{
 "query": "tocilizumab",
 "ingredient": "tocilizumab",
 "slug": "tocilizumab",
 "rxcui": "612865",
 "brands": [
  "Actemra"
 ],
 "names": [
  "tocilizumab"
 ],
 "classes": [
  {
   "id": "L04AC",
   "name": "Interleukin inhibitors"
  }
 ],
 "alternatives": [
  "anakinra",
  "basiliximab",
  "bimekizumab",
  "brodalumab",
  "canakinumab",
  "daclizumab",
  "guselkumab",
  "ixekizumab",
  "mirikizumab",
  "rilonacept",
  "risankizumab",
  "sarilumab",
  "satralizumab",
  "secukinumab",
  "siltuximab",
  "spesolimab",
  "tildrakizumab",
  "ustekinumab"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 4,
   "SUBCUTANEOUS": 3
  },
  "boxed_warning": "WARNING: RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt ACTEMRA until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before ACTEMRA use and during therapy. Treatment for latent infection should be initiated prior to ACTEMRA use. Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored fo...",
  "indications_and_usage": "\u00ae (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) ( 1.2 ) Adult patients with giant cell arteritis. Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) ( 1.3 ) Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) Polyarticular Juvenile Idiopathic Arthritis (PJIA) ( 1.4 ) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) ( 1.5 ) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Cytokine Release Syndrome (CRS) ( 1.6 ) Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome. Coronavirus Disease 2019 (COVID-19) ( 1.7 ) Hospitalized adult and pediatric patients aged 2 years and older with coronavir...",
  "contraindications": "is contraindicated in patients with known hypersensitivity to ACTEMRA [see Warnings and Precautions (5.6) ]. Known hypersensitivity to ACTEMRA. ( 4 )",
  "warnings_and_cautions": "Serious Infections \u2013 do not administer ACTEMRA during an active infection, including localized infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled. ( 5.1 ) Gastrointestinal (GI) perforation\u2014use with caution in patients who may be at increased risk. ( 5.2 ) Hepatotoxicity- Monitor patients for signs and symptoms of hepatic injury. Modify or discontinue ACTEMRA if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 2.10 , 5.3 ) Laboratory monitoring\u2014recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests. ( 2.10 , 5.4 ) Hypersensitivity reactions, including anaphylaxis and death, and serious cutaneous reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) \u2013 discontinue ACTEMRA, treat promptly, and monitor until reaction resolves. ( 5.6 ) Live vaccines\u2014Avoid use with ACTEMRA. ( 5.9 , 7.3 ) 5.1 Serious Infections Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, protozoal, or other opportunistic pathogens have been reported in patients receiving im...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described elsewhere in labeling: Serious Infections [see Warnings and Precautions (5.1) ] Gastrointestinal Perforations [see Warnings and Precautions (5.2) ] Laboratory Parameters [see Warnings and Precautions (5.4) ] Immunosuppression [see Warnings and Precautions (5.5) ] Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions (5.6) ] Demyelinating Disorders [see Warnings and Precautions (5.7) ] Active Hepatic Disease and Hepatic Impairment [see Warnings and Precautions (5.8) ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice. Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions. ( 6 ) 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 in ...",
  "drug_abuse_and_dependence": "No studies on the potential for ACTEMRA to cause dependence have been performed. However, there is no evidence from the available data that ACTEMRA treatment results in dependence.",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.7 ) 08/2025 Dosage and Administration ( 2.8 , 2.9 ) 08/2025 Warnings and Precautions ( 5.2 , 5.6 ) 09/2024",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Serious Infections Inform patients that ACTEMRA may lower their resistance to infections [see Warnings and Precautions (5.1) ] . Instruct the patient of the importance of contacting their doctor immediately when symptoms suggesting infection appear in order to assure rapid evaluation and appropriate treatment. Gastrointestinal Perforation Inform patients that some patients who have been treated with ACTEMRA have had serious side effects in the stomach and intestines [see Warnings and Precautions (5.2) ] . Instruct the patient of the importance of contacting their doctor immediately when symptoms of fever, severe, persistent abdominal pain, and change in bowel habits appear to assure rapid evaluation and appropriate treatment. Hypersensitivity and Serious Allergic Reactions Inform patients that some patients who have been treated with ACTEMRA have developed serious allergic reactions, including anaphylaxis, as well as serious skin reactions [see Warnings and Precautions (5.6) ] . Advise patients to stop taking ACTEMRA and seek immediate medical attention if they experience any...",
  "spl_medguide": "Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 08/2025 Medication Guide ACTEMRA \u00ae (AC-TEM-RA) (tocilizumab) injection for intravenous use ACTEMRA \u00ae (AC-TEM-RA) (tocilizumab) injection for subcutaneous use What is the most important information I should know about ACTEMRA? ACTEMRA can cause serious side effects including : 1. Serious Infections . ACTEMRA is a medicine that affects your immune system. ACTEMRA can lower the ability of your immune system to fight infections. Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should assess you for TB before starting ACTEMRA (except if you have COVID-19). If you have COVID-19, your healthcare provider should monitor you for signs and symptoms of new infections during and after treatment with ACTEMRA. Your healthcare provider should monitor you closely for signs and symptoms of TB during and after treatment with ACTEMRA. You should not start taking ACTEMRA if you have any kind of infection unless your healthc...",
  "clinical_studies": "14.1 Rheumatoid Arthritis \u2013 Intravenous Administration The efficacy and safety of intravenously administered ACTEMRA was assessed in five randomized, double-blind, multicenter studies in patients greater than 18 years with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria. Patients had at least 8 tender and 6 swollen joints at baseline. ACTEMRA was given intravenously every 4 weeks as monotherapy (Study I), in combination with methotrexate (MTX) (Studies II and III) or other disease-modifying anti-rheumatic drugs (DMARDs) (Study IV) in patients with an inadequate response to those drugs, or in combination with MTX in patients with an inadequate response to TNF antagonists (Study V). Study I (NCT00109408) evaluated patients with moderate to severe active rheumatoid arthritis who had not been treated with MTX within 24 weeks prior to randomization, or who had not discontinued previous methotrexate treatment as a result of clinically important toxic effects or lack of response. In this study, 67% of patients were MTX-na\u00efve, and over 40% of patients had rheumatoid arthritis less than 2 years. Patients received ACTEMRA 8 mg per kg monothe...",
  "brand_name": "ACTEMRA",
  "manufacturer": "Genentech, Inc.",
  "application_number": "BLA125276",
  "pharm_class_epc": [
   "Interleukin-6 Receptor Antagonist [EPC]"
  ],
  "route": [
   "INTRAVENOUS",
   "SUBCUTANEOUS"
  ],
  "effective_time": "20251216",
  "set_id": "2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 112017,
  "serious": 85671,
  "death": 12013,
  "hospitalization": 28478,
  "primary_suspect": 111926,
  "top_reactions": [
   [
    "Drug Ineffective",
    35346
   ],
   [
    "Rheumatoid Arthritis",
    22691
   ],
   [
    "Off Label Use",
    20818
   ],
   [
    "Pain",
    20183
   ],
   [
    "Arthralgia",
    17207
   ],
   [
    "Joint Swelling",
    16286
   ],
   [
    "Fatigue",
    15331
   ],
   [
    "Rash",
    13712
   ],
   [
    "Drug Intolerance",
    13149
   ],
   [
    "Contraindicated Product Administered",
    12177
   ],
   [
    "Arthropathy",
    10900
   ],
   [
    "Alopecia",
    10735
   ],
   [
    "Abdominal Discomfort",
    10543
   ],
   [
    "Synovitis",
    10541
   ],
   [
    "Swelling",
    10457
   ]
  ],
  "by_year": {
   "2019": 10394,
   "2020": 17660,
   "2021": 13175,
   "2022": 12129,
   "2023": 9466,
   "2024": 11139,
   "2025": 8083,
   "2026": 3137
  },
  "by_year_primary": {
   "2019": 10393,
   "2020": 17653,
   "2021": 13173,
   "2022": 12110,
   "2023": 9441,
   "2024": 11130,
   "2025": 8072,
   "2026": 3123
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 2,
  "nda": 0,
  "anda": 0,
  "first_approval": "20100108",
  "rems": false,
  "rems_last": "20150818",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "GENENTECH"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/08/2010"
 },
 "trials": {
  "total": 626,
  "completed": 329,
  "terminated": 74,
  "with_results": 171,
  "industry": 342,
  "phase3": 157,
  "results_share": 0.5197568389057751,
  "terminated_share": 0.1182108626198083
 },
 "pubmed": {
  "rct": 208,
  "meta": 118,
  "recent_rct": 83,
  "cochrane": [
   {
    "pmid": "35560150",
    "title": "Tocilizumab for giant cell arteritis",
    "year": "2022"
   },
   {
    "pmid": "34420204",
    "title": "Tocilizumab for giant cell arteritis",
    "year": "2021"
   },
   {
    "pmid": "30480323",
    "title": "Tocilizumab for thyroid eye disease",
    "year": "2018"
   },
   {
    "pmid": "20614469",
    "title": "Tocilizumab for rheumatoid arthritis",
    "year": "2010"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 87144.41,
  "records": 2811,
  "by_name": [
   [
    "Actemra",
    87144.41
   ]
  ],
  "names_checked": [
   "tocilizumab",
   "Actemra"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 91107,
  "beneficiaries": 13833,
  "spend": 368046318.6,
  "by_brand": [
   {
    "brand": "Actemra Actpen",
    "claims": 56900,
    "per_claim": 4150.1599318,
    "is_generic": false
   },
   {
    "brand": "Actemra",
    "claims": 34207,
    "per_claim": 3856.0007741,
    "is_generic": false
   }
  ],
  "per_claim": 4039.71504494715
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "tocilizumab",
  "matched": "tocilizumab",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Death share in reports is near or below the FAERS average (1.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 76,
   "letter": "B",
   "why": [
    "208 randomized trials and 118 systematic reviews/meta-analyses indexed in PubMed",
    "4 independent Cochrane review(s) exist",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "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 $87,144 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "18 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "questions": [
  "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 anakinra, basiliximab, bimekizumab? 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.)"
 ]
}