pharmacopeia
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Boxed warning

FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Fatal infusion-related reactions within 24 hours of RITUXAN infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RITUXAN infusion for severe reactions ( 5.1 ). Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 ). Infusion-Related Reactions RITUXAN administration can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RITUXAN infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ].

Mechanism of action

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Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab mediates B-cell lysis.

Indications

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  • RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.ICD-10: C85.90

Contraindications

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  • None.contraindicated

Dosage & administration

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Administer only as an intravenous infusion ( 2.1 ). Do not administer as an intravenous push or bolus ( 2.1 ). RITUXAN should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions that can be fatal if they occur. ( 2.1 ). The dose for adult and pediatric B-cell NHL is 375 mg/m 2 ( 2.2 ). The dose for CLL is 375 mg/m 2 in the first cycle and 500 mg/m 2 in cycles 2–6, in combination with FC, administered every 28 days ( 2.3 ). The dose as a component of Zevalin ® (ibritumomab tiuxetan) Therapeutic Regimen is 250 mg/m 2 ( 2.4 ). The dose for RA in combination with methotrexate is two-1,000 mg intravenous infusions separated by 2 weeks (one course) every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks. Methylprednisolone 100 mg intravenous or equivalent glucocorticoid is recommended 30 minutes prior to each infusion ( 2.5 ). The induction dose for adult patients with active GPA and MPA in combination with glucocorticoids is 375 mg/m 2 once weekly for 4 weeks. The follow up dose for adult patients with GPA and MPA who have achieved disease control with induction treatment, in combination with glucocorticoids is two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter based on clinical evaluation ( 2.6 ). The induction dose for pediatric patients with GPA and MPA in combination with glucocorticoids is 375 mg/m 2 once weekly for 4 weeks.

Warnings & precautions

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Tumor lysis syndrome: Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function ( 5.5 ). Infections: Withhold RITUXAN and institute appropriate anti-infective therapy ( 5.6 ). Cardiac adverse reactions: Discontinue infusions in case of serious or life-threatening events ( 5.7 ). Renal toxicity: Discontinue in patients with rising serum creatinine or oliguria ( 5.8 ). Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms ( 5.9 ). Immunizations: Live virus vaccinations prior to or during RITUXAN treatment not recommended ( 5.10 ). Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception ( 5.11 ). 5.1 Infusion-Related Reactions RITUXAN can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30–120 minutes. RITUXAN-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.

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Infusion-related reactions [see Warnings and Precautions (5.1) ] Severe mucocutaneous reactions [see Warnings and Precautions (5.2) ] Hepatitis B reactivation with fulminant hepatitis [see Warnings and Precautions (5.3) ] Progressive multifocal leukoencephalopathy [see Warnings and Precautions (5.4) ] Tumor lysis syndrome [see Warnings and Precautions (5.5) ] Infections [see Warnings and Precautions (5.6) ] Cardiovascular adverse reactions [see Warnings and Precautions (5.7) ] Renal toxicity [see Warnings and Precautions (5.8) ] Bowel obstruction and perforation [see Warnings and Precautions (5.9) ] Most common adverse reactions in clinical trials were: NHL (greater than or equal to 25%): infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia ( 6.1 ). Pediatric B-NHL/B-AL with chemotherapy (Grade 3 or higher greater than 15%): febrile neutropenia, stomatitis, enteritis, sepsis, alanine aminotransferase increased and hypokalemia ( 6.1 ). CLL (greater than or equal to 25%): infusion-related reactions and neutropenia ( 6.1 ). RA (greater than or equal to 10%): upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis (other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events) ( 6.1 ).

Use in specific populations

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Lactation: Advise not to breastfeed ( 8.2 ). Geriatric Use: In CLL patients older than 70 years of age, exploratory analyses suggest no benefit with the addition of RITUXAN to FC ( 8.5 ). 8.1 Pregnancy Risk Summary Based on human data, RITUXAN can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to RITUXAN in-utero ( see Clinical Considerations ). In animal reproduction studies, intravenous administration of rituximab to pregnant cynomolgus monkeys during the period of organogenesis caused lymphoid B-cell depletion in the newborn offspring at doses resulting in 80% of the exposure (based on AUC) of those achieved following a dose of 2 grams in humans. Advise pregnant women of the risk to a fetus. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk of major birth defects and miscarriage for the indicated populations is unknown. The estimated background risk in the U.S. general population of major birth defects is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies. Clinical Considerations Fetal/Neonatal Adverse Reactions Observe newborns and infants for signs of infection and manage accordingly.

Pharmacokinetics

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Metabolism
Non-Hodgkin's Lymphoma (NHL) Pharmacokinetics were characterized in 203 NHL patients receiving 375 mg/m 2 RITUXAN weekly by intravenous infusion for 4 doses. Rituximab was detectable in the serum of patients 3 to 6 months after completion of treatment.

Approval history

Sourced from openFDA
  • Nov 26, 1997BLABLA103705Genentech
  • Jun 22, 2017BLABLA761064Genentech Inc
  • Nov 28, 2018BLABLA761088Celltrion Inc
  • Jul 23, 2019BLABLA761103Pfizer Inc
  • Dec 17, 2020BLABLA761140Amgen Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
215,364 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use44,01120%
  2. 2Drug Ineffective33,92616%
  3. 3Rheumatoid Arthritis20,0369.3%
  4. 4Pain17,8828.3%
  5. 5Fatigue17,4458.1%
  6. 6Rash13,5046.3%
  7. 7Arthralgia13,3926.2%
  8. 8Pneumonia12,8316.0%
  9. 9Infusion Related Reaction12,7455.9%
  10. 10Drug Intolerance12,3435.7%
  11. 11Nausea11,8775.5%
  12. 12Joint Swelling11,8035.5%
  13. 13Pyrexia11,8025.5%
  14. 14Infection10,9635.1%
  15. 15Alopecia10,7465.0%

Literature

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Recent PubMed references pinned to Rituximab as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 2,763 ClinicalTrials.gov registrations naming Rituximab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Rituximab. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • FCGR3ACPIC D (provisional)ClinPGx 2B

Frequently asked questions

How does Rituximab work?
Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab mediates B-cell lysis.
What is Rituximab used for?
According to FDA labeling, Rituximab carries indications including: RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Rituximab?
Rituximab is classified as CD20 (Clusters of Differentiation 20) inhibitors, CD20-directed Cytolytic Antibody, Antibody-Receptor Interactions, CD20-directed Antibody Interactions, Increased Cellular Death.
What are the brand names for Rituximab?
Rituximab is marketed under brand names including Riabni, Rituxan, Rituxan Hycela, Ruxience, Truxima.
What are the contraindications for Rituximab?
Rituximab labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.
Note. Data for rituximab is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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