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This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

About REMICADE® (infliximab)

REMICADE has over 20 years of experience of treating patients with immune-mediated diseases in the field of Rheumatology, Gastroenterology and Dermatology1,5

What is REMICADE?

REMICADE is a monoclonal antibody; it is a TNFα (Tumour Necrosis Factor–alpha) inhibitor that is indicated for the treatment of a range of immune-mediated inflammatory disorders.1

Indications

REMICADE is a prescription-only product. It is presented as powder (100 mg/vial) to be reconstituted with water, diluted with saline and thereafter administered via intravenous infusion.1

About REMICADE

*From launch to August 2018

REMICADE Selected Safety Information

For complete information on the prescribing and safety information relating to use of REMICADE please refer to the Summary of Product Characteristics (SmPC).1

Contraindications

Tuberculosis (TB) or other severe infections such as sepsis, abscesses and opportunistic infections; hypersensitivity to infliximab, other murine proteins or any of the excipients; patients with moderate or severe heart failure (NYHA class III/IV).

Special warnings and precautions for use

  • REMICADE should be used with caution in patients with mild heart failure (NYHA class I/II). Monitor patients for new or worsening heart failure
  • Monitor patients closely for infections, including active and latent TB, before, during and six months after treatment. Patients should be tested for hepatitis B infection before initiating treatment
  • The concurrent administration of live vaccines with REMICADE is not recommended
  • REMICADE has also been associated with malignancies and lymphomas including HSTCL. Caution should be exercised in initiating or continuing anti-TNF therapy in patients with a history of/risk factors for malignancy
  • Patients should undergo periodic skin examination, particularly those with risk factors for skin cancer
  • Use of TNF-blocking agents, including infliximab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders. Refer to the SmPC for further information
  • The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process. Refer to the Summary of Product Characteristics for further information
  • There have been reports of haematologic reactions in patients receiving TNF-blockers, including REMICADE. Refer to the Summary of Product Characteristics for further information
  • Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last REMICADE treatment. Women must not breast feed for at least 6 months after REMICADE treatment

Most common side effects

Very Common ≥1/10: viral infection, headache, upper respiratory tract infection, sinusitis, abdominal pain, nausea, infusion related reaction, pain.

Further information about REMICADE

Patient website

Visit the REMICADE patient website

Visit myREMICADE.co.uk

References

  1. REMICADE Summary of Product Characteristics.
  2. European Medicines Agency. REMICADE: Scientific discussion. December 2005. Available from https://www.ema.europa.eu/en/documents/scientific-discussion/remicade-epar-scientific-discussion_en.pdf.
  3. European Medicines Agency. Humira: Procedural steps taken and scientific information after the authorisation. December 2018. Available from https://www.ema.europa.eu/en/documents/procedural-steps-after/humira-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf.
  4. European Medicines Agency. REMICADE: Steps taken after granting the marketing authorisation. December 2005. Available from https://www.ema.europa.eu/en/documents/steps-after-cutoff/remicade-epar-steps-taken-after-authorisation-when-cutoff-date-has-been-used_en.pdf.
  5. European Medicines Agency. REMICADE: Procedural steps taken and scientific information after the authorisation. March 2019. Available from https://www.ema.europa.eu/en/documents/procedural-steps-after/remicade-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf.
  6. MSD data on file [PSUR, GB-MAB-00040 April 2019].

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-MAB-00099 | Date of Preparation: September 2020