Simponi (Golimumab)

What Is Simponi and What Is It Used For?

Quick Answer: Simponi (golimumab) is a biologic medicine that belongs to the TNF inhibitor class. It blocks the inflammatory protein TNF-α and is primarily used to treat juvenile arthritis and pediatric ulcerative colitis in children, as well as several inflammatory conditions in adults including rheumatoid arthritis and ankylosing spondylitis.

Simponi contains the active substance golimumab, a fully human monoclonal antibody produced using recombinant DNA technology. It belongs to a group of medicines known as TNF inhibitors (also called anti-TNF agents or biologic disease-modifying antirheumatic drugs). These medicines represent a major advance in the treatment of chronic inflammatory conditions that do not respond adequately to conventional therapies.

The medicine works by specifically targeting and blocking the function of a protein called tumor necrosis factor alpha (TNF-α). This protein plays a central role in the inflammatory processes that drive autoimmune diseases. TNF-α is produced in excess by the immune system in conditions such as arthritis and inflammatory bowel disease, leading to chronic inflammation, tissue damage, and disease progression. By neutralizing TNF-α, Simponi helps reduce inflammation throughout the body and slow or halt disease progression.

Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Polyarticular juvenile idiopathic arthritis is a chronic inflammatory disease that causes pain, swelling, and stiffness in multiple joints in children. The condition affects at least five joints within the first six months and can significantly impact a child's physical development, mobility, and quality of life. Left untreated, it can lead to permanent joint damage and growth disturbances.

Simponi is approved for the treatment of pJIA in children aged 2 years and older who have not responded adequately to previous treatment with methotrexate. It is always used in combination with methotrexate. Clinical trials have demonstrated that golimumab significantly improves joint swelling, pain, and physical function in children with pJIA compared to placebo, with improvements sustained over long-term follow-up.

Pediatric Ulcerative Colitis

Ulcerative colitis is a chronic inflammatory bowel disease characterized by inflammation and ulceration of the inner lining of the large intestine (colon) and rectum. In children, it can cause bloody diarrhea, abdominal pain, urgency, fatigue, and growth impairment. Simponi is approved for the treatment of moderately to severely active ulcerative colitis in children aged 2 years and older who weigh at least 15 kg and have had an inadequate response to conventional therapy.

Adult Indications

In adults, Simponi is also approved for the treatment of moderately to severely active rheumatoid arthritis (in combination with methotrexate), active psoriatic arthritis, active ankylosing spondylitis (axial spondyloarthritis), and moderately to severely active ulcerative colitis. These approvals are based on extensive phase III clinical trial data demonstrating significant improvements in disease activity scores, physical function, and quality of life measures.

What Should You Know Before Taking Simponi?

Quick Answer: Before starting Simponi, you must be screened for tuberculosis and hepatitis B. Do not use Simponi if you have active tuberculosis, serious infections, or moderate to severe heart failure. Tell your doctor about all medical conditions and medications you take, including any history of cancer, demyelinating diseases, or autoimmune conditions.

Contraindications

Simponi must not be used in the following situations. If any of these apply to you, inform your doctor before treatment is considered:

• Allergy to golimumab – If you are allergic (hypersensitive) to golimumab or any of the other ingredients in Simponi (sorbitol, histidine, histidine hydrochloride monohydrate, polysorbat 80, water for injections).
• Active tuberculosis or other serious infections – If you have tuberculosis (TB) or any other serious active infection. Active infections must be treated and resolved before Simponi can be started.
• Moderate to severe heart failure – If you have heart failure classified as NYHA Class III or IV. TNF inhibitors can worsen heart failure and are contraindicated in these patients.

Warnings and Precautions

Infections: Because Simponi suppresses part of the immune system, you may be more susceptible to infections while using this medicine. Infections may develop more quickly and may be more severe than usual. Previously dormant infections can also reactivate. Tell your doctor immediately if you experience symptoms such as fever, cough, shortness of breath, flu-like symptoms, diarrhea, wounds, dental problems, or a burning sensation during urination.

Tuberculosis (TB): Cases of tuberculosis have been reported in patients treated with Simponi, including in patients who have received treatment for latent TB. Your doctor will test you for TB before starting treatment. It is extremely important to tell your doctor if you have ever had TB or have been in close contact with someone who has or has had TB. If your doctor considers you at risk of TB, you may receive anti-TB medicines before starting Simponi. TB can present with persistent cough, weight loss, fatigue, fever, and night sweats.

Hepatitis B virus (HBV): If you are a carrier of or have had hepatitis B, treatment with TNF inhibitors such as Simponi can cause reactivation of the virus, which in some cases can be life-threatening. Your doctor should test you for HBV before starting treatment. Symptoms of HBV reactivation include yellowing of the skin and eyes, dark urine, right-sided abdominal pain, fever, nausea, vomiting, and extreme fatigue.

Invasive fungal infections: Tell your doctor immediately if you have lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic. These infections can affect the lungs and other body systems and may be difficult to diagnose in patients on TNF inhibitor therapy.

Cancer and lymphoma: There is an increased risk of lymphoma and other cancers in patients treated with TNF inhibitors. Patients with severe, long-standing inflammatory diseases may already carry a higher baseline risk of lymphoma. Cases of cancer, including rare types, have been reported in children and adolescents receiving TNF inhibitors, some of which were fatal. A specific and severe type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF inhibitors, predominantly in young male patients also receiving azathioprine or 6-mercaptopurine. Patients with severe persistent asthma, COPD, or who are heavy smokers may have an increased cancer risk with Simponi treatment. Some patients treated with golimumab have developed skin cancers.

Heart failure: New or worsening heart failure has been reported with TNF inhibitors, including Simponi, and some of these cases were fatal. If you have mild heart failure and are treated with Simponi, you will be closely monitored. Tell your doctor immediately if you develop new or worsening symptoms such as shortness of breath or swelling of the feet.

Nervous system disorders: Tell your doctor immediately if you have ever been diagnosed with or develop symptoms of a demyelinating disease such as multiple sclerosis. Symptoms may include changes in vision, weakness in arms or legs, or numbness and tingling in any part of the body.

Autoimmune conditions: In rare cases, patients treated with TNF inhibitors have developed lupus-like syndrome. Symptoms may include persistent rash, fever, joint pain, and fatigue. If you develop these symptoms, contact your doctor. TNF inhibitors have also been associated with sarcoidosis and vasculitis in rare cases.

Blood disorders: In some patients, the body may not produce enough blood cells. If you develop persistent fever, bruise or bleed easily, or appear very pale, contact your doctor immediately.

Vaccinations

You should not receive live vaccines while being treated with Simponi, as live vaccines can cause infections in immunosuppressed patients. Certain vaccinations may be less effective during treatment. If you received Simponi during pregnancy, your infant may have an increased risk of infection from live vaccines for up to approximately six months after your last dose during pregnancy. Discuss the vaccination schedule for your child with their doctor. If possible, all age-appropriate vaccinations should be completed before starting Simponi therapy.

Pregnancy and Breastfeeding

There is limited data on the use of Simponi in pregnant women. Simponi should only be used during pregnancy if clearly necessary. Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose. You must not breastfeed until at least 6 months after your last Simponi dose.

If Simponi was administered during pregnancy, the infant may have an increased risk of infection for up to six months after the last dose given during pregnancy. It is essential to inform the infant's healthcare providers about Simponi exposure before the child receives any vaccines, particularly live vaccines.

How Does Simponi Interact with Other Drugs?

Quick Answer: Simponi should not be combined with other biologic DMARDs such as anakinra or abatacept due to increased infection risk. Live vaccines must be avoided during treatment. Concurrent use of azathioprine or 6-mercaptopurine may increase the risk of hepatosplenic T-cell lymphoma. Always inform your doctor about all medications and supplements you take.

Drug interactions with Simponi are clinically significant and must be carefully managed. Because Simponi modulates the immune system, combining it with other immunosuppressive agents can significantly increase the risk of serious infections and other adverse effects. Always tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Major Interactions

Minor Interactions and Considerations

Methotrexate: Simponi is often used in combination with methotrexate for rheumatoid arthritis and juvenile idiopathic arthritis. While methotrexate is immunosuppressive, this combination is well-established and supported by clinical trial data. Regular monitoring of liver function and blood counts is recommended.

Other immunosuppressive agents: Patients already taking other immunosuppressive medications should be closely monitored, as the combined immunosuppressive effect may increase infection risk. Your doctor will weigh the benefits of combination therapy against the risks.

Inactivated vaccines: Inactivated (killed) vaccines can generally be administered during Simponi treatment, although the immune response may be somewhat reduced. Seasonal influenza and pneumococcal vaccines are recommended for patients on biologic therapy.

What Is the Correct Dosage of Simponi?

Quick Answer: Simponi dosing depends on the condition being treated, the patient's body weight, and age. For pediatric patients, the dose is calculated based on body weight and height. For adults with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, the standard dose is 50 mg once monthly. It is administered as a subcutaneous injection on the same date each month.

Always use Simponi exactly as your doctor or pharmacist has instructed. The dose and dosing schedule will be determined by your healthcare provider based on the specific condition being treated, your body weight, and your response to therapy. Do not adjust the dose on your own.

Children – Polyarticular Juvenile Idiopathic Arthritis

Your doctor will evaluate response after the fourth dose and decide whether treatment should continue. Simponi should be used in combination with methotrexate for the treatment of pJIA.

Children – Pediatric Ulcerative Colitis

Adults

How Simponi Is Administered

Simponi is injected under the skin (subcutaneously). The injection can be given in the front of the thighs (recommended), the lower abdomen (avoiding the area approximately 5 cm around the navel), or the back of the upper arms (if administered by a caregiver). Rotate injection sites with each dose and do not inject into areas where the skin is tender, bruised, red, scaly, hard, or scarred.

Initially, a doctor or nurse may administer the injection. However, after proper training, patients or their caregivers can self-administer at home. The pre-filled pen is designed for ease of use and includes a needle safety guard that locks after injection.

Missed Dose

If you forget to take Simponi on your scheduled date, inject the missed dose as soon as you remember. Do not take a double dose to make up for the missed one. If you are less than 2 weeks late, inject the missed dose and continue with your original schedule. If you are more than 2 weeks late, inject the missed dose and consult your doctor or pharmacist about when to take the next dose.

Overdose

If you have used too much Simponi (either too much at a single injection or used it too frequently), contact your doctor or pharmacist immediately. Always bring the outer carton and this leaflet with you, even if they are empty. In clinical studies, single doses of up to 10 mg/kg have been administered intravenously without dose-limiting toxicity. There is no specific antidote for golimumab overdose; treatment is supportive.

What Are the Side Effects of Simponi?

Quick Answer: The most common side effects of Simponi are upper respiratory tract infections (affecting more than 1 in 10 patients). Common side effects include injection site reactions, headache, elevated liver enzymes, and bronchitis. Serious but rare side effects include serious infections, lymphoma, heart failure, and demyelinating diseases. Report any new or worsening symptoms to your doctor promptly.

Like all medicines, Simponi can cause side effects, although not everyone gets them. Some side effects can be serious and require immediate medical attention. Side effects may appear up to several months after the last injection. The following side effects have been observed with Simponi treatment:

If you notice any side effects not listed above, or if any side effect becomes serious, please tell your doctor, pharmacist, or nurse. You can also report suspected side effects directly to your national regulatory authority to help ensure continuous monitoring of the medicine's benefit-risk balance.

How Should You Store Simponi?

Quick Answer: Store Simponi in a refrigerator at 2°C to 8°C. Do not freeze. Keep it in the original carton to protect from light. It can be stored at room temperature (up to 25°C) for a single period of up to 30 days, but cannot be returned to the refrigerator afterward.

Proper storage of Simponi is essential to maintain the medicine's effectiveness and safety. Biologic medicines like golimumab are sensitive to temperature and light, and incorrect storage can degrade the active protein, rendering the medicine ineffective or potentially unsafe.

• Refrigerate: Store at 2°C to 8°C (36°F to 46°F). Do not freeze the medicine at any time. If accidentally frozen, do not use it.
• Protect from light: Keep the pre-filled pen in the original outer carton at all times to protect it from light exposure.
• Room temperature storage: Simponi may be stored outside the refrigerator at temperatures up to 25°C (77°F) for a single period of up to 30 days, but the original expiration date on the carton must not be exceeded. Write the new expiration date (maximum 30 days from removal from refrigerator) on the carton. Once stored at room temperature, do not return it to the refrigerator.
• Before injection: Allow the pre-filled pen to reach room temperature for 30 minutes before injection. Do not warm it by any other method.
• Visual inspection: Before use, check that the solution is clear to slightly opalescent (pearly sheen), colorless to slightly yellow, and may contain a few small translucent or white protein particles. Do not use if the solution is discolored, cloudy, or contains visible foreign particles.
• Expiration date: Do not use after the expiration date (EXP) printed on the label and carton. The expiration date refers to the last day of the stated month.
• Disposal: Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures help protect the environment.

Keep this medicine out of the sight and reach of children. Store in a secure location where children cannot access it.

What Does Simponi Contain?

Quick Answer: Simponi's active ingredient is golimumab. The 0.45 ml pre-filled pen contains 45 mg of golimumab (100 mg/ml). Other ingredients include sorbitol, histidine, histidine hydrochloride monohydrate, polysorbat 80, and water for injections.

Understanding the composition of your medicine is important, particularly if you have known allergies or sensitivities to specific excipients. Simponi is a biologic medicine containing a human monoclonal antibody produced using recombinant DNA technology in a mammalian cell expression system.

Active Ingredient

The active substance is golimumab. One 0.45 ml pre-filled injection pen contains 45 mg of golimumab, equivalent to a concentration of 100 mg per ml. Golimumab is a fully human IgG1κ monoclonal antibody that specifically targets and neutralizes tumor necrosis factor alpha (TNF-α).

Other Ingredients (Excipients)

• Sorbitol (E420) – 18.5 mg per pre-filled pen (2.05 mg per 0.05 ml). Used as a stabilizer. Patients with hereditary fructose intolerance should be aware of this ingredient.
• Histidine – Serves as a buffer to maintain the optimal pH for protein stability.
• Histidine hydrochloride monohydrate – Additional buffer component.
• Polysorbat 80 (E433) – 0.068 mg per pre-filled pen. A surfactant that prevents protein aggregation. Polysorbates can cause allergic reactions in sensitive individuals.
• Water for injections – The solvent vehicle.

Packaging and Appearance

Simponi is supplied as a solution for injection in a single-use pre-filled injection pen (VarioJect). It is available in packs of 1 pre-filled injection pen. The solution should appear clear to slightly opalescent (pearly sheen), colorless to slightly yellow, and may contain a few small translucent or white protein particles. The VarioJect pen allows for adjustable dosing from 0.1 ml to 0.45 ml (10 mg to 45 mg) in 0.05 ml increments, making it suitable for weight-based pediatric dosing.

The marketing authorization holder is Janssen-Cilag International NV (Belgium), and the manufacturer is Janssen Biologics B.V. (Netherlands). For further information about this medicine, contact the local representative of the marketing authorization holder in your country.

References

1. European Medicines Agency (EMA). Simponi (golimumab) – Summary of Product Characteristics (SmPC). Last updated 2025. Available from: EMA product information database.
2. U.S. Food and Drug Administration (FDA). SIMPONI (golimumab) – Full Prescribing Information. Janssen Biotech, Inc. Reference ID: 4901427.
3. Brunner HI, Ruperto N, Tzaribachev N, et al. Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial. Ann Rheum Dis. 2018;77(1):21-29. doi:10.1136/annrheumdis-2016-210456.
4. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146(1):85-95. doi:10.1053/j.gastro.2013.05.048.
5. World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. Geneva: WHO; 2023.
6. Singh JA, Saag KG, Bridges SL, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2016;68(1):1-26. doi:10.1002/art.39480.
7. National Institute for Health and Care Excellence (NICE). TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis. Technology appraisal guidance [TA383]. 2016.
8. European Crohn's and Colitis Organisation (ECCO). ECCO Guidelines on therapeutics in ulcerative colitis. J Crohns Colitis. 2022;16(2):162-187.

Editorial Team

Published: June 6, 2025 | Last reviewed: December 25, 2025 | Next review: June 25, 2026