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PERTZYE is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases.
Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether.
Each PERTZYE delayed-release capsule for oral administration contains bicarbonate-buffered enteric-coated microspheres ranging in size from 0.8 to1.4 mm in diameter for 4,000 USP units of lipase and 0.8 to 2.2 mm in diameter for 8,000 and 16,000 USP units of lipase.
The active ingredient evaluated in clinical trials is lipase. PERTZYE is dosed by lipase units. Other active ingredients include protease and amylase.
Inactive ingredients in PERTZYE include sodium bicarbonate, sodium carbonate, cellulose acetate phthalate, sodium starch glycolate, diethyl phthalate, ursodiol, polyvinylpyrrolidone, and talc and are contained in hard gelatin capsules.
4,000 USP units of lipase; 14,375 USP units of protease; 15,125 USP units of amylase. Delayed-Release Capsules have a clear body printed in green with “4” and a clear cap printed with a green circular stripe and “DCI”. The imprinting ink on the capsule contains FD&C Blue #1, D&C Yellow #10, black iron oxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, shellac and ammonium hydroxide.
8,000 USP units of lipase; 28,750 USP units of protease; 30,250 USP units of amylase. Delayed-Release Capsules have a clear body printed in blue with “8” and a clear cap printed with a blue circular stripe and “DCI”. The imprinting ink on the capsule contains FD&C Blue #1, ethanol, methanol, n-butyl alcohol, propylene glycol, shellac and ammonium hydroxide.
16,000 USP units of lipase; 57,500 USP units of protease; 60,500 USP units of amylase. Delayed-Release Capsules have a clear body printed in red with “16” and a clear cap printed with a red circular stripe and “DCI”. The imprinting ink on the capsule contains FD&C Red #40, povidone, titanium dioxide, dehydrated alcohol, sodium hydroxide, butyl alcohol, propylene glycol, isopropyl alcohol, and shellac.
The following serious or otherwise important adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure to PERTZYE in 21 patients, aged 8 to 43 years, with exocrine pancreatic insufficiency due to cystic fibrosis in a placebo-controlled clinical trial [see Clinical Studies (14)].
Table 1 enumerates adverse reactions that occurred in at least 2 patients (greater than or equal to 10%) treated with PERTZYE at a higher rate than with placebo.
Table 1. Adverse Reactions* in a Clinical Trial of Adult and Pediatric Patients 8 Years of Age and Older
with Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
| Adverse Reaction | PERTZYE N=21 (%) |
Placebo N=24 (%) |
| Diarrhea | 10% | 4% |
| Dyspepsia | 10% | 4% |
| Cough | 10% | 4% |
| * Reported in at least 2 PERTZYE-treated patients (≥ 10%) and at a higher rate than placebo-treated patients | ||
The following adverse reactions have been identified during post-approval use of PERTZYE or other pancreatic enzyme products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
No information provided
Included as part of the PRECAUTIONS section.
Fibrosing colonopathy has been reported following treatment with pancreatic enzyme products. Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with use of high-dose pancreatic enzyme products, usually with use over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. Pancreatic enzyme products exceeding 6,000 lipase units/kg/meal have been associated with colonic stricture, a complication of fibrosing colonopathy, in pediatric patients less than 12 years of age. The underlying mechanism of fibrosing colonopathy remains unknown.
If there is a history of fibrosing colonopathy, monitor patients during treatment with PERTZYE because some patients may be at risk of progressing to colonic stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs. Do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation. Higher dosages may be administered if they are documented to be effective by fecal fat measures or an improvement in signs and symptoms of malabsorption including measures of nutritional status. Patients receiving dosages higher than 6,000 lipase units/kg/meal should be frequently monitored for symptoms of fibrosing colonopathy and the dosage decreased or titrated downward to a lower range if clinically appropriate [see Dosage and Administration (2.1)].
Crushing or chewing PERTZYE capsules or mixing the capsule contents in foods having a pH greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity. Instruct the patient or caregiver of the following:
Pancreatic enzyme products contain purines that may increase blood uric acid levels. High dosages have been associated with hyperuricosuria and hyperuricemia [see Overdosage (10)]. Consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia during treatment with PERTZYE.
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.
Severe hypersensitivity reactions including anaphylaxis, asthma, hives, and pruritus have been reported with pancreatic enzyme products [see Adverse Reactions (6.2)]. If symptoms occur, initiate appropriate medical management.
Monitor patients with a known hypersensitivity reaction to proteins of porcine origin for hypersensitivity reactions during treatment with PERTZYE. The risks and benefits of continued PERTZYE treatment in patients with severe hypersensitivity reactions should be taken into
Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Advise the patient or caregiver that fibrosing colonopathy has been reported with high dosages of pancreatic enzyme products, usually with use over a prolonged period of time and in pediatric patients less than 12 years of age. Advise patients and caregivers that if signs and symptoms of colon stricture formation occur (e.g., stomach area (abdominal) pain, bloating, trouble passing stool (constipation), nausea, vomiting, diarrhea) to immediately contact their healthcare provider [see Warnings and Precautions (5.1)].
Advise the patient or caregiver that hyperuricemia may occur in patients with gout or renal impairment and to contact the healthcare provider if they experience pain, stiffness, redness or swelling of their joints [see Warnings and Precautions (5.3)].
Inform the patient or caregiver that severe hypersensitivity reactions, including anaphylaxis asthma, hives, and pruritus, have been reported with use of pancreatic enzyme products. Seek medical attention if signs or symptoms of a hypersensitivity reaction develop [see Warnings and Precautions (5.5)].
Advise the patient or caregiver to take or administer PERTZYE as prescribed, and to contact the healthcare provider if signs and symptoms of malabsorption persist [see Dosage and Administration (2.2)].
Instruct the patient or caregiver to:
Instruct the patient or caregiver as follows:
Chronic high dosages of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see Warnings and Precautions (5.1)]. High dosages of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia [see Warnings and Precautions (5.3)].
None.
Pancreatic enzyme products contain a mixture of lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.
For patients consuming a high fat diet in the clinical trials, the coefficient of fat absorption (CFA) was higher in patients who received PERTZYE compared to the placebo treatment group, indicating improved fat absorption [see Clinical Studies (14)].
The lipases, proteases, and amylases of PERTZYE are not substrates of CYP enzymes or transporters. CYP enzyme or transporter mediated drug interactions are not expected.
MEDICATION GUIDE
PERTZYE (pert-zye)
(pancrelipase)
delayed-release capsules
What is the most important information I should know about PERTZYE?
PERTZYE may increase the risk of having a rare bowel disorder called fibrosing colonopathy, especially if taken at a high dose for a long time in children with cystic fibrosis. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gives you.
Call your doctor right away if you have any unusual or severe:
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Take PERTZYE exactly as prescribed by your doctor. Do not take more PERTZYE than directed by your doctor.
What is PERTZYE?
Before taking PERTZYE, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How should I take PERTZYE?
What are the possible side effects of PERTZYE?
The most common side effects of PERTZYE include:
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Other possible side effects:
PERTZYE and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of PERTZYE. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.
How should I store PERTZYE?
Keep PERTZYE and all medicines out of the reach of children.
General information about the safe and effective use of PERTZYE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PERTZYE for a condition for which it was not prescribed. Do not give PERTZYE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about PERTZYE that is written for health professionals.
What are the ingredients in PERTZYE?
Active ingredients: lipase, protease, and amylase.
Inactive ingredients: cellulose acetate phthalate, diethyl phthalate, polyvinylpyrrolidone, sodium bicarbonate, sodium carbonate, sodium starch glycolate, talc, and ursodiol.
The hard gelatin capsule shells contain: gelatin and water.
The green imprinting ink on the 4,000 units of lipase; 14,375 units of protease; 15,125 units of amylase capsules contain: FD&C Blue #1, D&C Yellow #10, black iron oxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, shellac and ammonium hydroxide.
The blue imprinting ink on the 8,000 units of lipase; 28,750 units of protease; 30,250 units of amylase capsules contain: FD&C Blue #1, ethanol, methanol, n-butyl alcohol, propylene glycol, shellac and ammonium hydroxide.
The red imprinting ink on the 16,000 units of lipase; 57,500 units of protease; 60,500 units of amylase capsules contain: FD&C Red #40, povidone, titanium dioxide, dehydrated alcohol, sodium hydroxide, butyl alcohol, propylene glycol, isopropyl alcohol, and shellac.
The purple imprinting ink on the 24,000 units of lipase; 86,250 units of protease; 90,750 units of amylase capsules contain: FD&C Blue #2, D&C Red #7, titanium dioxide, strong ammonia solution, propylene glycol, butyl alcohol, isopropyl alcohol, dehydrated alcohol, and shellac.
For more information, go to www.Pertzye.com or call 1-877-882-5950.
Manufactured by: Digestive Care, Inc. 1120 Win Drive Bethlehem, PA 18017 U.S. License No. 2184 Product of USA
INSTRUCTIONS FOR USE
PERTZYE (pert-zye)
(pancrelipase)
delayed-release capsules
This Instructions for Use contains information on how to give PERTZYE by mouth and through a gastrostomy tube.
Important Information You Need to Know Before Taking PERTZYE:
Giving PERTZYE to infants (Children from Birth to 12 Months of Age) by mouth:
The two methods to give PERTZYE to Infants (Children from Birth to 12 Months of Age) are described below:
a) Giving with Applesauce Before Breast or Formula Feeding
b) Giving Directly into the Infant's Mouth Before Breast or Formula Feeding
Do not mix the PERTZYE capsule contents directly into a bottle of breast milk or formula.
Giving PERTZYE to children and adults by mouth:
Giving PERTZYE through a gastrostomy tube:
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Figure A
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Figure B
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Figure C
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Figure D
Storing PERTZYE:
Keep PERTZYE and all medicines out of the reach of children.
