Inflectra® | Contraindications and Safety Information

For Ulcerative Colitis

Important Safety Information

The Inflectra® Summary of Product Characteristics (SPC) should be read and understood in full before prescribing this medicine2.

Inflectra® 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 Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and severe plaque psoriasis for whom you are considering initiating Inflectra®2

Actively screen and monitor patients for infections

  • Screenings for latent/active tuberculosis and hepatitis B


  • Bring paediatric patients up to date with all vaccinations prior to initiating treatment if possible


  • The general condition of patients (e.g. symptoms of bacterial or viral infections, fever, ulcers, or purulent discharge from fistulas)

Discuss potential health issues with patients

  • Heart problems
  • Lymphoma or any other cancer
  • Lung disease or heavy smoking
  • Problems that affect the nervous system, such as multiple sclerosis, Guillain-Barre syndrome, or optic neuritis
  • Abnormal skin openings
  • Imminent operations
  • Dental issues, including planned operations or procedures

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

  • Closely monitor patients who require surgery 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 ≤6 months of age who have been exposed to infliximab in utero
Inflectra® Risk Minimisation Materials (RMM) materials including patient alert card and screening documents are available from . Patients treated with Inflectra® should be given the Patient Alert Card.

PP-IFA-GBR-0450. December 2020