e, and death can occur.
Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiatingtreatment with TRUXIMA. For patients who show evidence of prior hepatitis B infection(HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive),consult with physicians with expertise in managing hepatitis B regarding monitoring andconsideration for HBV antiviral therapy before and/or during TRUXIMA treatment.
Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signsof hepatitis or HBV reactivation during and for several months following TRUXIMA therapy.
HBV reactivation has been reported up to 24 months following completion of rituximab therapy.
In patients who develop reactivation of HBV while on TRUXIMA, immediately discontinueTRUXIMA and any concomitant chemotherapy, and institute appropriate treatment. Insufficientdata exist regarding the safety of resuming TRUXIMA treatment in patients who develop HBVreactivation. Resumption of TRUXIMA treatment in patients whose HBV reactivation resolvesshould be discussed with physicians with expertise in managing HBV.
5.4 Progressive Multifocal Leukoencephalopathy (PML)
JC virus infection resulting in PML and death can occur in rituximab product-treated patientswith hematologic malignancies. The majority of patients with hematologic malignanciesdiagnosed with PML received rituximab in combination with chemotherapy or as part of ahematopoietic stem cell transplant. Most cases of PML were diagnosed within 12 months oftheir last infusion of rituximab.
Consider the diagnosis of PML in any patient presenting with new-onset neurologicmanifestations. eva luation of PML includes, but is not limited to, consultation with a neurologist,brain MRI, and lumbar puncture.
Discontinue TRUXIMA and consider discontinuation or reduction of any concomitantchemotherapy or immunosuppressive therapy in patients who develop PML.
5.5 Tumor Lysis Syndrome (TLS)
Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia fromtumor lysis, sometimes fatal, can occur within 12−24 hours after the first infusion of rituximabproducts in patients with NHL. A high number of circulating malignant cells (≥25,000/mm3) orhigh tumor burden, confers a greater risk of TLS.
Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at highrisk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, andadminister supportive care, including dialysis as indicated. [see Warnings and Precautions (5.8)].
5.6 Infections
Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occurduring and following the completion of rituximab product-based therapy. Infections have beenreported in some patients with prolonged hypogammaglobulinemia (defined ashypogammaglobulinemia >11 months after rituximab exposure). New or reactivated viralinfections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zostervirus, West Nile virus, and hepatitis B and C. Discontinue TRUXIMA for serious infectionsand institute appropriate anti-infective therapy. [see Adverse Reactions (6.1, 6.2)]. TRUXIMAis not recommended for use in patients with severe, active infections.
5.7 Cardiovascular Adverse Reactions
Cardiac adverse reactions, includin |
