Actemra, Roactemra(tocilizumab)
Actemra, RoActemra, Tofidence, Tyenne (tocilizumab) is an antibody pharmaceutical. Tocilizumab was first approved as Roactemra on 2009-01-15. It is used to treat cytokine release syndrome, giant cell arteritis, juvenile arthritis, and rheumatoid arthritis in the USA. It has been approved in Europe to treat arthritis, cytokine release syndrome, giant cell arteritis, and rheumatoid arthritis.
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Commercial
Trade Name
FDA
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Actemra, Tofidence, Tyenne
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| actemra | Biologic Licensing Application | 2018-10-01 |
| actemra actemra actpen | Biologic Licensing Application | 2024-11-06 |
| tofidence | Biologic Licensing Application | 2024-12-10 |
| tyenne | Biologic Licensing Application | 2024-05-22 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
tocilizumab, Actemra, Genentech, Inc. | |||
| 2028-03-04 | Orphan excl. | ||
| 2024-08-30 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J3262 | Injection, tocilizumab, 1 mg |
| M0249 | Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ecmo) only, includes infusion and post administration monitoring, first dose |
| M0250 | Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ecmo) only, includes infusion and post administration monitoring, second dose |
| Q0249 | Injection, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ecmo) only, 1 mg |
Clinical
Clinical Trials
564 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | HP_0001369 | M05-M14 | 6 | 3 | 63 | 23 | 61 | 156 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 2 | 3 | 57 | 21 | 59 | 142 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | 4 | — | 6 | 2 | 2 | 14 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | 1 | 2 | 4 | 1 | 1 | 9 |
| Polymyalgia rheumatica | D011111 | EFO_0008518 | M35.3 | 1 | 2 | 4 | 1 | 1 | 9 |
| Arteritis | D001167 | EFO_0009011 | I77.6 | 1 | 2 | 3 | 1 | 1 | 8 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | 1 | — | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 16 | 10 | 4 | — | — | 21 |
| B-cell lymphoma | D016393 | — | — | 13 | 8 | 2 | — | — | 15 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 10 | 7 | 1 | — | — | 11 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 5 | 2 | 1 | — | — | 7 |
| Covid-19 | D000086382 | — | — | 1 | 3 | 2 | — | — | 6 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 2 | 2 | — | — | 4 |
| Follicular lymphoma | D008224 | — | C82 | 2 | 2 | 1 | — | — | 3 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34.0 | — | — | 2 | — | — | 2 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | — | 2 | — | — | 2 |
| Sclerosis | D012598 | — | — | — | — | 2 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 3 | 1 | — | — | — | 3 |
| Adenocarcinoma | D000230 | — | — | 3 | 1 | — | — | — | 3 |
| Multiple myeloma | D009101 | — | C90.0 | 3 | 2 | — | — | — | 3 |
| Plasma cell neoplasms | D054219 | — | — | 3 | 2 | — | — | — | 3 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 2 | 1 | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 1 | — | — | — | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 1 | — | — | — | 2 |
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | 1 | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 1 | — | — | — | 1 |
| Transitional cell carcinoma | D002295 | — | — | 1 | 1 | — | — | — | 1 |
Show 8 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 3 | — | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 3 | — | — | — | — | 3 |
| Colorectal neoplasms | D015179 | — | — | 2 | — | — | — | — | 2 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 2 | — | — | — | — | 2 |
| Lymphoid leukemia | D007945 | — | C91 | 2 | — | — | — | — | 2 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | 2 | — | — | — | — | 2 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | — | — | — | 1 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Uveal neoplasms | D014604 | EFO_1001230 | — | 1 | — | — | — | — | 1 |
Show 9 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Emergencies | D004630 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tocilizumab |
| INN | tocilizumab |
| Description | Tocilizumab, also known as atlizumab, is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer. It was developed by Hoffmann–La Roche and Chugai.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1237022 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06273 |
| UNII ID | I031V2H011 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Actemra – Roche
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Trends
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Additional graphs summarizing 39,285 documents
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Safety
Black-box Warning
Black-box warning for: Actemra, Actemra actemra actpen, Tofidence, Tyenne
Adverse Events
Top Adverse Reactions
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102,927 adverse events reported
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