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
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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 | 2024-10-24 |
| tofidence | Biologic Licensing Application | 2024-07-29 |
| 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
562 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 | 12 | 9 | 93 | 46 | 86 | 244 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 8 | 8 | 79 | 44 | 84 | 222 |
| Covid-19 | D000086382 | — | — | 4 | 20 | 21 | 4 | 27 | 74 |
| Pneumonia | D011014 | EFO_0003106 | — | 1 | 8 | 7 | 1 | 10 | 27 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | 5 | 2 | 14 | 2 | 3 | 25 |
| Arteritis | D001167 | EFO_0009011 | I77.6 | 3 | 7 | 6 | 4 | 3 | 22 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | 3 | 8 | 7 | 2 | 3 | 22 |
| Polymyalgia rheumatica | D011111 | EFO_0008518 | M35.3 | 3 | 8 | 7 | 2 | 3 | 22 |
| Cytokine release syndrome | D000080424 | — | D89.83 | 3 | 4 | 3 | 2 | 6 | 16 |
| Syndrome | D013577 | — | — | 1 | 8 | 2 | 1 | 4 | 14 |
Show 22 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 20 | 15 | 4 | — | — | 29 |
| B-cell lymphoma | D016393 | — | — | 15 | 9 | 2 | — | — | 17 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 6 | 1 | — | 8 | 15 |
| Leukemia | D007938 | — | C95 | 10 | 5 | 1 | — | — | 15 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 11 | 10 | 1 | — | — | 14 |
| Infections | D007239 | EFO_0000544 | — | 1 | 5 | 3 | — | 5 | 12 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 7 | 3 | 1 | — | — | 9 |
| Communicable diseases | D003141 | — | — | 1 | 3 | 1 | — | 4 | 7 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34.0 | 1 | 1 | 4 | — | 1 | 6 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | 1 | 4 | — | 1 | 6 |
Show 49 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 6 | 4 | — | — | 2 | 10 |
| Lymphoid leukemia | D007945 | — | C91 | 6 | 3 | — | — | — | 8 |
| Graft vs host disease | D006086 | — | D89.81 | 2 | 5 | — | — | — | 6 |
| Virus diseases | D014777 | — | B34 | — | 4 | — | — | 2 | 6 |
| Hematologic neoplasms | D019337 | — | — | 2 | 5 | — | — | — | 6 |
| Uveitis | D014605 | HP_0000554 | H20.9 | 2 | 5 | — | — | 1 | 6 |
| Non-small-cell lung carcinoma | D002289 | — | — | 3 | 3 | — | — | 1 | 5 |
| Adenocarcinoma | D000230 | — | — | 3 | 3 | — | — | — | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 3 | — | — | — | 5 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 3 | 2 | — | — | — | 5 |
Show 108 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 2 | — | — | — | 1 | 3 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | 3 | — | — | — | — | 3 |
| Myeloid leukemia | D007951 | — | C92 | 2 | — | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | — | — | — | — | 2 |
| Uveal neoplasms | D014604 | EFO_1001230 | — | 1 | — | — | — | — | 1 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 1 | — | — | — | — | 1 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Sarcoma | D012509 | — | — | 1 | — | — | — | — | 1 |
| Basal cell carcinoma | D002280 | — | — | 1 | — | — | — | — | 1 |
Show 13 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Critical illness | D016638 | — | — | — | — | — | — | 5 | 5 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 4 | 4 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | — | — | 2 | 2 |
| Rheumatic fever | D012213 | EFO_1001160 | I00-I02 | — | — | — | — | 2 | 2 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | — | — | — | — | 1 | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
Show 41 more
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) |
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Actemra – Roche
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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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95,396 adverse events reported
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