared to lower body weights).
Use: Labeled Indications
Ankylosing spondylitis (Simponi, Simponi Aria): Treatment of adults with active ankylosing spondylitis.
Polyarticular juvenile idiopathic arthritis (Simponi Aria): Treatment of active polyarticular juvenile idiopathic arthritis in patients ≥2 years of age.
Simponi: Treatment of adults with active psoriatic arthritis (alone or in combination with methotrexate).
Simponi Aria: Treatment of adults and pediatric patients ≥2 years of age with active psoriatic arthritis.
Rheumatoid arthritis (Simponi, Simponi Aria): Treatment of adults with moderately to severely active rheumatoid arthritis (in combination with methotrexate).
Ulcerative colitis (Simponi): Treatment of moderately to severely active ulcerative colitis in adults with corticosteroid dependence or who have had an inadequate response to conventional therapy (to induce and maintain clinical response, improve mucosal appearance during induction, induce clinical remission, and achieve and sustain remission in induction responders).
Off Label Uses
Axial spondyloarthritis (active, nonradiographic)
Data from a randomized, double-blind, placebo-controlled study supports the use of golimumab in the management of patients with active, nonradiographic axial spondyloarthritis who have a positive MRI and/or elevated CRP at baseline [Sieper 2015].
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to golimumab, latex, or any other component of formulation or packaging; patients with severe infections (eg, sepsis, tuberculosis, opportunistic infections); moderate or severe heart failure (NYHA class III/IV)
Note: Corticosteroids, nonbiologic disease-modifying antirheumatic drugs (DMARDs), and/or nonsteroidal anti-inflammatory drugs may be continued for the treatment of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. Golimumab should not be used in combination with biologic DMARDs.
IV: 2 mg/kg at weeks 0, 4, and then every 8 weeks thereafter.
SubQ: 50 mg once a month (either alone or in combination with methotrexate or other nonbiologic DMARDs).
IV: 2 mg/kg at weeks 0, 4, and then every 8 weeks thereafter.
SubQ: 50 mg once a month (either alone or in combination with methotrexate or other nonbiologic DMARDs).
IV: 2 mg/kg at weeks 0, 4, and then every 8 weeks thereafter (in combination with methotrexate).
SubQ: 50 mg once a month (in combination with methotrexate).
Ulcerative colitis: SubQ: Induction: 200 mg at week 0, then 100 mg at week 2, followed by maintenance therapy of 100 mg every 4 weeks.
Axial spondyloarthritis (active, nonradiographic) (off-label use): SubQ: 50 mg once every 4 weeks for 16 weeks (Sieper 2015).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Refer to adult dosing.
Juvenile idiopathic arthritis (JIA), polyarticular: Children ≥2 years and Adolescents: Simponi Aria: IV: 80 mg/m2/dose at weeks 0, 4, and then every 8 weeks thereafter.
Psoriatic arthritis: Children ≥2 years and Adolescents: Simponi Aria: IV: 80 mg/m2/dose at weeks 0, 4, and then every 8 weeks thereafter.
Ulcerative colitis (UC): Limited data available (Hyams 2017):
Children ≥6 years and Adolescents ≤17 years:
<45 kg: 90 mg/m2 (maximum dose: 200 mg/dose) at week 0 followed by 45 mg/m2 (maximum dose: 100 mg/dose) at week 2.
≥45 kg: 200 mg/dose at week 0 followed by 100 mg at week 2.
Maintenance (beginning at week 6): SubQ:
<45 kg: 45 mg/m2/dose every 4 weeks; maximum dose: 100 mg/dose.
≥45 kg: 100 mg every 4 weeks.
Note: Dosing based on an open-label pharmacokinetic trial of patients with moderately to severely active UC (n=35; median age:15 years) receiving golimumab. Concomitant medications (eg, corticosteroids, thiopurines, methotrexate, 5-ASA) were continued in 85.7% of patients. At week 6, 21 patients (60%) had achieved Mayo clinical response, 15 (43%) had achieved clinical remission, and 19 (54%) had evidence of mucosal healing (Hyams 2017).
Intact solution should be colorless to light yellow; solution may develop a few fine, translucent particles.
SubQ: Bring to room temperature by allowing syringe/autoinjector to sit at room temperature outside the carton for ≥30 minutes prior to administration (do not warm in any other way). Do not use if discolored, cloudy, or if foreign particles are present.
IV: Do not use if solution is discolored, or contains opaque or foreign particles. Dilute for infusion by slowly adding calculated dose/volume to NS or 1/2 NS to a total volume of 100 mL. Gently mix.
Discard unused portion of vial/syringe/autoinjector.
Note: The safety and efficacy of switching between the IV and SubQ formulations and routes have not been studied.
IV: Dilute prior to use. Infuse over 30 minutes, using an infusion set with an in-line low protein-binding 0.22 micron filter. Do not infuse in the same line with other medications.
Subcutaneous injection: Hold autoinjector firmly against skin and inject subcutaneously into thigh, lower abdomen (below navel), or upper arm. A loud click is heard when injection has begun. Continue to hold autoinjector against skin until second click is heard (may take 3 to 15 seconds). Following second click, lift autoinjector from injection site. Rotate injection sites and avoid injecting into tender, red, scaly, hard, or bruised skin, or areas with scars or stretch marks. If multiple injections are required for a single dose, administer at different sites on body.
Store intact vials and syringes refrigerated at 2°C to 8°C (36°F to 46°F); do not freeze. May also store at room temperature (≤25°C [77°F]) for ≤30 days; do not return to refrigerator. Do not shake. Store product in original carton to protect from light.
IV: Solutions diluted for infusion may be stored at room temperature for ≤4 hours.
Abatacept: Anti-TNF Agents may enhance the immunosuppressive effect of Abatacept. Avoid combination
Anakinra: Anti-TNF Agents may enhance the adverse/toxic effect of Anakinra. An increased risk of serious infection during concomitant use has been reported. Avoid combination
BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
Belimumab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Avoid combination
Belimumab: May enhance the immunosuppressive effect of Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Avoid combination
Biologic Disease-Modifying Antirheumatic Drugs (DMARDs): May enhance the immunosuppressive effect of other Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Avoid combination
Canakinumab: Anti-TNF Agents may enhance the adverse/toxic effect of Canakinumab. Specifically, the risk for serious infections and/or neutropenia may be increased. Avoid combination
Certolizumab Pegol: Anti-TNF Agents may enhance the immunosuppressive effect of Certolizumab Pegol. Avoid combination
Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Management: Consider avoiding Echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Consider therapy modification
Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification
Inebilizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy
InFLIXimab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Avoid combination
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination
Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Management: Avoid use of immunosuppressants (including systemic corticosteroids) prior to initiation of nivolumab. Use of immunosuppressants after administration of nivolumab (eg, for immune-related toxicity) is unlikely to affect nivolumab efficacy. Consider therapy modification
Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy
Ozanimod: Immunosuppressants may enhance the immunosuppressive effect of Ozanimod. Monitor therapy
Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Rilonacept: Anti-TNF Agents may enhance the adverse/toxic effect of Rilonacept. Avoid combination
Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Management: Consider avoiding concomitant use of roflumilast and immunosuppressants as recommended by the Canadian product monograph. Inhaled or short-term corticosteroids are unlikely to be problematic. Consider therapy modification
Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification
Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Talimogene Laherparepvec: Immunosuppressants may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk for disseminated herpetic infection may be increased. Avoid combination
Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy
Thiopurine Analogs: Anti-TNF Agents may enhance the adverse/toxic effect of Thiopurine Analogs. Specifically, the risk for T-cell non-Hodgkin's lymphoma (including hepatosplenic T-cell lymphoma) may be increased. Monitor therapy
Tocilizumab: May enhance the immunosuppressive effect of Anti-TNF Agents. Avoid combination
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated less than 2 weeks before starting or during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination
Vedolizumab: Anti-TNF Agents may enhance the adverse/toxic effect of Vedolizumab. Avoid combination
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. As reported with combination therapy.
Hematologic & oncologic: Positive ANA titer (IV: 17%, anti-dsDNA: <1%; subcutaneous: 4%, anti-dsDNA: <1%)
Immunologic: Antibody development (subcutaneous: Drug-tolerant EIA: 16% to 38%; IV: Drug-tolerant EIA: 19% to 21%; approximately 1/3 were neutralizing)
Infection: Infection (27% to 28%)
Respiratory: Upper respiratory tract infection (13% to 16%)
1% to 10%:
Cardiovascular: Hypertension (3%)
Central nervous system: Dizziness (≤2%), paresthesia (≤2%)
Dermatologic: Skin rash (3%)
Gastrointestinal: Constipation (≤1%)
Hematologic & oncologic: Decreased neutrophils (≤5%), leukopenia (1%)
Hepatic: Increased serum alanine aminotransferase (≤8%), increased serum aspartate aminotransferase (≤5%)
Infection: Viral infection (4% to 5%; includes herpes and influenza), fungal infection (≤2%; may be invasive or superficial), bacterial infection (1%)
Local: Injection site reaction (subcutaneous: 3% to 6%)
Respiratory: Nasopharyngitis (≤6%), bronchitis (2% to 3%), sinusitis (≤2%)
Miscellaneous: Fever (2%), infusion-related reaction (intravenous: 1%)
Frequency not defined:
Infection: Opportunistic infections, sepsis, serious infection
Respiratory: Activated tuberculosis, reactivated tuberculosis
<1%, postmarketing, and/or case reports: Abscess, agranulocytosis, anaphylaxis, aplastic anemia, atypical serious infection, bullous skin disease, cardiac failure, demyelinating disease of the central nervous system, dyspnea, exfoliation of skin, Guillain-Barre syndrome, hepatitis B, hepatotoxicity (idiosyncratic), hypersensitivity angiitis, hypersensitivity reaction, infective bursitis, interstitial pulmonary disease, leukemia, lichenoid eruption, lupus-like syndrome, malignant lymphoma, malignant melanoma, malignant neoplasm, Merkel cell carcinoma, multiple sclerosis, mycobacterial infection, nausea, neutropenia, non-Hodgkin's lymphoma, optic neuritis, pancytopenia, peripheral demyelinating polyneuropathy, pneumonia, pruritus, psoriasis (including new onset, palmoplantar, pustular, or exacerbation), pyelonephritis, sarcoidosis, septic arthritis, septic shock, thrombocytopenia, urticaria, vasculitis
ALERT: U.S. Boxed WarningSerious infection:
Patients treated with golimumab are at an increased risk of developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.
Discontinue golimumab if a patient develops a serious infection.
Reported infections with tumor necrosis factor (TNF) blockers include the following:
Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before golimumab use and during therapy. Initiate treatment for latent infection prior to golimumab use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk of invasive fungal infections who develop severe systemic illness.
Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
Consider the risks and benefits of treatment prior to initiating therapy in patients with chronic or recurrent infection.
Monitor patients closely for the development of signs and symptoms of infection during and after treatment, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Malignancy:
Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers.
Concerns related to adverse effects:
• Autoimmune disorder: Positive antinuclear antibody titers have been detected in patients (with negative baselines). Rare cases of autoimmune disorder, including lupus-like syndrome, have been reported; monitor and discontinue if symptoms develop.
• Demyelinating disease: Rare cases of new-onset or exacerbation of demyelinating disorders (eg, multiple sclerosis, optic neuritis, Guillain-Barré syndrome, polyneuropathy) have been reported. Consider discontinuing in patients who develop peripheral or CNS demyelinating disorders during treatment. Use with caution in patients with pre-existing or recent onset central or peripheral nervous system demyelinating disorders.
• Heart failure: Worsening and new-onset heart failure (HF) (some fatal) have been reported with golimumab and other TNF-blockers. Monitor closely and discontinue with onset or worsening of symptoms. Use with caution in patients with HF or decreased left ventricular function. In a scientific statement from the American Heart Association, TNF blockers have been determined to be agents that may either cause direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: major) (AHA [Page 2016]).
• Hematologic effects: Cases of pancytopenia and other significant cytopenias, including aplastic anemia, have been reported with TNF-blocking agents. Pancytopenia, leukopenia, neutropenia, and thrombocytopenia have occurred with golimumab. Consider discontinuing with significant hematologic abnormalities. Use with caution in patients with underlying hematologic disorders.
• Hepatitis B: Rare reactivation of hepatitis B virus (HBV), sometimes fatal, has occurred in chronic virus carriers, usually in patients receiving concomitant immunosuppressants; evaluate for HBV prior to initiation in all patients. Patients who test positive for HBV surface antigen should be referred for hepatitis B evaluation/treatment prior to golimumab initiation. Monitor for clinical and laboratory signs of active infection during and for several months following discontinuation of golimumab treatment in HBV carriers; interrupt therapy if reactivation occurs and treat appropriately with antiviral therapy; if resumption of therapy is deemed necessary, exercise caution and monitor patient closely.
• Hypersensitivity reactions: Severe systemic hypersensitivity reactions (including anaphylaxis) have been reported (some have occurred with the first dose) following intravenous and subcutaneous administration. Symptoms associated with reactions may include dyspnea, hives, nausea, and pruritus; reactions occurred during and within 1 hour of the start of IV infusion. Discontinue immediately if signs develop and initiate appropriate treatment.
• Infections: [US Boxed Warning]: Patients receiving golimumab are at increased risk for serious infections which may result in hospitalization and/or fatality; infections usually developed in patients receiving concomitant immunosuppressive agents (eg, methotrexate or corticosteroids). Active tuberculosis (or reactivation of latent tuberculosis), invasive fungal (including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, and pneumocystosis) and bacterial, viral, or other opportunistic infections (including legionellosis and listeriosis) have been reported in patients receiving TNF-blocking agents, including golimumab. May present as disseminated (rather than local) disease. Histoplasmosis testing (antigen or antibody) may be negative in some patients with active infection. Monitor closely for signs/symptoms of infection. Discontinue for serious infection or sepsis. Consider risks versus benefits prior to use in patients with a history of chronic or recurrent infection. Consider empiric antifungal therapy in patients who are at risk for invasive fungal infection and develop severe systemic illness. Caution should be exercised (consider risks versus benefits) when considering use in the elderly, patients taking concomitant immunosuppressants, patients with chronic or recurrent infection, patients who have been exposed to tuberculosis, patients with a history of opportunistic infection, patients with comorbid conditions that predispose them to infections (eg, diabetes), or residence/travel from areas of endemic mycoses (blastomycosis, coccidioidomycosis, histoplasmosis). Do not initiate golimumab therapy in patients with active infection, including localized infection, which is clinically important. Patients who develop a new infection while undergoing treatment should be monitored closely.
• Malignancy: [US Boxed Warning]: Lymphoma and other malignancies (some fatal) have been reported in children and adolescent patients receiving TNF-blocking agents. Half of the malignancies reported in children were lymphomas (Hodgkin and non-Hodgkin) while other cases varied and included malignancies not typically observed in this population. The onset of malignancy was after a median of 30 months (range: 1 to 84 months) after the initiation of the TNF-blocking agent; most patients were receiving concomitant immunosuppressants. The impact of golimumab on the development and course of malignancy is not fully defined. Compared with the general population, an increased risk of lymphoma has been noted in clinical trials; however, rheumatoid arthritis alone has been previously associated with an increased rate of lymphoma. Lymphomas and other malignancies were also observed (at rates higher than expected for the general population) in adult patients receiving TNF-blocking agents. Hepatosplenic T-cell lymphoma (HSTCL), a rare T-cell lymphoma, has also been associated with TNF-blocking agents, primarily reported in adolescent and young adult males with Crohn disease or ulcerative colitis treated with a TNF-blocking agent and concurrent or prior azathioprine or mercaptopurine. Melanoma and Merkel cell carcinoma have been reported in patients receiving TNF-blocking agents including golimumab. Perform periodic skin examinations in all patients during therapy, particularly those at increased risk for skin cancer. Consider risks versus benefits in patients with a known malignancy (other than a successfully treated nonmelanoma skin cancer) and if considering continuing treatment in a patient who develops a malignancy.
• Tuberculosis: [US Boxed Warning]: Tuberculosis (disseminated or extrapulmonary) has been reported in patients receiving golimumab; both reactivation of latent infection and new infections have been reported. Patients should be evaluated for tuberculosis risk factors and latent tuberculosis infection (with a tuberculin skin test) prior to and during therapy. Treatment of latent tuberculosis should be initiated before use. Monitor for development of tuberculosis throughout treatment in patients with initial negative tuberculin skin tests, patients currently receiving treatment for latent tuberculosis, or patients previously treated for tuberculosis; active tuberculosis has developed in this population during treatment with TNF-blocking agents. Use with caution in patients who have resided in regions where tuberculosis is endemic. Consider antituberculosis therapy if an adequate course of treatment cannot be confirmed in patients with a history of latent or active tuberculosis or for patients with risk factors despite negative skin test. Prior to use, consider risks versus benefits in patients who have been exposed to tuberculosis.
• Elderly: Use with caution; general incidence of infection is higher in elderly patients.
• Pediatric: [US Boxed Warning]: Lymphoma and other malignancies (some fatal) have been reported in children and adolescent patients receiving TNF-blocking agents.
Dosage form specific issues:
• Latex: Some dosage forms may contain dry natural rubber (latex).
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
• Administration formulation/route: The safety and efficacy of switching between the IV and SubQ formulations and routes have not been studied.
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; there is no data available concerning secondary transmission of infection by live vaccines in patients receiving therapy. In clinical trials, humoral response to pneumococcal vaccine was not suppressed in psoriatic arthritis patients receiving golimumab. It is recommended to wait 6 months following the mother’s last infusion during pregnancy before administering any live vaccine to infants exposed to golimumab in utero.
CBC with differential; latent TB screening (prior to initiating and periodically during therapy); HBV screening (prior to initiating [all patients]; during and for several months following therapy [HBV carriers]); monitor improvement of symptoms and physical function assessments; signs/symptoms of infection (prior to, during, and following therapy); signs/symptoms/worsening of heart failure signs and symptoms of hypersensitivity reaction; symptoms of lupus-like syndrome; signs/symptoms of malignancy (eg, splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss) including periodic skin examination
Treatment algorithms are available for use of biologics in female patients with Crohn disease who are planning a pregnancy (Weizman 2019). Serum levels should be optimized prior to conception (Mahadevan 2019).
Golimumab crosses the placenta (Benoit 2019).
Golimumab is a humanized monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Following administration of golimumab 100 mg every 2 weeks throughout pregnancy to a patient with ulcerative colitis, cord blood concentrations of golimumab were 121% of the maternal serum concentration at delivery. Delivery occurred 3 days after the last maternal dose (Benoit 2019).
Information related to this class of medications is emerging, but based on available data, tumor necrosis factor alpha (TNFα) blocking agents are considered to have low to moderate risk when used in pregnancy (ACOG 776 2019).
Vaccination with live vaccines (eg, rotavirus vaccine) should be avoided for the first 6 months of life if exposure to a biologic agent occurs during the third trimester of pregnancy (eg, >27 weeks' gestation) (Mahadevan 2019).
Inflammatory bowel disease is associated with adverse pregnancy outcomes including an increased risk of miscarriage, premature delivery, delivery of a low birth weight infant, and poor maternal weight gain. Management of maternal disease should be optimized prior to pregnancy. Treatment decreases disease flares, disease activity, and the incidence of adverse pregnancy outcomes (Mahadevan 2019).
Use of immune modulating therapies in pregnancy should be individualized to optimize maternal disease and pregnancy outcomes (ACOG 776 2019). When treatment for inflammatory bowel disease is needed in pregnant women, appropriate biologic therapy can be continued without interruption. Serum levels should be evaluated prior to conception and optimized to avoid subtherapeutic concentrations or high levels which may increase placental transfer. Dosing can be adjusted so delivery occurs at the lowest serum concentration. For golimumab, the final injection can be given 4 to 6 weeks prior to the estimated date of delivery, then continued 48 hours' postpartum (Mahadevan 2019).
What is this drug used for?
• It is used to treat rheumatoid arthritis.
• It is used to treat ankylosing spondylitis.
• It is used to treat psoriatic arthritis.
• It is used to treat ulcerative colitis.
• It may be given to you for other reasons. Talk with the doctor.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Injection site irritation
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.
• Lupus like rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Heart problems like cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out.
• Chest pain
• Severe loss of strength and energy
• Mole changes
• Skin changes
• Vision changes
• Swollen glands
• Night sweats
• Excessive weight loss
• Skin growths
• Pale skin
• Severe headache
• Severe dizziness
• Passing out
• Flu-like symptoms
• Skin sores
• Skin redness
• Skin pain
• Nerve problems like sensitivity to heat or cold; decreased sense of touch; burning, numbness, or tingling; pain, or weakness in the arms, hands, legs, or feet.
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Frequently asked questions
More about golimumab
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- Drug class: TNF alfa inhibitors
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