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Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products.4,5 Fibrosing colonopathy is a rare serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually with use over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown. Doses of pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with colonic strictures in children less than 12 years of age.1 Patients with fibrosing colonopathy should be closely monitored because some patients may be at risk of progressing to stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs.1 It is generally recommended, unless clinically indicated, that enzyme doses should be less than 2,500 lipase units/kg of body weight per meal (or less than 10,000 lipase units/kg of body weight per day) or less than 4,000 lipase units/g fat ingested per day [see DOSAGE AND ADMINISTRATION].
Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Patients receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.
Potential for Irritation to Oral Mucosa
Care should be taken to ensure that no drug is retained in the mouth. PERTZYE should not be crushed or chewed or mixed in foods having a pH greater than 4.5. These actions can disrupt the protective enteric coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss or enzyme activity [see DOSAGE AND ADMINISTRATION and PATIENT INFORMATION]. For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents mixed with a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce. The PERTZYEsoft food mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion.
Potential for Risk of Hyperuricemia
Porcine-derived pancreatic enzyme products contain purines that may increase blood uric acid levels. Consider monitoring serum uric acid levels in patients with hyperuricemia, gout, or renal impairment.
Potential Viral Exposure from the Product Source
PERTZYE is sourced from pancreatic tissue from swine used for food consumption. Although the risk that PERTZYE will transmit an infectious agent to humans has been reduced by testing for certain viruses during manufacturing and by inactivating certain viruses during manufacturing, there is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. Thus, the presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.
Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin. Rarely, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus, have been reported with other pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase). The risks and benefits of continued PERTZYE treatment in patients with severe allergy should be taken into consideration with the overall clinical needs of the patient.
Patient Counseling Information
“See FDA-approved patient labeling (Medication Guide)”
Dosing and Administration
- Instruct patients and caregivers that PERTZYE should only be taken as directed by their healthcare professional. Patients should be advised that the total daily dose should not exceed 10,000 lipase units/kg body weight/day unless clinically indicated. This needs to be especially emphasized for patients eating multiple snacks and meals per day. Patients should be informed that if a dose is missed, the next dose should be taken with the next meal or snack as directed. Doses should not be doubled. [see DOSAGE AND ADMINISTRATION]
- Instruct patients and caregivers that PERTZYE should always be taken with food. Patients should be advised that PERTZYE delayed-release capsules and the capsule contents must not be crushed or chewed as doing so could cause early release of enzymes and/or loss of enzymatic activity and irritation to the oral mucosa. Patients should swallow the intact capsules with adequate amounts of liquid at mealtimes. If necessary, the capsule contents can also be mixed with soft acidic foods. [see DOSAGE AND ADMINISTRATION]
- Any unused portion of capsule contents should be discarded, and not used for subsequent dosing. The remaining exposed contents may lose potency and become less effective. [see DOSAGE AND ADMINISTRATION]
- Instruct patients that use of PERTZYE in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Instruct patients that attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended. [see DOSAGE AND ADMINISTRATION]
- Instruct patients to keep out of the reach of children.
Advise patients and caregivers to follow dosing instructions carefully, as doses of pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal (10,000 lipase units/kg body weight/day) have been associated with colonic strictures in children below the age of 12 years. [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS]
Advise patients and caregivers to contact their healthcare professional immediately if allergic reactions to PERTZYE develop. [see WARNINGS AND PRECAUTIONS]
Pregnancy and Breast Feeding
- Instruct patients to notify their physician if they are pregnant or are thinking of becoming pregnant during treatment with PERTZYE. [see Use in Specific Populations]
- Instruct patients to notify their physician if they are breast feeding or are thinking of breast feeding during treatment with PERTZYE. [see Use In Specific Populations]
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, genetic toxicology, and animal fertility studies have not been performed with pancrelipase.
Use In Specific Populations
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. PERTZYE should be given to a pregnant woman only if clearly needed. 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.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PERTZYE is administered to a nursing mother. The risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a nursing mother with exocrine pancreatic insufficiency.
The short-term safety and efficacy of PERTZYE were assessed in a randomized, doubleblind, placebo-controlled, crossover study of 24 patients with exocrine pancreatic insufficiency due to cystic fibrosis, including 10 patients between 8 and 17 years of age. The safety and efficacy in 8 to 17 year old patients in this study were similar to adult patients [see ADVERSE REACTIONS and Clinical Studies].
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. However, use of PERTZYE in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended [see DOSAGE AND ADMINISTRATION]. Doses of other pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with fibrosing colonopathy and colonic strictures in children less than 12 years of age [see WARNINGS AND PRECAUTIONS].
1. Borowitz DS, Grand RJ, Durie PR, et al. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. Journal of Pediatrics. 1995; 127: 681-684.
4. Smyth RL, Ashby D, O'Hea U, et al. Fibrosing colonopathy in cystic fibrosis: results of a case-control study. Lancet. 1995; 346: 1247-1251.
5. FitzSimmons SC, Burkhart GA, Borowitz DS, et al. High-dose pancreatic-enzyme supplements and fibrosing colonopathy in children with cystic fibrosis. New England Journal of Medicine. 1997; 336: 1283-1289.
Last reviewed on RxList: 5/24/2012
This monograph has been modified to include the generic and brand name in many instances.
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