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Remicads 100mg Powder for Concentrate for Solution (Infliximab)

Infliximab

FDA/SD.265-040499 Infliximab 5mg antineoplastic and immunomodulating agents INN generic

What it does

Infliximab is a medication used to treat certain autoimmune conditions by reducing inflammation in the body.

Commonly used for: rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis …

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Registration & product details

Registration no.
FDA/SD.265-040499
Registration date
2026-04-21
Expiry date
2031-05-01
Status
Valid
Active ingredient
Infliximab
Dosage form
Infliximab
Strength
5mg
Pack size
-
Therapeutic class
-
ATC class (WHO)
L04AB - Tumor necrosis factor alpha (TNF-alpha) inhibitors
RxNorm RxCUI
191831
Manufacturer / MAH
Cilag
Applicant / LTR
Ernest Chemist
Country of origin
Switzerland
Manufacturer location
Hochstrasse 201, 8200 Schaffhausen, Switzerland

Source: Food and Drugs Authority · fetched 2026-05-22 02:34:51 · updated 2026-10-20 04:00:10

Drug Interactions

1
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Pharmacodynamic Warnings

Infliximab appears in TABLE 15: Drugs that cause myelosuppression

Severe (1)

Infliximab - increases risk of immunosuppression

Filgotinib is predicted to increase the risk of immunosuppression when given with monoclonal antibodies (adalimumab, certolizumab pegol, golimumab, infliximab, rituximab, sarilumab, secukinumab, tocil

Severe Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Infliximab is a medication used to treat certain autoimmune conditions by reducing inflammation in the body.

What it treats

  • rheumatoid arthritis
  • Crohn's disease
  • ulcerative colitis
  • ankylosing spondylitis
  • psoriasis

How it works

It works by blocking a specific protein in the immune system that causes inflammation.

Who it's for

It is for adults and some children with specific autoimmune diseases.

Cautions

  • • Be cautious if taking other medications that can reduce blood cell production.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Infliximab

BNF-referenced

Infliximab is a chimeric monoclonal antibody that inhibits tumor necrosis factor-alpha (TNF-alpha), a key pro-inflammatory cytokine involved in various autoimmune diseases. By binding to TNF-alpha, infliximab prevents it from interacting with its receptors, thereby reducing inflammation and altering the immune response. It is primarily used for the treatment of autoimmune conditions such as rheumatoid arthritis, Crohn's disease, and psoriasis.

Indications

  • Rheumatoid arthritis
  • Crohn's disease
  • Fistulating Crohn's disease
  • Ankylosing spondylitis
  • Psoriatic arthritis

Dosage

Children: For children aged 6-17 years with severe active Crohn's disease, initially 5 mg/kg by intravenous infusion

Adults: Initially 3 mg/kg by intravenous infusion, then 3 mg/kg at weeks 2 and 6, followed by 3 mg/kg every 8 weeks. For Crohn's disease, initially 5 mg/kg, then 5 mg/kg after 2 weeks, and maintenance dosing may be adjusted based on clinical response.

Mechanism of action

Infliximab works by specifically binding to TNF-alpha, blocking its interaction with TNF receptors on the surface of cells. This action inhibits the downstream inflammatory signaling pathways that TNF-alpha activates, leading to reduced inflammation, decreased immune system activity, and improved symptoms in autoimmune diseases.

Pharmacodynamics

The pharmacodynamics of infliximab involve its ability to neutralize the effects of TNF-alpha, thereby decreasing the inflammatory response. This results in a reduction of inflammatory cytokines, chemokines, and adhesion molecules, leading to decreased migration of inflammatory cells to tissues and a reduction in disease activity. Clinical improvement can be seen in conditions such as rheumatoid arthritis and Crohn's disease, where TNF-alpha plays a significant role in pathogenesis.

Pharmacokinetics

Infliximab is administered via intravenous infusion. It has a half-life of approximately 7 to 12 days, allowing for convenient dosing schedules. The drug is primarily metabolized through proteolytic degradation, and its clearance can be affected by factors such as concomitant medications, disease state, and patient characteristics. It is important to monitor for therapeutic response and adjust dosing based on clinical judgement.

Contra-indications

  • Hypersensitivity to infliximab or any of its components
  • Severe heart failure (New York Heart Association class III or IV)
  • Active infections, including tuberculosis

Adverse effects

  • Infusion-related reactions
  • Increased risk of infections
  • Headache
  • Abdominal pain
  • Nausea
  • Fatigue
  • Hypertension
  • Anemia
  • Neutropenia
  • Rash
  • Lymphadenopathy

Interactions

  • Live vaccines (increased risk of infection)
  • Filgotinib (increases risk of immunosuppression)

Precautions

  • Monitor for signs of infection during treatment
  • Consider screening for tuberculosis prior to initiation
  • Caution in patients with a history of recurrent infections
  • Discontinue if no response within 12 weeks of initial infusion

Pregnancy

Data on the use of infliximab in pregnancy are limited. Use only if the potential benefit justifies the potential risk to the fetus. TNF-alpha inhibitors may affect fetal immune system development.

Breast-feeding

Infliximab is excreted in breast milk; caution should be exercised when administering to nursing mothers.

Storage

Store at 2°C to 8°C. Do not freeze. Protect from light.

Formulations

  • Solution for injection (by intravenous infusion)
BNF 85 (British National Formulary) p.1252 BNF for Children 2019-2020 p.57 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.

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