CREON is not interchangeable with any other pancrelipase product. (2.1)

Do not crush or chew capsules and capsule contents. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food, e.g., applesauce. (2.1) Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines. (2.2)

Infants (up to 12 months)

• Prior to each feeding, infants may be given 3,000 lipase units (one capsule) per 120 mL of formula or per breast-feeding. (2.1)
• Do not mix CREON capsule contents directly into formula or breast milk prior to administration. (2.1)

Children Older than 12 Months and Younger than 4 Years

• Begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day. (2.2)

Children 4 Years and Older and Adults

• Begin with 500 lipase units/kg of body weight per meal for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day. (2.2)

Adults with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy

• Individualize dosage based on clinical symptoms, the degree of steatorrhea present and the fat content of the diet. (2.2)

None (4)
WARNINGS AND PRECAUTIONS

• Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement in the treatment of cystic fibrosis patients. Exercise caution when doses of CREON exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day). (5.1)
• To avoid irritation of oral mucosa, do not chew CREON or retain in the mouth. (5.2)
• Exercise caution when prescribing CREON to patients with gout, renal impairment, or hyperuricemia. (5.3)
• There is theoretical risk of viral transmission with all pancreatic enzyme products including CREON. (5.4)
• Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin. (5.5)

• Adverse reactions occurring in at least 2 cystic fibrosis patients (greater than or equal to 4%) receiving CREON are vomiting, dizziness, and cough. (6.1)
• Adverse reactions that occurred in at least 1 chronic pancreatitis or pancreatectomy patient (greater than or equal to 4%) receiving CREON are hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, and nasopharyngitis. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.