Creon®

Overview

Creon® can optimise nutritional status and control symptoms of maldigestion, frequency/consistency of bowel movements & abdominal pain in patients with pancreatic exocrine insufficiency (PEl).1,2

Introducing Creon®

Since PEI is caused by a lack of pancreatic enzymes, treatments such as Creon (pancreatic extract) contain the extra enzymes the body needs. These treatments are called PERT - Pancreatic Enzyme Replacement Therapy.

Pancreatic Exocrine Insufficiency (PEI) 3,4

When the pancreas produces less than 10% of the normal amount of lipase units, the body cannot break down enough fat to maintain normal digestion. When this happens, important fats and nutrients cannot be extracted and absorbed from the food, and are instead passed through the body as waste, resulting in fatty, smelly, and unpleasant diarrhoea. This condition is referred to as Pancreatic Exocrine Insufficiency (PEI).

PEI is a major consequence of a wide range of pancreatic conditions and diseases.5-13

Regardless of the underlying disorder, there are four possible mechanisms causing PEI: 4,14

  1. Damage to the pancreatic parenchyma making it unable to synthesise sufficient enzymes
  2. Asynchrony between digestive enzyme secretion and meal delivery
  3. Obstruction of the pancreatic duct
  4. Decreased endogenous stimulation

Pancreatic Enzyme Replacement Therapy (PERT) is the gold standard therapy for PEI 1,5

Creon® can help patients with PEI:

  • reduce PEI symptoms and improve nutritional status2, 15-17
  • improve quality of life15,16

Creon® has a well-established safety profile.1,10,18,19

Abbreviations: PEI = Pancreatic Exocrine Insufficiency; PERT = Pancreatic Enzyme Replacement Therapy.

References

  1. Creon® Data Sheet. Available at www.medsafe.govt.nz. Accessed August 2023.
  2. Ramesh H, et al. Pancreatology. 2013; 13:133-9.
  3. DiMagno EP, et al. Relations between pancreatic enzyme outputs and malabsorption in severe pancreatic insufficiency. N Engl J Med. 1973;288(16):813-815.
  4. Keller J, et al. Human pancreatic exocrine response to nutrients in health and disease. Gut. 2005 Jul;54 Suppl 6:vi1-28. doi:10.1136/gut.2005.065946.
  5. Smith RC, et al. Australasian guidelines for the management of pancreatic exocrine insufficiency. Australasian Pancreatic Club, October 2015. Available at: https://www.pancreas.org.au/resources. Accessed August 2023.
  6. Lohr JM, et al. United European Gastroenterol J 2017; 5 (2):153-99.
  7. Ketler J et al. Gut 2005; 54(Suppl VI): vi1-vi28.
  8. Nakajima K. et a Core evidence 2012;7:77-91.
  9. Conwell D, et al. Pancreas 2014;43;1143-62.
  10. Cystic Fibrosis Nutrition Guideline Authorship Group (2017). Nutrition Guidelines for Cystic Fibrosis in Australia and New Zealand, ed. Scott C. Bell, Thoracic Society of Australia and New Zealand, Sydney. Available at: https://thoracic.org.au/wp-content/uploads/2021/06/NHMRC-NutritionGuidelines-CF-ANZ-final-web.pdf. Accessed August 2023.
  11. Dominguez-Munoz JE. HPB. 2009;11 Suppl 3:3-6.
  12. Mohaprata S. et al. Pancreas 2016;45;8:1104-10.
  13. Evans K, et al. Dig Dis Sci. 2010;55:299-3004.
  14. Nikfarjam M, et al. Diagnosis and management of pancreatic exocrine insufficiency. Med J Aust. 2017;207(4):161-165.
  15. D'Haese JG, et al. Pancreas. 2014;43(6):834-41.
  16. Safdi M, et al. Pacreas. 2006;33(2): 1 56-62.
  17. Seller CM et al. Altment Pharmacol Ther. 2013;37(7):691-702.
  18. Dominguez-Munoz JE, et al. Clin Gastro & Hep. 2007; 5:484-88.
  19. Kuhn RJ, et al. Adv Ther. 2010;27(12):895-916.

CREON® (Pancreatic Extract). Modified release capsules: General Sale (10,000 IU lipase) & Prescription Medicine (25,000 IU lipase); Modified release granules: General Sale (Micro 5,000 IU lipase). Indications: For treatment of conditions associated with pancreatic exocrine insufficiency (PEI), such as: cystic fibrosis (CF), chronic pancreatitis, post-pancreatectomy, post gastrointestinal bypass surgery, ductal obstruction of the pancreas or common bile duct. Contraindications: Hypersensitivity to porcine protein or to any of the excipients. Precautions: Fibrosing colonopathy, pregnancy, lactation. Adverse Effects: Abdominal pain, nausea, vomiting, constipation, diarrhoea, abdominal distension, rash, pruritus, urticaria. Dosage & Administration: The dose required depends on the severity of disease and the composition of food. It is recommended to take the enzymes during or immediately after each meal or snack. Always ensure adequate hydration of patients to avoid constipation. The capsules should be swallowed intact however when swallowing of capsules is difficult, the capsules may be opened and the minimicrospheres added to acidic soft food such as apple sauce, yoghurt or fruit juice with pH < 5.5, or taken with liquid such as fruit juice with pH < 5.5, e.g. apple, orange or pineapple juice. Rinse mouth out afterwards to ensure no product is retained in the mouth. Treatment of adult patients with PEI associated with nonCF conditions – Required dose for meals: 25,000 to 80,000 lipase units; Snacks: half of meal dose. Refer to data sheet for dose titration considerations. Treatment of paediatric and adult patients with CF - Children < 4 years: Starting dose of 1,000 lipase units/kg bodyweight per meal; Patients ≥ 4 years: Starting dose of 500 lipase units/kg bodyweight per meal. For CF patients, maximum dose of 4,000 lipase units/gram dietary fat intake. Creon® is a fully funded medicine. Before recommending this medicine, please refer to the full Data Sheet available from www.medsafe.govt.nz. Creon® is a Viatris company trade mark, Viatris Limited, Auckland. CRE-2023-0643. TAPS DA 2303MM-0712. 

Signs and Symptoms

The Pancreas 1

The pancreas produces enzymes (e.g. lipase, amylase, trypsin and chymotrypsin) and bicarbonate, both of which are important for macronutrient digestion.5 These secretions enter the second portion of the duodenum via the pancreatic duct following mediation by hormonal and neuronal mechanisms.6

The healthy pancreas releases around 720,000 lipase units in response to a 300-600 kcal meal, with ~10% needed to maintain normal digestion.7

Untreated or undertreated PEI can have serious consequences for patients2-4

Abbreviation: PEI = Pancreatic Exocrine Insufficiency

References

  1. Zhou Q, et al. Pancreas regeneration. Nature. 2018 May;557(7705):351-358.
  2. Sikkens EC, et al. J Gastrointest Surg 2012; 16: 1487-92
  3. Kuhlmann L, et al. JOP J Pancreas (Online) 2018; 19(4): 183-89
  4. Nikfarjam M, et al. MJA 2017; 207(4):161-65
  5. 2015 Australasian Pancreatic Club. Australasian guidelines for the management of pancreatic exocrine insufficiency. https:// static1.squarespace.com/static/5b5e94e7aa49a1a136248110/t/5db0c976c894034e9ce620b8/1571867020139/ APC+Guidelines+on+PEI.pdf
  6. Brennan GT, Saif MW. Pancreatic Enzyme Replacement Therapy: A Concise Review. JOP. 2019;20(5):121-125.
  7. Keller J, Layer P. Human pancreatic exocrine response to nutrients in health and disease. Gut. 2005 Jul;54 Suppl 6(Suppl 6):vi1-28

CREON® (Pancreatic Extract). Modified release capsules: General Sale (10,000 IU lipase) & Prescription Medicine (25,000 IU lipase); Modified release granules: General Sale (Micro 5,000 IU lipase). Indications: For treatment of conditions associated with pancreatic exocrine insufficiency (PEI), such as: cystic fibrosis (CF), chronic pancreatitis, post-pancreatectomy, post gastrointestinal bypass surgery, ductal obstruction of the pancreas or common bile duct. Contraindications: Hypersensitivity to porcine protein or to any of the excipients. Precautions: Fibrosing colonopathy, pregnancy, lactation. Adverse Effects: Abdominal pain, nausea, vomiting, constipation, diarrhoea, abdominal distension, rash, pruritus, urticaria. Dosage & Administration: The dose required depends on the severity of disease and the composition of food. It is recommended to take the enzymes during or immediately after each meal or snack. Always ensure adequate hydration of patients to avoid constipation. The capsules should be swallowed intact however when swallowing of capsules is difficult, the capsules may be opened and the minimicrospheres added to acidic soft food such as apple sauce, yoghurt or fruit juice with pH < 5.5, or taken with liquid such as fruit juice with pH < 5.5, e.g. apple, orange or pineapple juice. Rinse mouth out afterwards to ensure no product is retained in the mouth. Treatment of adult patients with PEI associated with nonCF conditions – Required dose for meals: 25,000 to 80,000 lipase units; Snacks: half of meal dose. Refer to data sheet for dose titration considerations. Treatment of paediatric and adult patients with CF - Children < 4 years: Starting dose of 1,000 lipase units/kg bodyweight per meal; Patients ≥ 4 years: Starting dose of 500 lipase units/kg bodyweight per meal. For CF patients, maximum dose of 4,000 lipase units/gram dietary fat intake. Creon® is a fully funded medicine. Before recommending this medicine, please refer to the full Data Sheet available from www.medsafe.govt.nz. Creon® is a Viatris company trade mark, Viatris Limited, Auckland. CRE-2023-0643. TAPS DA 2303MM-0712. 

Mode of Action

Safety and Tolerability

Creon® improves symptoms associated with PEI †

Creon® is effective and well-tolerated in patients with PEI, significantly improving patients' long-term nutritional status.1, 2

Study design: A 51-week, open-label extension of a 1-week, double-blind, randomized, placebo-controlled group study in India. Patients at least 18 years old with proven chronic pancreatitis and PEI (N=61), received Creon®40,000 at dose of 80,000 lipase units per main mean and 40,000 with snacks. 1

Abbreviations: PEI = Pancreatic Exocrine Insufficiency

References

  1. Ramesh H, et al. Pancreatology. 2013; 13:133-9.
  2. Löhr JM et al. United European Gastroenterology Journal 2017; 5(2): 153-99.

CREON® (Pancreatic Extract). Modified release capsules: General Sale (10,000 IU lipase) & Prescription Medicine (25,000 IU lipase); Modified release granules: General Sale (Micro 5,000 IU lipase). Indications: For treatment of conditions associated with pancreatic exocrine insufficiency (PEI), such as: cystic fibrosis (CF), chronic pancreatitis, post-pancreatectomy, post gastrointestinal bypass surgery, ductal obstruction of the pancreas or common bile duct. Contraindications: Hypersensitivity to porcine protein or to any of the excipients. Precautions: Fibrosing colonopathy, pregnancy, lactation. Adverse Effects: Abdominal pain, nausea, vomiting, constipation, diarrhoea, abdominal distension, rash, pruritus, urticaria. Dosage & Administration: The dose required depends on the severity of disease and the composition of food. It is recommended to take the enzymes during or immediately after each meal or snack. Always ensure adequate hydration of patients to avoid constipation. The capsules should be swallowed intact however when swallowing of capsules is difficult, the capsules may be opened and the minimicrospheres added to acidic soft food such as apple sauce, yoghurt or fruit juice with pH < 5.5, or taken with liquid such as fruit juice with pH < 5.5, e.g. apple, orange or pineapple juice. Rinse mouth out afterwards to ensure no product is retained in the mouth. Treatment of adult patients with PEI associated with nonCF conditions – Required dose for meals: 25,000 to 80,000 lipase units; Snacks: half of meal dose. Refer to data sheet for dose titration considerations. Treatment of paediatric and adult patients with CF - Children < 4 years: Starting dose of 1,000 lipase units/kg bodyweight per meal; Patients ≥ 4 years: Starting dose of 500 lipase units/kg bodyweight per meal. For CF patients, maximum dose of 4,000 lipase units/gram dietary fat intake. Creon® is a fully funded medicine. Before recommending this medicine, please refer to the full Data Sheet available from www.medsafe.govt.nz. Creon® is a Viatris company trade mark, Viatris Limited, Auckland. CRE-2023-0643. TAPS DA 2303MM-0712.

Dosing and Administration

Creon® is available in three different strengths in New Zealand, including Creon® Micro (5,000), Creon® 10,000, and Creon® 25,000.1

Each strength of Creon® contains three pancreatic enzymes: lipase, amylase and protease to help the digestion of fats, carbohydrates and proteins respectively.1

Creon® dosing should be individualized accordingly to control gastrointestinal symptoms and maintain good nutritional status.1,3,4

  • Maximum meal dose 80,000 units lipase1
  • Maximum daily dose 10,000 units lipase/kg bodyweight1
  • Low fat diet is not required or recommended when on Creon® therapy.1,3

Suggested adult maintenance dose for optimal nutritional status and QoL*1-5

NZ Prescribing data suggests that PEI patients may be sub-optimally dosed.6

* Maximum dose per meal is 80,000 lipase units.1

Abbreviations: PEI = Pancreatic Exocrine Insufficiency; QoL = Quality of Life

References:

  1. Creon Data Sheet. Available at medsafe.govt.nz. Accessed August 2023.
  2. Keller J et al. Human pancreatic exocrine response to nutrients in health and disease. Gut, 2005; 54 (6) vi-1-28.
  3. Smith RC, et al. Australasian guidelines for the management of pancreatic exocrine insufficiency. Australasian Pancreatic Club, October 2015. Available at: https://www.pancreas.org.au/resources [Accessed August 2023].
  4. Löhr JM, et al. United European Gastroenterol J 2017;5(2):153-99.
  5. Ramesh H et al. Pancreatology 2013; 13(2):133-39.
  6. Average daily dosing of Creon®. Pharmaceutical Collection. Data from Feb 2021 to Jan 2022.

CREON® (Pancreatic Extract). Modified release capsules: General Sale (10,000 IU lipase) & Prescription Medicine (25,000 IU lipase); Modified release granules: General Sale (Micro 5,000 IU lipase). Indications: For treatment of conditions associated with pancreatic exocrine insufficiency (PEI), such as: cystic fibrosis (CF), chronic pancreatitis, post-pancreatectomy, post gastrointestinal bypass surgery, ductal obstruction of the pancreas or common bile duct. Contraindications: Hypersensitivity to porcine protein or to any of the excipients. Precautions: Fibrosing colonopathy, pregnancy, lactation. Adverse Effects: Abdominal pain, nausea, vomiting, constipation, diarrhoea, abdominal distension, rash, pruritus, urticaria. Dosage & Administration: The dose required depends on the severity of disease and the composition of food. It is recommended to take the enzymes during or immediately after each meal or snack. Always ensure adequate hydration of patients to avoid constipation. The capsules should be swallowed intact however when swallowing of capsules is difficult, the capsules may be opened and the minimicrospheres added to acidic soft food such as apple sauce, yoghurt or fruit juice with pH < 5.5, or taken with liquid such as fruit juice with pH < 5.5, e.g. apple, orange or pineapple juice. Rinse mouth out afterwards to ensure no product is retained in the mouth. Treatment of adult patients with PEI associated with nonCF conditions – Required dose for meals: 25,000 to 80,000 lipase units; Snacks: half of meal dose. Refer to data sheet for dose titration considerations. Treatment of paediatric and adult patients with CF - Children < 4 years: Starting dose of 1,000 lipase units/kg bodyweight per meal; Patients ≥ 4 years: Starting dose of 500 lipase units/kg bodyweight per meal. For CF patients, maximum dose of 4,000 lipase units/gram dietary fat intake. Creon® is a fully funded medicine. Before recommending this medicine, please refer to the full Data Sheet available from www.medsafe.govt.nz. Creon® is a Viatris company trade mark, Viatris Limited, Auckland. CRE-2023-0643. TAPS DA 2303MM-0712.

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