{
 "query": "ocrelizumab",
 "ingredient": "ocrelizumab",
 "slug": "ocrelizumab",
 "rxcui": "1876366",
 "brands": [
  "Ocrevus"
 ],
 "names": [
  "ocrelizumab"
 ],
 "classes": [
  {
   "id": "L04AG",
   "name": "Monoclonal antibodies"
  }
 ],
 "alternatives": [
  "alemtuzumab",
  "anifrolumab",
  "axatilimab",
  "belimumab",
  "efalizumab",
  "emapalumab",
  "inebilizumab",
  "muromonab-cd3",
  "natalizumab",
  "ofatumumab",
  "rozanolixizumab",
  "sibeprenlimab",
  "teprotumumab",
  "ublituximab",
  "vedolizumab"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "OCREVUS is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Primary progressive MS, in adults Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more. OCREVUS is a CD20-directed cytolytic antibody indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 ) Primary progressive MS, in adults ( 1 ) Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more ( 1 )",
  "contraindications": "OCREVUS is contraindicated in patients with: Active HBV infection [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] A history of life-threatening infusion reaction to OCREVUS [see Warnings and Precautions (5.1) ] Active hepatitis B virus infection ( 4 ) History of life-threatening infusion reaction to OCREVUS ( 4 )",
  "warnings_and_cautions": "Infusion Reactions: Management recommendations for infusion reactions depend on the type and severity of the reaction. Permanently discontinue OCREVUS if a life-threatening or disabling infusion reaction occurs ( 2.3 , 5.1 ) Infections: Serious, including life-threatening and fatal infections, have occurred. Delay OCREVUS administration in patients with an active infection until the infection is resolved. Vaccination with live-attenuated or live vaccines is not recommended during treatment with OCREVUS and after discontinuation, until B-cell repletion ( 5.2 ) Progressive Multifocal Leukoencephalopathy (PML): Withhold OCREVUS at the first sign or symptom suggestive of PML ( 5.3 ) Reduction in Immunoglobulins: Monitor the level of immunoglobulins at the beginning of treatment. Monitor during and after discontinuation of treatment with OCREVUS, until B-cell repletion, and especially when recurrent serious infections are suspected. Consider discontinuing OCREVUS in patients with serious opportunistic or recurrent serious infections, and if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins ( 2.1 , 5.4 ) Malignancies: An increased risk of malignancy, inc...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3) ] Reduction in Immunoglobulins [see Warnings and Precautions (5.4) ] Malignancies [see Warnings and Precautions (5.5) ] Immune-Mediated Colitis [see Warnings and Precautions (5.6) ] Liver Injury [see Warnings and Precautions (5.7) ] The most common adverse reactions were: RMS (incidence \u226510% and > REBIF \u00ae ): upper respiratory tract infections and infusion reactions ( 6.1 ) PPMS (incidence \u226510% and > placebo): upper respiratory tract infections, infusion reactions, skin infections, and lower respiratory tract infections ( 6.1 ) RRMS in pediatric patients 10 years of age and older: Adverse reactions were consistent with those observed in adults with RMS ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1 ) 5/2026 Dosage and Administration ( 2.1 ) 8/2025 Dosage and Administration ( 2.2 , 2.3 , 2.6 ) 5/2026 Warnings and Precautions ( 5.1 , 5.2 ) 5/2026 Warnings and Precautions ( 5.7 ) 8/2025",
  "information_for_patients": "Advise the patient and caregiver to read the FDA-approved patient labeling (Medication Guide). Infusion Reactions Inform patients and caregivers about the signs and symptoms of infusion reactions, and that infusion reactions can occur up to 24 hours after infusion. Advise patients and caregivers to contact the patient's healthcare provider immediately for signs or symptoms of infusion reactions [see Warnings and Precautions (5.1) ] . Infection Advise patients and caregivers to contact the patient's healthcare provider for any signs of infection during treatment or after the last dose [see Clinical Pharmacology (12.2) ]. Signs include fever, chills, constant cough, dysuria, or signs of herpes such as cold sores, shingles, or genital sores [see Warnings and Precautions (5.2) ] . Advise patients and caregivers that OCREVUS may cause reactivation of hepatitis B infection and that monitoring will be required if the patient is at risk [see Warnings and Precautions (5.2) ] . Advise patients and caregivers that herpes infections, including serious herpes infections affecting the central nervous system, skin, and eyes, have occurred during treatment with OCREVUS. Advise patients and caregiv...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 5/2026 MEDICATION GUIDE OCREVUS \u00ae (oak-rev-us) (ocrelizumab) injection, for intravenous use This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you are the parent or guardian of a child who is being treated with OCREVUS, the following information applies to your child. What is the most important information I should know about OCREVUS? OCREVUS can cause serious side effects, including: Infusion reactions : Infusion reactions are a common side effect of OCREVUS, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms: itchy skin rash hives tiredness coughing or wheezing trouble breathing throat irritation or pain feeling faint fever redness on your face (flushing) nausea headache swelling of the throat dizziness shortness of breath fatigue fast heart beat These infusion reactions can happen for up ...",
  "clinical_studies": "14.1 Relapsing Forms of Multiple Sclerosis in Adults The efficacy of OCREVUS was demonstrated in two randomized, double-blind, double-dummy, active comparator-controlled clinical trials of identical design, in adult patients with relapsing forms of multiple sclerosis (RMS) treated for 96 weeks (Study 1 and Study 2). The dose of OCREVUS was 600 mg every 24 weeks (initial treatment was given as two 300 mg IV infusions administered 2 weeks apart, and subsequent doses were administered as a single 600 mg IV infusion) and placebo subcutaneous injections were given 3 times per week. The dose of REBIF, the active comparator, was 44 mcg given as subcutaneous injections 3 times per week and placebo IV infusions were given every 24 weeks. Both studies included patients who had experienced at least one relapse within the prior year, or two relapses within the prior two years, and had an Expanded Disability Status Scale (EDSS) score from 0 to 5.5. Patients with primary progressive forms of multiple sclerosis (MS) were excluded. Neurological evaluations were performed every 12 weeks and at the time of a suspected relapse. Brain MRIs were performed at baseline and at Weeks 24, 48, and 96. The pr...",
  "brand_name": "OCREVUS",
  "manufacturer": "Genentech, Inc.",
  "application_number": "BLA761053",
  "pharm_class_epc": [
   "CD20-directed Cytolytic Antibody [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20260514",
  "set_id": "9da42362-3bb5-4b83-b4bb-b59fd4e55f0d",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 1",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 61617,
  "serious": 30936,
  "death": 1511,
  "hospitalization": 11181,
  "primary_suspect": 61589,
  "top_reactions": [
   [
    "Covid-19",
    11573
   ],
   [
    "Fatigue",
    6215
   ],
   [
    "Urinary Tract Infection",
    3781
   ],
   [
    "Headache",
    3265
   ],
   [
    "Multiple Sclerosis",
    3026
   ],
   [
    "Multiple Sclerosis Relapse",
    2727
   ],
   [
    "Gait Disturbance",
    2716
   ],
   [
    "Asthenia",
    2705
   ],
   [
    "Nasopharyngitis",
    2569
   ],
   [
    "Pain",
    2540
   ],
   [
    "Fall",
    2529
   ],
   [
    "Off Label Use",
    2446
   ],
   [
    "Pneumonia",
    2441
   ],
   [
    "Drug Ineffective",
    2439
   ],
   [
    "Infusion Related Reaction",
    2217
   ]
  ],
  "by_year": {
   "2019": 6276,
   "2020": 5550,
   "2021": 7194,
   "2022": 11404,
   "2023": 8925,
   "2024": 9566,
   "2025": 4549,
   "2026": 1965
  },
  "by_year_primary": {
   "2019": 6275,
   "2020": 5549,
   "2021": 7193,
   "2022": 11399,
   "2023": 8923,
   "2024": 9560,
   "2025": 4547,
   "2026": 1956
  }
 },
 "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": "20170328",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "GENENTECH INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/28/2017"
 },
 "trials": {
  "total": 157,
  "completed": 67,
  "terminated": 19,
  "with_results": 41,
  "industry": 103,
  "phase3": 45,
  "results_share": 0.6119402985074627,
  "terminated_share": 0.12101910828025478
 },
 "pubmed": {
  "rct": 39,
  "meta": 10,
  "recent_rct": 21,
  "cochrane": [
   {
    "pmid": "35583174",
    "title": "Ocrelizumab for multiple sclerosis",
    "year": "2022"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 1700823.42,
  "records": 8954,
  "by_name": [
   [
    "Ocrevus",
    1700823.42
   ]
  ],
  "names_checked": [
   "ocrelizumab",
   "Ocrevus"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 5163,
  "beneficiaries": 3085,
  "spend": 195066361.89,
  "by_brand": [
   {
    "brand": "Ocrevus",
    "claims": 5163,
    "per_claim": 37781.592464,
    "is_generic": false
   }
  ],
  "per_claim": 37781.592463683904
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "ocrelizumab",
  "matched": "ocrelizumab",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 53,
   "letter": "D",
   "why": [
    "39 randomized trials and 10 systematic reviews/meta-analyses indexed in PubMed",
    "1 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": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $1,700,823 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "15 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are covid-19, fatigue, urinary tract infection, headache. How would we recognize and handle those?",
  "Why this one over alemtuzumab, anifrolumab, axatilimab? 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?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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.)"
 ]
}