Infliximab

Pronunciation: in-FLIKS-ih-mab.

Generic name
infliximab
Drug class
Tumour necrosis factor (TNF) alpha inhibitor (biologic, chimeric human-murine monoclonal antibody)
Form
Powder for concentrate for solution for infusion (100 mg per vial, reconstituted and diluted); some biosimilars also available as a subcutaneous injection
Route
Intravenous infusion
Legal status
Prescription-only

Availability and supply rules vary by country

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

Australia: Remicade (originator) plus biosimilars Inflectra, Remsima, IXIFI (5) · Full directory

What infliximab is and how it works

Infliximab is a prescription-only biologic medicine given by infusion into a vein 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, skin, and bowel. (1)

Infliximab is given as an infusion into a vein, usually at a hospital or infusion centre, on a schedule that starts with doses at week 0, 2, and 6, then continues every 4 to 8 weeks depending on your condition. 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 infliximab works

Infliximab is a chimeric human-murine IgG1-kappa monoclonal antibody produced in murine hybridoma cells by 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 infliximab is used for

Rheumatoid arthritis

Used 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) (6)

Crohn's disease

Used for moderately to severely active Crohn's disease in adults and, in most markets reviewed, in children and adolescents aged 6 years and older, including for fistulising Crohn's disease (to reduce draining fistulae). (1) (6)

Ulcerative colitis

Used for moderately to severely active ulcerative colitis in adults and, in most markets reviewed, in children and adolescents aged 6 years and older, when other treatments have not worked well enough. (1) (6)

Ankylosing spondylitis and psoriatic arthritis

Used for active ankylosing spondylitis, and for active psoriatic arthritis (alone or with methotrexate), in adults who have not responded well enough to conventional treatment. (1) (6)

Plaque psoriasis

Used for moderate to severe plaque psoriasis in adults for whom phototherapy or other systemic treatments have not worked well enough or are not appropriate. (1) (6)

Before taking infliximab

Do not take / not appropriate for

  • Do not use infliximab if you have an active, serious infection such as tuberculosis, sepsis, or another opportunistic infection. (all countries) (1) (2) (6)
  • Do not use infliximab if you have moderate or severe heart failure (NYHA class III or IV) -- this is an outright contraindication at any dose in the UK and EU label. In the US label, this restriction applies specifically to doses above 5 mg/kg; lower doses may be used with caution and close monitoring. (United Kingdom and European Union (any dose); United States (doses above 5 mg/kg)) (2) (1)
  • Do not use infliximab if you have had a severe allergic reaction to infliximab, other murine (mouse-derived) proteins, or any of its other ingredients. (all countries) (1) (2)

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 infliximab can cause hepatitis B to reactivate.
  • Any history of cancer, 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 infliximab.
  • All other medicines you take, especially other biologic medicines for arthritis or bowel disease (such as abatacept or anakinra) or azathioprine/6-mercaptopurine.
  • Pregnancy, plans for pregnancy, or breastfeeding.
  • Whether you have surgery planned -- treatment may need to be timed around it.
(1) (2) (6)

How to take infliximab

  • Infliximab is given as an infusion into a vein, usually over at least 2 hours, at a hospital or specialist infusion centre by a healthcare professional.
  • You will usually be monitored for at least 1 hour after the infusion finishes for any reaction.
  • Do not change your dose, frequency, or schedule on your own -- follow your prescriber's plan exactly.
  • Your prescriber will test you for tuberculosis and hepatitis B before your first dose.
(1) (6)

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 scheduled infusion, contact your prescriber or infusion centre for guidance on when to reschedule -- do not attempt to self-administer or adjust your dose.

Overdose

Seek urgent medical attention if you develop signs of a serious infection or a severe reaction during or after an infusion. Because infliximab is given under medical supervision, accidental overdose is unlikely, but any concerns should be raised with your infusion team immediately. (1)

Side effects

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

Upper respiratory tract infections, sinusitis, and pharyngitis (common cold-type symptoms) -- very common.

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

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

Infusion-related reactions (fever, chills, itching, or changes in blood pressure during or shortly after the infusion).

What to notice: Infusion-related reactions (fever, chills, itching, or changes in blood pressure during or shortly after the infusion).

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

Headache.

What to notice: Headache.

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

Abdominal pain.

What to notice: Abdominal pain.

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

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 infliximab and monitored for infection throughout treatment; treatment will be stopped by your prescriber if a serious infection develops. (1) (6)

Signs suggestive of lymphoma or other cancer, including hepatosplenic T-cell lymphoma — boxed_warning

Symptoms: Unexplained swollen glands, unusual lumps, unexplained weight loss, persistent fatigue, or abdominal swelling/pain.

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. A rare, aggressive, usually fatal lymphoma (hepatosplenic T-cell lymphoma) has also been reported, almost always in young men with inflammatory bowel disease also taking azathioprine or 6-mercaptopurine. (1) (6)

Signs of hepatitis B reactivation or liver injury — 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 -- infliximab can reactivate hepatitis B in carriers and has rarely been linked to serious liver injury; you will be tested before starting and monitored during and after treatment. (1) (6)

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. Infliximab is not recommended, or is contraindicated depending on dose and country, in moderate-to-severe heart failure, and should be used with caution and monitored closely at lower doses. (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) (6)

Signs of a serious infusion reaction or allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives; chest tightness during or shortly after the infusion.

Action: Seek emergency medical help immediately. Most reactions occur during or within 2 hours of the infusion, which is why you are monitored at the infusion centre. (1)

Interactions

  • Combining infliximab with abatacept is not recommended -- both suppress the immune system and the combination increases the risk of serious infection. (1) (2)
  • Combining infliximab with anakinra is not recommended, for the same reason. (1) (2)
  • Live vaccines should not be given while you are being treated with infliximab. If you were exposed to infliximab before birth (your mother was treated during pregnancy), live vaccines should generally be delayed for 6 months (US guidance) to 12 months (UK guidance) after birth -- discuss the exact timing with your baby's clinician. (1) (2)
  • Methotrexate can be used together with infliximab and is required for the rheumatoid arthritis indication -- it raises infliximab blood levels somewhat and reduces the chance of the body making antibodies against infliximab. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Observational studies have not shown an increased risk of major birth defects with infliximab compared to non-biologic treatments, but infliximab crosses the placenta and can be detected in the infant's blood for up to 6-12 months after birth (source estimates vary by market). Combination therapy with other immune-suppressing medicines has been linked to preterm birth and lower birth weight. Discuss the specific timing of any planned vaccinations for your infant with their clinician. (1) (2) (3) (4) (5) (6)

Breastfeeding

Infliximab passes into breast milk at low levels; because it is broken down in the infant's gut, systemic exposure to the baby is expected to be minimal. Breastfeeding is generally considered acceptable with monitoring -- discuss with your prescriber. (1) (2) (3) (4) (5) (6)

Children

Approved for Crohn's disease and ulcerative colitis in children and adolescents aged 6 years and older in the markets reviewed. Not established as effective for juvenile rheumatoid arthritis. Children may have higher rates of infusion reactions and antibody formation than adults. (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

No specific dose adjustment is described in the sources reviewed; liver enzyme elevations can occur during treatment and should be monitored. (1) (2) (3) (4) (5) (6)

Renal_impairment

No specific dose adjustment is described in the sources reviewed for kidney impairment. (1) (2) (3) (4) (5) (6)

Source_ids

US-DAILYMED-REMICADE-2026,UK-EMC-REMICADE-2026,NZ-MEDSAFE-REMICADE-2026 (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
  • For fistulising Crohn's disease, exclusion of an abscess or other infection source

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 during and for at least 1 hour after each infusion for reactions.
  • Monitoring for new or worsening heart failure symptoms.
  • Blood counts and liver function tests if any signs suggestive of a blood disorder or liver injury develop.
(1) (6)

Storage

Unopened vials are stored in the refrigerator at 2-8°C (36-46°F), protected from light, until reconstitution and infusion by a healthcare professional. Infliximab is not self-stored or self-administered by patients in most current formulations.

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, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis

Dose summary: RA: 3 mg/kg IV at weeks 0,2,6 then q8w (with methotrexate); other indications: 5 mg/kg IV at weeks 0,2,6 then q6-8w; dose/frequency escalation possible for inadequate response. Contraindicated at doses >5 mg/kg in moderate/severe heart failure.

Renal context: No specific dosing adjustment described for renal impairment in the source reviewed for this dossier. (1)

United Kingdom / European Union

Indication: RA, Crohn's disease, UC, AS, PsA, psoriasis

Dose summary: 3-5 mg/kg IV at weeks 0,2,6 then every 4-8 weeks depending on indication; dose escalation up to 7.5 mg/kg possible in some contexts. Moderate/severe heart failure (NYHA III/IV) is an ABSOLUTE contraindication at any dose -- broader than the US dose-based restriction.

Renal context: No specific dosing adjustment described for 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 given rare reports of hepatotoxicity including liver failure.

Overdose note

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

Frequently asked questions

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

Yes, it is approved and available in all of these regions as the originator Remicade, and most markets also have one or more biosimilar versions available (such as Inflectra, Remsima, IXIFI, or Renflexis). (1) (2) (3) (4) (5) (6)

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

Infliximab 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, infliximab can cause hepatitis B to reactivate in people who carry the virus, so testing and monitoring are required. (1)

What is hepatosplenic T-cell lymphoma, and how worried should I be?

It is a rare, aggressive, and usually fatal type of lymphoma that has been reported with infliximab and other TNF blockers. It has occurred almost exclusively in adolescent and young adult males with Crohn's disease or ulcerative colitis who were also taking azathioprine or 6-mercaptopurine alongside their TNF blocker. It is rare, but this is exactly why it is part of the medicine's boxed warning -- discuss your personal risk factors with your prescriber, especially if you are also taking azathioprine or 6-mercaptopurine. (1)

Can I have infliximab 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 at any dose -- infliximab must not be used. In the US label, this restriction specifically applies to doses above 5 mg/kg; lower doses may be used with caution and close monitoring. Discuss your specific heart failure severity with your prescriber. (1) (2)

What is the mechanism of action of infliximab?

Infliximab is a chimeric human-murine IgG1-kappa monoclonal antibody produced in murine hybridoma cells by 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 Infliximab?

The generic name is infliximab. (1)

What class of drug is infliximab?

Infliximab is classed as: Tumour necrosis factor (TNF) alpha inhibitor (biologic, chimeric human-murine monoclonal antibody). (1)

References

  1. REMICADE (infliximab) for injection, for intravenous 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. Remicade 100 mg powder for concentrate for solution for infusion -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Merck Sharp & Dohme (or Janssen-Cilag) Ltd · United Kingdom · accessed 2026-07-30 · source 2
  3. Remicade (infliximab) -- EPAR medicine overviewEuropean Medicines Agency (EMA) -- Remicade EPAR · European Union · accessed 2026-07-30 · source 3
  4. REMICADE (infliximab) Product Monograph, plus biosimilar product monographs (Remsima SC, Inflectra, Remdantry)Health Canada product monographs, Janssen Inc. (Remicade) and biosimilar sponsors (Remsima, Inflectra, Remdantry) · Canada · accessed 2026-07-30 · source 4
  5. REMICADE and infliximab biosimilar ARTG entries (Remicade, Inflectra, Remsima, IXIFI)Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-30 · source 5
  6. REMICADE (infliximab) New Zealand Data Sheet (ADSv4.0, 24 June 2024) plus biosimilar data sheets (Renflexis, Remsima SC)Medsafe (New Zealand regulator) · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

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

Priority countries

United States

  • AVSOLA100 mg0mL · amgen, inc
  • REMICADE100 mg0mL · janssen biotech, inc.
  • INFLECTRA100 mg0mL · pfizer laboratories div pfizer inc

United Kingdom

  • Remicade (originator) (2)MHRA licensed emc smpc confirmed · 100 mg powder for concentrate for IV infusion · Merck Sharp & Dohme / Janssen-Cilag Ltd

Canada

  • REMICADE
  • INFLECTRA
  • REMSIMA

Australia

  • Remicade (originator) plus biosimilars Inflectra, Remsima, IXIFI (5)TGA ARTG registered 2000-08-02 confirmed plus biosimilars · 100 mg powder for IV infusion, 120 mg/mL prefilled syringe/auto-injector (Remsima) · Janssen-Cilag Pty Ltd (Remicade); Pfizer Australia (Inflectra, IXIFI); Celltrion Healthcare Australia (Remsima)

New Zealand

  • Remicade (originator) plus biosimilars Renflexis, Remsima SC (6)Medsafe approved confirmed via current NZ data sheet plus biosimilars · 100 mg powder for IV infusion, subcutaneous formulation (Remsima SC) · Janssen-Cilag (New Zealand) Ltd; other biosimilar sponsors
View brands in additional countries.

European Union

Remicade (originator) and biosimilars including Remsima (3)

This page provides general reference information about infliximab (Remicade) 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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