Tocilizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2005
- First approval year
- 2005
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Tocilizumab
- actemra roactemra
- Actemra roactemra
- roactemra
- Roactemra
- tofidence
- Tofidence
- tyenne
- Tyenne
- actemra
- Actemra
- actemra mtx
- Actemra(EU-licensed)
- Actemra®
- atlizumab
- Atlizumab
- ATLIZUMAB
- avtozma
- Avtozma
- AVTOZMA
- bat 1806
- BAT-1806
- bat1806
- Bat1806
- BAT1806
- BAT1806 injection
- biib 800
- BIIB-800
- biib800
- Biib800
- BIIB800
- CT-P47 AI (tocilizumab)
- CT-P47 PFS (tocilizumab)
- immunoglobulin g1 anti human interleukin 6 receptor human mouse monoclonal mra heavy chain disulfide with human mouse monoclonal mra kappa chain dimer
And 86 more, listed on the interactive page.
- ATC classification codes
- L04AC07
Sources for recorded values
- CAS registry numbers
- 375823-41-9
- ChEMBL ID
- CHEMBL1237022
- FDA ingredient codes (UNII)
- I031V2H011
- 612865
- 2679427
- Applicant
- GENENTECH
- Approval date
- 8 Jan 2010
- Application number
- BLA125276
- Status
- Authorised
- Status date
- 16 Jan 2009
- Authorisation date
- 16 Jan 2009
- Approved indications
- RoActemra, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients. RoActemra, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older. RoActemra, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
- Product number
- EMEA/H/C/000955
- Authorisation holder
- Roche Registration GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 4
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Arthritis, Juvenile Rheumatoid
- Arthritis, Rheumatoid
- COVID-19 virus infection
- Cytokine Release Syndrome
- Giant Cell Arteritis
European medicines record
- Patents
- 0
- Designations
- 4
- Earliest recorded loss of exclusivity
- 4 Sept 2028
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- tocilizumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- Interleukin-6 receptor
- Gene symbol
- IL6ST
- Protein identifier
- P08887
- Median affinity
- 8.6
- Affinity units
- pKd
- Primary target
- Yes
- Action
- Binding
- Action type
- Binding
- Target
- Interleukin-6 receptor
- Gene symbol
- IL6R
- Protein identifier
- P40189
- Median affinity
- 8.6
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Interleukin-6 receptor alpha subunit inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-6 receptor subunit alpha
- Protein identifier
- P08887
Open Targets mechanisms
- Mechanism
- Interleukin-6 receptor alpha subunit inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-6 receptor subunit alpha
- Condition
- Cytokine Release Syndrome
- Highest recorded phase
- 4
- Subject identifier
- D000080424
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000094
- Subject identifier
- D015456
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Astrocytoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000272
- Subject identifier
- D001254
- Condition
- Dermatomyositis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000398
- Subject identifier
- D003882
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Epilepsy
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000474
- Subject identifier
- D004827
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Scleroderma, Systemic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000717
- Subject identifier
- D012595
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- Virus Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000763
- Subject identifier
- D014777
- Condition
- HIV Infections
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Hypertension, Pulmonary
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001361
- Subject identifier
- D006976
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
And 55 more, listed on the interactive page.
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000182
- Condition identifier
- EFO_0000220
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000222
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000398
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000403
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000474
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000612
- Condition identifier
- EFO_0000616
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0000694
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000717
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000764
- Condition identifier
- EFO_0001073
- Condition identifier
- EFO_0001361
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002609
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003046
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Condition identifier
- EFO_0003063
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003780
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003782
- Highest recorded phase
- 2
And 149 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Warning
- Black Box Warning
- Effect
- infectious disease
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Event
- abdominal discomfort
- Reports
- 3,246
- Reporting signal score
- 4,252.8
- Event
- acute kidney injury
- Reports
- 1,844
- Reporting signal score
- 880.1
- Event
- alopecia
- Reports
- 3,408
- Reporting signal score
- 4,573.06
- Event
- anti-cyclic citrullinated peptide antibody positive
- Reports
- 1,306
- Reporting signal score
- 4,397.3
- Event
- arthralgia
- Reports
- 5,644
- Reporting signal score
- 4,803.09
- Event
- arthritis
- Reports
- 1,115
- Reporting signal score
- 1,027.71
- Event
- arthropathy
- Reports
- 3,268
- Reporting signal score
- 6,484.98
- Event
- blister
- Reports
- 919
- Reporting signal score
- 868.558
- Event
- blood iron abnormal
- Reports
- 237
- Reporting signal score
- 731.448
- Event
- bone erosion
- Reports
- 500
- Reporting signal score
- 1,399.81
- Event
- c-reactive protein abnormal
- Reports
- 1,012
- Reporting signal score
- 2,924.52
- Event
- c-reactive protein increased
- Reports
- 1,257
- Reporting signal score
- 1,538.66
- Event
- condition aggravated
- Reports
- 3,379
- Reporting signal score
- 2,048.06
- Event
- discomfort
- Reports
- 1,358
- Reporting signal score
- 2,055.05
- Event
- diverticulitis
- Reports
- 769
- Reporting signal score
- 907.529
- Event
- drug hypersensitivity
- Reports
- 3,541
- Reporting signal score
- 2,152.2
- Event
- drug intolerance
- Reports
- 5,175
- Reporting signal score
- 8,803.87
- Event
- duodenal ulcer perforation
- Reports
- 618
- Reporting signal score
- 1,743.7
- Event
- fatigue
- Reports
- 5,443
- Reporting signal score
- 1,950.28
- Event
- folliculitis
- Reports
- 675
- Reporting signal score
- 1,546.61
- Event
- gastrointestinal disorder
- Reports
- 1,057
- Reporting signal score
- 852.167
- Event
- glossodynia
- Reports
- 2,140
- Reporting signal score
- 5,829.06
- Event
- hand deformity
- Reports
- 2,054
- Reporting signal score
- 6,341.44
- Event
- helicobacter infection
- Reports
- 698
- Reporting signal score
- 1,691.6
- Event
- hepatic enzyme increased
- Reports
- 2,268
- Reporting signal score
- 3,074.44
And 44 more, listed on the interactive page.
- NCT00106522
- NCT00106535
- NCT00106548
- NCT00106574
- NCT00109408
- NCT00144508
- NCT00144521
- NCT00144534
- NCT00144547
- NCT00144586
- NCT00144651
- NCT00365001
- NCT00380601
- NCT00531817
- NCT00535782
- NCT00720798
- NCT00721123
- NCT00750880
- NCT00754559
- NCT00754572
- NCT00773461
- NCT00810199
- NCT00810277
- NCT00845832
- NCT00848120
And 281 more, listed on the interactive page.
- Dose
- 4 mg per kg
- Route
- Intravenous
- How often
- Every 4 weeks
Conditions of use
- Initial dose in RA, GCA, PJIA, SJIA: 4 mg per kg, then increase to 8 mg per kg based on response
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 50242-135
- 50242-136
- 50242-137
- 50242-138
- 50242-143
- 64406-022
- 64406-023
- 64406-024
- 65219-584
- 65219-586
- 65219-590
- 65219-592
- 65219-594
- 65219-596
- 65219-598
- 72606-042
- 72606-043
- 72606-044
- 72606-045
- 78206-200
- 78206-201
- 78206-202
Related records
Trials (526)
- "Comparison of the Efficacy and Safety of Adalimumab to That of Tocilizumab in Severe Uveitis of Behçet's Disease"
- A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
- A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)
- A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.
- A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420.
- A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma
- A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
- A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
- A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)
- A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926
- A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study
- A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core Study
- A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis
- A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis
- A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)
- A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).
- A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
- A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid Arthritis
- A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488
- A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis
Approved for (9)
- COVID-19
- Cytokine release syndrome
- Immune system disorder
- Juvenile idiopathic arthritis
- Polyarticular juvenile idiopathic arthritis
- Rheumatoid arthritis
- Severe acute respiratory syndrome
- Systemic sclerosis
- Temporal arteritis
In development for (68)
- Acute lymphoblastic leukemia Phase 1
- Acute myeloid leukemia Phase 1
- Acute respiratory distress syndrome Phase 2
- Adult-onset Still disease Phase 2
- Amyotrophic lateral sclerosis Phase 2
- Ankylosing spondylitis Phase 3
- Astrocytoma (excluding glioblastoma) Phase 2
- B-cell acute lymphoblastic leukemia Phase 1
- B-cell chronic lymphocytic leukemia Phase 1
- B-cell non-Hodgkin lymphoma Phase 1
- Behcet disease Phase 2
- Breast cancer Phase 2
- Castleman disease Phase 2
- Chondrocalcinosis Phase 2
- Chronic kidney disease Phase 1
- Colorectal cancer Phase 1
- Dermatomyositis Phase 2
- Diffuse large B-cell lymphoma Phase 3
- Epilepsy Phase 3
- Erdheim-Chester disease Phase 2
Other linked conditions (4)
- Acute graft versus host disease
- Myocardial infarction
- Nasopharyngeal carcinoma
- Obesity disorder
Targets (1)
- IL6R Interleukin-6 receptor alpha subunit inhibitor