Infusion Reactions
Administration of rituximab products, including TRUXIMA, can result in serious,
including fatal, infusion reactions. Deaths within 24 hours of rituximab infusion have
occurred. Approximately 80% of fatal infusion reactions occurred in association
with the first infusion. Monitor patients closely. Discontinue TRUXIMA infusion for
severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions
[see Warnings and Precautions (5.1), Adverse Reactions (6.1)].
Severe Mucocutaneous Reactions
Severe, including fatal, mucocutaneous reactions can occur in patients receiving
rituximab products [see Warnings and Precautions (5.2)].
Hepatitis B Virus (HBV) Reactivation
HBV reactivation can occur in patients treated with rituximab products, in some
cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients
for HBV infection before treatment initiation, and monitor patients during and after
treatment with TRUXIMA. Discontinue TRUXIMA and concomitant medications in
the event of HBV reactivation [see Warnings and Precautions (5.3)].
Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur
in patients receiving rituximab products [see Warnings and Precautions (5.4) and
Adverse Reactions (6.1)].
1 INDICATIONS AND USAGE
1.1 Non–Hodgkin’s Lymphoma (NHL)
TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with:
•Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a singleagent.
•Previously untreated follicular, CD20-positive, B-cell NHL in combination with firstline chemotherapy and, in patients achieving a complete or partial response to a
rituximab product in combination with chemotherapy, as single-agent maintenancetherapy.
•Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL asa single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP)
chemotherapy.
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosing Information
Administer only as an Intravenous Infusion [see Dosage and Administration (2.4)].
Do not administer as an intravenous push or bolus. TRUXIMA should only be administered bya healthcare professional with appropriate medical support to manage severe infusionreactions that can be fatal if they occur [see Warnings and Precautions (5.1)].
Premedicate before each infusion [see Dosage and Administration (2.3)].Prior to First Infusion: Screen all patients for HBV infection by measuring HBsAg and antiHBc
before initiating treatment with TRUXIMA [see Warnings and Precautions (5.3)].
Obtain complete blood counts including platelets (CBC) prior to the first dose.
During TRUXIMA Therapy: In patients with lymphoid malignancies, during treatment withTRUXIMA monotherapy, obtain complete blood counts (CBC) with differential and plateletcounts prior to each TRUXIMA course. During treatment with TRUXIMA and chemotherapy,obtain CBC with differential and platelet counts at weekly to monthly intervals and morefrequently in patients who develop cytopenias [see Adverse Reactions (6.1)].
•First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusiontoxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a
maximum of 400 mg/hr.