Important safety information

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

• 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)

• 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

• 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

• 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

• Closely monitor patients who require surgery for infections

• 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).