![PERTZYE pancrelipase 16000 [USP'U]/1; 60500 [USP'U]/1; 57500 [USP'U]/1 Capsule, Delayed Release, 100-count — NDC 59767-0016-01 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=481eec00-9abf-11dd-b71c-0002a5d5c51b&name=pertzye-07.jpg)
PERTZYE pancrelipase 16000 [USP'U]/1; 60500 [USP'U]/1; 57500 [USP'U]/1 Capsule, Delayed Release, 100-count
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Pancrelipase capsules are used to improve digestion of food in infants, children, and adults who have pancreatic insufficiency (a condition in which the pancreas does not have enough pancreatic enzymes (substances needed to break down food so it can be digested) because they have a condition that affects the pancreas (a gland that produces several important substances including enzymes needed to digest food). Pancrelipase tablets are used along with another medication (proton pump inhibitor; PPI) to improve digestion of foods in adults who cannot digest food normally because they have chronic...
Read the full MedlinePlus article ↗- The enzymes in pancrelipase only work when there's food for them to digest — so timing really does matter. Even a small snack needs about half your usual meal dose. Skipping doses...
- Why do I have to take this with every meal? Can I skip it if I'm not very hungry?
- Yes, but carefully. You can sprinkle the contents onto a small amount of soft, acidic food like applesauce — just make sure to swallow it right away without chewing. What you absol...
- Can I open the capsule if I have trouble swallowing it?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Pancrelipase (prescription drug) — tap one for details:
Pancrelipase (prescription drug) may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F2O5O2OI9F
A cellulose derivative made by chemically modifying plant fiber. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the digestive system.
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UNII UF064M00AF
Diethyl phthalate is a clear, colorless liquid made from phthalic acid. It's used in medicines as a plasticizer to make tablet coatings flexible and as a solvent to help dissolve and distribute active ingredients evenly throughout the product.
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UNII RDH86HJV5Z
Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
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UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
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UNII 45P3261C7T
Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
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UNII H8AV0SQX4D
A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 724L30Y2QR
Ursodiol is a naturally occurring bile acid used in oral medications as an active pharmaceutical ingredient, not an excipient. However, if present as an inactive component, it may serve to solubilize other drugs or aid in formulation stability within the product.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $5.321 | $532.13 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $5.42 | $541.97 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $5.32 | $532.46 / 100 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pertzye 16000 [USP'U]/1; 60500 [USP'U]/1; 57500 [USP'U]this 59767-0016-01 | Digestive | 100 capsules | $5.321 | — | Availability likely | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 59767-0016-01 You're viewing this | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-01) | $5.32 / ea | $532.13 | 2012-05-17 | Active |
| 59767-0016-02 | 250 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-02) | $5.32 / ea | $1,330.32 | 2012-05-17 | Active |
| 59767-0016-00 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-00) | — | — | 2014-01-23 | Active |
| 59767-0016-99 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-99) | — | — | 2012-05-17 | Active |
This pack has the lowest per-ea cost of the 2 priced pack sizes ($5.32 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 93% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 59767-0016-01?
What is the difference between NDC 59767-0016-01 and NDC 59767-0016-00?
What NDC number is used to bill for this package of PERTZYE pancrelipase 16000 [USP'U]/1; 60500 [USP'U]/1; 57500 [USP'U]/1 Capsule, Delayed Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE PERTZYE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. PERTZYE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Important Dosing Information ( 2.1 ) PERTZYE is a mixture of enzymes including lipases, proteases, and amylases and dosing is based on lipase units. Dosing scheme based on actual body weight or fat ingestion. Individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.
Do not exceed 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. ( 5.1 ) The total daily dosage in adult and pediatric patients greater than 12 months of age should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed dose for a meal.
Do not substitute other pancreatic enzyme products for PERTZYE. When switching from another pancreatic enzyme product to PERTZYE, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed. Recommended Dosage ( 2.2 ) Adults and Pediatric Patients Greater than 12 Months : The recommended initial starting dosage is: 500 lipase units/kg/meal for adult and pediatric patients 4 years of age and older.
1,000 lipase units/kg/meal for pediatric patients greater than 12 months to less than 4 years of age. Titrate the dosage to either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day. Higher dosages may be administered if documented to be effective by fecal fat measures or improvement in malabsorption.
Pediatric Patients Birth to 12 Months: The recommended dosage is 4,000 lipase units (one capsule) per 120 mL of formula or per breastfeeding. Preparation and Administration Instructions ( 2.3 ) Swallow capsules whole. For patients unable to swallow intact capsule(s), the capsule contents may be sprinkled on soft acidic food (e.g., applesauce).
The 4,000 USP lipase unit capsule may be administered with applesauce via gastrostomy tube (14 French or larger). The contents of no more than two capsules may be administered at a time. Do not crush or chew PERTZYE capsules or capsule contents.
Consume sufficient liquids to ensure complete swallowing of PERTZYE. ( 5.2 ) See the full prescribing information for additional information on administering to pediatric patients birth to 12 months of age.
2.1Important Dosing Information PERTZYE is a mixture of enzymes including lipases, proteases, and amylases. PERTZYE dosing is based on lipase units. Use either an actual body weight or fat ingestion-based dosing scheme.
Start at the lowest recommended dosage and individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Changes in dosage may require an adjustment period of several days. Do not exceed 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 [see Warnings and Precautions (5.1) ] .
The total daily dosage in adult and pediatric patients greater than 12 months of age should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed PERTZYE dose for a meal. Do not substitute other pancreatic enzyme products for PERTZYE.
When switching from another pancreatic enzyme product to PERTZYE, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed.
2.2Recommended Dosage Adults and Pediatric Patients Greater than 12 Months of Age The recommended oral initial starting dosage is: 500 lipase units/kg/meal for adult and pediatric patients 4 years of age and older. 1,000 lipase units/kg/meal for pediatric patients greater than 12 months to less than 4 years of age. If signs and symptoms of malabsorption persist, increase the dosage. Titrate to either 2,500…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Delayed-release capsules are available in the following strengths: 4,000 USP units of lipase; 14,375 USP units of protease; and 15,125 USP units of amylase in a two-piece hard gelatin capsule with a clear body printed in green with "4" and a clear cap printed with a green circular stripe and "DCI" 8,000 USP units of lipase; 28,750 USP units of protease; and 30,250 USP units of amylase in a two-piece hard gelatin capsule with a clear body printed in blue with "8" and a clear cap printed with a blue circular stripe and "DCI" 16,000 USP units of lipase; 57,500 USP units of protease; and 60,500 USP units of amylase in a two-piece hard gelatin capsule with a clear body printed in red with "16" and a clear cap printed with a red circular stripe and "DCI" 24,000 USP units of lipase; 86,250 USP units of protease; and 90,750 USP units of amylase in a two-piece hard gelatin capsule with a clear body printed in purple with "24" and a clear cap printed with a purple circular stripe and "DCI" Delayed-Release Capsules ( 3 ): 4,000 USP units of lipase; 14,375 USP units of protease; and 15,125 USP units of amylase.
8,000 USP units of lipase; 28,750 USP units of protease; and 30,250 USP units of amylase. 16,000 USP units of lipase; 57,500 USP units of protease; and 60,500 USP units of amylase. 24,000 USP units of lipase; 86,250 USP units of protease; and 90,750 USP units of amylase.
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Fibrosing Colonopathy : Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease.
Do not exceed the recommended dosage, unless clinically indicated. ( 2.1 , 5.1 ) Irritation of the Oral Mucosa : May occur due to loss of protective enteric coating on the capsule contents. ( 5.2 ) Hyperuricemia : Reported with high dosages, consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia.
( 5.3 ) Risk of Viral Transmission : The presence of porcine viruses that might infect humans cannot be definitely excluded. ( 5.4 ) Hypersensitivity Reactions : Monitor patients with known reactions to proteins of porcine origin. If symptoms occur, initiate appropriate medical management; consider the risks and benefits of continued treatment.
( 5.5 )
5.1Fibrosing Colonopathy 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) ] .
5.2Irritation of the Oral Mucosa 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: Swallow capsules whole. For patients who cannot swallow the capsules whole, the capsules can be opened, and the contents sprinkled on a small amount of acidic soft food with a pH of 4.5 or less (e.g., applesauce).
The 4,000 USP lipase unit capsule may also be administered with applesauce via a gastrostomy tube with a diameter of 14 French or larger. Do not crush or chew PERTZYE capsules or capsule contents. Consume sufficient liquids (juice, water, breast milk, or formula) immediately following administration of PERTZYE to ensure complete swallowing.
Visually inspect the mouth of pediatric patients less than 12 months of age and of patients who are unable to swallow intact capsules to ensure no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see Dosage and Administration (2.3) ] .
5.3Hyperuricemia Pancreatic enzyme products contain purines that may increase blood uric acid levels. High dosages have been associated with hyperuricosuria and hyperuricemia…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Fibrosing Colonopathy [see Warnings and Precautions (5.1) ] Irritation of the Oral Mucosa [see Warnings and Precautions (5.2) ] Hyperuricemia [see Warnings and Precautions (5.3) ] Risk of Viral Transmission [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥ 10%) are: diarrhea, dyspepsia, and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Digestive Care Inc. at 1-877-882-5950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience 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 Reported in at least 2 PERTZYE-treated patients (≥10%) and at a higher rate than placebo-treated patients 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%
6.2Postmarketing Experience 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. Eye Disorders blurred vision Gastrointestinal Disorders fibrosing colonopathy, distal intestinal obstruction syndrome abdominal pain, flatulence, constipation, and nausea Immune System Disorders anaphylaxis, asthma, hives, and pruritus Investigations asymptomatic elevations of liver enzymes Musculoskeletal System myalgia, muscle spasm Skin and Subcutaneous Tissue Disorders urticaria and rash
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. Animal reproduction studies have not been conducted with pancrelipase.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
8.2Lactation Risk Summary There are no data on the presence of pancrelipase in either human or animal milk, the effects on the breastfed infant or the effects on milk production. Pancrelipase is minimally absorbed systemically following oral administration, therefore maternal use is not expected to result in clinically relevant exposure of breastfed infants to the drug. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PERTZYE and any potential adverse effects on the breastfed infant from PERTZYE or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of PERTZYE for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of PERTZYE for this indication is supported by a randomized, double-blind, placebo-controlled, crossover study of 24 pediatric patients, 8 years and older with exocrine pancreatic insufficiency due to cystic fibrosis. The safety in pediatric patients was similar to that observed in adult patients [see Adverse Reactions (6.1) and Clinical Studies (14) ] .
Dosages exceeding 6,000 lipase units/kg/meal have been reported postmarketing to be associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age. If there is a history of fibrosing colonopathy, monitor patients during treatment with PERTZYE because some patients may be at risk of progressing to stricture formation. 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 pediatric patients greater than 12 months of age without further investigation [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ] .
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: consume sufficient liquids (juice, water, breast milk, or formula) to ensure complete swallowing, and visually inspect the mouth of pediatric patients less than 12 months of age to ensure that no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see Dosage and Administration (2.3) and Warnings and Precautions (5.2) ] .
8.5Geriatric Use Clinical studies of PERTZYE did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between patients aged 65 years and over and younger adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. Animal reproduction studies have not been conducted with pancrelipase.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of PERTZYE for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of PERTZYE for this indication is supported by a randomized, double-blind, placebo-controlled, crossover study of 24 pediatric patients, 8 years and older with exocrine pancreatic insufficiency due to cystic fibrosis. The safety in pediatric patients was similar to that observed in adult patients [see Adverse Reactions (6.1) and Clinical Studies (14) ] .
Dosages exceeding 6,000 lipase units/kg/meal have been reported postmarketing to be associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age. If there is a history of fibrosing colonopathy, monitor patients during treatment with PERTZYE because some patients may be at risk of progressing to stricture formation. 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 pediatric patients greater than 12 months of age without further investigation [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ] .
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: consume sufficient liquids (juice, water, breast milk, or formula) to ensure complete swallowing, and visually inspect the mouth of pediatric patients less than 12 months of age to ensure that no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see Dosage and Administration (2.3) and Warnings and Precautions (5.2) ] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of PERTZYE did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between patients aged 65 years and over and younger adult patients.
🆘 Overdosage ▾
10 OVERDOSAGE 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) ] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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.
12.2Pharmacodynamics 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) ] .
12.3Pharmacokinetics Following oral administration, the lipases, proteases, and amylases released from PERTZYE are not absorbed from the gastrointestinal tract in appreciable amounts. Drug Interactions 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.
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING PERTZYE (pancrelipase) delayed-release capsules, containing light tan/cream-colored delayed-release microspheres are supplied as follows: Strength Description Supplied As NDC Number 4,000 USP units of lipase; 14,375 USP units of protease; 15,125 USP units of amylase Two-piece hard gelatin capsule with a clear body printed in green with "4" and a clear cap printed with a green circular stripe and "DCI" Bottles of 100 59767-004-01 8,000 USP units of lipase; 28,750 USP units of protease; 30,250 USP units of amylase Two-piece hard gelatin capsule with a clear body printed in blue with "8" and a clear cap printed with a blue circular stripe and "DCI" Bottles of 100 Bottles of 250 59767-008-01 59767-008-02 16,000 USP units of lipase; 57,500 USP units of protease; 60,500 USP units of amylase Two-piece hard gelatin capsule with a clear body printed in red with "16" and a clear cap printed with a red circular stripe and "DCI" Bottles of 100 Bottles of 250 59767-016-01 59767-016-02 24,000 USP units of lipase; 86,250 USP units of protease; 90,750 USP units of amylase Two-piece hard gelatin capsule with a clear body printed in purple with "24" and a clear cap printed with a purple circular stripe and "DCI" Bottles of 80 Bottles of 200 59767-024-01 59767-024-02 Storage and Handling Store PERTZYE at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 40°C (59°F to 104°F) for up to 30 days.
PERTZYE hard gelatin capsules should be stored in a dry place in the original container or equivalent airtight container. After opening, keep the container tightly closed between uses to protect from moisture. PERTZYE is dispensed in bottles containing a desiccant.
📦 Storage and Handling ▾
Storage and Handling Store PERTZYE at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 40°C (59°F to 104°F) for up to 30 days. PERTZYE hard gelatin capsules should be stored in a dry place in the original container or equivalent airtight container. After opening, keep the container tightly closed between uses to protect from moisture. PERTZYE is dispensed in bottles containing a desiccant.
📋 Description ▾
11 DESCRIPTION Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated microspheres in PERTZYE are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. PERTZYE (pancrelipase) delayed-release capsules are for oral administration, include a two-piece hard gelatin shell containing light tan/cream-colored bicarbonate-buffered enteric-coated microspheres ranging in size from 0.8 to 1.4 mm in diameter for 4,000 USP units of lipase and 0.8 to 2.2 mm in diameter for 8,000, 16,000, and 24,000 USP units of lipase, and are available as follows: 4,000 USP units of lipase ; 14,375 USP units of protease; and 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; and 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; and 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. 24,000 USP units of lipase ; 86,250 USP units of protease; and 90,750 USP units of amylase; delayed-release capsules have a clear body printed in purple with "24" and a clear cap printed with a purple circular stripe and "DCI".
The imprinting ink on the capsule contains FD&C Blue #2, D&C Red #7, titanium dioxide, strong ammonia solution, propylene glycol, butyl alcohol, isopropyl alcohol, dehydrated alcohol, and shellac. PERTZYE (pancrelipase) delayed-release capsules include the following inactive ingredients: cellulose acetate phthalate, diethyl phthalate, polyvinylpyrrolidone, sodium bicarbonate, sodium carbonate, sodium starch glycolate, talc, and ursodiol.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Fibrosing Colonopathy 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) ].
Hyperuricemia 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) ]. Hypersensitivity Reactions 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) ] .
Dosage 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) ]. Administration Instruct the patient or caregiver to: Take PERTZYE with meals or snacks. Swallow capsules whole.
For patients unable to swallow intact capsules: the capsule contents may be sprinkled on a small amount of soft acidic food with a pH of 4.5 or less (e.g., applesauce). The 4,000 USP lipase unit capsule may also be administered with applesauce via gastrostomy tube 14 French or larger. For pediatric patients birth to 12 months of age, PERTZYE capsules can be opened, and the capsule contents sprinkled directly into the infant's mouth.
See the Instructions for Use for a description of all preparation and administration instructions. Consume sufficient liquids (juice, water, breast milk, or formula) and visually inspect an infant's mouth to ensure complete swallowing of PERTZYE capsules or capsule contents [see Warnings and Precautions (5.2) ] . Do not crush or chew PERTZYE capsules or capsule contents.
Do not mix the PERTZYE capsule contents directly into a bottle of breast milk or formula. Storage Instruct the patient or caregiver as follows: Keep PERTZYE in a dry place and protect from moisture and heat. After opening, keep the container tightly closed between uses to protect from moisture.
The desiccant packet should not be eaten or thrown away.
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 02/2024 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: stomach area (abdominal) pain bloating trouble passing stool (constipation) nausea vomiting diarrhea Take PERTZYE exactly as prescribed by your doctor. Do not take more PERTZYE than directed by your doctor. What is PERTZYE?
PERTZYE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes. PERTZYE capsules contain a mixture of digestive enzymes including lipases, proteases and amylases from pig pancreas. PERTZYE is safe and effective in adults and children.
Before taking PERTZYE, tell your doctor about all of your medical conditions, including if you: are allergic to pork (pig) products. have a history of blockage of your intestines or scarring or thickening of your bowel wall (fibrosing colonopathy). have gout, kidney disease, or high blood uric acid (hyperuricemia). have trouble swallowing capsules. have any other medical condition. are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed. It is not known if PERTZYE passes into your breast milk.
Talk to your doctor about the best way to feed your baby if you take PERTZYE. 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? See the Instructions for Use at the end of this Medication Guide for detailed instructions about how to give PERTZYE by mouth and through a gastrostomy tube.
Take PERTZYE capsules exactly as your doctor tells you. Contact your doctor if you continue to have signs and symptoms of malabsorption (not absorbing nutrients from food) such as abdominal pain, abdominal bloating, fatty stools, or weight loss. Your dose may need to be changed.
You should not switch PERTZYE with any other pancreatic enzyme product without first talking with your doctor. Do not take more capsules in a day than the number your doctor tells you to take (total daily dose). Always take PERTZYE with a meal or snack.
If you eat a lot of meals or snacks in a day, be careful not to go over your total daily dose. Your doctor may change your dose based on the amount of fatty foods you eat or based on your weight. PERTZYE capsules should be swallowed whole.
Do not crush or chew the PERTZYE capsules or their contents and do not hold the capsule or capsule contents in your mouth. Crushing or chewing the PERTZYE capsules may cause irritation in your mouth or change the way PERTZYE works in your body. Drink plenty of liquid to ensure complete swallowing of the PERTZYE capsules or PERTZYE capsule contents-food mixture.
Throw away the PERTZYE capsule contents-food mixture that is not used. Do not save this mixture for later use. If you miss a dose of PERTZYE, wait until your next meal or snack and take your prescribed dose.
Take your next dose at your usual time. Do not take two doses at one time. What are the possible side effects of PERTZYE?
See " What is the most important information I should know about PERTZYE? " Irritation of the inside of your mouth. This can happen if PERTZYE is not swallowed completely, is crushed or chewed, or is mixed in foods that are not recommended. Increase in blood uric acid levels (hyperuricemia).
This may…