Simponi (golimumab) is a tumor necrosis factor blocker indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis, adults with active ankylosing spondylitis, and adults and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis. Simponi is indicated for the treatment of severely active rheumatoid arthritis in combination with methotrexate, and is also indicated for the treatment of active psoriatic arthritis alone or in combination with methotrexate.
Simponi was approved for adult patients with moderately to severely active ulcerative colitis in May 2013. It was later approved for pediatric patients living with ulcerative colitis in October 2025.
Read on to learn more about Simponi, including its dosage and administration information, adverse reactions, and more.
Medication Overview:
- Brand Name: Simponi
- Generic Name: Golimumab
- Treatment for: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis
- Manufacturer: Johnson & Johnson
- Initial FDA Approval: April 2009
| Indicated Condition | Indication | Age | Date Approved |
|---|---|---|---|
| Rheumatoid Arthritis | Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate. | Adults | April 2009 |
| Psoriatic Arthritis | Indicated for the treatment of adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate. | Adults | April 2009 |
| Ankylosing Spondylitis | Indicated for the treatment of adult patients with active ankylosing spondylitis (AS). | Adults | April 2009 |
| Ulcerative Colitis | Indicated for the treatment of adult and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC). | Adult and Pediatric Patients | October 2025 |
Warnings and Precautions:
- Serious Infections: Do not start Simponi during an active infection. If an infection develops, monitor carefully, and stop Simponi if infection becomes serious.
- Invasive Fungal Infections: For patients who develop a systemic illness on Simponi, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic.
- Malignancies: Incidence of lymphoma was greater than in the general U.S. population. Cases of other malignancies have been observed among patients receiving TNF blockers.
- Congestive Heart Failure: Worsening, or new onset, may occur. Stop Simponi if new or worsening symptoms occur.
- Demyelinating Disorders: Exacerbation or new onset may occur.
- Hepatitis B Reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Simponi and begin antiviral therapy.
- Lupus-like Syndrome: Discontinue Simponi if symptoms develop.
- Hypersensitivity Reactions: Serious systemic hypersensitivity reactions including anaphylaxis may occur.
Dosage and Administration:
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis: 50 mg administered by subcutaneous injection once a month.
Ulcerative colitis: The recommended dosage and administration by subcutaneous injection in adults and pediatric patients weighing at least 15 kg is:
- Adults and pediatric patients 40 kg and greater*: Week 0: 200 mg; Week 2: 100 mg; Week 6 and every four weeks thereafter: 100 mg.
- Pediatric patients at least 15 kg to less than 40 kg*: Week 0: 100 mg; Week 2: 50 mg; Week 6 and every four weeks thereafter: 50 mg.
*For pediatric patients weighing 15 kg or greater, administer the appropriate dose using the prefilled syringe (50 mg/0.5 mL or 100 mg/mL).
Contraindications:
None listed.
Drug Interactions:
- Abatacept: Increased risk of serious infection.
- Anakinra: Increased risk of serious infection.
- Live vaccines/therapeutic infectious agents: Avoid use with Simponi.
Adverse Reactions:
Most common adverse reactions in adults (incidence >5%) are upper respiratory tract infection, nasopharyngitis, injection site reactions.
Examples of Golimumab in Guidelines:
- American College of Gastroenterology (ACG), June 2025
- “In patients with moderately to severely active UC, we recommend anti-TNF therapy using adalimumab or golimumab for induction of remission.”
Pharmacological Management of Moderate-to-Severe Ulcerative Colitis
- American Gastroenterological Association (AGA), December 2024
- “In adult outpatients with moderate-to-severe UC, the AGA recommends the use of infliximab, golimumab, vedolizumab, tofacitinib,a upadacitinib,a ustekinumab, ozanimod, etrasimod, risankizumab and guselkumab over no treatment.”
Management of Reproductive Health and Rheumatic and Musculoskeletal Diseases
- American College of Rheumatology (ACR), February 2020
- “We conditionally recommend continuing tumor necrosis factor inhibitor therapy with infliximab, etanercept, adalimumab, or golimumab prior to and during pregnancy. The tumor necrosis factor inhibitor certolizumab does not contain an Fc chain and thus has minimal placental transfer.”
Please note: This article is current as of April 17, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.
Sign up for alerts to keep up with the latest clinical guidelines and guideline updates.