Version January 2024
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.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers.
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 or Janus kinase (Jak) inhibitors.
Ankylosing spondylitis:
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).
Psoriatic arthritis:
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).
Rheumatoid arthritis: Note: For use as adjunctive therapy in patients who have not met treatment goals despite maximally tolerated methotrexate therapy; may also be used off-label as an alternative to methotrexate in DMARD-naive patients with moderate to high disease activity (Ref).
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 (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
Demyelinating disorders: Consider discontinuing golimumab.
Heart failure (new or worsening symptoms): Discontinue golimumab.
Hypersensitivity (anaphylactic or other serious allergic reaction): Discontinue golimumab.
Infection (serious or opportunistic) or sepsis: Discontinue golimumab.
Lupus-like syndrome (symptoms suggestive of lupus-like syndrome): Discontinue golimumab.
Refer to adult dosing.
(For additional information see "Golimumab: Pediatric drug information")
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 (Ref):
Children ≥6 years and Adolescents ≤17 years:
Induction: SubQ:
<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 (Ref).
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. As reported with combination therapy.
>10%:
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 31%; ~1/3 to 1/2 were neutralizing)
Infection: Infection (27% to 28%)
Respiratory: Upper respiratory tract infection (13% to 16%)
1% to 10%:
Cardiovascular: Hypertension (3%)
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: Bacterial infection (1%), fungal infection (≤2%; may be invasive or superficial), viral infection (4% to 5%; includes herpes and influenza)
Local: Injection site reaction (subcutaneous: 3% to 6%)
Nervous system: Dizziness (≤2%), paresthesia (≤2%)
Respiratory: Bronchitis (2% to 3%), nasopharyngitis (≤6%), sinusitis (≤2%)
Miscellaneous: Fever (2%), infusion-related reaction (intravenous: 1%)
<1%:
Cardiovascular: Hypersensitivity angiitis, septic shock, vasculitis
Dermatologic: Psoriasis (including new onset, palmoplantar, pustular, or exacerbation)
Hematologic: Leukemia
Infection: Abscess, atypical mycobacterial infection
Neuromuscular & skeletal: Septic arthritis
Renal: Pyelonephritis
Respiratory: Pneumonia
Frequency not defined:
Dermatologic: Cellulitis
Infection: Opportunistic infections, sepsis, serious infection
Respiratory: Active tuberculosis, reactivated tuberculosis
Postmarketing:
Cardiovascular: Cardiac failure
Dermatologic: Bullous skin disease, exfoliation of skin, lichenoid eruption, pruritus, urticaria
Gastrointestinal: Nausea
Hematologic & oncologic: Agranulocytosis, aplastic anemia, malignant lymphoma (including Hodgkin’s lymphoma and non-Hodgkins’s lymphoma), malignant melanoma, malignant neoplasm, Merkel cell carcinoma, neutropenia, pancytopenia, sarcoidosis, thrombocytopenia
Hepatic: Hepatitis B, hepatotoxicity (idiosyncratic) (Chalasani 2014)
Hypersensitivity: Anaphylaxis, hypersensitivity reaction (including dyspnea, nausea, pruritus, urticaria)
Infection: Infective bursitis
Nervous system: Demyelinating disease of the central nervous system, Guillain-Barre syndrome, peripheral demyelinating polyneuropathy
Neuromuscular & skeletal: Lupus-like syndrome, multiple sclerosis
Ophthalmic: Optic neuritis
Respiratory: Dyspnea, interstitial pulmonary disease
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)
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). Tuberculosis (TB) disease (active TB) (or reactivation of tuberculosis infection [latent TB]), 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 TB, 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 TB infection (latent TB) and new infections have been reported. Patients should be evaluated for TB risk factors and TB infection (with a tuberculin skin test) prior to and during therapy. Treatment of TB infection should be initiated before use. Monitor for development of TB throughout treatment in patients with initial negative tuberculin skin tests, patients currently receiving treatment for TB infection, or patients previously treated for TB; TB disease (active TB) has developed in this population during treatment with TNF-blocking agents. Use with caution in patients who have resided in regions where TB is endemic. Consider antituberculosis therapy if an adequate course of treatment cannot be confirmed in patients with a history of TB infection or disease or for patients with risk factors despite negative skin test. Prior to use, consider risks versus benefits in patients who have been exposed to TB.
Special populations:
• Older adult: Use with caution; general incidence of infection is higher in elderly patients.
• Patients with rheumatic musculoskeletal disease undergoing hip or knee replacement surgery: Hold biologic disease-modifying antirheumatic drugs (DMARDs) prior to surgery and plan surgery after the next dose is due. Surgery can occur after holding medication for 1 full dosing cycle (eg, for medications administered every 4 weeks, schedule surgery 5 weeks from last administered dose); therapy can be restarted once surgical wound shows evidence of healing (eg, no swelling, erythema, or drainage), sutures/staples are removed, and no ongoing nonsurgical site infections (typically ~14 days to reduce infection risk). Decisions to withhold therapy should be based on shared decision making; ensure the patient and their provider weigh risks of interrupting therapy and disease control versus risks of continuing therapy and surgical complications (ACR/AAHKS [Goodman 2022]).
• 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.
Other warnings/precautions:
• 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.
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]
No
Solution (Simponi Aria Intravenous)
50 mg/4 mL (per mL): $599.76
Solution Auto-injector (Simponi Subcutaneous)
50 mg/0.5 mL (per 0.5 mL): $7,040.93
100 mg/mL (per mL): $8,097.08
Solution Prefilled Syringe (Simponi Subcutaneous)
50 mg/0.5 mL (per 0.5 mL): $7,040.93
100 mg/mL (per mL): $8,097.08
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Simponi I.V.: 50 mg/4 mL (4 mL) [contains polysorbate 80]
Solution Auto-injector, Subcutaneous:
Simponi: 50 mg/0.5 mL (0.5 mL); 100 mg/mL (1 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous:
Simponi: 50 mg/0.5 mL (0.5 mL); 100 mg/mL (1 mL) [contains polysorbate 80]
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.
Parenteral: Note: The safety and efficacy of switching between the IV and SubQ formulations and routes have not been studied.
IV: Dilution required prior to administration. Infuse over 30 minutes, using an infusion set with an in-line low protein-binding filter (≤0.22 micron). Do not infuse in the same line with other medications.
SubQ: Administer subcutaneously into thigh, back of upper arm, or lower abdomen (avoid areas within 2 inches of navel). 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 each injection at a different site on the body.
Autoinjector: Hold autoinjector firmly against clean skin and press button. 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.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Simponi: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125289s146lbl.pdf#page=38
Simponi Aria: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125433s032lbl.pdf#page=34
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.
Psoriatic arthritis:
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).
Axial spondyloarthritis (active, nonradiographic)
Golimumab may be confused with sarilumab.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abatacept: Anti-TNF Agents may enhance the immunosuppressive effect of Abatacept. Risk X: Avoid combination
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: 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. Risk X: Avoid combination
Anifrolumab: Biologic Anti-Psoriasis Agents may enhance the immunosuppressive effect of Anifrolumab. Risk X: Avoid combination
Anifrolumab: Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) may enhance the immunosuppressive effect of Anifrolumab. Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Belimumab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider therapy modification
Belimumab: May enhance the immunosuppressive effect of Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider therapy modification
Biologic Disease-Modifying Antirheumatic Drugs (DMARDs): May enhance the immunosuppressive effect of other Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: 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. Risk X: Avoid combination
Certolizumab Pegol: Anti-TNF Agents may enhance the immunosuppressive effect of Certolizumab Pegol. Risk X: Avoid combination
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
InFLIXimab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Risk X: Avoid combination
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Rilonacept: Anti-TNF Agents may enhance the adverse/toxic effect of Rilonacept. Risk X: Avoid combination
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
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. Risk C: Monitor therapy
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Vedolizumab: Anti-TNF Agents may enhance the adverse/toxic effect of Vedolizumab. Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
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).
It is not known if golimumab is present in breast milk.
Breast milk was sampled in one woman for up to 7 days following golimumab injection. Golimumab was not detected in any of the samples (Matro 2018).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. However, tumor necrosis factor alpha (TNFα) blocking agents are considered compatible with breastfeeding (ACOG 776 2019; Mahadevan 2019).
CBC with differential; tuberculosis (TB) infection (latent TB) screening (prior to initiating and periodically during therapy); hepatitis B virus (HBV) screening (prior to initiating [all patients]; during and for several months following therapy [HBV carriers]); hepatitis C virus screening. If clinically appropriate, may consider antidrug antibody testing; refer to clinical guidelines. Monitor improvement of symptoms and physical function assessments. Monitor for signs/symptoms of demyelinating disease, heart failure (including worsening heart failure), hypersensitivity reaction, infection (prior to, during, and following therapy), and lupus-like syndrome. Monitor for signs/symptoms of malignancy (eg, splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss) including periodic skin examination.
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.
Distribution: Vd:
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).
Bioavailability: SubQ: ~53%.
Metabolism: Pathway unknown.
Half-life elimination:
Children ≥6 years and Adolescents ≤17 years (Xu 2019):
<45 kg: Median: 7.53 days.
≥45 kg: Median: 11.9 days.
Adults: ~2 weeks.
Time to peak, serum: SubQ: 2 to 6 days.
Body weight: Following IV administration, patients with higher body weights tend to have higher serum golimumab concentrations (compared to lower body weights).
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
