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Adalimumab information


Adalimumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetTNF alpha
Clinical data
Trade namesHumira
Other namesD2E7
Biosimilarsadalimumab-aacf,[1] adalimumab-aaty,[2] adalimumab-adaz,[3] adalimumab-adbm,[4] adalimumab-afzb,[5] adalimumab-aqvh,[6] adalimumab-atto,[7] adalimumab-bwwd,[8] adalimumab-fkjp,[9] adalimumab-ryvk,[10] Abrilada,[11] Amgevita,[12] Amsparity,[13] Ardalicip,[14] Cadalimab,[15] Ciptunec,[14] Cyltezo,[16] Exemptia,[17] Hadlima,[8] Halimatoz,[18] Hefiya,[19] Hukyndra,[20] Hulio,[21] Hyrimoz,[22] Idacio,[23] Imraldi,[24] Kromeya,[25] Libmyris,[26] Mabura, Simlandi,[27][10] Solymbic,[28] Trudexa,[29] Yuflyma,[2][30] Yusimry[6]
AHFS/Drugs.comMonograph
MedlinePlusa603010
License data
  • US DailyMed: Adalimumab
Pregnancy
category
  • AU: C[31][32][14]
Routes of
administration		Subcutaneous
Drug classTNF inhibitor
ATC code
  • L04AB04 (WHO)
Legal status
Legal status
  • AU: S4 (Prescription only)[34][35][36][37][38][39][32][14]
  • CA: ℞-only / Schedule D[40]
  • UK: POM (Prescription only)[41]
  • US: WARNING[33]Rx-only[42][3][1][5][6][8][9][2]
  • EU: Rx-only[43]
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Bioavailability64% (subcutaneous), 0% (by mouth)
Elimination half-life10–20 days
Identifiers
CAS Number
  • 331731-18-1 checkY
DrugBank
  • DB00051 checkY
ChemSpider
  • none
UNII
  • FYS6T7F842
KEGG
  • D02597 checkY
ChEMBL
  • ChEMBL1201580 ☒N
ECHA InfoCard100.224.376 Edit this at Wikidata
Chemical and physical data
FormulaC6428H9912N1694O1987S46
Molar mass144190.64 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Adalimumab, sold under the brand name Humira and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.[44][45][46] It is administered by subcutaneous injection (injection under the skin).[44] It works by inactivating tumor necrosis factor-alpha (TNFα).[44]

Common side effects include upper respiratory tract infections, pain at the site of injection, rash, and headache.[44] Other side effects may include serious infections, cancer, anaphylaxis, reactivation of hepatitis B, new onset or exacerbation of demyelinating diseases (such as multiple sclerosis), heart failure, liver failure, and aplastic anemia.[44] Use during pregnancy is not recommended, but some sources show use during breastfeeding may be safe.[31][45]

Adalimumab was approved for medical use in the United States in 2002.[44][47] It is on the World Health Organization's List of Essential Medicines.[48] It is available as a biosimilar medication.[49] In 2021, it was the 236th most commonly prescribed medication in the United States, with more than 1 million prescriptions.[50][51]

  1. ^ a b Cite error: The named reference Idacio FDA label was invoked but never defined (see the help page).
  2. ^ a b c "Yuflyma- adalimumab injection". DailyMed. 27 May 2023. Archived from the original on 26 June 2023. Retrieved 25 June 2023.
  3. ^ a b Cite error: The named reference Hyrimoz FDA label was invoked but never defined (see the help page).
  4. ^ Cite error: The named reference Cyltezo FDA label was invoked but never defined (see the help page).
  5. ^ a b Cite error: The named reference Abrilada FDA label was invoked but never defined (see the help page).
  6. ^ a b c Cite error: The named reference Yusimry FDA label was invoked but never defined (see the help page).
  7. ^ Cite error: The named reference Amjevita FDA label was invoked but never defined (see the help page).
  8. ^ a b c Cite error: The named reference Hadlima FDA label was invoked but never defined (see the help page).
  9. ^ a b Cite error: The named reference Hulio FDA label was invoked but never defined (see the help page).
  10. ^ a b Cite error: The named reference Simlandi FDA label was invoked but never defined (see the help page).
  11. ^ Cite error: The named reference Abrilada SBD was invoked but never defined (see the help page).
  12. ^ Cite error: The named reference Amgevita EPAR was invoked but never defined (see the help page).
  13. ^ Cite error: The named reference Amsparity EPAR was invoked but never defined (see the help page).
  14. ^ a b c d "Ciptunec/Ardalicip APMDS". Therapeutic Goods Administration (TGA). 27 September 2022. Retrieved 29 September 2022.
  15. ^ Cite error: The named reference Cadalimab PR was invoked but never defined (see the help page).
  16. ^ Cite error: The named reference Cyltezo EPAR was invoked but never defined (see the help page).
  17. ^ "First biosimilar Humira launches in India". 17 December 2014. Archived from the original on 25 March 2023. Retrieved 4 July 2023.
  18. ^ Cite error: The named reference Halimatoz EPAR was invoked but never defined (see the help page).
  19. ^ Cite error: The named reference Hefiya EPAR was invoked but never defined (see the help page).
  20. ^ Cite error: The named reference Hukyndra EPAR was invoked but never defined (see the help page).
  21. ^ Cite error: The named reference Hulio EPAR was invoked but never defined (see the help page).
  22. ^ Cite error: The named reference Hyrimoz EPAR was invoked but never defined (see the help page).
  23. ^ Cite error: The named reference Idacio EPAR was invoked but never defined (see the help page).
  24. ^ Cite error: The named reference Imraldi EPAR was invoked but never defined (see the help page).
  25. ^ Cite error: The named reference Kromeya EPAR was invoked but never defined (see the help page).
  26. ^ Cite error: The named reference Libmyris EPAR was invoked but never defined (see the help page).
  27. ^ Cite error: The named reference Simlandi SBD was invoked but never defined (see the help page).
  28. ^ Cite error: The named reference Solymbic EPAR was invoked but never defined (see the help page).
  29. ^ "Trudexa EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 18 February 2020. Retrieved 27 August 2021.
  30. ^ Cite error: The named reference Yuflyma EPAR was invoked but never defined (see the help page).
  31. ^ a b "Adalimumab Pregnancy and Breastfeeding Warnings". Drugs.com. Archived from the original on 17 April 2021. Retrieved 19 March 2019.
  32. ^ a b "Yuflyma APMDS". Therapeutic Goods Administration (TGA). 8 April 2022. Archived from the original on 24 April 2022. Retrieved 24 April 2022.
  33. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  34. ^ AusPAR: Adalimumab. Therapeutic Goods Administration (TGA) (Report). September 2020. Archived from the original on 8 April 2023. Retrieved 6 October 2023.
  35. ^ AusPAR: Adalimumab. Therapeutic Goods Administration (TGA) (Report). September 2020. Archived from the original on 6 October 2023. Retrieved 6 October 2023.
  36. ^ AusPAR: Adalimumab. Therapeutic Goods Administration (TGA) (Report). September 2020. Archived from the original on 6 October 2023. Retrieved 6 October 2023.
  37. ^ Cite error: The named reference Idacio AusPAR was invoked but never defined (see the help page).
  38. ^ AusPAR: Adalimumab. Therapeutic Goods Administration (TGA) (Report). September 2020. Archived from the original on 6 October 2023. Retrieved 6 October 2023.
  39. ^ AusPAR: Adalimumab. Therapeutic Goods Administration (TGA) (Report). September 2020. Archived from the original on 6 October 2023. Retrieved 6 October 2023.
  40. ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
  41. ^ "Humira 40 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)". (emc). 27 November 2019. Archived from the original on 4 August 2020. Retrieved 12 August 2020.
  42. ^ Cite error: The named reference Humira FDA label was invoked but never defined (see the help page).
  43. ^ Cite error: The named reference Humira EPAR was invoked but never defined (see the help page).
  44. ^ a b c d e f "Adalimumab Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. 14 May 2018. Archived from the original on 21 November 2020. Retrieved 18 March 2019.
  45. ^ a b British national formulary: BNF 76 (76 ed.). Pharmaceutical Press. 2018. p. 1074. ISBN 9780857113382.
  46. ^ Cite error: The named reference hidradenitis suppurativa was invoked but never defined (see the help page).
  47. ^ Cite error: The named reference FDA approval was invoked but never defined (see the help page).
  48. ^ World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.
  49. ^ Cite error: The named reference pmid31322440 was invoked but never defined (see the help page).
  50. ^ "The Top 300 of 2021". ClinCalc. Archived from the original on 15 January 2024. Retrieved 14 January 2024.
  51. ^ "Adalimumab - Drug Usage Statistics". ClinCalc. Archived from the original on 8 July 2020. Retrieved 14 January 2024.

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