Simponi
(Golimumab)Dosage & Administration
| Recommended Dosage | |||
|---|---|---|---|
| Weight for Patients with UC | Week 0 | Week 2 | Week 6 and every 4 weeks thereafter |
| Adults and pediatric patients 40 kg and greaterFor pediatric patients weighing 15 kg or greater, administer the appropriate dose using the prefilled syringe (50 mg/0.5 mL or 100 mg/mL). | 200 mg | 100 mg | 100 mg |
| Pediatric patients at least 15 kg to less than 40 kg | 100 mg | 50 mg | 50 mg |
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Simponi Prescribing Information
Indications and Usage (SIMPONI is indicated for the treatment of adults and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis . | 10/2025 | |||||||||||||||
Dosage and Administration (Prior to initiating treatment with SIMPONI:
The recommended dosage is shown in Table 1.
SIMPONI is intended for use under the guidance and supervision of a healthcare provider after proper training in subcutaneous injection technique. Patients may self-inject with SIMPONI if a physician determines that it is appropriate. Instruct patients to follow the directions provided in the Instructions for Use. SIMPONI Prefilled Syringe
SIMPONI SmartJect®Autoinjector
• To ensure proper use, allow the prefilled syringe or autoinjector to sit at room temperature outside the carton for at least 30 minutes prior to subcutaneous injection. Do not warm SIMPONI in any other way. • Prior to administration, visually inspect the solution for particles and discoloration through the viewing window. SIMPONI is clear to slightly opalescent and colorless to light yellow. Do not use SIMPONI, if the solution is discolored, or cloudy, or if foreign particles are present. • Do not use any leftover product remaining in the prefilled syringe or prefilled autoinjector. • Instruct patients sensitive to latex not to handle the needle cover on the prefilled syringe or the needle cover of the prefilled syringe within the autoinjector cap because it contains dry natural rubber (a derivative of latex). • At the time of dosing, if multiple injections are required, administer the injections at different sites on the body. • Rotate injection sites and never give injections into areas where the skin is tender, bruised, red, or hard. • If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. | 10/2025 | |||||||||||||||
Warnings and Precautions (Live Vaccines Patients treated with SIMPONI may receive vaccinations, except for live vaccines. In patients receiving anti-TNF therapy, limited data are available on the response to live vaccination, or on the secondary transmission of infection by live vaccines. Use of live vaccines could result in clinical infections, including disseminated infections. If possible, it is recommended that prior to initiating therapy with SIMPONI, pediatric patients be brought up to date with all immunizations in agreement with current immunization guidelines. Therapeutic Infectious Agents Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections. It is recommended that therapeutic infectious agents not be given concurrently with SIMPONI. Non-live Vaccines In the Phase 3 PsA trial, after pneumococcal vaccination, a similar proportion of SIMPONI-treated and placebo-treated patients were able to mount an adequate immune response of at least a 2-fold increase in antibody titers to pneumococcal polysaccharide vaccine. In both SIMPONI-treated and placebo-treated patients, the proportions of patients with response to pneumococcal vaccine were lower among patients receiving MTX compared with patients not receiving MTX. The data suggest that SIMPONI does not suppress the humoral immune response to the pneumococcal vaccine. | 10/2025 | |||||||||||||||
SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of:
- adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate ()
1.1 Rheumatoid ArthritisSIMPONI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
- adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate ()
1.2 Psoriatic ArthritisSIMPONI, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis.
- adult patients with active ankylosing spondylitis (AS) ()
1.3 Ankylosing SpondylitisSIMPONI is indicated for the treatment of adult patients with active ankylosing spondylitis.
- adult and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC) ()
1.4 Ulcerative ColitisSIMPONI is indicated for the treatment of adults and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis.
- RA, PsA, and AS: 50 mg administered by subcutaneous injection once a month ()
2.2 Recommended Dosage for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing SpondylitisThe recommended SIMPONI dosage in adults is 50 mg administered by subcutaneous injection once a month.
For patients with rheumatoid arthritis (RA), SIMPONI should be given in combination with methotrexate and for patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS), SIMPONI may be given with or without methotrexate or other nonbiologic Disease-Modifying Antirheumatic Drugs (DMARDs). For patients with RA, PsA, or AS, corticosteroids, non-biologic DMARDs, and/or NSAIDs may be continued during treatment with SIMPONI.
- UC: The recommended dosage and administration by subcutaneous injection in adults and pediatric patients weighing at least 15 kg is shown in the table ()
2.3 Recommended Dosage for Moderately to Severely Active Ulcerative Colitis in Adults and Pediatric Patients Weighing at least 15 kgThe recommended dosage is shown in Table 1.Table 1: Recommended Subcutaneous Dosage for Adults and Pediatric Patients Weighing at least 15 kg with Moderately to Severely Active Ulcerative Colitis Weight for Patients with UCRecommended Dosage of SIMPONI Week 0 Week 2 Week 6 and every 4 weeks thereafter Adults and pediatric patients 40 kg and greaterFor pediatric patients weighing 15 kg or greater, administer the appropriate dose using the prefilled syringe (50 mg/0.5 mL or 100 mg/mL).200 mg 100 mg 100 mg Pediatric patients at least 15 kg to less than 40 kg100 mg 50 mg 50 mg
| Recommended Dosage | |||
|---|---|---|---|
| Weight for Patients with UC | Week 0 | Week 2 | Week 6 and every 4 weeks thereafter |
| Adults and pediatric patients 40 kg and greaterFor pediatric patients weighing 15 kg or greater, administer the appropriate dose using the prefilled syringe (50 mg/0.5 mL or 100 mg/mL). | 200 mg | 100 mg | 100 mg |
| Pediatric patients at least 15 kg to less than 40 kg | 100 mg | 50 mg | 50 mg |
Injection: 50 mg/0.5 mL and 100 mg/mL clear to slightly opalescent, colorless to light yellow solution in a single-dose prefilled syringe or single-dose SmartJect® autoinjector.
Available data from postmarketing case reports with golimumab use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. An observational study of northern European births observed similar unadjusted rates of major birth defects in infants exposed
An observational, exposure-based, cohort study based on data from the Swedish, Danish, and Finnish Medical Birth Registers conducted between 2006–2020 (Sweden and Denmark) and 2006–2019 (Finland) compared the risk of major birth defects in 134 live-born infants exposed to golimumab (116 from women treated for rheumatic conditions, 18 from women treated for ulcerative colitis) to no treatment or non-biologic systemic therapy. The unadjusted rate of major birth defects in infants exposed
In an embryofetal developmental toxicology study in which pregnant cynomolgus monkeys were treated with golimumab during the period organogenesis from gestation days (GD) 20 to 51, exposures up to 360 times greater than the exposure at the MRHD (on an area under the curve (AUC) basis with maternal subcutaneous doses up to 50 mg/kg twice weekly) produced no evidence of fetal malformations or embryotoxicity. There was no evidence of maternal toxicity. Umbilical cord blood samples collected at the end of the second trimester showed that fetuses were exposed to golimumab during gestation.
In a pre- and post-natal developmental study in which pregnant cynomolgus monkeys were treated with golimumab from gestation day 50 to postpartum day 33, maximal drug concentrations approximately 460 times greater than that found with the MRHD (on a maximum blood concentration (Cmax) basis at steady state with maternal subcutaneous doses up to 50 mg/kg twice weekly) were not associated with any evidence of developmental defects in infants. There was no evidence of maternal toxicity. Golimumab was present in fetal serum at the end of the second trimester and in neonatal serum from the time of birth and for up to 6 months postpartum.
Monoclonal antibodies, such as golimumab, are transported across the placenta during the third trimester of pregnancy and may affect immune response in the
Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis or ulcerative colitis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.
Golimumab crosses the placenta during pregnancy. Another TNF-blocking monoclonal antibody administered during pregnancy was detected for up to 6 months in the serum of infants. Consequently, these infants may be at increased risk of infection. Administration of live vaccines to infants exposed to SIMPONI
An observational, exposure-based, cohort study based on data from the Swedish, Danish, and Finnish Medical Birth Registers conducted between 2006–2020 (Sweden and Denmark) and 2006–2019 (Finland) compared the risk of major birth defects in 134 live-born infants exposed to golimumab (116 from women treated for rheumatic conditions, 18 from women treated for ulcerative colitis) to no treatment or non-biologic systemic therapy. The unadjusted rate of major birth defects in infants exposed
In an embryofetal developmental toxicology study in which pregnant cynomolgus monkeys were treated with golimumab during the period organogenesis from gestation days (GD) 20 to 51, exposures up to 360 times greater than the exposure at the MRHD (on an area under the curve (AUC) basis with maternal subcutaneous doses up to 50 mg/kg twice weekly) produced no evidence of fetal malformations or embryotoxicity. There was no evidence of maternal toxicity. Umbilical cord blood samples collected at the end of the second trimester showed that fetuses were exposed to golimumab during gestation.
In a pre- and post-natal developmental study in which pregnant cynomolgus monkeys were treated with golimumab from gestation day 50 to postpartum day 33, maximal drug concentrations approximately 460 times greater than that found with the MRHD (on a maximum blood concentration (Cmax) basis at steady state with maternal subcutaneous doses up to 50 mg/kg twice weekly) were not associated with any evidence of developmental defects in infants. There was no evidence of maternal toxicity. Golimumab was present in fetal serum at the end of the second trimester and in neonatal serum from the time of birth and for up to 6 months postpartum.
An observational, exposure-based, cohort study based on data from the Swedish, Danish, and Finnish Medical Birth Registers conducted between 2006–2020 (Sweden and Denmark) and 2006–2019 (Finland) compared the risk of major birth defects in 134 live-born infants exposed to golimumab (116 from women treated for rheumatic conditions, 18 from women treated for ulcerative colitis) to no treatment or non-biologic systemic therapy. The unadjusted rate of major birth defects in infants exposed
In an embryofetal developmental toxicology study in which pregnant cynomolgus monkeys were treated with golimumab during the period organogenesis from gestation days (GD) 20 to 51, exposures up to 360 times greater than the exposure at the MRHD (on an area under the curve (AUC) basis with maternal subcutaneous doses up to 50 mg/kg twice weekly) produced no evidence of fetal malformations or embryotoxicity. There was no evidence of maternal toxicity. Umbilical cord blood samples collected at the end of the second trimester showed that fetuses were exposed to golimumab during gestation.
In a pre- and post-natal developmental study in which pregnant cynomolgus monkeys were treated with golimumab from gestation day 50 to postpartum day 33, maximal drug concentrations approximately 460 times greater than that found with the MRHD (on a maximum blood concentration (Cmax) basis at steady state with maternal subcutaneous doses up to 50 mg/kg twice weekly) were not associated with any evidence of developmental defects in infants. There was no evidence of maternal toxicity. Golimumab was present in fetal serum at the end of the second trimester and in neonatal serum from the time of birth and for up to 6 months postpartum.
Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis or ulcerative colitis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.
Golimumab crosses the placenta during pregnancy. Another TNF-blocking monoclonal antibody administered during pregnancy was detected for up to 6 months in the serum of infants. Consequently, these infants may be at increased risk of infection. Administration of live vaccines to infants exposed to SIMPONI
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and of miscarriage is 15–20%, respectively.
None.