Label Changes for:

Remicade (inflximab) IV Infusion

April 2009

Changes have been made to the BOXED WARNING, WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

BOXED WARNING

  • This information pertains to the risk of histoplasmosis with the use of the class of TNF-inhibitors.
  • Hepatosplenic T-Cell Lymphomas

WARNINGS

  • Risk of Serious Infections: histoplasmosis
  • Hepatosplenic T-Cell Lymphomas

ADVERSE REACTIONS

MEDICATION GUIDE

BOXED WARNING

  • Histoplasmosis...Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe
    systemic illness...
  • Hepatosplenic T-Cell Lymphomas Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including Remicade. These cases have had a very aggressive disease course and have been fatal. All reported Remicade cases have occurred in patients with Crohn’s disease or ulcerative colitis andthe majority were in adolescent and young adult males. All of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with Remicade at or prior to diagnosis.

WARNINGS

  • Risk of Serious Infections: histoplasmosis... live or have lived in certain parts of the country...
  • Hepatosplenic T-Cell Lymphomas
    • Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including Remicade. These cases have had a very aggressive disease course and have been fatal.15 All reported Remicade cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. All of these patients had received treatment with the immunosuppressants azathioprine or 6-mercaptopurine concomitantly with Remicade at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to Remicade or Remicade in combination with these other immunosuppressants.

ADVERSE REACTIONS

  • Infections...histoplasmosis (1 case was fatal)...
  • Post-marketing Adverse Events
    • hepatosplenic T-cell lymphomas

MEDICATION GUIDE

  • Before starting Remicade, tell your doctor if you
    • live or have lived in certain parts of the country where there is an increased risk for getting certain kinds of fungal infections
  • After starting Remicade, Cancer
    • Some patients with Crohn’s disease or ulcerative colitis who have received Remicade have developed a rare type of cancer called Hepatosplenic T-cell Lymphoma.
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