Pancreatic enzymes (medication) explained

Drug Name:Pancreatic enzymes
Tradename:Creon, Pancreaze, Pertzye, others[1]
Routes Of Administration:By mouth
Atc Prefix:A09
Atc Suffix:AA02
Legal Au:S4
Legal Eu:Rx-only
Legal Eu Comment:[2]
Legal Status:Rx-only
Cas Number:53608-75-6
Drugbank:DB00085
Chemspiderid:none
Unii:FQ3DRG0N5K

Pancreatic enzymes, also known as pancreases or pancrelipase and pancreatin, are commercial mixtures of amylase, lipase, protease and lactase.[3] They are used to treat malabsorption syndrome due to certain pancreatic problems. These pancreatic problems may be due to cystic fibrosis, surgical removal of the pancreas, long term pancreatitis, pancreatic cancer, or MODY 5, among others. The preparation is taken by mouth.[4]

Common side effects include vomiting, abdominal pain, constipation, and diarrhea.[4] Other side effects include perianal irritation and high blood uric acid. The enzymes are from pigs. Use is believed to be safe during pregnancy.[5] The components are digestive enzymes similar to those normally produced by the human pancreas.[6] They help the person digest fats, starches, and proteins.[5]

Pancreatic enzymes have been used as medications since at least the 1800s.[7] They are on the World Health Organization's List of Essential Medicines.[8] In 2021, it was the 243rd most commonly prescribed medication in the United States, with more than 1million prescriptions.[9] [10]

Medical uses

Pancrelipases are generally a first line approach in treatment of exocrine pancreatic insufficiency and other digestive disorders, accompanying cystic fibrosis, complicating surgical pancreatectomy, or resulting from chronic pancreatitis. The formulations are generally hard capsules filled with gastro-resistant granules. Pancrelipases and pancreatins are similar, except pancrelipases has an increased lipase component.

Pancreatin is a mixture of several digestive enzymes produced by the exocrine cells of the pancreas. It is composed of amylase, lipase and protease. This mixture is used to treat conditions in which pancreatic secretions are deficient, such as surgical pancreatectomy, pancreatitis and cystic fibrosis.[11] [12] It has been claimed to help with food allergies, celiac disease, autoimmune disease, cancer and weight loss. Pancreatin is sometimes called "pancreatic acid", although it is neither a single chemical substance nor an acid.

Pancreatin contains the pancreatic enzymes trypsin, amylase and lipase. A similar mixture of enzymes is sold as pancrelipase, which contains more active lipase enzyme than does pancreatin. The trypsin found in pancreatin works to hydrolyze proteins into oligopeptides; amylase hydrolyzes starches into oligosaccharides and the disaccharide maltose; and lipase hydrolyzes triglycerides into fatty acids and glycerols. Pancreatin is an effective enzyme supplement for replacing missing pancreatic enzymes, and aids in the digestion of foods in cases of pancreatic insufficiency.[13]

Pancreatin reduces the absorption of iron from food in the duodenum during digestion.[14]

Some contact lens-cleaning solutions contain porcine pancreatin extractives to assist in the intended protein-removal process.[15]

Side effects

High doses over a long period of time are associated with fibrosing colonopathy.[16] Due to this association a maximum dose of 10,000 IU of lipase per kilogram per day is recommended.[17]

Though never reported there is a theoretical risk of a viral infection as they are from pigs.[18]

Society and culture

Brand names

Brand names include Creon,[19] Pancreaze, Pertzye, Sollpura[20] (Liprotamase[21] [22]), Ultresa,[23] and Zenpep.[24]

In some countries, Creon is marketed by Viatris after Upjohn merged with Mylan to create Viatris.[25] [26]

Legal status

United States

Longstanding pancreatic enzyme replacement products (PERPs)—some in use for a century or more—fell under a 2006 FDA requirement that pharmaceutical companies with porcine-derived PERP products submit a New Drug Application (NDA) for each; Creon (AbbVie Inc.), the first of the commercial PERP products approved after the FDA directive, reached market in 2009.[19]

The specific requirement and reasoning for the FDA directive was that manufacturers submit a Risk Evaluation and Mitigation Strategy (REMS) and Medication Guide to ensure patients are adequately informed regarding potential risks associated with administration of high doses of porcine-derived PERP products, especially with regard to "the theoretical risk of transmission of viral disease from pigs to patients", the risk of which (alongside other off-target effects) is reduced by patient adherence to label dosing instructions.[19]

Shortages and alternatives

Due to its non-constant supply, being sourced from pigs, there have been several pancreatin shortages in different markets.[27] [28] [29]

This has led for alternative sources of enzymes to be studied and commercialised, mainly being of bacterial or fungal origin.[30] [31]

Notes and References

  1. Web site: Pancrelipase Uses, Side Effects & Warnings .
  2. Web site: Micrazym and associated names . European Medicines Agency . 21 March 2024 . 13 June 2024.
  3. Web site: Pancreatin. The American Society of Health-System Pharmacists. 8 January 2017. live. https://web.archive.org/web/20170118050216/https://www.drugs.com/monograph/pancreatin.html. 18 January 2017.
  4. Web site: Pancrelipase. The American Society of Health-System Pharmacists. 8 January 2017. live. https://web.archive.org/web/20170118050218/https://www.drugs.com/monograph/pancrelipase.html. 18 January 2017.
  5. Book: British national formulary: BNF 69. 2015. British Medical Association . 978-0-85711-156-2. 82–83. 69.
  6. Book: Stuhan MA . Understanding Pharmacology for Pharmacy Technicians . 2013. ASHP. 978-1-58528-360-6. 597. en. live. https://web.archive.org/web/20170914034832/https://books.google.ca/books?id=L902nod-xOIC&pg=PT597. 14 September 2017.
  7. Book: Banik SP, Khowala S, Pal C, Mukherjee S . Proteomic approaches to identify novel therapeutics and nutraceuticals from filamentous fungi: prospects and challenges . Bagchi D, Swaroop A, Bagchi M . Genomics, Proteomics and Metabolomics in Nutraceuticals and Functional Foods . 2015. John Wiley & Sons . 978-1-118-93046-5 . 274. https://books.google.com/books?id=wOudCgAAQBAJ&pg=PA274 . en. live. https://web.archive.org/web/20170918183242/https://books.google.ca/books?id=wOudCgAAQBAJ&pg=PA274. 18 September 2017.
  8. Book: ((World Health Organization)) . World Health Organization model list of essential medicines: 21st list 2019 . 2019 . 10665/325771 . World Health Organization . World Health Organization . Geneva . WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO .
  9. Web site: The Top 300 of 2021 . ClinCalc . 14 January 2024 . 15 January 2024 . https://web.archive.org/web/20240115223848/https://clincalc.com/DrugStats/Top300Drugs.aspx . live .
  10. Web site: Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease - Drug Usage Statistics . ClinCalc . 14 January 2024.
  11. Whitehead AM . Study to compare the enzyme activity, acid resistance and dissolution characteristics of currently available pancreatic enzyme preparations . Pharmaceutisch Weekblad. Scientific Edition . 10 . 1 . 12–16 . February 1988 . 2451209 . 10.1007/BF01966429 . 41763055 .
  12. Löhr JM, Hummel FM, Pirilis KT, Steinkamp G, Körner A, Henniges F . Properties of different pancreatin preparations used in pancreatic exocrine insufficiency . European Journal of Gastroenterology & Hepatology . 21 . 9 . 1024–1031 . September 2009 . 19352190 . 10.1097/MEG.0b013e328328f414 . 13480750 .
  13. Thorat V, Reddy N, Bhatia S, Bapaye A, Rajkumar JS, Kini DD, Kalla MM, Ramesh H . Randomised clinical trial: the efficacy and safety of pancreatin enteric-coated minimicrospheres (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis--a double-blind, placebo-controlled study . Alimentary Pharmacology & Therapeutics . 36 . 5 . 426–436 . September 2012 . 22762290 . 3528066 . 10.1111/j.1365-2036.2012.05202.x . free . PDF version
  14. Iron Deficiency and Iron Overload . Archives of Disease in Childhood . 40 . 212 . 343–363 . August 1965 . 14329251 . 2019287 . 10.1136/adc.40.212.343 . Smith RS .
  15. Baines MG, Cai F, Backman HA . Adsorption and removal of protein bound to hydrogel contact lenses . Optometry and Vision Science . 67 . 11 . 807–810 . November 1990 . 2250887 . 10.1097/00006324-199011000-00003 . 29228849 .
  16. Lloyd-Still JD, Beno DW, Kimura RM . Cystic fibrosis colonopathy . Current Gastroenterology Reports . 1 . 3 . 231–237 . June 1999 . 10980955 . 10.1007/s11894-999-0040-4 . 37595322 .
  17. Schibli S, Durie PR, Tullis ED . Proper usage of pancreatic enzymes . Current Opinion in Pulmonary Medicine . 8 . 6 . 542–546 . November 2002 . 12394164 . 10.1097/00063198-200211000-00010 . 8935747 .
  18. Web site: CREON® (pancrelipase) Delayed-Release Capsule Official Website. www.creon.com. 10 October 2019.
  19. News: U.S. Food and Drug Administration . FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States: Creon designed to help those with cystic fibrosis, others with exocrine pancreatic insufficiency. News & Events, FDA News Release. 7 May 2009 . 20 July 2014 .
  20. News: Fierce Biotech. 12 March 2018. Adams B . Anthera's Sollpura canned after phase 3 flop, shares plunge. 23 October 2021.
  21. Web site: 19 March 2019. FDA Committee Declines to Recommend Liprotamase for EPI. 22 May 2021. The Boomer Esiason Foundation. en-US.
  22. Did not make it past Phase 3 trials
  23. Web site: Ultresa - Search results. Page 1 of about 39 results. 22 May 2021. Drugs.com. en.
  24. Web site: Zenpep: Uses, Dosage & Side Effects Information. 22 May 2021. Drugs.com .
  25. Web site: Pfizer Completes Transaction to Combine Its Upjohn Business with Mylan . Pfizer . Business Wire . 16 November 2020 . 17 June 2024.
  26. Web site: Brands . Viatris . 16 November 2020 . 17 June 2024.
  27. News: Pancreatic cancer action . Temporary shortage of Creon (Pancreatin) 25k. Pancreatic cancer news. 21 April 2020 . 15 July 2020 .
  28. News: Mylan . Pancreatin - Cambridgeshire and Peterborough CCG . 1 February 2019 . 15 July 2020 . 28 August 2021 . https://web.archive.org/web/20210828204648/https://www.cambridgeshireandpeterboroughccg.nhs.uk/_resources/assets/attachment/full/0/17434.PDF . dead .
  29. News: Greater Glasgow and Clyde Medicines . Medicines Update Primary Care . July 2016 . 15 July 2020 . 15 July 2020 . https://web.archive.org/web/20200715153109/http://www.ggcprescribing.org.uk/blog/medicines-update-primary-care-july-2016/ . dead .
  30. Layer P, Keller J . Lipase supplementation therapy: standards, alternatives, and perspectives . Pancreas . 26 . 1 . 1–7 . January 2003 . 12499909 . 10.1097/00006676-200301000-00001 . 12365426 .
  31. Roxas M . The role of enzyme supplementation in digestive disorders . Alternative Medicine Review . 13 . 4 . 307–314 . December 2008 . 19152478 .

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