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AboutInfliximabWhat is infliximabInflammatory Bowel DiseaseMaximising patient outcomes with IBDBiosimilarsWhat is a biosimilarFuture of biosimilarsBiologic switchingINFLECTRA® Introducing INFLECTRA® Position statementsECCOEULARESPGHANDosing & safetyDosingIV dosingAdministration & storageAdministrationStorageSafety informationImportant safety informationConsiderations for SwitchingSwitching to InflectraSafety informationImportant safety informationSafety informationSafety informationClinical evidenceRandomised controlled trial evidenceSummary: randomised controlled trial evidenceReal-world experienceSummary: real-world evidenceSupporting ResourcesVideosMaterialsPatient Support


Inflectra®(infliximab) Prescribing Information. Adverse events reporting information can be found at the bottom of the page.

 

Important Safety information

The Inflectra Summary of Product Characteristics (SmPC) should be read and understood in full before prescribing this medicine.

INFLECTRA® (CT-P13*/infliximab) must not be given in:
  • Cases of tuberculosis, or other severe infections such as sepsis, abscesses and opportunistic infections
  • Patients with a history of hypersensitivity to infliximab (or any of its excipients) or other murine proteins
  • Patients with moderate or severe heart failure (NYHA class III/IV)
Also consider the safety and screening recommendations below for any patient diagnosed with CD, UC, RA, AS, PsA or severe plaque PsO for whom you are considering initiating INFLECTRA®1Actively screen and monitor patients for infections1
  • Monitor patients closely for infections, including tuberculosis, before, during and after treatment with INFLECTRA®
  • Further treatment with INFLECTRA® must not be given in a patient who develops a serious infection or sepsis1
Vaccinate1
  • If possible, it is recommended that patients be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Inflectra therapy. Patients on infliximab may receive concurrent vaccinations, except for live vaccines (see sections 4.5 and 4.6 of the SmPC)
Discuss with patients and follow up on these potential health issues
  • Heart problems
  • Lymphoma or other cancer
  • Lung disease or heavy smoking
  • Conditions that affect the nervous system, such as multiple sclerosis, Guillain-Barre syndrome, and optic neuritis
  • Abnormal skin openings
  • Imminent operations
  • Dental issues, including planned operations or procedures
  • Symptoms and signs of liver dysfunction

  • Haematologic abnormalities (e.g. persistent fever, bruising, etc)

Consider the long half-life of infliximab when planning certain vaccinations or surgical procedures

Patients who require surgery should closely monitored for infections

Avoid concurrent administration of Inflectra with live vaccines or therapeutic infectious agents such as live attenuated bacteria

Also avoid administration of live vaccines in infants <12 months of age who have been exposed to infliximab in utero

The administration of live vaccines to a breastfed infant when the mother is receiving infliximab is not recommended unless infant infliximab serum levels are undetectable.

Summary of the safety profile

Upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in clinical trials, occurring in 25.3% of infliximab-treated patients compared with 16.5% of control patients. The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4 of the SmPC). 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 dose of treatment.

    Return to our Inflectra homepage to explore more about Infliximab 

    CT-P13 is marketed under different brand names including INFLECTRA® and REMSIMA™.AS, Ankylosing spondylitis; CD, Crohn’s disease; NYHA, New York Heart Association; PsA, Psoriatic arthritis; PsO, Psoriasis; RA, Rheumatoid arthritis; UC, Ulcerative colitis.Reference:INFLECTRA® Summary of Product Characteristics.
    PP-IFA-GBR-0615. April 2023
    Safety information
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    Explore our resources and materials that are available for Inflectra

    Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

    for MHRA Yellow Card in Google Play or Apple App Store

     

    Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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