HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TRUXIMA safely and effectively. See full prescribing information for
TRUXIMA.
TRUXIMA(rituximab-abbs) injection, for intravenous use
Initial U.S. Approval: 2018
TRUXIMA (rituximab-abbs) is biosimilar* to RITUXAN® (rituximab) for the
indications listed. (1)
WARNING: FATAL INFUSION REACTIONS, SEVERE
MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS
REACTIVATION and PROGRESSIVE MULTIFOCAL
LEUKOENCEPHALOPATHY
See full prescribing information for complete boxed warning.
•Fatal infusion reactions within 24 hours of rituximab infusion;approximately 80% of fatal reactions occurred with first infusion.
Monitor patients and discontinue TRUXIMA infusion for severereactions (5.1).
•Severe mucocutaneous reactions, some with fatal outcomes (5.2).
•Hepatitis B virus (HBV) reactivation, in some cases resulting infulminant hepatitis, hepatic failure, and death (5.3).
•Progressive multifocal leukoencephalopathy (PML) resulting indeath (5.4).
INDICATIONS AND USAGE
TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated forthe treatment of adult patients with:
•Non-Hodgkin’s Lymphoma (NHL) (1.1).
oRelapsed or refractory, low grade or follicular, CD20-positive B-cellNHL as a single agent.
oPreviously untreated follicular, CD20-positive, B-cell NHL incombination with first line chemotherapy and, in patients achieving acomplete or partial response to a rituximab product in combination withchemotherapy, as single-agent maintenance therapy.
oNon-progressing (including stable disease), low-grade, CD20-positive,B-cell NHL as a single agent after first-line cyclophosphamide,vincristine, and prednisone (CVP) chemotherapy.
DOSAGE AND ADMINISTRATION
•Administer only as an intravenous infusion.
•Do not administer as an intravenous push or bolus.
•TRUXIMA should only be administered by a healthcare professional withappropriate medical support to manage severe infusion reactions that can befatal if they occur.
•The dose for NHL is 375 mg/m2 (2.2).
DOSAGE FORMS AND STRENGTHS
•Injection: 100 mg/10 mL (10 mg/mL) and 500 mg/50 mL (10 mg/mL)solution in single-dose vials (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•Tumor lysis syndrome: Administer aggressive intravenous hydration,anti-hyperuricemic agents, monitor renal function (5.5).
•Infections: Withhold TRUXIMA and institute appropriate anti-infectivetherapy (5.6).
•Cardiac adverse reactions: Discontinue infusions in case of serious or lifethreateningevents (5.7).
•Renal toxicity: Discontinue in patients with rising serum creatinine oroliguria (5.8).
•Bowel obstruction and perforation: Consider and eva luate for abdominalpain, vomiting, or related symptoms (5.9).
•Immunizations: Live virus vaccinations prior to or during TRUXIMAtreatment not recommended (5.10).
•Embryo-Fetal toxicity: Can cause neonatal harm. Advise of potential riskto neonates and use of effective contraception (5.11).
ADVERSE REACTIONS
Most common adverse reactions in clinical trials were:
•NHL (≥25%): infusion reactions, fever, lymphopenia, chills, infection andasthenia (6.1).
To report SU