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Supply constraint of Creon® 10000 Creon® 25000 (Pancreatin)
4th July 2024

As the marketing authorisation holder and distributor of Creon® in the UK, we were notified by our third-party manufacturing partner, Abbott, of a supply constraint of Creon® (pancreatin) in the UK.

This constrained supply is due to high global demand and reaching maximum manufacturing supply output.

Creon® is a biologic product with a natural variation of its raw material and is made using a complex manufacturing process. The complexity of the process means that the ability to increase manufacturing capacity in the short-term is limited.

There is a long-term strategic initiative between Viatris and Abbott to increase the supply output of Creon® at the manufacturing facility. This work has already begun with expected completion in 2026.

During this supply constraint, we hope to be able to supply approximately 90-95% of the average monthly demand for Creon® lipase units into the market each month, until this supply constraint is resolved.

If you require additional information or have any questions, please contact customer services on 01707 853100 or via email; productenquiries@viatris.co.uk. For medical enquiries please contact our medical information team on 01707 853 000 or via email; info.uk@viatris.co.uk.

UK-CRE-2024-00006 July 2024

Viatris Connect
Keywords..

Diabetes

Patients with different types of diabetes mellitus frequently show alterations in pancreatic morphology and exocrine function. PEI can therefore occur as a result of long-standing type 1 and type 2 diabetes.1,2

  • In a 2015 audit, 24% of patients with diabetes had abnormal stools (score 5 on the Bristol Stool Chart), steatorrhoea or unexplained weight loss3
  • 42% of symptomatic patients who provided a stool sample had FE-1 levels indicative of PEI3

One study examined the efficacy of Creon® in patients with tropical calculous pancreatitis, a form of chronic pancreatitis largely attributed to malnutrition that’s prevalent in India and other Afro-Asian countries in which patients present with abdominal pain, pancreatic calculi and insulin-resistant diabetes.4

After 6 months of Creon® treatment patients achieved better control of diabetes, improvement in abdominal symptoms and overall sense of well being.4 This included a significant reduction in post-prandial plasma glucose and glycosylated haemoglobin at six months vs. baseline.4

Significant reduction in post-prandial plasma glucose and glycosylated haemoglobin at baseline vs. 6 months treatment with Creon® (total dose 8,000 lipase units)4

Adapted from Mohan V et al. Int J Pancreatol. 1998.

Furthermore, these patients showed significant improvements in PEI symptoms, including the following:4

Trial Information
Double-blind, multi-centre, prospective, 16-week study investigating the effects of Creon® on glucose metabolism and clinical symptoms in a group of 80 insulin-treated, diabetic patients with FE-1 <100 mcg/g. Patients received 4 x Creon® 10000 capsules (n = 39) or placebo (n = 41) taken three times a day with main meals, plus two or three snacks with 2 x Creon® 10000 capsules or placebo each day.

References

  1. Hardt PD and Ewald N. Exocrine pancreatic insufficiency in diabetes mellitus: a complication of diabetic neuropathy or a different type of diabetes? Exp Diabetes Res. 2011; 761950. Epub 2011 Aug 1.
  2. Ewald N and Hardt PD. Diagnosis and treatment of diabetes mellitus in chronic pancreatitis. World J Gastroenterol. 2013; 19(42): 7276-7281
  3. Cummings MH, et al. Gastrointestinal symptoms and pancreatic exocrine insufficiency in type 1 and type 2 diabetes. Practical Diabetes. 2015; 32(2): 54-58
  4. Mohan V, et al. Oral pancreatic enzyme therapy in the control of diabetes mellitus in tropical calculous pancreatitis. Int J Pancreatol. 1998; 24(1): 19-22
  5. Löhr J-M, et al. Synopsis of recent guidelines on pancreatic exocrine insufficiency. United European Gastroenterol J. 2013; 1(2): 79-83

Patients with diabetes may have an increased risk of developing PEI, if PEI is diagnosed, these patients should be treated.5

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Please continue to report suspected adverse drug reactions and device failures with any medicine or vaccine to the MHRA through the Yellow Card Scheme. It is easiest and quickest to report adverse drug reactions and device failures online via the Yellow Card website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Alternatively, you can report via some clinical IT systems (EMIS/SystmOne/Vision/MiDatabank) or by calling the Commission on Human Medicines (CHM) free phone line: 0800-731-6789.
Adverse reactions/events and device failures should also be reported to MAH at e-mail address: pv.uk@viatris.com.

This website is intended for UK healthcare professionals. If you are a patient who has been prescribed Creon® please click here

Viatris UK Healthcare Limited (company registration number 09189103), an English company with a registered office address at 20 Station Close, Potters Bar, Hertfordshire, EN6 1TL (VAT - 421 623 781).

Creon® is indicated for the treatment of pancreatic exocrine insufficiency.

CRE-2021-0769 December 2023.

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