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Important safety information

For full safety information, access the INFLECTRA® Summary of Product Characteristics

INFLECTRA® (CT-P13*/infliximab) must not be given in:1
  • 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®1
Actively screen and monitor patients for infections1
  • Screen and monitor patients closely for infections, including tuberculosis, invasive fungal infections and hepatitis B, before, during and after treatment with INFLECTRA®
  • Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period
  • Further treatment with INFLECTRA® must not be given in a patient who develops a serious infection or sepsis
Vaccinate1
  • Patients on infliximab may receive concurrent vaccinations, except for live vaccines
  • Bring patients up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating treatment if possible
Discuss potential health issues and their symptoms with patients2
  • Recognising signs and symptoms of infection (e.g. fever, tiredness, cough, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds/ulcers, dental problems, dysuria) and seeking prompt medical attention
  • Heart problems
  • Lymphoma or any other cancer
  • Lung disease and heavy smoking
  • Neurological events, such as multiple sclerosis, Guillain-Barre syndrome, or optic neuritis
  • Operations or procedures - monitor closely for infections
  • Haematological reactions/blood dyscrasias
  • Heapatobiliary events/liver dysfunction
  • Autoimmune symptoms/lupus-like syndrome
  • Infusion reactions and hypersensitivity
Consider the long half-life of infliximab when planning certain vaccinations or surgical procedures1
  • Closely monitor patients who require surgery for infections
Avoid concurrent administration of INFLECTRA® with live vaccines or therapeutic infectious agents such as live attenuated bacteria1
  • Use of live vaccines can result in clinical infections, including disseminated infections. The concurrent administration of live vaccines with infliximab is not recommended.
  • Administration of a live vaccine to a breastfed infant while the mother is receiving infliximab is not recommended unless infant infliximab serum levels are undetectable
  • Also avoid administration of live vaccines in infants up to 12 months of age who have been exposed to infliximab in utero (if infant infliximab serum levels are undetectable or infliximab administration was limited to the first trimester of pregnancy, administration of a live vaccine might be considered at an earlier timepoint if there is a clear clinical benefit for the individual infant).
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.

Please refer to the INFLECTRA® Summary of Product Characteristics for full prescribing information

Reference:INFLECTRA® Summary of Product Characteristics. INFLECTRA® Patient Information Leaflet
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Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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