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U.S. Department of Health and Human Services

Safety

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Rituxan (rituximab) Injection For Intravenous Use

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2008 and April 2012


 

April 2012

Summary View

 

ADVERSE REACTIONS

Clinical Trials Experience in Lymphoid Malignancies
Cytopenia and hypogammaglobulinemia
  • In CLL trials, the frequency of prolonged neutropenia and late-onset neutropenia was higher in patients treated with R-FC compared to patients treated with FC…
 
Postmarketing Experience
Hematologic:
  • Grade 3-4 prolonged or late-onset neutropenia

 

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.


 

January 2008

Summary View

 

Sections ModifiedSummary of Changes to Contraindications and Warnings

BOXED WARNING

  • Infusion Reactions

WARNINGS AND PRECAUTIONS

  • Infusion Reactions

ADVERSE REACTIONS

  • The most common adverse reactions of Rituxan (incidence ≥25%) observed in patients with NHL are infusion reactions, fever, chills, infection, asthenia, and lymphopenia...
  • Clinical Trials Experience Non-Hodgkin's Lymphoma
    • Infections
    • Cytopenias and Hypogammaglobulinemia
  • Postmarketing Reports
    • Pulmonary

USE IN SPECIFIC POPULATIONS

  • Pregnancy
  • Nursing Mothers

MEDICATION GUIDE (new - previously Patient Package Insert)

BOXED WARNING

Infusion Reactions

Rituxan administration can result in serious, iucluding fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred...

...Carefully monitor patients during infusions. Discontinue Rituxan infusion and provide medical treatment for Grade 3 or 4 infusion reactions...

WARNINGS AND PRECAUTIONS

Infusion Reactions

...Premedicate patients with an antihistamine and acetaminophen prior to dosing. Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion reactions as needed. Depending on the severity of the infusion reaction and the required interventions, consider resumption of the infusion at a minimum 50% reduction in rate after symptoms have resolved...