Golimumab

Pronunciation: goh-LIM-yoo-mab.

Generic name
golimumab
Drug class
Tumour necrosis factor (TNF) alpha inhibitor (biologic, human monoclonal antibody)
Form
Injection (50 mg/0.5 mL or 100 mg/mL prefilled syringe or autoinjector pen); 50 mg/4 mL concentrate for intravenous infusion (Simponi Aria)
Route
Subcutaneous injection (Simponi); intravenous infusion (Simponi Aria)
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Simponi (5) · Full directory

What golimumab is and how it works

Golimumab is a prescription-only injectable biologic medicine that blocks tumour necrosis factor-alpha (TNF-alpha), an inflammation-driving substance in the body. It is used for several long-term inflammatory autoimmune conditions affecting the joints and bowel. (1)

Golimumab is given either as a self-administered injection under the skin roughly once a month (Simponi) or, for some indications in some countries, as an infusion into a vein at a clinic (Simponi Aria). Because it affects your immune system, your prescriber will test you for tuberculosis and hepatitis B before you start, and will monitor you throughout treatment for infection and other effects.

Mechanism of action: how golimumab works

Golimumab is a human IgG1-kappa monoclonal antibody produced by a murine hybridoma cell line using recombinant DNA technology, that binds with high affinity to both soluble and transmembrane forms of TNF-alpha, preventing it from binding to its receptors and thereby neutralising its pro-inflammatory activity. (1)

What golimumab is used for

Rheumatoid arthritis

Used, usually together with methotrexate, to reduce the signs and symptoms of moderately to severely active rheumatoid arthritis in adults and to help slow the progression of joint damage. (1) (4)

Psoriatic arthritis

Used, alone or with methotrexate, for active psoriatic arthritis in adults. (1)

Ankylosing spondylitis and non-radiographic axial spondyloarthritis

Used for active ankylosing spondylitis in adults. In the UK, EU, and Australia, golimumab is also approved for non-radiographic axial spondyloarthritis with objective signs of inflammation. (1) (2) (5)

Ulcerative colitis

Used for moderately to severely active ulcerative colitis in adults and, in the US label, in children weighing 15 kg or more, when other treatments have not worked well enough. (1)

Polyarticular juvenile idiopathic arthritis (some countries)

In the UK and EU, golimumab is also approved, with methotrexate, for polyarticular juvenile idiopathic arthritis in children aged 2 years and older. (2) (3)

Before taking golimumab

Do not take / not appropriate for

  • Do not use golimumab if you have an active, serious infection such as tuberculosis, sepsis, or another opportunistic infection. (all countries) (1) (2) (4)
  • Do not use golimumab if you have moderate or severe heart failure (NYHA class III or IV) -- this is an outright contraindication in the UK and EU label. (United Kingdom and European Union) (2)
  • Do not use golimumab if you have had an allergic reaction to golimumab, latex, or any of its other ingredients (some delivery devices contain a latex derivative). (all countries) (1) (4)

Tell your clinician about

  • Any current infection, or history of recurrent or serious infections, including tuberculosis (or close contact with someone who has had TB).
  • Any history of hepatitis B infection, since golimumab can cause hepatitis B to reactivate.
  • Any history of cancer, or heart failure (even mild), or symptoms of nervous system conditions such as multiple sclerosis.
  • Any planned vaccinations -- live vaccines should not be given while you are on golimumab.
  • All other medicines you take, especially other biologic medicines for arthritis or bowel disease (such as abatacept or anakinra).
  • Pregnancy, plans for pregnancy, or breastfeeding.
(1) (2)

How to take golimumab

  • Simponi (subcutaneous) is usually self-injected under the skin of the thigh or abdomen, once a month on the same date each month, using a prefilled syringe or autoinjector pen after training from a healthcare professional.
  • Simponi Aria (intravenous), where available, is given as an infusion into a vein at a clinic or infusion centre by a healthcare professional.
  • Do not change your dose, frequency, or formulation on your own -- follow your prescriber's plan exactly.
  • Your prescriber will test you for tuberculosis and hepatitis B before your first dose.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a monthly injection, contact your prescriber for guidance on when to give the missed dose and how to resume your regular monthly schedule -- do not double up doses on your own.

Overdose

Seek urgent medical attention if too much golimumab may have been given, or if signs of a serious infection or allergic reaction develop after a dose. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Upper respiratory tract infections and nasopharyngitis (common cold-type symptoms) -- very common.

What to notice: Upper respiratory tract infections and nasopharyngitis (common cold-type symptoms) -- very common.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Injection-site reactions (redness, itching, swelling, or pain at the injection site).

What to notice: Injection-site reactions (redness, itching, swelling, or pain at the injection site).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Other viral infections, bronchitis, and superficial fungal infections.

What to notice: Other viral infections, bronchitis, and superficial fungal infections.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Elevated liver enzymes on blood tests.

What to notice: Elevated liver enzymes on blood tests.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Headache, dizziness, and raised blood pressure.

What to notice: Headache, dizziness, and raised blood pressure.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Signs of a serious infection, including tuberculosis — boxed_warning

Symptoms: Fever, night sweats, weight loss, persistent cough, feeling very unwell, or a wound or area of skin that will not heal.

Action: Contact your prescriber promptly. You will be screened for TB before starting golimumab and monitored for infection throughout treatment; treatment will be stopped by your prescriber if a serious infection develops. (1)

Signs suggestive of lymphoma or other cancer — boxed_warning

Symptoms: Unexplained swollen glands, unusual lumps, unexplained weight loss, or persistent fatigue.

Action: Tell your prescriber promptly -- rare cases of lymphoma and other cancers, some fatal, have occurred with TNF blockers, mostly reported in children and adolescents. (1)

Signs of hepatitis B reactivation — high caution

Symptoms: Yellowing of the skin or eyes, dark urine, unusual tiredness, or abdominal pain, especially if you have ever had hepatitis B.

Action: Tell your prescriber immediately -- golimumab can reactivate hepatitis B in carriers; you will be tested before starting and monitored during and after treatment. (1) (2)

Signs of worsening heart failure — high caution

Symptoms: New or worsening shortness of breath, swelling of the ankles or legs, or sudden weight gain.

Action: Contact your prescriber promptly. Golimumab is not recommended in moderate-to-severe heart failure (an outright contraindication in the UK/EU) and should be used with caution and monitored closely in milder heart failure. (1) (2)

New or worsening nervous system symptoms — high caution

Symptoms: Numbness, tingling, vision changes, or weakness.

Action: Contact your prescriber -- TNF blockers have rarely been linked to new or worsening central or peripheral nervous system demyelinating conditions (such as multiple sclerosis or Guillain-Barre syndrome). (1) (2)

Signs suggestive of a blood disorder — high caution

Symptoms: Persistent fever, easy bruising or bleeding, or unusual paleness.

Action: Seek prompt medical attention -- rare blood-cell disorders (including very low white cell or platelet counts) have been reported with TNF blockers. (1) (2)

Signs of a serious allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives.

Action: Seek emergency medical help immediately. (1)

Interactions

  • Combining golimumab with abatacept is not recommended -- both suppress the immune system and the combination increases the risk of serious infection. (1) (2)
  • Combining golimumab with anakinra is not recommended, for the same reason. (1) (2)
  • Live vaccines should not be given while you are being treated with golimumab. (1) (2)
  • Methotrexate can be used together with golimumab and is often prescribed alongside it -- it raises golimumab blood levels somewhat and reduces the chance of the body making antibodies against golimumab, but no dose adjustment is needed. (1) (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Postmarketing reports have not identified a clear drug-associated risk of major birth defects, miscarriage, or adverse pregnancy outcomes, but golimumab crosses the placenta. A baby exposed to golimumab before birth may be at increased risk of infection for about 6 months afterward, and live vaccines should generally be delayed in the infant during that time -- discuss the specific timing with the infant's clinician. New Zealand's data sheet advises that use in pregnancy is not recommended; discuss the balance of benefits and risks with your prescriber. (1) (2) (3) (4) (5) (6)

Breastfeeding

There is no human milk data in the US label, but the UK/EU label explicitly advises against breastfeeding during treatment and for at least 6 months after the last dose. Discuss with your prescriber. (1) (2) (3) (4) (5) (6)

Children

Approved for ulcerative colitis in children 15 kg and above (US) and, in the UK/EU, for polyarticular juvenile idiopathic arthritis in children 2 years and older (with methotrexate) -- always under specialist supervision. (1) (2) (3) (4) (5) (6)

Elderly

No specific dose adjustment is described based on age alone, but older adults may be at higher risk of infection generally, so monitoring is important. (1) (2) (3) (4) (5) (6)

Hepatic Impairment

Golimumab has not been specifically studied in liver impairment; liver enzyme elevations can occur during treatment and should be monitored. (1) (2) (3) (4) (5) (6)

Renal Impairment

Golimumab has not been specifically studied in kidney impairment; discuss with your prescriber if you have kidney disease. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Screening for active and latent tuberculosis (skin test/IGRA and chest X-ray)
  • Hepatitis B testing
  • Assessment for heart failure symptoms
  • Review of vaccination history and any planned live vaccines
  • Baseline blood counts and liver function tests

During treatment

  • Ongoing monitoring for signs and symptoms of infection, including tuberculosis, even if the baseline TB test was negative.
  • Monitoring of hepatitis B carriers during and for several months after treatment.
  • Monitoring for new or worsening heart failure symptoms.
  • Periodic skin examination, particularly in patients with skin cancer risk factors.
  • Blood counts if any signs suggestive of a blood disorder develop.
  • Liver function monitoring.
(1) (2)

Storage

Store golimumab prefilled syringes/pens in the refrigerator at 2-8°C (36-46°F), in the original carton to protect from light. Do not freeze. Do not shake. If needed, a single prefilled syringe or pen may be kept at room temperature for a limited time as directed on the product labelling before use.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and UK emc SmPC; verify against the current full label in the relevant jurisdiction before prescribing.

United States

Indication: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis

Dose summary: SC 50 mg once monthly (RA/PsA/AS); consider 100 mg monthly in RA patients >100 kg with inadequate response after 3-4 doses. UC: weight-based induction/maintenance (200 mg/100 mg/100 mg for >=40 kg; 100 mg/50 mg/50 mg for 15-<40 kg). IV formulation (Simponi Aria) available for RA/PsA/AS in some regimens.

Renal context: Not specifically studied in renal impairment in the source reviewed for this dossier. (1)

United Kingdom / European Union

Indication: RA, PsA, AS, non-radiographic axial SpA, UC, pJIA

Dose summary: SC 50 mg once monthly (RA/PsA/AS/nr-axial SpA), consider 100 mg monthly in RA >100 kg with inadequate response. UC weight-tiered regimen at <80 kg vs >=80 kg. pJIA: 50 mg once monthly with methotrexate in children >=40 kg, age 2 years and older.

Renal context: Not specifically studied in renal impairment in the source reviewed for this dossier. (2)

Mechanism of action

Hepatic guidance

No specific dose adjustment described for hepatic impairment in the sources reviewed; monitor liver enzymes during treatment.

Overdose note

Reported overdose experience is limited; manage supportively with monitoring for signs of infection or hypersensitivity. (1)

Frequently asked questions

Is golimumab (Simponi) available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes, it is approved and available in all of these regions as the subcutaneous Simponi injection; an intravenous Simponi Aria formulation is also authorised in several of these markets, including the US, EU, and Australia. (1) (2) (3) (4) (5) (6)

Why do I need to be tested for tuberculosis and hepatitis B before starting golimumab?

Golimumab carries a boxed (highest-level) FDA warning for serious infections, including tuberculosis, because it suppresses part of the immune system. Testing beforehand, and treating any latent TB, reduces the risk of the infection becoming active during treatment. Similarly, golimumab can cause hepatitis B to reactivate in people who carry the virus, so testing and monitoring are required. (1)

Can I have golimumab if I have heart failure?

It depends on how severe your heart failure is and where you live. In the UK and EU, moderate-to-severe heart failure (NYHA class III or IV) is an outright contraindication -- golimumab must not be used. In the US label, golimumab is described as needing caution in heart failure rather than being an absolute contraindication. Discuss your specific heart failure severity with your prescriber. (1) (2)

What is the mechanism of action of golimumab?

Golimumab is a human IgG1-kappa monoclonal antibody produced by a murine hybridoma cell line using recombinant DNA technology, that binds with high affinity to both soluble and transmembrane forms of TNF-alpha, preventing it from binding to its receptors and thereby neutralising its pro-inflammatory activity. (1)

What is the generic name of Golimumab?

The generic name is golimumab. (1)

What class of drug is golimumab?

Golimumab is classed as: Tumour necrosis factor (TNF) alpha inhibitor (biologic, human monoclonal antibody). (1)

References

  1. SIMPONI (golimumab) injection, for subcutaneous use -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Janssen Biotech, Inc. · United States · accessed 2026-07-30 · source 1
  2. Simponi 50 mg solution for injection in pre-filled syringe/pen -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Janssen-Cilag Ltd (a Johnson & Johnson company) · United Kingdom · accessed 2026-07-30 · source 2
  3. Simponi (golimumab) -- EPAR medicine overview and product informationEuropean Medicines Agency (EMA) · European Union · accessed 2026-07-30 · source 3
  4. SIMPONI (golimumab injection) Product MonographHealth Canada product monograph, Janssen Inc. · Canada · accessed 2026-07-30 · source 4
  5. SIMPONI (golimumab) -- ARTG registration and AusPARTherapeutic Goods Administration (TGA) / Australian Public Assessment Report (AusPAR), Australia · Australia · accessed 2026-07-30 · source 5
  6. SIMPONI (golimumab) New Zealand Data SheetMedsafe (New Zealand regulator) via Janssen New Zealand data sheet · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient golimumab names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Simponi100 mg/mL, 50 mg/.5mL · janssen biotech, inc.
  • SIMPONI ARIA50 mg/4mL · janssen biotech, inc.

United Kingdom

  • Simponi (2)MHRA licensed emc smpc confirmed · 50 mg/0.5 mL prefilled syringe/pen, 100 mg/mL prefilled syringe/pen · Janssen-Cilag Ltd (a Johnson & Johnson company)

Canada

  • SIMPONI
  • SIMPONI I.V.

Australia

  • Simponi (5)TGA ARTG registered 2009-11-13 confirmed PBS listed · 50 mg/0.5 mL SC prefilled syringe/pen, IV concentrate for infusion (2019 registration) · Janssen-Cilag Pty Ltd

New Zealand

  • Simponi (6)Medsafe approved confirmed via janssen nz data sheet · 50 mg/0.5 mL SC prefilled syringe/pen · Janssen-Cilag (New Zealand) Ltd
View brands in additional countries.

European Union

Simponi (3)

This page provides general reference information about golimumab (Simponi) and is not a substitute for advice from the prescriber managing your treatment. All dosing, screening, and treatment decisions should be made with your prescriber.

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