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REMICADE® Receives FDA Approval as First Biologic Treatment for Pediatric Ulcerative Colitis
Date:9/23/2011

l check you for TB with a skin test.  If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE®.
  • Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
  • Infections that keep coming back, have diabetes or an immune system problem.
  • Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
  • Heart failure or any heart condition.  Many people with heart failure should not take REMICADE®.
  • Hepatitis B virus (HBV) infection or think you may be a carrier of HBV.
  • Nervous system disorders (like multiple sclerosis or Guillain-Barre syndrome).  Also tell your doctor about any medications you are taking, including vaccines or Kineret (anakinra), Orencia (abatacept) and Actemra (tocilizumab) and if you are pregnant, plan to become pregnant or are nursing.  Adults and children should not receive a live vaccine while taking REMICADE®.

  • The following serious (sometimes fatal) side effects have been reported in people taking REMICADE®.  Patients should tell their doctors right away if you have any of the signs listed below:

    • Infections (like TB, blood infections, pneumonia) -- fever, tiredness, cough, flu, or warm, red or painful skin or any open sores.  REMICADE® can make you more likely to get an infection or make any infection that you have worse.
    • Lymphoma, or any other cancers in adults and children.  
    • Heart failure -- new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
    • Reactivation of HBV -- feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
    • Liver injury -- jaundice (yellow skin and eyes), dark brown urine, right-sided abdom
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    SOURCE Janssen Biotech, Inc.
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