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Adalimumab
Identification
- Name
- Adalimumab
- Accession Number
- DB00051
- Description
Adalimumab is a subcutaneously administered biological disease modifier for the treatment of rheumatoid arthritis and other chronic debilitating diseases mediated by tumor necrosis factor 2, 3. It was originally launched by Abbvie in the U.S. and approved in 2002 by the FDA 1. This drug is frequently known as Humira. It is produced by recombinant DNA technology using a mammalian cell expression system. This drug is available in a prefilled syringe form and convenient pen form for subcutaneous self-administered doses 1. A new biosimilar to adalimumab, named adalimumab-adaz, was approved by the FDA on October 31, 2018. This biosimilar is known as Hyrimoz, and is a trademark of Novartis AG 9.
- Type
- Biotech
- Groups
- Approved, Experimental
- Biologic Classification
- Protein Based Therapies
Monoclonal antibody (mAb) - Protein Structure
- Protein Chemical Formula
- C6428H9912N1694O1987S46
- Protein Average Weight
- 144190.3 Da
- Sequences
> Adalimumab Light chain: DIQMTQSPSSLSASVGDRVTITCRASQGIRNYLAWYQQKPGKAPKLLIYAASTLQSGVPS RFSGSGSGTDFTLTISSLQPEDVATYYCQRYNRAPYTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
> Adalimumab Heavy chain: EVQLVESGGGLVQPGRSLRLSCAASGFTFDDYAMHWVRQAPGKGLEWVSAITWNSGHIDY ADSVEGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCAKVSYLSTASSLDYWGQGTLVTVS SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS SGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLG GPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQY NSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRD ELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSR WQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Download FASTA Format- Synonyms
- Adalimumab (genetical recombination)
- adalimumab-adaz
- adalimumab-adbm
- adalimumab-afzb
- adalimumab-atto
- adalimumab-bwwd
- adalimumab-fkjp
- External IDs
- ABP-501
- BCD-057
- BI-695501
- BI695501
- CHS-1420
- D2E7
- GP-2017
- GP2017
- LU-200134
- LU200134
- M-923
- M923
- MSB-11022
- MSB11022
- ONS-3010
- SB-5
- SB5
Pharmacology
- Indication
The following are conditions for which adalimumab has been indicated 12, Label, 10, 5, 6, 11.
Rheumatoid Arthritis (Moderate to Severe)
Juvenile Idiopathic Arthritis (Moderately to Severely Active)
Psoriatic Arthritis (Active)
Ankylosing Spondylitis (Active)
Crohn’s Disease (Moderately to Severely Active)
Ulcerative Colitis (Moderately to Severely Active)
Plaque Psoriasis (Moderate to Severe Chronic)
Non-infectious Intermediate, Posterior and Panuveitis
Hidradenitis Suppurativa (Moderate to Severe)
Pyoderma Gangrenosum (off-label)
- Associated Conditions
- Crohn's Disease (CD)
- Non-infectious Intermediate, Posterior and Panuveitis
- Pediatric Crohn's Disease
- Psoriatic arthritis aggravated
- Pyoderma Gangrenosum
- Severe Plaque psoriasis
- Severe Ulcerative Colitis
- Active Ankylosing spondylitis
- Moderate Hidradenitis Suppurativa
- Moderate Juvenile idiopathic arthritis
- Moderate Plaque psoriasis
- Moderate Rheumatoid arthritis
- Moderate Ulcerative colitis
- Severe Hidradenitis Suppurativa
- Severe Juvenile idiopathic arthritis
- Severe Rheumatoid arthritis
- Contraindications & Blackbox Warnings
Learn about our commercial Contraindications & Blackbox Warnings data.
Learn More- Pharmacodynamics
After treatment with adalimumab, a decrease in levels of acute phase reactant proteins of inflammation (C reactive protein [CRP] and erythrocyte sedimentation rate [ESR]) and serum cytokines (IL-6) was measured compared to baseline in patients diagnosed with rheumatoid arthritis. A decrease in CRP levels was also observed in patients diagnosed with Crohn’s disease. Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that lead to the tissue remodeling responsible for cartilage destruction were also found to be decreased after administration of adalimumab 12, Label. A reduction in signs and symptoms of disease, the induction of a clinical response, an inhibition of structural damage, and improvements in physical function in adult and pediatric patients with various inflammatory conditions have been demonstrated 1, 3, Label.
- Mechanism of action
Adalimumab binds with specificity to tumor necrosis factor-alpha (TNF-alpha) 2, 3 and inhibits its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface tumor necrosis factor expressing cells in vitro when in the presence of complement. Adalimumab does not bind or inactivate lymphotoxin (Tumor necrosis factor-beta). TNF is a naturally occurring cytokine that plays a role in normal inflammatory and immune responses 3. Increased levels of TNF are found in the joint synovial fluid of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients, and play an imperative role in pathologic inflammation and the joint destruction that are major complications of these diseases. Increased levels of TNF are also measured in psoriasis plaques. In plaque psoriasis, treatment with adalimumab may decrease the epidermal thickness and inflammatory cell infiltration. The relationship between these pharmacodynamics and the mechanism(s) by which adalimumab achieves its clinical effects is not known. Additionally, adalimumab alters biological responses that are induced/regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration during inflammation (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10M) 12.
Target Actions Organism ATumor necrosis factor antibodyHumans - Absorption
The maximum serum concentration (Cmax) and the time to reach the maximum concentration (Tmax) were 4.7 ± 1.6 μg/mL and 131 ± 56 hours respectively, following a single 40 mg subcutaneous administration of adalimumab to healthy adult subjects. The average absolute bioavailability of adalimumab estimated from three clinical studies after a single 40 mg subcutaneous dose of adalimumab was 64%. The pharmacokinetics of adalimumab showed a linear pattern over the dose range of 0.5 to 10.0 mg/kg following a single intravenous dose 12.
- Volume of distribution
The distribution volume (Vss) ranged from 4.7-6.0 L 12. Adalimumab concentrations in the synovial fluid from five rheumatoid arthritis patients ranged from 31-96% of those in serum 12.
- Protein binding
- Not Available
- Metabolism
Most likely removed by opsonization via the reticuloendothelial system 7.
- Route of elimination
- Not Available
- Half-life
The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies 12.
- Clearance
12 mL/hr [RA patients with dose 0.25-10 mg/kg] 12. Population pharmacokinetic analyses in patients with rheumatoid arthritis showed a trend toward a higher apparent clearance of adalimumab in the presence of anti-adalimumab antibodies, and a lower clearance with increasing age in patients aged 40 years old to greater than 75 years old 12.
- Adverse Effects
Learn about our commercial Adverse Effects data.
Learn More- Toxicity
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies of adalimumab products have not been performed to study the carcinogenic potential or the drug's effect on fertility 12.
Refer to the "Adverse Effects" section for more information on adverse effects and "Blackbox Warnings" section for important black box information/warnings.
Rare side effects include: worsening or initiation of congestive heart failure, a lupus-like syndrome, lymphoma, medically significant cytopenias, and worsening or initiation of multiple sclerosis/neurological diseases. There has been reported pancytopenia and increased liver transaminases with the use of adalimumab, which suggests that laboratory value monitoring blood counts and liver function, at least intermittently, are important 4.
- Affected organisms
- Humans and other mammals
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- 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.
Drug Interaction Unlock Additional DataAbatacept The risk or severity of infection can be increased when Adalimumab is combined with Abatacept. Abciximab The risk or severity of adverse effects can be increased when Adalimumab is combined with Abciximab. Abiraterone The metabolism of Abiraterone can be increased when combined with Adalimumab. Acalabrutinib The metabolism of Acalabrutinib can be increased when combined with Adalimumab. Acebutolol The metabolism of Acebutolol can be increased when combined with Adalimumab. Acenocoumarol The metabolism of Acenocoumarol can be increased when combined with Adalimumab. Acetaminophen The metabolism of Acetaminophen can be increased when combined with Adalimumab. Acetohexamide The metabolism of Acetohexamide can be increased when combined with Adalimumab. Acetylsalicylic acid The metabolism of Acetylsalicylic acid can be increased when combined with Adalimumab. Acyclovir The metabolism of Acyclovir can be increased when combined with Adalimumab. Additional Data Available- Extended DescriptionExtended Description
Extended description of the mechanism of action and particular properties of each drug interaction.
Learn more - Severity
- Evidence Level
- ActionAction
An effect category for each drug interaction. Know how this interaction affects the subject drug.
Learn more
- Food Interactions
- Not Available
Products
- International/Other Brands
- Amjevita (Amgen, Inc.) / Cyltezo (Boehringer Ingelheim Pharmaceuticals, Inc.) / Humira Pen (Abbott Laboratories)
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Unlock Additional DataHadlima Solution Subcutaneous Samsung Bioepis Co., Ltd. Not applicable Not applicable Canada 
Hadlima Pushtouch Solution Subcutaneous Samsung Bioepis Co., Ltd. Not applicable Not applicable Canada Humira Injection, solution 40 mg Subcutaneous Abb Vie Deutschland Gmb H & Co. Kg 2003-09-08 Not applicable EU 
Humira Injection, solution 40 mg Subcutaneous Abb Vie Deutschland Gmb H & Co. Kg 2003-09-08 Not applicable EU Humira Injection, solution 40 mg Subcutaneous Abb Vie Deutschland Gmb H & Co. Kg 2003-09-08 Not applicable EU Humira Solution 20 mg Subcutaneous Abbvie 2020-08-18 Not applicable Canada Humira Solution 40 mg Subcutaneous Abbvie 2004-09-24 Not applicable Canada Humira Injection, solution 40 mg Subcutaneous Abb Vie Deutschland Gmb H & Co. Kg 2003-09-08 Not applicable EU Humira Injection, solution 40 mg Subcutaneous Abb Vie Deutschland Gmb H & Co. Kg 2003-09-08 Not applicable EU Humira Injection, solution 40 mg Subcutaneous Abb Vie Deutschland Gmb H & Co. Kg 2003-09-08 Not applicable EU Additional Data Available- Application NumberApplication Number
A unique ID assigned by the FDA when a product is submitted for approval by the labeller.
Learn more - Product CodeProduct Code
A governmentally-recognized ID which uniquely identifies the product within its regulatory market.
Learn more
- Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Humira Adalimumab (20 mg/0.4mL) + Isopropyl alcohol (0.70 mL/1mL) Subcutaneous; Topical AbbVie Inc. 2008-02-21 Not applicable US 
Humira Adalimumab (40 mg/0.8mL) + Isopropyl alcohol (0.70 mL/1mL) Subcutaneous; Topical A-S Medication Solutions 2006-06-23 2019-12-31 US Humira Adalimumab (40 mg/0.8mL) + Isopropyl alcohol (0.70 mL/1mL) Subcutaneous; Topical AbbVie Inc. 2002-12-31 Not applicable US Humira Adalimumab (80 mg/0.8mL) + Adalimumab (40 mg/0.4mL) + Isopropyl alcohol (0.7 mL/1mL) Subcutaneous; Topical AbbVie Inc. 2017-04-21 Not applicable US Humira Adalimumab (80 mg/0.8mL) + Isopropyl alcohol (0.70 mL/1mL) Subcutaneous; Topical AbbVie Inc. 2016-10-17 Not applicable US Humira Adalimumab (40 mg/0.4mL) + Isopropyl alcohol (0.70 mL/1mL) Subcutaneous; Topical AbbVie Inc. 2016-03-09 Not applicable US Humira Adalimumab (40 mg/0.8mL) + Isopropyl alcohol (0.70 mL/1mL) Subcutaneous; Topical AbbVie Inc. 2006-06-23 Not applicable US Humira Adalimumab (10 mg/0.1mL) + Isopropyl alcohol (0.7 mL/1mL) Subcutaneous; Topical AbbVie Inc. 2017-04-28 Not applicable US Humira Adalimumab (80 mg/0.8mL) + Adalimumab (40 mg/0.4mL) + Isopropyl alcohol (0.7 mL/1mL) Subcutaneous; Topical AbbVie Inc. 2017-04-21 Not applicable US Humira Adalimumab (40 mg/0.8mL) + Isopropyl alcohol (0.70 mL/1mL) Subcutaneous; Topical A-S Medication Solutions 2006-06-23 Not applicable US
Categories
- ATC Codes
- L04AB04 — Adalimumab
- Drug Categories
- Agents reducing cytokine levels
- Amino Acids, Peptides, and Proteins
- Anti-Inflammatory Agents
- Antibodies
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Antineoplastic and Immunomodulating Agents
- Antirheumatic Agents
- Biological Products
- Biologics for Rheumatoid Arthritis Treatment
- Blood Proteins
- Complex Mixtures
- Disease-modifying Antirheumatic Agents
- Globulins
- Immunoglobulins
- Immunomodulatory Agents
- Immunoproteins
- Immunosuppressive Agents
- Miscellaneous GI Drugs
- Proteins
- Serum Globulins
- Tumor Necrosis Factor Alpha (TNF-α) Inhibitors
- Tumor Necrosis Factor Blocker
- Tumor Necrosis Factor Receptor Blocking Activity
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
Chemical Identifiers
- UNII
- FYS6T7F842
- CAS number
- 331731-18-1
References
- General References
- Kivitz A, Segurado OG: HUMIRA pen: a novel autoinjection device for subcutaneous injection of the fully human monoclonal antibody adalimumab. Expert Rev Med Devices. 2007 Mar;4(2):109-16. doi: 10.1586/17434440.4.2.109. [PubMed:17359217]
- Mease PJ: Adalimumab in the treatment of arthritis. Ther Clin Risk Manag. 2007 Mar;3(1):133-48. [PubMed:18360621]
- Scheinfeld N: Adalimumab (HUMIRA): a review. J Drugs Dermatol. 2003 Aug;2(4):375-7. [PubMed:12884458]
- Scheinfeld N: Adalimumab: a review of side effects. Expert Opin Drug Saf. 2005 Jul;4(4):637-41. doi: 10.1517/14740338.4.4.637. [PubMed:16011443]
- Fonder MA, Cummins DL, Ehst BD, Anhalt GJ, Meyerle JH: Adalimumab therapy for recalcitrant pyoderma gangrenosum. J Burns Wounds. 2006 Nov 20;5:e8. [PubMed:17149453]
- Hinterberger L, Muller CS, Vogt T, Pfohler C: Adalimumab: a treatment option for pyoderma gangrenosum after failure of systemic standard therapies. Dermatol Ther (Heidelb). 2012 Dec;2(1):6. doi: 10.1007/s13555-012-0006-6. Epub 2012 May 12. [PubMed:23205329]
- Ryman JT, Meibohm B: Pharmacokinetics of Monoclonal Antibodies. CPT Pharmacometrics Syst Pharmacol. 2017 Sep;6(9):576-588. doi: 10.1002/psp4.12224. Epub 2017 Jul 29. [PubMed:28653357]
- Patent: Methods related to adalimumab [Link]
- Sandoz received US FDA approval for bio similar, Hyrimoz [Link]
- HUMIRA website [Link]
- Abbvie Website [Link]
- HUMIRA FDA LABEL [File]
- External Links
- UniProt
- P01857
- Genbank
- J00228
- KEGG Drug
- D02597
- PubChem Substance
- 46504982
- 327361
- ChEMBL
- CHEMBL1201580
- Therapeutic Targets Database
- DAP000392
- PharmGKB
- PA10004
- RxList
- RxList Drug Page
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Adalimumab
- AHFS Codes
- 92:36.00 — Disease-modifying Antirheumatic Agents
- 92:20.00 — Immunomodulatory Agents
- 56:92.00 — Miscellaneous GI Drugs
- FDA label
- Download (3.64 MB)
- MSDS
- Download (157 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Active Not Recruiting Basic Science Psoriasis 1 4 Active Not Recruiting Basic Science Rheumatoid Arthritis 1 4 Active Not Recruiting Prevention Cardiovascular Heart Disease / Rheumatoid Arthritis 1 4 Active Not Recruiting Treatment Ankylosing Spondylitis (AS) 1 4 Active Not Recruiting Treatment CD 1 4 Active Not Recruiting Treatment Crohn's Disease (CD) 1 4 Active Not Recruiting Treatment Crohn's Disease (CD) / Inflammatory Bowel Diseases (IBD) / Stricture; Bowel 1 4 Active Not Recruiting Treatment Rheumatoid Arthritis 2 4 Active Not Recruiting Treatment Ulcerative Colitis 1 4 Completed Not Available Rheumatoid Arthritis 3
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Abbott Laboratories Ltd.
- Vetter Pharma Fertigung GmbH and Co. KG
- Dosage Forms
Form Route Strength Injection, solution Cutaneous; Parenteral 20 MG Injection, solution Cutaneous; Parenteral 40 MG Solution Subcutaneous 50 mg Solution Subcutaneous Injection, solution Cutaneous 20 MG Injection, solution Cutaneous 40 MG Injection, solution Cutaneous 40 MG/0.8ML Injection, solution Cutaneous; Parenteral 80 MG Injection, solution Subcutaneous 40 mg Solution Subcutaneous 10 mg Solution Subcutaneous 20 mg Solution Subcutaneous 40 mg Solution Subcutaneous 80 mg Injection 20 mg/0.2ml Injection 40 mg/0.8ml Injection 40 mg/0.4ml Injection, solution 40 mg/0.8ml Solution Solution Subcutaneous 100 mg Injection, solution Cutaneous; Parenteral 40 MG/0.8ML Injection, solution Subcutaneous 40 mg/0.8mL - Prices
Unit description Cost Unit Humira (1 Box = Two 40 mg/0.8ml Syringes) Box 1995.1USD box Humira 2 20 mg/0.4ml Kit 1 Box = Two 20 mg/0.4ml Syringes 1995.1USD box Humira Pen 2 40 mg/0.8ml Kit (1 Box = 1 Kit Containing Two 40 mg/0.8ml Pens) 1995.1USD box Humira 20 mg/0.4 ml syringe 959.19USD syringe Humira 40 mg/0.8 ml pen 959.19USD pen Humira crohn's starter pack 959.19USD each Humira psoriasis starter pack 959.19USD each DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region Unlock Additional DataCA2243459 No 2002-09-17 2017-02-10 Canada Additional Data Available- Filed On
Properties
- State
- Liquid
- Experimental Properties
Property Value Source isoelectric point 8.25 http://www.druglib.com/activeingredient/adalimumab/chembio/
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Antibody
- General Function
- Tumor necrosis factor receptor binding
- Specific Function
- Cytokine that binds to TNFRSF1A/TNFR1 and TNFRSF1B/TNFBR. It is mainly secreted by macrophages and can induce cell death of certain tumor cell lines. It is potent pyrogen causing fever by direct ac...
- Gene Name
- TNF
- Uniprot ID
- P01375
- Uniprot Name
- Tumor necrosis factor
- Molecular Weight
- 25644.15 Da
References
- Lorenz HM: Technology evaluation: adalimumab, Abbott laboratories. Curr Opin Mol Ther. 2002 Apr;4(2):185-90. [PubMed:12044041]
- Flendrie M, Creemers MC, Welsing PM, den Broeder AA, van Riel PL: Survival during treatment with tumour necrosis factor blocking agents in rheumatoid arthritis. Ann Rheum Dis. 2003 Nov;62 Suppl 2:ii30-3. [PubMed:14532145]
- Aguillon JC, Contreras J, Dotte A, Cruzat A, Catalan D, Salazar L, Molina MC, Guerrero J, Lopez M, Soto L, Salazar-Onfray F, Cuchacovich M: [New immunological weapons for medicine in the 21st Century: biological therapy based on the use of the latest generation monoclonal antibodies]. Rev Med Chil. 2003 Dec;131(12):1445-53. [PubMed:15022409]
- Bang LM, Keating GM: Adalimumab: a review of its use in rheumatoid arthritis. BioDrugs. 2004;18(2):121-39. [PubMed:15046527]
Drug created on June 13, 2005 07:24 / Updated on September 22, 2020 02:11
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