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Distribution and Supply Information for TRUXIMA1

  • Available for order from your primary distributor/wholesaler
  • Supplied as 100 mg/10mL and 500 mg/50mL single-dose vials
  • May be stored in the refrigerator as a diluted infusion solution at 2°C to 8°C (36°F to 46°F) for 24 hours

    — Protect from direct sunlight

Q Code: Q51152

Received pass-through status3

TRUXIMA vial and packaging

TRUXIMA NDCs1*:
63459-0103-10 (100 mg/10 mL)

63459-0104-50 (500 mg/50 mL)

*Note that the product’s NDC has been “zero-filled” to ensure the creation
of an 11-digit code that meets CMS standards. The zero-filled location is
indicated in bold and underline.

Jump to: Dosing Administration

Dose TRUXIMA the Same as Rituxan® in NHL and CLL1,4

Established dosing regimens for treatment settings in NHL and CLL

Click one of the indications below
to learn more

NHL (CD20-positive B Cell)1
First-line DLBCL
Indicated RegimenScheduleTRUXIMA Dose
R-CHOP or other anthracycline-based chemotherapy regimens Day 1 of each cycle of chemotherapy x8 375 mg/m2

Indicated Regimen

R-CHOP or other anthracycline-based chemotherapy regimens

Schedule

Day 1 of each cycle of chemotherapy x8

TRUXIMA Dose

375 mg/m2

First-line FL
Indicated RegimenScheduleTRUXIMA Dose
R+first-line chemotherapy Day 1 of each cycle of chemotherapy x8 375 mg/m2

Indicated Regimen

R+first-line chemotherapy

Schedule

Day 1 of each cycle of chemotherapy x8

TRUXIMA Dose

375 mg/m2

Following a CR or PR to first-line
R+chemotherapy in FL
Indicated RegimenScheduleTRUXIMA Dose
R+first-line chemotherapy -> R 8 weeks following completion of TRUXIMA in combination with chemotherapy, administer every 8 weeks for 12 doses 375 mg/m2

Indicated Regimen

R+first-line chemotherapy -> R

Schedule

8 weeks following completion of TRUXIMA in combination with chemotherapy, administer every 8 weeks for 12 doses

TRUXIMA Dose

375 mg/m2

Non-progressing, low-grade NHL,
after first-line CVP chemotherapy
Indicated RegimenScheduleTRUXIMA Dose
CVP -> R Following completion of 6-8 cycles of CVP chemotherapy, administer once weekly for 4 doses at 6-month intervals to a maximum of 16 doses 375 mg/m2

Indicated Regimen

CVP -> R

Schedule

Following completion of 6-8 cycles of CVP chemotherapy, administer once weekly for 4 doses at 6-month intervals to a maximum of 16 doses

TRUXIMA Dose

375 mg/m2

Relapsed or refractory,
low-grade or FL NHL
Indicated RegimenScheduleTRUXIMA Dose
R Weekly x4 or 8 doses 375 mg/m2
R (retreatment) Weekly x4 375 mg/m2
Indicated Regimen
R R (retreatment)
Schedule Schedule
Weekly x4 or 8 doses Weekly x4
TRUXIMA Dose TRUXIMA Dose
375 mg/m2 375 mg/m2
CLL (CD20-positive)1
First-line and previously
treated CLL
Indicated RegimenScheduleTRUXIMA Dose
R-FC Day prior to the first cycle of FC chemotherapy 375 mg/m2
  Day 1 of cycles 2-6; every 28 days 500 mg/m2
Indicated Regimen
R-FC
Schedule Schedule
Day prior to the first cycle of FC chemotherapy Day 1 of cycles 2-6; every 28 days
TRUXIMA Dose TRUXIMA Dose
375 mg/m2 500 mg/m2

FOR COMPLETE DOSING INFORMATION REFER TO FULL PRESCRIBING INFORMATION

DLBCL=diffuse large B-cell lymphoma, FL=follicular NHL, R=rituximab, CR=complete response, PR=partial response, CVP=cyclophosphamide, vincristine, and prednisone, CHOP=cyclophosphamide, doxorubicin, vincristine, and prednisone, FC=fludarabine and cyclophosphamide, q8w=every 8 weeks.

TRUXIMA is not recommended for use in patients with severe, active infections.1

Jump to: Dosing Administration

Administer TRUXIMA the Same Way You Administer Rituxan in NHL and CLL1,4

Select to reveal standard or 90-minute infusion rates

Standard Infusion1

Administration guidance

Follow these instructions when administering TRUXIMA.

See dosing and administration section of the Prescribing Information for complete details.

  • Administer only as an intravenous (IV) infusion
  • Do not administer as an intravenous push or bolus
  • Premedicate patients with an antihistamine and acetaminophen prior to dosing
  • Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate
  • Depending on the severity of the infusion reaction and the required interventions, temporarily or permanently discontinue TRUXIMA
    • Resume infusion at a minimum 50% reduction in rate after symptoms have resolved
  • Institute medical management (eg, glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion reactions as needed
  • Closely monitor the following patients: those with preexisting cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (≥25,000/mm3)
  • TRUXIMA should only be administered by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur
  • Prior to First Infusion: Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with TRUXIMA. Obtain complete blood counts (CBCs) including platelets prior to the first dose
  • During TRUXIMA therapy: In patients with lymphoid malignancies, during treatment with TRUXIMA monotherapy, obtain CBCs with differential and platelet counts prior to each TRUXIMA course. During treatment with TRUXIMA and chemotherapy, obtain CBCs with differential and platelet counts at weekly to monthly intervals and more frequently in patients who develop cytopenias

Administration1

INFUSIONINFUSION RATE
First
  • Initiate infusion at 50 mg/hr
  • In the absence of infusion toxicity, increase the rate by 50 mg/hr every 30 minutes
  • Maximum infusion rate is 400 mg/hr
Subsequent standard
  • Initiate infusion at 100 mg/hr
  • In the absence of infusion toxicity, increase the rate by 100 mg/hr every 30 minutes
  • Maximum infusion rate is 400 mg/hr
90-minute Infusion

90-minute TRUXIMA infusion for appropriate previously untreated DLBCL and follicular NHL patients in cycles 2-81

When administering TRUXIMA using the 90-minute infusion protocol, adhere to the administration guidance outline under the standard infusion.

See dosing and administration section of the Prescribing Information for complete details.

If a patient did not experience a Grade 3 or 4 infusion related adverse event during Cycle 1, a 90-minute infusion can be administered in Cycle 2 with a glucocorticoid-containing chemotherapy regimen.

The 90-minute TRUXIMA infusion can be administered to patients who:

  • Have previously untreated DLBCL or follicular lymphoma, receiving R-CHOP or R-CVP, respectively
  • Are ≥18 years of age
  • Have an ECOG PS 0-2
  • Have a circulating lymphocyte count ≤5,000/µL at the start of Cycle 2
  • Did not experience any infusion-related serious adverse event (SAE) or Grade 3/4 infusion-related reaction (IRR) in Cycle 1
  • Do not have significant cardiovascular disease
  • All patients are premedicated with acetaminophen and an antihistamine prior to TRUXIMA administration1

The 90-minute TRUXIMA infusion rate for appropriate patients is1:

  • 20% of the total dose over the first 30 minutes (75 mg/m2)
  • 80% of the total dose over the following 60 minutes (300 mg/m2)
  • If the 90-minute infusion is tolerated in Cycle 2, the same rate can be used when administering the remainder of the treatment regimen (through Cycle 6 or 8)
Jump to: Dosing Administration

Dose TRUXIMA the Same as Rituxan® in RA1,4

Established dosing regimen for RA

RA1
Following inadequate response
to one or more TNF antagonist
therapies
Indicated RegimenTRUXIMA
Dose
  • Two 1000-mg intravenous infusions separated by 2 weeks, every 16-24 weeks based on clinical evaluation
 1000 mg
  • Recommended 30 minutes prior to each infusion:
    • Administer glucocorticoids, as methylprednisolone 100 mg intravenous or its equivalent, to reduce incidence and severity of infusion-related reactions
  • Given in combination with methotrexate
  

Indicated Regimen

  • Two 1000-mg intravenous infusions separated by 2 weeks, every 16-24 weeks based on clinical evaluation
  • Recommended 30 minutes prior to each infusion:
    • Administer glucocorticoids, as methylprednisolone 100 mg intravenous or its equivalent, to reduce incidence and severity of infusion-related reactions
  • Given in combination with methotrexate

TRUXIMA Dose

1000 mg

FOR COMPLETE DOSING INFORMATION REFER TO FULL PRESCRIBING INFORMATION

TNF=tumor necrosis factor.

TRUXIMA is not recommended for use in patients with severe, active infections.1

Jump to: Dosing Administration

Administer TRUXIMA the Same Way You Administer Rituxan in RA1,4

Select to reveal standard infusion rate

Standard Infusion

Administration guidance

Follow these instructions when administering TRUXIMA in patients with RA.

See dosing and administration section of the Prescribing Information for complete details.

General administration guidance

  • Administer only as an intravenous (IV) infusion1
  • Do not administer as an intravenous push or bolus1
  • TRUXIMA should only be administered by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur1

Premedicate before each infusion1

  • Premedicate patients with an antihistamine and acetaminophen prior to dosing1
  • Methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion1

Prior to each infusion

  • Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with TRUXIMA.1
    • Obtain complete blood counts (CBCs) including platelets prior to the first dose1

During TRUXIMA therapy

  • Obtain CBCs with differential and platelet counts at 2 to 4 month intervals during TRUXIMA therapy.1
  • Continue to monitor for cytopenias after final dose and until resolution1

Management of infusion reactions

  • Institute medical management (eg, glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion reactions as needed1
  • Depending on the severity of the infusion reaction and the required interventions, temporarily or permanently discontinue TRUXIMA1
    • Resume infusion at a minimum 50% reduction in rate after symptoms have resolved

Closely monitor patients who have1:

  • Preexisting cardiac or pulmonary conditions
  • Experienced prior cardiopulmonary adverse reactions
  • High numbers of circulating malignant cells (≥25,000/mm3)

Administration1

INFUSIONINFUSION RATE
First
  • Initiate infusion at 50 mg/hr
  • In the absence of infusion toxicity, increase the rate by 50 mg/hr every 30 minutes
  • Maximum infusion rate is 400 mg/hr
Subsequent standard
  • Initiate infusion at 100 mg/hr
  • In the absence of infusion toxicity, increase the rate by 100 mg/hr every 30 minutes
  • Maximum infusion rate is 400 mg/hr
Jump to: Dosing Administration

Dose TRUXIMA the Same as Rituxan® in GPA and MPA1,4 Dose TRUXIMA the Same as Rituxan® in GPA and MPA1,4

Established dosing regimen for GPA and MPA

Click one of the dosing schedules below
to learn more

GPA and MPA in adult patients1
Induction treatment for active
disease
Indicated RegimenTRUXIMA
Dose
  • One intravenous infusion weekly for 4 weeks
 375 mg/m2
  • Fourteen days prior to or with the initiation of treatment:
    • Glucocorticoids administered as methylprednisolone 1000 mg intravenously per day for 1 to 3 days followed by oral prednisone as per clinical practice
    • May continue regimen during and after the 4-week induction course
  

Indicated Regimen

  • One intravenous infusion weekly for 4 weeks
  • Fourteen days prior to or with the initiation of treatment:
    • Glucocorticoids administered as methylprednisolone 1000 mg intravenously per day for 1 to 3 days followed by oral prednisone as per clinical practice
    • May continue regimen during and after the 4-week induction course

TRUXIMA Dose

375 mg/m2

Follow-up treatment for disease
controlled with induction
treatment
Indicated RegimenTRUXIMA
Dose
  • Two intravenous infusions separated by 2 weeks, then every 6 months thereafter based on clinical evaluation
 500 mg
  • If induction treatment of active disease was with a rituximab product, initiate follow-up treatment with TRUXIMA within 24 weeks after the last induction infusion with a rituximab product or based on clinical evaluation, but no sooner than 16 weeks after the last induction infusion with a rituximab product
  

Indicated Regimen

  • Two intravenous infusions separated by 2 weeks, then every 6 months thereafter based on clinical evaluation
  • If induction treatment of active disease was with a rituximab product, initiate follow-up treatment with TRUXIMA within 24 weeks after the last induction infusion with a rituximab product or based on clinical evaluation, but no sooner than 16 weeks after the last induction infusion with a rituximab product

TRUXIMA Dose

500 mg

FOR COMPLETE DOSING INFORMATION REFER TO FULL PRESCRIBING INFORMATION

TRUXIMA is not recommended for use in patients with severe, active infections.1

Jump to: Dosing Administration

Administer TRUXIMA the Same Way You Administer Rituxan in GPA and MPA1,4

Select to reveal standard infusion rate

Standard Infusion

Administration guidance

Follow these instructions when administering TRUXIMA in patients with GPA or MPA.

See dosing and administration section of the Prescribing Information for complete details.

General administration guidance

  • Administer only as an intravenous (IV) infusion1
  • Do not administer as an intravenous push or bolus1
  • TRUXIMA should only be administered by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur1

Premedicate before each infusion1

  • Premedicate patients with an antihistamine and acetaminophen prior to dosing1
  • Methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion1

Prior to each infusion

  • Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with TRUXIMA.1
    • Obtain complete blood counts (CBCs) including platelets prior to the first dose1

During TRUXIMA therapy

  • Obtain CBCs with differential and platelet counts at 2 to 4 month intervals during TRUXIMA therapy.1
  • Continue to monitor for cytopenias after final dose and until resolution1

Management of infusion reactions

  • Institute medical management (eg, glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion reactions as needed1
  • Depending on the severity of the infusion reaction and the required interventions, temporarily or permanently discontinue TRUXIMA1
    • Resume infusion at a minimum 50% reduction in rate after symptoms have resolved

Closely monitor patients who have1:

  • Preexisting cardiac or pulmonary conditions
  • Experienced prior cardiopulmonary adverse reactions
  • High numbers of circulating malignant cells (≥25,000/mm3)

Administration1

INFUSIONINFUSION RATE
First
  • Initiate infusion at 50 mg/hr
  • In the absence of infusion toxicity, increase the rate by 50 mg/hr every 30 minutes
  • Maximum infusion rate is 400 mg/hr
Subsequent standard
  • Initiate infusion at 100 mg/hr
  • In the absence of infusion toxicity, increase the rate by 100 mg/hr every 30 minutes
  • Maximum infusion rate is 400 mg/hr

INDICATIONS

TRUXIMA® (rituximab-abbs) Injection is indicated for the treatment of adult patients with:

Non-Hodgkin’s Lymphoma (NHL)

  • Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.
  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
  • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
  • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.

Chronic Lymphocytic Leukemia (CLL)

  • In combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.

Rheumatoid Arthritis (RA)

  • In combination with methotrexate, for the treatment of adult patients with moderately- to severely-active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)

  • In combination with glucocorticoids, for the treatment of adult patients with GPA and MPA

Pemphigus Vulgaris (PV)

  • Moderate to severe PV.

IMPORTANT SAFETY INFORMATION

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Infusion-Related Reactions: Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related 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-related reactions.

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products.

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.

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products.

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions - Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes. Rituximab product-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death.

Premedicate patients with an antihistamine and acetaminophen prior to dosing. For RA, GPA and MPA, and PV patients, methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion. Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Depending on the severity of the infusion-related reaction and the required interventions, temporarily or permanently discontinue TRUXIMA. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved. Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (greater than or equal to 25,000/mm3).

Severe Mucocutaneous Reactions - Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab products. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these reactions has been variable and includes reports with onset on the first day of rituximab exposure. Discontinue TRUXIMA in patients who experience a severe mucocutaneous reaction. The safety of re-administration of rituximab products to patients with severe mucocutaneous reactions has not been determined

Hepatitis B Virus Reactivation - Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation has also occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs] positive).

HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases, increase in bilirubin levels, liver failure, and death can occur.

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment 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 and consideration for HBV antiviral therapy before and/or during TRUXIMA treatment.

Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of 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 discontinue TRUXIMA and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming TRUXIMA treatment in patients who develop HBV reactivation. Resumption of TRUXIMA treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV.

Progressive Multifocal Leukoencephalopathy (PML) - JC virus infection resulting in PML and death can occur in rituximab product-treated patients with hematologic malignancies or with autoimmune diseases. The majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. The patients with autoimmune diseases had prior or concurrent immunosuppressive therapy. Most cases of PML were diagnosed within 12 months of their last infusion of rituximab.

Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation 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 concomitant chemotherapy or immunosuppressive therapy in patients who develop PML.

Tumor Lysis Syndrome (TLS) - Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 12 to 24 hours after the first infusion of rituximab products in patients with NHL. A high number of circulating malignant cells (≥25,000/mm3) or high tumor burden, confers a greater risk of TLS.

Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated.

Infections - Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab product-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure). New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue TRUXIMA for serious infections and institute appropriate anti-infective therapy. TRUXIMA is not recommended for use in patients with severe, active infections.

Cardiovascular Adverse Reactions - Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of TRUXIMA for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina.

Renal Toxicity - Severe, including fatal, renal toxicity can occur after rituximab product administration in patients with NHL. Renal toxicity has occurred in patients who experience TLS and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and TRUXIMA is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue TRUXIMA in patients with a rising serum creatinine or oliguria.

Bowel Obstruction and Perforation - Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab products in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1 to 77) days in patients with NHL. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur.

Immunization - The safety of immunization with live viral vaccines following rituximab product therapy has not been studied and vaccination with live virus vaccines is not recommended before or during treatment.

Prior to initiating TRUXIMA physicians should ensure patients’ vaccinations and immunizations are up-to-date with guidelines. Administration of any non-live vaccines should occur at least 4 weeks prior to a course of TRUXIMA.

Embryo-Fetal Toxicity - Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed in-utero. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRUXIMA and for 12 months after the last dose. Verify pregnancy status in females with reproductive potential before starting TRUXIMA.

Concomitant Use With Other Biologic Agents and Disease Modifying Antirheumatic Drugs (DMARDs), Other Than Methotrexate, in RA, GPA, and MPA, PV

Limited data are available on the safety of the use of biologic agents or DMARDs other than methotrexate in RA patients exhibiting peripheral B-cell depletion following treatment with rituximab products. Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly.

Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA or PV patients exhibiting peripheral B-cell depletion following treatment with rituximab products.

Use in RA Patients Who Have Not Had Prior Inadequate Response to Tumor Necrosis Factor (TNF) Antagonists

The use of TRUXIMA in patients with RA who have not had prior inadequate response to one or more TNF antagonists is not recommended.

Lactation - There are limited data on the presence of rituximab in human milk and the effect on the breastfed child, and there are no data on the effect on milk production. Rituximab has been reported to be excreted at low concentrations in human breast milk. Given that the clinical significance of this finding for children is not known, advise women not to breastfeed during treatment with TRUXIMA and for 6 months after the last dose due to the potential of serious adverse reactions in breastfed children.

Most common adverse reactions in clinical trials of NHL (≥25%) were: infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia.

Most common adverse reactions in clinical trials of CLL (≥25%) were: infusion-related reactions and neutropenia.

Most common adverse reactions in clinical trials of RA (≥10%) were: upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis (other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events).

Most common adverse reactions in clinical trials of GPA and MPA (≥15%) were: infections, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema, and infusion-related reactions.

Most common adverse reactions in clinical trials of PV (greater than or equal to 15%) were: were: infusion-related reactions, depression, upper respiratory tract infection/nasopharyngitis, headache (other important adverse reactions include infections).

Please click here for full Prescribing Information for TRUXIMA, including BOXED WARNINGS.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

References: 1. TRUXIMA® (rituximab-abbs) Prescribing Information. Incheon, Republic of Korea: Celltrion, Inc. 2. HCPCS Codes. TRUXIMA HCPCS Code. https://hcpcs.codes/q-codes/Q5115/. Accessed June 20, 2025. 3. Centers for Medicare Services (CMS). April 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS). March 6, 2020. 4. Rituxan® (rituximab) full Prescribing Information. South San Francisco, CA: Genentech, Inc.