Golimumab Injection
Golimumab injection is a TNF-blocking biologic used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis in adults and some pediatric patients.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Golimumab (Simponi Aria) carries a serious black-box warning about life-threatening infections and cancer risk. Patients taking this medicine have a higher chance of getting severe infections — including tuberculosis (TB), bacterial blood infections (sepsis), and invasive fungal infections like histoplasmosis — that may require hospitalization or can be fatal. Most patients who developed these infections were also taking other medicines that suppress the immune system, such as methotrexate or corticosteroids. You should be tested for TB before starting and monitored for it throughout treatment, even if your first test was negative. Simponi Aria must be stopped if a serious infection develops. Additionally, cases of lymphoma and other cancers — some fatal — have been reported in children and teenagers treated with TNF-blocking medicines like golimumab. Watch for signs of infection (fever, chills, cough, unusual fatigue) or unusual lumps and swollen glands, and report them to your doctor immediately.
📖 Golimumab Injection: Patient Information Guide
A plain-language walkthrough of Golimumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Golimumab injection is approved to treat several serious inflammatory conditions across its two branded products. Specific approvals depend on the brand and route.
- Simponi (subcutaneous injection) treats moderately to severely active rheumatoid arthritis in adults, used in combination with methotrexate
- Simponi (subcutaneous injection) treats active psoriatic arthritis in adults, alone or with methotrexate
- Simponi (subcutaneous injection) treats active ankylosing spondylitis (a type of spinal inflammatory arthritis) in adults
- Simponi (subcutaneous injection) treats moderately to severely active ulcerative colitis in adults and in pediatric patients weighing at least 15 kg
- Simponi Aria (intravenous infusion) treats moderately to severely active rheumatoid arthritis in adults, used in combination with methotrexate
⚙️How it works▾
Golimumab is a human monoclonal antibody — a precisely engineered protein — that targets and blocks TNF-alpha (tumor necrosis factor-alpha), a chemical messenger that drives inflammation. In conditions like rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, TNF-alpha levels are elevated in the blood and joints, triggering the pain, swelling, and joint damage that characterize these diseases. By binding to TNF-alpha and preventing it from attaching to its receptors, golimumab interrupts this inflammatory chain reaction. The exact mechanism in ulcerative colitis is not fully known, but golimumab appears to reduce inflammatory signals in the gut lining as well.
💊How it's taken▾
The route and schedule depend on the product and condition being treated — your prescriber will determine the right regimen for you. Simponi is given as a subcutaneous (under-the-skin) injection, typically once a month for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. For ulcerative colitis, Simponi uses a higher-dose induction schedule in the first weeks, followed by regular monthly injections. Simponi Aria is administered as an intravenous infusion in a healthcare setting at intervals determined by your doctor.
- Simponi can be self-injected at home after proper training from your healthcare provider
- If you miss a dose of Simponi, give it as soon as you remember, then return to your regular schedule
- Never adjust your dose or schedule without talking to your prescriber first
🤒Side effects — in detail▾
The most common side effects with golimumab include:
- Upper respiratory infections (colds, sore throat)
- Bronchitis
- Elevated liver enzymes (a sign the liver may be under stress)
- Viral infections
- Low neutrophil count (a type of white blood cell that fights infection)
- High blood pressure
- Skin rash
More serious reactions — including life-threatening infections, TB reactivation, lymphoma, liver failure, and severe allergic reactions — can occur and require immediate medical attention. Call your doctor right away if you develop a fever, persistent cough, unusual fatigue, shortness of breath, yellowing of the skin, or any signs of a severe allergic reaction.
⚠️Warnings & precautions▾
- Serious infections: Golimumab suppresses the immune system, raising the risk of bacterial, viral, fungal, and opportunistic infections. TB is a key concern — you must be tested before starting and monitored throughout. Do not start golimumab during an active infection.
- Cancer risk: Cases of lymphoma and other malignancies — some fatal — have occurred, especially in children, adolescents, and young adults treated with TNF blockers. The rate of lymphoma in clinical trials was higher than in the general population.
- Hepatitis B reactivation: Patients who carry the hepatitis B virus can have it reactivate during treatment. Testing before starting and monitoring during therapy are essential.
- Heart failure: New or worsening congestive heart failure has been reported. Stop treatment if heart failure symptoms develop or worsen.
- Demyelinating disorders: Nerve-sheath damage (demyelination), such as multiple sclerosis, may be triggered or worsened — report any new numbness, tingling, vision problems, or weakness.
- Lupus-like syndrome: A lupus-like reaction can occur; stop treatment if symptoms appear.
- Skin cancer: Cases of melanoma and Merkel cell carcinoma have been reported; periodic skin checks are recommended.
🔀What it interacts with▾
Golimumab can interact with several other medicines. Tell your prescriber and pharmacist about everything you take:
- Other biologic medicines (abatacept, anakinra, rituximab): Combining biologics significantly increases the risk of serious infections — concurrent use is not recommended
- Live vaccines: Must not be given while on golimumab; live vaccines should also be delayed 6 months in infants whose mothers received golimumab during pregnancy
- Methotrexate: Often prescribed alongside golimumab, particularly for rheumatoid arthritis; it slows how quickly golimumab is cleared from the body and reduces the likelihood of developing antibodies against it
- Narrow therapeutic index drugs (warfarin, cyclosporine, theophylline): Golimumab may change how the body metabolizes these medicines; monitoring of drug levels or effects may be needed when starting or stopping golimumab
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- You must be screened for tuberculosis before starting — if the test is positive, TB must be treated first
- You must be tested for hepatitis B before starting
- Tell your doctor about any active, chronic, or recurring infections, or if you've lived in or traveled to areas where TB or fungal infections are common
- Tell your doctor if you have heart failure, any nerve or neurological condition, or a history of cancer
- Make sure all age-appropriate vaccines are up to date before beginning treatment — live vaccines cannot be given during therapy
- Pregnancy: Golimumab crosses the placenta in the third trimester; discuss risks with your doctor; live vaccines should be held for 6 months in infants exposed in utero
- Breastfeeding: It is unknown whether golimumab passes into human milk; discuss with your doctor before breastfeeding
- Pediatric patients: Simponi is approved for ulcerative colitis in patients weighing at least 15 kg; it is not approved for rheumatoid arthritis in children
- Older adults (65+): Extra caution is advised because older adults already have a higher baseline risk of infection
🚑If you take too much▾
In a clinical study, five patients received very high single intravenous doses of Simponi Aria without serious reactions. If you think you or someone else has received too much of this medicine, contact your healthcare provider or seek emergency care right away.
📡Pharmacodynamics — effects in the body▾
After treatment with golimumab, measurable reductions in several markers of inflammation are seen in the blood — including C-reactive protein (CRP, a general marker of inflammation), IL-6 (a pro-inflammatory signaling protein), and matrix metalloproteinases (enzymes involved in joint and tissue damage). These changes reflect the drug quieting down the inflammatory process that drives joint destruction and symptoms. The clinical significance of each individual biomarker change is not fully established, but together they suggest meaningful suppression of the inflammatory pathway targeted by golimumab.
🔬Pharmacokinetics — how your body processes it▾
When Simponi is injected subcutaneously, peak blood levels are typically reached within 2 to 6 days. The drug stays in the body for a relatively long time — its half-life (the time it takes for the level to drop by half) is approximately 2 weeks in both healthy people and patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. Golimumab is distributed mainly within the bloodstream, with limited spread into other body tissues. Its exact breakdown pathway in the body is unknown. Taking golimumab alongside methotrexate slows the clearance of golimumab somewhat and increases steady-state blood levels, which is one reason these two drugs are often used together for rheumatoid arthritis.
📦How to store it▾
Refrigerate SIMPONI between 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light until the time of use. Do not freeze. stored at room temperature up to 77 °F (25 °C) for a maximum single period of 30 days in the original carton to protect from light.
📄 Written from Golimumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Golimumab Injection
53 supplements and herbal products have documented interactions with Golimumab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 52
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Golimumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What conditions does golimumab actually treat? ▾
How do I give myself the Simponi injection at home? ▾
What infections should I be worried about while taking this medication? ▾
Is there a cancer risk I should know about? ▾
Can I get vaccinated while on golimumab? ▾
What should I do if I'm pregnant or planning to become pregnant? ▾
Is Golimumab Injection available over the counter? ▾
When was Golimumab Injection first available? ▾
💬 Answers drafted from Golimumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Golimumab Injection comes
Golimumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Simponi (subcutaneous) is used for adults with moderately to severely active rheumatoid arthritis (with methotrexate), active psoriatic arthritis, and active ankylosing spondylitis
- Simponi (subcutaneous) is used for moderately to severely active ulcerative colitis in adults and in pediatric patients weighing at least 15 kg
- Simponi Aria (intravenous) is used for adults with moderately to severely active rheumatoid arthritis
- Simponi (subcutaneous) is self-injected under the skin once a month for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, following a specific higher-frequency induction schedule for ulcerative colitis; follow your prescriber's directions
- Simponi prefilled syringe may be self-injected by adults and pediatric patients 12 years and older; the SmartJect autoinjector is for adult self-injection only
- Simponi Aria is given as an intravenous infusion in a clinical or healthcare setting — it is not a self-injection product
- For Simponi, allow the prefilled syringe or autoinjector to sit at room temperature for at least 30 minutes before injecting; rotate injection sites and never inject into skin that is bruised, red, or tender
📊 Golimumab Injection across the U.S. market
How Golimumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
📈 How widely Golimumab Injection is used
A general measure of how commonly Golimumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Golimumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Golimumab Injection prescribed? Of the 1,597 medications we measure, Golimumab Injection ranks #753 by Medicaid prescriptions — more than 53% of them.
Utilization by Golimumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
4 ML golimumab 12.5 MG/ML Injection Most dispensed
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1431642
0.5 ML golimumab 100 MG/ML Auto-Injector
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1653142
1 ML golimumab 100 MG/ML Auto-Injector
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1653165
0.5 ML golimumab 100 MG/ML Prefilled Syringe
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 848160
1 ML golimumab 100 MG/ML Prefilled Syringe
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1482813
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Golimumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 10 listed Golimumab Injection NDCs with Medicaid activity.
🔍 Compare Golimumab Injection products
A representative set of FDA-listed product records for Golimumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 50 mg/0.5 mL | Subcutaneous | Janssen Biotech, Inc. × 3 listings | BLA | View NDC → |
| 50 mg/4 mL | Intravenous | Janssen Biotech, Inc. × 3 listings | BLA | View NDC → |
| 100 mg/mL | Subcutaneous | Janssen Biotech, Inc. × 3 listings | BLA | View NDC → |
Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Golimumab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Golimumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Golimumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Golimumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 819300 3 dose forms · 5 strengths
-
Dose form (SCDF) Auto-Injector RxCUI 1653141In current FDA listingsClinical drug / strength (SCD) 0.5 ML golimumab 100 MG/MLRxCUI 16531421 ML golimumab 100 MG/MLRxCUI 1653165 -
Dose form (SCDF) Injection RxCUI 1653569In current FDA listingsClinical drug / strength (SCD) 4 ML golimumab 12.5 MG/MLRxCUI 1431642 -
Dose form (SCDF) Prefilled Syringe RxCUI 848159No current FDA listingClinical drug / strength (SCD) 0.5 ML golimumab 100 MG/MLRxCUI 8481601 ML golimumab 100 MG/MLRxCUI 1482813
Look up RxCUI 819300 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Golimumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Golimumab Injection belongs to the Tumor Necrosis Factor Blocker class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Janssen Biotech, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.