Safety
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
ADVERSE REACTIONS
Clinical Trials Experience in Lymphoid Malignancies
- 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…
- 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
| Sections Modified | Summary of Changes to Contraindications and Warnings |
BOXED WARNING
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
USE IN SPECIFIC POPULATIONS
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... |
