{
 "query": "rituximab",
 "ingredient": "rituximab",
 "slug": "rituximab",
 "rxcui": "121191",
 "brands": [
  "Rituxan"
 ],
 "names": [
  "rituximab"
 ],
 "classes": [
  {
   "id": "L01FA",
   "name": "CD20 (Clusters of Differentiation 20) inhibitors"
  }
 ],
 "alternatives": [
  "obinutuzumab",
  "ofatumumab"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 2
  },
  "boxed_warning": "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 ...",
  "indications_and_usage": "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. 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, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. Pediatric patients aged 6 months and older with mature B-cell NHL and mature B-cell acute leukemia (B-AL) ( 1.1 ) Previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy. Adult patie...",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "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\u2013120 minutes. RITUXAN-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ven...",
  "warnings": "",
  "adverse_reactions": "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 th...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.1 ) 12/2021 Dosage and Administration, Important Dosing Information ( 2.1 ) 12/2021 Dosage and Administration, NHL ( 2.2 .) 12/2021 Dosage and Administration, Premedication and Prophylactic Medication ( 2.8 ) 12/2021 Dosage and Administration, Administration and Storage ( 2.9 ) 6/2021 Warnings and Precautions, Infusion-Related Reactions ( 5.1 ) 12/2021",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Infusion-Related Reactions Inform patients about the signs and symptoms of infusion-related reactions. Advise patients to contact their healthcare provider immediately to report symptoms of infusion-related reactions including urticaria, hypotension, angioedema, sudden cough, breathing problems, weakness, dizziness, palpitations, or chest pain [see Warnings and Precautions (5.1) ] . Severe Mucocutaneous Reactions Advise patients to contact their healthcare provider immediately for symptoms of severe mucocutaneous reactions, including painful sores or ulcers on the mouth, blisters, peeling skin, rash, and pustules [see Warnings and Precautions (5.2) ] . Hepatitis B Virus Reactivation Advise patients to contact their healthcare provider immediately for symptoms of hepatitis including worsening fatigue or yellow discoloration of skin or eyes [see Warnings and Precautions (5.3) ] . Progressive Multifocal Leukoencephalopathy (PML) Advise patients to contact their healthcare provider immediately for signs and symptoms of PML, including new or changes in neurological symptoms such as confusion, dizziness or l...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 04/2024 MEDICATION GUIDE RITUXAN\u00ae (ri tuk san) (rituximab) injection What is the most important information I should know about RITUXAN? RITUXAN can cause serious side effects that can lead to death including: Infusion-related reactions. Infusion-related reactions are very common side effects of RITUXAN treatment. Serious infusion-related reactions can happen during your or your child's infusion or within 24 hours after your or your child's infusion of RITUXAN. Your healthcare provider should give you or your child medicines before your or your child's infusion of RITUXAN to decrease your or your child's chance of having a severe infusion-related reaction. Tell your healthcare provider or get medical help right away if you or your child get any of these symptoms during or after an infusion of RITUXAN: hives (red itchy welts) or rash itching swelling of your lips, tongue, throat or face sudden cough shortness of breath, difficulty breathing, or wheezing weakness dizziness or feel faint palpitations (feel like your heart is racing or fluttering) chest pain Severe skin and mouth reactions. Tell ...",
  "clinical_studies": "14.1 Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL The safety and effectiveness of RITUXAN in relapsed, refractory CD20+ NHL were demonstrated in 3 single-arm studies enrolling 296 patients. NHL Study 1 A multicenter, open-label, single-arm study was conducted in 166 patients with relapsed or refractory, low-grade or follicular, B-cell NHL who received 375 mg/m 2 of RITUXAN given as an intravenous infusion weekly for 4 doses. Patients with tumor masses > 10 cm or with > 5,000 lymphocytes/\u00b5L in the peripheral blood were excluded from the study. Results are summarized in Table 11 . The median time to onset of response was 50 days. Disease-related signs and symptoms (including B-symptoms) resolved in 64% (25/39) of those patients with such symptoms at study entry. NHL Study 2 In a multicenter, single-arm study, 37 patients with relapsed or refractory, low-grade NHL received 375 mg/m 2 of RITUXAN weekly for 8 doses. Results are summarized in Table 11 . NHL Study 3 In a multicenter, single-arm study, 60 patients received 375 mg/m 2 of RITUXAN weekly for 4 doses. All patients had relapsed or refractory, low-grade or follicular, B-cell NHL and had achieved an ...",
  "brand_name": "Rituxan",
  "manufacturer": "Genentech, Inc.",
  "application_number": "BLA103705",
  "pharm_class_epc": [
   "CD20-directed Cytolytic Antibody [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20250106",
  "set_id": "b172773b-3905-4a1c-ad95-bab4b6126563",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 211947,
  "serious": 188551,
  "death": 34466,
  "hospitalization": 66602,
  "primary_suspect": 211590,
  "top_reactions": [
   [
    "Off Label Use",
    45577
   ],
   [
    "Drug Ineffective",
    36340
   ],
   [
    "Rheumatoid Arthritis",
    21728
   ],
   [
    "Pain",
    18710
   ],
   [
    "Fatigue",
    17913
   ],
   [
    "Arthralgia",
    14169
   ],
   [
    "Rash",
    13974
   ],
   [
    "Drug Intolerance",
    13318
   ],
   [
    "Infusion Related Reaction",
    13155
   ],
   [
    "Pneumonia",
    13059
   ],
   [
    "Joint Swelling",
    12539
   ],
   [
    "Nausea",
    12026
   ],
   [
    "Pyrexia",
    11938
   ],
   [
    "Alopecia",
    11297
   ],
   [
    "Contraindicated Product Administered",
    11150
   ]
  ],
  "by_year": {
   "2019": 17381,
   "2020": 26883,
   "2021": 22066,
   "2022": 22206,
   "2023": 21074,
   "2024": 26117,
   "2025": 19302,
   "2026": 8538
  },
  "by_year_primary": {
   "2019": 17380,
   "2020": 26876,
   "2021": 22060,
   "2022": 22159,
   "2023": 21034,
   "2024": 25925,
   "2025": 19255,
   "2026": 8526
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 0,
  "anda": 0,
  "first_approval": "19971126",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "GENENTECH"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/26/1997"
 },
 "trials": {
  "total": 2815,
  "completed": 1287,
  "terminated": 460,
  "with_results": 798,
  "industry": 1198,
  "phase3": 525,
  "results_share": 0.62004662004662,
  "terminated_share": 0.16341030195381884
 },
 "pubmed": {
  "rct": 613,
  "meta": 307,
  "recent_rct": 155,
  "cochrane": [
   {
    "pmid": "40607605",
    "title": "Rituximab for myasthenia gravis",
    "year": "2025"
   },
   {
    "pmid": "40066932",
    "title": "Rituximab for people with multiple sclerosis",
    "year": "2025"
   },
   {
    "pmid": "35709102",
    "title": "Rituximab for thyroid-associated ophthalmopathy",
    "year": "2022"
   },
   {
    "pmid": "34748215",
    "title": "Rituximab for people with multiple sclerosis",
    "year": "2021"
   },
   {
    "pmid": "34423414",
    "title": "Rituximab for eradicating inhibitors in people with acquired haemophilia A",
    "year": "2021"
   },
   {
    "pmid": "32761818",
    "title": "Rituximab for treating inhibitors in people with inherited severe hemophilia",
    "year": "2020"
   },
   {
    "pmid": "28685500",
    "title": "Rituximab for treating inhibitors in people with inherited severe hemophilia",
    "year": "2017"
   },
   {
    "pmid": "27387850",
    "title": "Rituximab for eradicating inhibitors in people with acquired haemophilia A",
    "year": "2016"
   },
   {
    "pmid": "25841099",
    "title": "Rituximab for treating inhibitors in people with inherited severe hemophilia",
    "year": "2015"
   },
   {
    "pmid": "25603545",
    "title": "Rituximab for rheumatoid arthritis",
    "year": "2015"
   },
   {
    "pmid": "24310855",
    "title": "Rituximab for relapsing-remitting multiple sclerosis",
    "year": "2013"
   },
   {
    "pmid": "23728689",
    "title": "Rituximab for thyroid-associated ophthalmopathy",
    "year": "2013"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 37.2,
  "records": 2,
  "by_name": [
   [
    "Rituxan",
    37.2
   ]
  ],
  "names_checked": [
   "rituximab",
   "Rituxan"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3244,
  "beneficiaries": 1499,
  "spend": 38719960.43,
  "by_brand": [
   {
    "brand": "Rituxan",
    "claims": 3244,
    "per_claim": 11935.86943,
    "is_generic": false
   }
  ],
  "per_claim": 11935.8694297164
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20130925",
   "title": "Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm366406.htm",
   "kind": "drug",
   "matched": "rituxan"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "rituximab",
  "matched": "rituximab",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 54,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2013 (-8)",
    "Death appears in 1.8x the share of reports seen across all of FAERS (-3)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 95,
   "letter": "A",
   "why": [
    "613 randomized trials and 307 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "12 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $37 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 60,
   "letter": "D",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "questions": [
  "In 2013 the FDA issued a safety communication about this drug (Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing). Does that risk apply to me?",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are rheumatoid arthritis, pain. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over obinutuzumab, ofatumumab? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}