CREON

What it is

CREON is a porcine pancreatic enzyme preparation containing pancreatic extract encapsulated in minimicrospheres with a pH-sensitive coating. It is available in five strengths: CREON 10,000, CREON 20,000, CREON 25,000, CREON 35,000 and CREON 40,000.

Approved indications

— Pancreatic enzyme replacement in paediatric and adult patients with pancreatic exocrine insufficiency.

Dosing overview

The dose of CREON required is adjusted according to the fat content of the meal and the severity of the disease. Capsules should be swallowed without crushing or chewing, with enough fluid during or after each meal or snack. For paediatric and adult cystic fibrosis patients, children under four years require a starting dose of 1,000 units lipase per kilogramme bodyweight per meal with a maximum dose of 4,000 units lipase per gramme dietary fat intake, whilst patients aged four years and over require a starting dose of 500 units lipase per kilogramme bodyweight per meal with a maximum dose of 10,000 units lipase per kilogramme bodyweight per day. For adult patients with pancreatic exocrine insufficiency, the starting dose is 25,000 to 40,000 units lipase per meal, with a snack dose of half the meal dose, and a maximum dose of 10,000 units lipase per kilogramme bodyweight per day.

Key safety warnings

Fibrosing colonopathy has been reported in cystic fibrosis patients treated with some high potency enzyme supplements, and doses in excess of 10,000 Ph.Eur. units lipase per kilogramme per day should be used with caution. Patients who use doses in excess of 10,000 Ph.Eur. units lipase per kilogramme per day and who develop new symptoms or have a medical history of gastrointestinal complications should be reviewed regularly by ultrasound. Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than 5.5 can disrupt the protective enteric coating, which can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Adequate hydration is important at all times, especially during periods of increased loss of fluids, as inadequate hydration may aggravate constipation.

Contraindications

CREON capsules are contraindicated in patients who are known to be hypersensitive to porcine protein or any of the ingredients.

PBS listing

CREON 10,000 capsules are PBS listed as 2 items with restricted benefit at an ex-manufacturer price of A$24.35. CREON 25,000 capsules are PBS listed as 2 items with restricted benefit at an ex-manufacturer price of A$48.53. CREON 35,000 capsules are PBS listed as 2 items with restricted benefit at an ex-manufacturer price of A$67.93. CREON granules providing not less than 5,000 BP units of lipase activity per 100 mg are PBS listed as 2 items with restricted benefit at an ex-manufacturer price of A$30.99.

Regulatory history

CREON 10,000 and CREON 25,000 capsules were first listed on the ARTG on 26 March 2009. CREON MICRO granules were first listed on the ARTG on 29 September 2010. CREON 20,000 and CREON 35,000 capsules were first listed on the ARTG on 21 April 2020. In November 2020, the PBAC recommended CREON for pancreatic exocrine insufficiency. In March 2023, the PBAC recommended CREON for cystic fibrosis with unrestricted benefit.