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We would like to inform you that Viatris, the marketing authorisation holder for Creon® has decided to increase the capsule length of Creon® 25000 from 21.7mm to 24.2mm. The diameter of the capsule will not change.

The new size of Creon® 25000 capsule does not affect the efficacy of the product and should not have an impact on the patient’s ability to swallow the capsules whole.

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Cystic fibrosis

Studies have shown that PEI occurs in more than 85% of patients with cystic fibrosis.1 Malnutrition and growth failure are important prognostic factors in children with cystic fibrosis and both may adversely affect the course of the disease with declining lung function and poor outcomes.2 Population-based studies in both adults and children with cystic fibrosis have shown a clear association between normal growth status and both pulmonary function and survival.3

Adult cystic fibrosis and PEI

Following a parallel design of 2 randomised placebo-controlled studies with an open-label run-in-phase whereby all patients were stabilised on Creon®, patients who were then randomised to Creon® experienced positive improvement in the mean coefficient of fat absorption (CFA), unlike those randomised to placebo, whose mean CFA decreased significantly (p<0.001).4

Dose of pancreatin: 4537.8 mean lipase units/kg/day.
Adapted from Stern RC et al. Am J Gastroenterol 2000.

Trial Information
In the open label run in phase, 50 adult patients with PEI were stabilised on Creon® and a high-fat diet (target of 100 g fat/day). They could adjust their Creon® dose to optimise digestion. 36 eligible patients with >80% CFA who were on a controlled high fat diet for 6 days proceeded to the double-blind phase and were randomised (1:1) to continue with Creon® or switched to placebo. During double-blind treatment, placebo patients received the number of capsules equivalent to the actual mean lipase dose of 5107.0 U/kg/day and Creon® patients received 4537.8 mean lipase U/kg/day.

Infant and child cystic fibrosis and PEI

In infants with cystic fibrosis aged 1 to 24 months, Creon® produced a rapid improvement in mean coefficient of fat absorption (CFA).2

CFA:Coefficient of fat absorption

Adapted from Colombo C et al. Pancreas 2009.

Trial Information
Multicentre, open-label, single arm, eight-week study in 12 babies < 24 months. CFA was measured after two weeks of treatment based on 72-hour fat assessments. Patients’ weight and height increased after eight weeks of treatment. Creon® Micro 5000 units was provided but individual patient doses were based on dietary fat intake. Daily doses of 2000 u/g fat were recommended but higher doses were administered in two patients who were taking a higher dose of PERT before enrolment.

Furthermore, treatment with Creon® Micro was found to:2

  • increase length and weight over 8 weeks
  • decrease the proportion of patients with steatorrhoea from 100% to 58% at 2 weeks
  • increase the number of patients with normal stool characteristics at 2 weeks
  • reduce mean faecal energy loss at 2 weeks

References

  1. Littlewood JM, et al. Diagnosis and treatment of intestinal malabsorption in cystic fibrosis. Pediatric Pulmonology. 2006; 41(1): 35-49
  2. Colombo C, et al. Efficacy and tolerability of Creon for Children in infants and toddlers with pancreatic exocrine insufficiency caused by cystic fibrosis: an open-label, single-arm, multicenter study. Pancreas. 2009; 38(6): 693-699
  3. Stallings VA, et al. Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: results of a systematic review. J Am Diet Assoc. 2008; 108(5): 832-839
  4. Stern RC, et al. A comparison of the efficacy and tolerance of pancrelipase and placebo in the treatment of steatorrhea in cystic fibrosis patients with clinical exocrine pancreatic insufficiency. Am J Gastroenterol. 2000; 95(8): 1932-1938

Creon®’s optimally sized minimicrospheres and enteric coating ensure your PEI patients get the right dose.

You will now leave the Creon patient website and go to the Creon Track site where you can join the Creon Track patient support programme

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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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