Actemra, Roactemra(tocilizumab)
Actemra, RoActemra (tocilizumab) is an antibody pharmaceutical. Tocilizumab was first approved as Roactemra on 2009-01-15. It is used to treat giant cell arteritis, juvenile arthritis, and rheumatoid arthritis in the USA. It has been approved in Europe to treat covid-19, cytokine release syndrome, giant cell arteritis, juvenile arthritis, and rheumatoid arthritis.
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COVID-19
Case Study: COVID-19
Commercial
Trade Name
FDA
EMA
Actemra
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 actemra actpen | Biologic Licensing Application | 2021-03-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| giant cell arteritis | EFO_1001209 | D013700 | M31.6 |
| juvenile arthritis | EFO_0002609 | D001171 | M08 |
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
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
425 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 8 | 7 | 75 | 38 | 31 | 158 |
| Covid-19 | D000086382 | U07.1 | 2 | 14 | 12 | 4 | 10 | 41 | |
| Juvenile arthritis | D001171 | EFO_0002609 | M08 | 5 | 1 | 11 | 2 | 2 | 20 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 5 | 5 | 1 | 4 | 15 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | 3 | 5 | 4 | 2 | — | 13 |
| Cytokine release syndrome | D000080424 | D89.83 | 1 | 2 | 1 | 1 | 5 | 9 | |
| Healthy volunteers/patients | — | 4 | — | — | 1 | 2 | 7 | ||
| Takayasu arteritis | D013625 | EFO_1001857 | M31.4 | — | 2 | 1 | 1 | 1 | 5 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 2 | — | — | 1 | — | 3 |
| Retroperitoneal fibrosis | D012185 | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | C85.9 | 9 | 7 | 1 | — | — | 12 | |
| Neoplasms | D009369 | C80 | 5 | 3 | 1 | — | 1 | 9 | |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 2 | 1 | — | 3 | 5 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 2 | 3 | — | — | 4 |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 3 | 1 | 1 | — | — | 4 | |
| Polymyalgia rheumatica | D011111 | EFO_0008518 | M35.3 | — | 1 | 2 | — | 1 | 4 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | 1 | 1 | — | 1 | 3 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | 1 | 1 | — | 1 | 2 |
| Inflammation | D007249 | — | — | 1 | — | 1 | 2 | ||
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | 1 | 2 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | C90.0 | 7 | 2 | — | — | — | 7 | |
| Myeloid leukemia acute | D015470 | C92.0 | 3 | 2 | — | — | — | 5 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 2 | 3 | — | — | — | 4 | |
| Non-small-cell lung carcinoma | D002289 | 2 | 3 | — | — | — | 3 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 3 | 2 | — | — | — | 3 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 3 | — | — | — | 3 |
| Leukemia | D007938 | C95 | — | 3 | — | — | — | 3 | |
| Graft vs host disease | D006086 | D89.81 | 1 | 2 | — | — | — | 3 | |
| Hematologic neoplasms | D019337 | 1 | 3 | — | — | — | 3 | ||
| Relapsing polychondritis | D011081 | EFO_1001148 | M94.1 | — | 2 | — | — | 1 | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | 3 | — | — | — | — | 3 | ||
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 3 | — | — | — | — | 3 | |
| Colorectal neoplasms | D015179 | 1 | — | — | — | — | 1 | ||
| Uveal neoplasms | D014604 | EFO_1001230 | 1 | — | — | — | — | 1 | |
| Mantle-cell lymphoma | D020522 | C83.1 | 1 | — | — | — | — | 1 | |
| Biliary tract neoplasms | D001661 | C24.9 | 1 | — | — | — | — | 1 | |
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 1 | — | — | — | — | 1 |
| Precursor b-cell lymphoblastic leukemia-lymphoma | D015452 | 1 | — | — | — | — | 1 | ||
| Small cell lung carcinoma | D055752 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 3 | 3 |
| Critical illness | D016638 | — | — | — | — | 1 | 1 | ||
| Infections | D007239 | EFO_0000544 | — | — | — | — | 1 | 1 | |
| Adiposity | D050154 | — | — | — | — | 1 | 1 | ||
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | 1 | 1 | ||
| Defense mechanisms | D003674 | — | — | — | — | 1 | 1 | ||
| Treatment refusal | D016312 | — | — | — | — | 1 | 1 | ||
| Appetitive behavior | D001070 | — | — | — | — | 1 | 1 | ||
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 1 | 1 |
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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 | 375823-41-9 |
| RxCUI | 612865 |
| ChEMBL ID | CHEMBL1237022 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06273 |
| UNII ID | I031V2H011 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Actemra - Roche
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 32,220 documents
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Safety
Black-box Warning
Black-box warning for: Actemra actemra actpen
Adverse Events
Top Adverse Reactions
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14,121 adverse events reported
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