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Accession Number
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)

Tocilizumab is a recombinant, humanized, anti-human interleukin 6 (IL-6) receptor monoclonal antibody that achieves a significant therapeutic response rate. The light chain is made up of 214 amino acids. The heavy chain is made up of 448 amino acids. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. FDA approved on January 8, 2010.

Tocilizumab (injection) was further approved by the FDA for the treatment of adults with giant cell arteritis, an inflammation of the blood vessels (vasculitis) in May, 2017. In a double-blind, placebo-controlled study, the patients achieved sustained remission from Week 12 through Week 52, which was associated with significant improvements in symptoms of giant cell arteritis, normalization of inflammatory laboratory tests and tapering the use of corticosteroids 2.

Protein structure
Protein chemical formula
Protein average weight
148000.0 Da
Not Available
  • Atlizumab
External IDs
MRA / R-1569 / RHPM-1 / RO-4877533
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
ActemraInjection, solution180 mg/1mLSubcutaneousGenentech, Inc.2013-10-21Not applicableUs
ActemraSolutionIntravenousHoffmann La Roche2010-05-26Not applicableCanada
ActemraInjection, solution, concentrate20 mg/1mLIntravenousGenentech, Inc.2010-01-08Not applicableUs
ActemraSolutionSubcutaneousHoffmann La Roche2014-05-30Not applicableCanada
ActemraInjection, solution, concentrate20 mg/1mLIntravenousGenentech, Inc.2010-01-08Not applicableUs
ActemraSolution162 mgSubcutaneousHoffmann La Roche2019-01-15Not applicableCanada
ActemraSolutionIntravenousHoffmann La Roche2010-05-26Not applicableCanada
ActemraInjection, solution, concentrate20 mg/1mLIntravenousGenentech, Inc.2010-01-08Not applicableUs
ActemraSolutionIntravenousHoffmann La Roche2010-05-26Not applicableCanada
Actemra ACTPenInjection, solution180 mg/1mLSubcutaneousGenentech, Inc.2018-11-19Not applicableUs
Additional Data Available
  • Application Number
    Application Number

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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International/Other Brands
CAS number



Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). It is also indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) and active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older.

Associated Conditions

A decrease in C-reactive protein (CRP) was noted as early as week 2. Changes in pharmacodynamic parameters were observed (i.e., decreases in rheumatoid factor, erythrocyte sedimentation rate (ESR), serum amyloid A and increases in hemoglobin) with both doses, however the greatest improvements were observed with 8 mg per kg tocilizumab. Similar pharmacodynamic changes were also observed in active polyarticular juvenile idiopathic arthritis and active systemic juvenile idiopathic arthritis patients.

Mechanism of action

Interleukin (IL)-6 plays essential roles not only in the immune response, but also in haematopoiesis and the central nervous system. Unregulated production of IL-6 has been found in chronic inflammatory autoimmune diseases, such as rheumatoid arthritis (RA), systemic onset juvenile idiopathic arthritis (soJIA), Crohn's disease (CD), systemic lupus erythematosus (SLE) and vasculitis. Furthermore, IL-6 activities can explain many symptoms of these diseases. More importantly, serum levels of IL-6 are correlated with disease activity. Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors.

AInterleukin-6 receptor subunit alpha
Additional Data Available
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When 4 mg/kg of tocilizumab was given every 4 weeks to RA patients, the pharmacokinetic parameters at steady state are as follows: AUC = 13000 ± 5800 mcg∙h/mL; Cmax = 88.3 ± 41.4 mcg/mL. Tocilizumab accumulates following repeated doses. Furthermore, an increased body weight may increase plasma levels of tocilizumab.

When a dose of 8 mg/kg of tocilizumab is given to PJIA patients, the pharmacokinetic parameters are as follows: AUC = 29500 ± 8660 mcg∙h/mL; Cmax = 182 ± 37 mcg/mL.

When a dose of 8 mg/kg of tocilizumab is given to SJIA patients, the pharmacokinetic parameters are as follows: AUC = 32200 ± 9960 mcg∙h/mL; Cmax = 245 ± 57.2 mcg/mL.

Volume of distribution

In rheumatoid arthritis patients the central volume of distribution was 3.5 L and the peripheral volume of distribution was 2.9 L, resulting in a volume of distribution at steady state of 6.4 L.

In pediatric patients with PJIA, the central volume of distribution was 1.98 L, the peripheral volume of distribution was 2.1 L, resulting in a volume of distribution at steady state of 4.08 L.

In pediatric patients with SJIA, the central volume of distribution was 0.94 L, the peripheral volume of distribution was 1.60 L resulting in a volume of distribution at steady state of 2.54 L.

Protein binding
Not Available
Not Available
Route of elimination

Following intravenous dosing, tocilizumab undergoes biphasic elimination from the circulation.

Half life

The half-life of tocilizumab is concentration-dependent. The concentration-dependent apparent half-life is up to 11 days for 4 mg/kg and up to 13 days for 8 mg/kg every 4 weeks in patients with RA at steady-state. The half-life in children with PJIA is up to 16 days. The half-life in pediatric patients with SJIA is up to 23 days.


The clearance of tocilizumab decreases with increasing dose. At the 10 mg/kg single dose in RA patients, mean clearance was 0.29 ± 0.10 mL/hr/kg. The total clearance of tocilizumab is concentration-dependent and is the sum of the linear clearance and the nonlinear clearance. At low concentrations, concentration-dependent nonlinear clearance is dominant. At high concentrations, linear clearance dominates. The estimated linear clearances for specific patient populations are as follows: RA = 12.5 mL/h; PJIA, pediatric patients = 5.8 mL/h; SJIA, pediatric patients = 7.1 mL/h.


Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT.

Affected organisms
  • Humans and other mammals
Not Available
Pharmacogenomic Effects/ADRs
Not Available


Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
(R)-warfarinThe metabolism of (R)-warfarin can be increased when combined with Tocilizumab.
(S)-WarfarinThe metabolism of (S)-Warfarin can be increased when combined with Tocilizumab.
2-MethoxyethanolThe risk or severity of adverse effects can be increased when 2-Methoxyethanol is combined with Tocilizumab.
4-hydroxycoumarinThe metabolism of 4-hydroxycoumarin can be increased when combined with Tocilizumab.
4-MethoxyamphetamineThe metabolism of 4-Methoxyamphetamine can be increased when combined with Tocilizumab.
5-methoxy-N,N-dimethyltryptamineThe metabolism of 5-methoxy-N,N-dimethyltryptamine can be increased when combined with Tocilizumab.
6-O-benzylguanineThe metabolism of 6-O-benzylguanine can be increased when combined with Tocilizumab.
8-azaguanineThe metabolism of 8-azaguanine can be increased when combined with Tocilizumab.
8-chlorotheophyllineThe metabolism of 8-chlorotheophylline can be increased when combined with Tocilizumab.
9-(N-methyl-L-isoleucine)-cyclosporin AThe risk or severity of adverse effects can be increased when Tocilizumab is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.
Additional Data Available
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Food Interactions
Not Available


General References
  1. Mihara M, Nishimoto N, Ohsugi Y: The therapy of autoimmune diseases by anti-interleukin-6 receptor antibody. Expert Opin Biol Ther. 2005 May;5(5):683-90. [PubMed:15934843]
  2. FDA Press Announcements: FDA approves first drug to specifically treat giant cell arteritis [Link]
External Links
PubChem Substance
RxList Drug Page Drug Page
ATC Codes
L04AC07 — Tocilizumab
AHFS Codes
  • 92:36.00 — Disease-modifying Antirheumatic Agents
FDA label
Download (512 KB)
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Clinical Trials

Clinical Trials
0RecruitingTreatmentAdamantinomatous Craniopharyngioma1
0WithdrawnTreatmentMultiple Myeloma (MM)1
1Active Not RecruitingTreatmentGiant Cell Arteritis (GCA)1
1Active Not RecruitingTreatmentJuvenile Idiopathic Arthritis (JIA)1
1Active Not RecruitingTreatmentRheumatoid Arthritis1
1CompletedBasic ScienceHealthy Volunteers1
1CompletedBasic ScienceRheumatoid Arthritis1
1CompletedTreatmentCastleman's Disease1
1CompletedTreatmentHealthy Volunteers2
1CompletedTreatmentJuvenile Idiopathic Arthritis (JIA)2
1CompletedTreatmentJuvenile Idiopathic Arthritis (JIA) / Juvenile Idiopathic Arthritis, Rheumatoid Arthritis / Systemic Juvenile Idiopathic Arthritis (SJIA)1
1CompletedTreatmentRheumatoid Arthritis3
1CompletedTreatmentSolid Cancers / Tumors, Solid1
1CompletedTreatmentTumors, Solid1
1Not Yet RecruitingTreatmentFollicular Lymphoma (FL)1
1Not Yet RecruitingTreatmentGraft Versus Host Disease (GVHD) / Steroid Refractory GVHD1
1RecruitingTreatmentB-cell Non-Hodgkin's Lymphomas1
1RecruitingTreatmentBreast Cancer1
1RecruitingTreatmentCD19 Positive / CD20 Positive / Chronic Lymphocytic Leukemia (CLL) - Refractory / Chronic, recurrent Lymphocytic Leukemia / Recurrent Diffuse Large B-Cell Lymphoma / Recurrent Follicular Lymphoma / Recurrent Mantle Cell Lymphoma / Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma / Recurrent Small Lymphocytic Lymphoma / Refractory Diffuse Large B Cell Lymphoma / Refractory Follicular Lymphoma / Refractory Mantle Cell Lymphoma / Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma / Refractory Small Lymphocytic Lymphoma1
1RecruitingTreatmentChronic Leukemias / Leukemia, Acute / Malignant Lymphomas / Multiple Myeloma (MM) / Myelodysplastic Syndromes1
1RecruitingTreatmentColorectal Cancers1
1RecruitingTreatmentFollicular Lymphoma (FL) / Lymphoma, B-Cell / Non-Hodgkin's Lymphoma (NHL)1
1RecruitingTreatmentNon-Hodgkin's Lymphoma (NHL)2
1RecruitingTreatmentPsychotic Disorder NOS / Schizophrenia1
1TerminatedTreatmentB-Cell Chronic Lymphocytic Leukemia / Chronic Lymphocytic Leukaemia (CLL)1
1TerminatedTreatmentLeukemia Acute Myeloid Leukemia (AML)1
1, 2Active Not RecruitingBasic ScienceHuman Immunodeficiency Virus (HIV) Infections1
1, 2Active Not RecruitingTreatmentChorioretinitis / Non-infectious Intermediate, Posterior, or Pan-uveitis / Pan-uveitis / Uveitis, Intermediate1
1, 2CompletedTreatmentEnd Stage Renal Disease (ESRD)1
1, 2CompletedTreatmentNeuromyelitis Optica / Neuromyelitis Optica Spectrum Disorders1
1, 2CompletedTreatmentRecurrent Ovarian Cancer1
1, 2Not Yet RecruitingTreatmentHepatocellular,Carcinoma1
1, 2RecruitingPreventionCytokine Release Syndrome / Stem Cell Transplant Complications1
1, 2RecruitingTreatmentAcute Lymphocytic Leukemia, Pediatric / B-cell Acute Lymphoblastic Leukemia1
1, 2RecruitingTreatmentB-cell Non-Hodgkin's Lymphomas1
1, 2RecruitingTreatmentChronic Subdural Hematomas1
1, 2RecruitingTreatmentGiant Cell Arteritis (GCA)1
1, 2RecruitingTreatmentLiving-Donor Kidney Transplants / Renal Transplant Recipient Patients1
1, 2RecruitingTreatmentLung Cancer Non-Small Cell Cancer (NSCLC)1
1, 2RecruitingTreatmentLymphoma, Large B-Cell, Diffuse (DLBCL)1
1, 2RecruitingTreatmentTransitional Cell Carcinoma1
1, 2RecruitingTreatmentTransplantation, Kidney1
1, 2TerminatedTreatmentGraft Versus Host Disease, Acute1
1, 2TerminatedTreatmentJuvenile Idiopathic Arthritis Associated Uveitis1
2Active Not RecruitingTreatmentHeart Arrest / Out-Of-Hospital Cardiac Arrest / Systemic Inflammatory Response Syndrome (SIRS)1
2Active Not RecruitingTreatmentLate Complication From Kidney Transplant1
2Active Not RecruitingTreatmentNew-onset Type 1 Diabetes Mellitus / T1D / T1DM / Type 1 Diabetes Mellitus1
2CompletedPreventionAcute Graft Versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation / Hematopoietic Stem Cell Transplantation (HSCT)1
2CompletedTreatmentAmyotrophic Lateral Sclerosis (ALS) / Lou Gehrig's Disease / Motor Neurone Disease1
2CompletedTreatmentDermatomyositis / Polymyositis1
2CompletedTreatmentFibrous Dysplasia of Bone1
2CompletedTreatmentGiant Cell Arteritis (GCA)2
2CompletedTreatmentNon-ST Elevation Myocardial Infarction1
2CompletedTreatmentPolymyalgia Rheumatica (PMR)1
2CompletedTreatmentPulmonary Arterial Hypertension (PAH)1
2CompletedTreatmentRheumatoid Arthritis5
2CompletedTreatmentSchnitzler's Syndrome1
2Not Yet RecruitingTreatmentAutoimmune Diseases / Inflammatory Diseases1
2Not Yet RecruitingTreatmentGiant Cell Arteritis (GCA) / Ischemic Optic Neuropathy1
2Not Yet RecruitingTreatmentMajor Depressive Disorder (MDD)1
2Not Yet RecruitingTreatmentMalignant Neoplasm of Pancreas1
2RecruitingTreatmentAcute Lymphoblastic Leukaemias (ALL) / Leukemia Acute Myeloid Leukemia (AML) / Leukemia, Acute / Leukemias / Lymphoma, Hodgkins / Myelodysplastic Syndromes / Myelodysplastic-Myeloproliferative Diseases / Myeloproliferative Disorders / Non-Hodgkin's Lymphoma (NHL)1
2RecruitingTreatmentBehcet's Syndrome / Uveitis1
2RecruitingTreatmentBiotherapy / Uveitis1
2RecruitingTreatmentCardiac Transplant1
2RecruitingTreatmentCastleman's Disease / Giant Lymph Node Hyperplasia1
2RecruitingTreatmentCoronary Heart Disease (CHD) / Myocardial Infarction1
2RecruitingTreatmentFamilial Mediterranean Fever (FMF )1
2RecruitingTreatmentLymphohistiocytosis, Hemophagocytic1
2RecruitingTreatmentMajor Depressive Disorder (MDD)1
2RecruitingTreatmentMalignancies, Hematologic1
2RecruitingTreatmentUnresectable Pancreatic Carcinoma1
2TerminatedTreatmentBehcet's Syndrome1
2TerminatedTreatmentErdheim-Chester Disease (ECD)1
2TerminatedTreatmentGlucocorticosteroid Refractory Acute GVHD1
2TerminatedTreatmentRheumatoid Arthritis1
2Unknown StatusTreatmentAdult's Still Disease1
2WithdrawnSupportive CareGraft Versus Host Disease (GVHD)1
2WithdrawnTreatmentDiabetic Macular Edema (DME)1
2WithdrawnTreatmentRelapsing Polychondritis1
2, 3CompletedTreatmentNeuromyelitis Optica / Neuromyelitis Optica Spectrum Disorders1
2, 3CompletedTreatmentPrimary Sjögren's Syndrome (pSS)1
3Active Not RecruitingSupportive CarePolymyalgia Rheumatica1
3Active Not RecruitingTreatmentJuvenile Idiopathic Arthritis (JIA)1
3CompletedTreatmentGiant Cell Arteritis (GCA)2
3CompletedTreatmentJuvenile Idiopathic Arthritis (JIA)5
3CompletedTreatmentOsteoarthritis of the Hands1
3CompletedTreatmentPolyarticular Juvenile Idiopathic Arthritis1
3CompletedTreatmentRheumatoid Arthritis67
3CompletedTreatmentSclerosis, Progressive Systemic2
3CompletedTreatmentSystemic Juvenile Idiopathic Arthritis (SJIA)3
3CompletedTreatmentThyroid Associated Ophthalmopathy / Thyroid Eye Disease1
3RecruitingTreatmentGiant Cell Arteritis (GCA) / Patients Diagnosed of Giant-cell Arteritis1
3RecruitingTreatmentPolymyalgia Rheumatica1
3RecruitingTreatmentRheumatoid Arthritis3
3RecruitingTreatmentTakayasu's Disease1
3TerminatedTreatmentAnkylosing Spondylitis (AS)2
3TerminatedTreatmentJuvenile Idiopathic Arthritis (JIA)1
3TerminatedTreatmentRheumatoid Arthritis1
4Active Not RecruitingBasic ScienceRheumatoid Arthritis1
4Active Not RecruitingTreatmentRheumatoid Arthritis2
4CompletedNot AvailableHealthy Volunteers1
4CompletedDevice FeasibilityRheumatoid Arthritis1
4CompletedOtherRheumatoid Arthritis1
4CompletedTreatmentCardiovascular Disease, Rheumatoid Arthritis / Rheumatoid Arthritis1
4CompletedTreatmentJuvenile Idiopathic Arthritis (JIA)1
4CompletedTreatmentRheumatoid Arthritis17
4CompletedTreatmentSchizoaffective Disorders / Schizophrenia1
4Enrolling by InvitationTreatmentRheumatoid Arthritis1
4Not Yet RecruitingTreatmentRheumatoid Arthritis of Knee1
4RecruitingTreatmentGiant Cell Arteritis (GCA)2
4RecruitingTreatmentJuvenile Idiopathic Arthritis (JIA)1
4RecruitingTreatmentRheumatoid Arthritis8
4RecruitingTreatmentRheumatoid Arthritis / Tocilizumab1
4TerminatedTreatmentRheumatoid Arthritis3
4Unknown StatusTreatmentRheumatoid Arthritis1
4WithdrawnTreatmentRheumatoid Arthritis1
Not AvailableActive Not RecruitingNot AvailableRheumatoid Arthritis1
Not AvailableActive Not RecruitingTreatmentLymphoblastic Leukemia, Acute, Childhood1
Not AvailableCompletedNot AvailablePolymyalgia Rheumatica1
Not AvailableCompletedNot AvailablePsoriatic Arthritis / Rheumatoid Arthritis / Spondyloarthritis1
Not AvailableCompletedNot AvailableRheumatoid Arthritis20
Not AvailableCompletedPreventionBMI >30 kg/m2 / Type 2 Diabetes Mellitus1
Not AvailableCompletedTreatmentMyocardial Infarction1
Not AvailableCompletedTreatmentRelapsing Polychondritis1
Not AvailableCompletedTreatmentRheumatoid Arthritis3
Not AvailableNo Longer AvailableNot AvailableJuvenile Idiopathic Arthritis (JIA)1
Not AvailableNot Yet RecruitingNot AvailableInfection / Rheumatoid Arthritis1
Not AvailableNot Yet RecruitingNot AvailableRheumatoid Arthritis1
Not AvailableRecruitingNot AvailableAnkylosing Spondylitis (AS) / Psoriatic Arthritis / Rheumatoid Arthritis1
Not AvailableRecruitingNot AvailableInflammatory Reaction / Rheumatoid Arthritis1
Not AvailableRecruitingNot AvailableMechanisms, Defense / Outcomes / Pregnancy Related / Takayasu's Disease / Treatment Refusal1
Not AvailableRecruitingNot AvailableRheumatoid Arthritis1
Not AvailableRecruitingBasic ScienceBMI >30 kg/m2 / Healthy Volunteers1
Not AvailableRecruitingOtherAdiposity1
Not AvailableRecruitingOtherEnd-Stage Renal Disease (ESRD) / Hla-incompatible Kidney Transplant Candidates / Transplantation, Kidney1
Not AvailableRecruitingTreatmentArthritis / Colitis / Tumors, Solid1
Not AvailableTerminatedTreatmentRheumatoid Arthritis, Juvenile / Still's Disease, Juvenile Onset1


Not Available
Not Available
Dosage forms
Injection, solutionSubcutaneous180 mg/1mL
Injection, solution, concentrateIntravenous20 mg/1mL
SolutionSubcutaneous162 mg
Not Available
Patent NumberPediatric ExtensionApprovedExpires (estimated)
Additional Data Available
  • Filed On
    Filed On

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Experimental Properties
Not Available


Not Available
Organic Compounds
Super Class
Organic Acids
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Alternative Parents
Not Available
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available


Pharmacological action
General Function
Protein homodimerization activity
Specific Function
Part of the receptor for interleukin 6. Binds to IL6 with low affinity, but does not transduce a signal. Signal activation necessitate an association with IL6ST. Activation may lead to the regulati...
Gene Name
Uniprot ID
Uniprot Name
Interleukin-6 receptor subunit alpha
Molecular Weight
51547.015 Da
  1. Smolen JS, Maini RN: Interleukin-6: a new therapeutic target. Arthritis Res Ther. 2006;8 Suppl 2:S5. Epub 2006 Jul 28. [PubMed:16899109]


Pharmacological action
General Function
Vitamin d3 25-hydroxylase activity
Specific Function
Cytochromes P450 are a group of heme-thiolate monooxygenases. In liver microsomes, this enzyme is involved in an NADPH-dependent electron transport pathway. It performs a variety of oxidation react...
Gene Name
Uniprot ID
Uniprot Name
Cytochrome P450 3A4
Molecular Weight
57342.67 Da
  1. Long TJ, Cosgrove PA, Dunn RT 2nd, Stolz DB, Hamadeh H, Afshari C, McBride H, Griffith LG: Modeling Therapeutic Antibody-Small Molecule Drug-Drug Interactions Using a Three-Dimensional Perfusable Human Liver Coculture Platform. Drug Metab Dispos. 2016 Dec;44(12):1940-1948. doi: 10.1124/dmd.116.071456. Epub 2016 Sep 12. [PubMed:27621203]
  2. Tocilizumab FDA label [Link]

Drug created on March 19, 2008 10:20 / Updated on February 27, 2020 21:29