reactions including anaphylaxis, asthma, hives, and pruritus. The most commonly reported adverse events were gastrointestinal disorders, including abdominal pain, diarrhea, flatulence, constipation and nausea, and skin disorders including pruritus, urticaria and rash. In general, these products have a well defined and favorable risk-benefit profile in exocrine pancreatic insufficiency.
7 DRUG INTERACTIONS
No drug interactions have been identified. No formal interaction studies have been conducted.
8 USE IN SPECIFIC POPULATIONS
Enter section text here
8.1 Pregnancy
Teratogenic effects
Pregnancy Category C: Animal reproduction studies have not been conducted with pancrelipase. It is also not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. Adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. Reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes. Patients should notify their healthcare professional if they are pregnant or are thinking of becoming pregnant during treatment with CREON.
8.3 Nursing Mothers
It is not known if pancrelipase is excreted in human milk. Patients should notify their healthcare professional if they are breast-feeding.
8.4 Pediatric Use
The short-term safety and efficacy of CREON were assessed in a single, randomized, double-blind, placebo-controlled, crossover study of 32 patients with exocrine pancreatic insufficiency due to cystic fibrosis, including 12 patients between 12 and 18 years of age. The safety and efficacy in 12 to 18 year old patients in this study were similar to adult patients [see Adverse Reactions (6.1) and Clinical Studies (14)].
The safety and efficacy of pancreatic enzyme products with different formulations of pancrelipase consisting of the same active ingredient (lipases, proteases, and amylases) for treatment of children with exocrine pancreatic insufficiency due to cystic fibrosis have been described in the medical literature and through clinical experience.
Dosing of pediatric patients should be in accordance with recommended guidance from the Cystic Fibrosis Foundation Consensus Conferences [see Dosage and Administration (2.1)]. Doses of other pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with fibrosing colonopathy in children less than 12 years of age [see Warnings and Precautions (5.1)].
10 OVERDOSAGE
There have been no reports of overdose in clinical trials with CREON, or in clinical trials or postmarketing surveillance with other pancreatic enzyme products. Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)]. High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia, and should be used with caution in patients with a history of hyperuricemia, gout, or renal impairment [see Warnings and Precautions (5.3)].
11 DESCRIPTION
CREON is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains mul |
