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PANCREAZE 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.
Each capsule for oral administration contains enteric-coated microtablets that are each approximately 2 mm in diameter.
The active ingredient evaluated in clinical trials is lipase. PANCREAZE is dosed by lipase units. Other active ingredients include protease and amylase.
Inactive ingredients in PANCREAZE include cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, montan glycol wax, simethicone emulsion, talc and triethyl citrate.
PANCREAZE is available in four color coded strengths. Each PANCREAZE capsule strength contains the specified amounts of lipase, protease, and amylase as follows:
4,200 USP units of lipase; 10,000 USP units of protease; 17,500 USP units of amylase. The hard gelatin capsules have a yellow opaque body and clear cap imprinted with “McNEIL” and “MT 4”. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate, iron oxide, and gelatin capsule imprint ink.
10,500 USP units of lipase; 25,000 USP units of protease; 43,750 USP units of amylase. The hard gelatin capsules have a pink opaque body and clear cap imprinted with “McNEIL” and “MT 10”. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate, iron oxide, and gelatin capsule imprint ink.
16,800 USP units of lipase; 40,000 USP units of protease; 70,000 USP units of amylase. The hard gelatin capsules have a salmon opaque body and clear cap imprinted with “McNEIL” and “MT 16”. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate, iron oxide, and gelatin capsule imprint ink.
21,000 USP units of lipase; 37,000 USP units of protease; 61,000 USP units of amylase. The hard gelatin capsules have a white opaque body and cap imprinted with “McNEIL” and “MT 20”. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate, and gelatin capsule imprint ink.
PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
PANCREAZE is a mixture of enzymes including lipases, proteases, and amylases.
PANCREAZE dosing is based on lipase units.
The recommended oral initial starting dosage is:
The recommended oral dosage is 2,600 lipase units per 120 mL of formula or per breast-feeding.
Instruct adult and pediatric patients greater than 12 months of age, or their caregivers, of the following:
Instruct caregivers of pediatric patients birth to 12 months of age of the following:
Delayed-release capsules are available in the following strengths:
PANCREAZE (pancrelipase) delayed-release capsules are supplied as follows:
| Strength | Description | Supplied As NDC Number |
| 2,600 USP units of lipase; 8,800 USP units of protease; 15,200 USP units of amylase | two-piece hypromellose capsule with a light orange opaque body and clear cap imprinted with “VIVUS” and “MT 2” | Bottles of 100 NDC 62541-401-10 |
| 4.200 USP units of lipase; 14.200 USP units of protease; 24,600 USP units of amylase | two-piece hypromellose capsule with a yellow opaque body and clear cap imprinted with “VIVUS” and “MT 4” | Bottles of 100 NDC 62541-402-10 |
| 10.500 USP units of lipase; 35.500 USP units of protease; 61.500 USP units of amylase | two-piece hypromellose capsule with a pink opaque body and clear cap imprinted with “VIVUS” and “MT 10” | Bottles of 100 NDC 62541-403-10 |
| 16.800 USP units of lipase; 56.800 USP units of protease; 98,400 USP units of amylase | two-piece hypromellose capsule with a flesh opaque body and clear cap imprinted with “VIVUS” and “MT 16” | Bottles of 100 NDC 62541-404-10 |
| 21,000 USP units of lipase; 54,700 USP units of protease; 83,900 USP units of amylase | two-piece hypromellose capsule with a white opaque body and cap imprinted with “VIVUS” and “MT 20” | Bottles of 100 NDC 62541-405-10 |
| 37,000 USP units of lipase; 97,300 USP units of protease; 149,900 USP units of amylase | Two-piece hypromellose capsule with an iron grey opaque body and white opaque cap imprinted with “VIVUS” and “MT 37” amylase | 2 bottles of 50- (NDC 62541-406-50) inside a carton (NDC 62541-406-10) |
Store PANCREAZE at room temperature between 15°C and 25°C (59°F to 77°F), excursion permitted up to 40°C (104°F) for 24 hours.
After opening, keep bottle tightly closed between uses to protect from moisture.
All PANCREAZE bottles contain a desiccant canister. Store and dispense PANCREAZE in the original container.
Finished Product Manufactured at: Nordmark Pharma GmbH 25436 Uetersen, Germany. Manufactured by: VIVUS LLC 900 E. Hamilton Ave., Suite 550 Campbell. Revised: Feb 2024
The following serious or otherwise important adverse reactions are described elsewhere in the labeling:
The data described below reflect exposure to PANCREAZE in 57 adult and pediatric patients with exocrine pancreatic insufficiency due to cystic fibrosis in two clinical trials. Study 1 was conducted in 40 patients, aged 8 years to 57 years; Study 2 was conducted in 17 pediatric patients, aged 6 months to 30 months [see Clinical Studies]. The most common adverse reactions were gastrointestinal, including diarrhea and vomiting.
The following adverse reactions have been identified during post-approval use of PANCREAZE 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 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 strictures, 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 PANCREAZE 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].
Crushing or chewing PANCREAZE 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]. Consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia during treatment with PANCREAZE.
PANCREAZE is sourced from pancreatic tissue from swine used for food consumption. Although the risk that PANCREAZE 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.
Serious hypersensitivity reactions including anaphylaxis, asthma, hives, and pruritus have been reported with pancreatic enzyme products [see ADVERSE REACTIONS]. 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 PANCREAZE. The risks and benefits of continued PANCREAZE treatment in patients with serious hypersensitivity reactions should be taken into consideration with the overall clinical needs of the patient.
Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide).
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 with cystic fibrosis. Colonic stricture has been reported 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].
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].
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].
Advise the patient or caregiver to take or administer PANCREAZE as prescribed, and to contact the healthcare provider if signs and symptoms of malabsorption persist [see DOSAGE AND ADMINISTRATION].
Instruct the patient or caregiver to:
Instruct the patient or caregiver as follows:
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.
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 PANCREAZE and any potential adverse effects on the breastfed infant from PANCREAZE or from the underlying maternal condition.
The safety and effectiveness of PANCREAZE for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients.
Use of PANCREAZE for this indication is supported by an adequate and well-controlled trial in adult and pediatric patients 8 to 17 years of age (Study 1) along with supportive data from a randomized, investigator-blinded, dose-ranging study in 17 pediatric patients aged 6 to 30 months (Study 2). Both study populations consisted of patients with exocrine pancreatic insufficiency due to cystic fibrosis. The safety in pediatric patients in these studies was similar to that observed in adult patients [see ADVERSE REACTIONS and Clinical Studies].
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 PANCREAZE 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 and WARNINGS AND PRECAUTIONS].
Crushing or chewing PANCREAZE 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 no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
Clinical studies of PANCREAZE 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.
In Study 1, a 10 year-old patient was administered a PANCREAZE dose of 12,399 lipase units/kg/day for the duration of the open-label and randomized withdrawal periods (21 days). The patient experienced mild abdominal pain throughout both study periods. Abnormal chemistry data at the end of the study included mild elevations of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and serum phosphate. Abnormal hematology data at the end of the study included mild elevations of hematocrit. No abnormalities from analyses of urinalysis or uric acid were noted.
Chronic high dosages of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see WARNINGS AND PRECAUTIONS]. High dosages of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia [see WARNINGS AND PRECAUTIONS].
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 maltriose 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 PANCREAZE compared to the placebo treatment group, indicating improved fat absorption [see Clinical Studies].
Following oral administration, the lipases, proteases, and amylases released from PANCREAZE are not absorbed from the gastrointestinal tract in appreciable amounts.
The lipases, proteases, and amylases of PANCREAZE are not substrates of CYP enzymes or transporters. CYP enzymes or transporters mediated drug interactions are not expected.
Studies 1 and 2 were conducted in 57 adult and pediatric patients, aged 6 months to 17 years, with exocrine pancreatic insufficiency due to cystic fibrosis.
Study 1 was a randomized, double-blind, placebo-controlled study of 40 patients, ages 8 to 57 years. In this study, patients received PANCREAZE at individually titrated doses (not to exceed 2,500 lipase units/kg/meal) for 14 days (open-label period) followed by randomization to PANCREAZE or matching placebo for 7 days of treatment (double-blind withdrawal period). Only patients with coefficient of fat absorption (CFA) ≥80% in the open-label period were randomized to the double-blind withdrawal period. The mean dosage during the 70day placebo-controlled treatment period was 6,400 lipase units/kg/day. All patients consumed a high-fat diet (greater than or equal to 100 grams of fat per day) during the treatment period. The population was nearly evenly distributed in biological sex and approximately 96% of patients were White.
The primary efficacy endpoint was the change in CFA from the open label period to the end of the double-blind withdrawal period. The CFA was determined by a 72-hour stool collection period during both treatment periods, when both fat excretion and fat ingestion were measured (Table 1).
Table 1: Change in CFA in Study 1 (Open-Label Period to End of Double-Blind Withdrawal Period)
| PANCREAZE N=20 |
Placebo N=20 |
|
| CFA [%l | ||
| Open-Label Perioda (Mean, SD) | 88 (5) | 91 (5) |
| End of Double-Blind Withdrawal Periodb (Mean, SD) | 87 (8) | 56 (25) |
| Change in CFAc [%] | ||
| Open-Label Period to End of Double-Blind Withdrawal Period (Mean, SD) | -2 (6) | -34 (23) |
| Treatment Difference Point Estimate (95% CI) | 33 (25, 40) | |
| a Minimum of 72 hours from start of open label period. b Double-blind withdrawal period ranged from 4 to 7 days. c p<0.001 |
||
At the end of the double-blind withdrawal period, the mean change in CFA from the open-label period to the end of the double-blind withdrawal period was -2% with PANCREAZE treatment compared to -34% with placebo treatment. There were similar responses to PANCREAZE by age and biological sex.
Study 2 was a randomized, investigator-blinded, dose-ranging study of 17 pediatric patients, ages 6 months to 30 months (mean 18 months). The final analysis population was limited to 16 patients; 1 patient was excluded due to withdrawal of consent. All patients were transitioned from their usual pancreatic enzyme treatment to PANCREAZE at 375 lipase units/kg/meal for a 6-day run-in period. Patients were then randomized to receive PANCREAZE at one of four dosages (375, 750, 1,125, and 1,500 lipase units/kg/meal) for 5 days.
Coefficient Of Fat Absorption Endpoint And Results
The CFA was measured at the end of the run-in period and at the end of the randomized period (Table 2).
Table 2: Change in CFA in Study 2 (End of Run-in Period to End of Study)
| 375 lipase units /kg/meal N=4 |
750 lipase units /kg/meal N=4 |
1,125 lipase units /kg/meal N=4 |
1,500 lipase units /kg/meal N=4 |
|
| CFA (%) | ||||
| Day 6a (Mean, SD) | 93 (2) | 90 (5) | 81 (11) | 93 (3) |
| Day 11b (Mean, SD) | 92 (3) | 91 (4) | 80 (13) | 91 (2) |
| Change in CFA (%) Day 6 to Day 11 (Mean, SD) | -2 (3) | 1 (3) | -1 (3) | -2 (3) |
| a End of Run-in Period; b End of Study | ||||
Overall, patients showed similar CFA at the end of the run-in period (mean PANCREAZE dosage of 1,600 lipase units/kg/day) and at the end of the study across the four treatment arms.
PANCREAZE®
(pan-kre-aze)
(pancrelipase)delayed-release capsules
What is the most important information I should know about PANCREAZE?
PANCREAZE may increase your chance 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 gave you. Call your doctor right away if you have any unusual or severe:
Take PANCREAZE exactly as prescribed by your doctor. Do not take more PANCREAZE than directed by your doctor.
What is PANCREAZE?
PANCREAZE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes.
PANCREAZE contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.
PANCREAZE is safe and effective in adults and children.
Before taking PANCREAZE, tell your doctor about all your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-thecounter medicines, vitamins, or 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 PANCREAZE?
Giving PANCREAZE to Infants (Children from Birth up to 12 Months of Age): The two ways to give PANCREAZE to infants (children from birth to 12 months of age) are described below:
a) Giving with Acidic Soft Food
b) Giving Directly Into Infant's Mouth Before Breast or Formula Feeding
If a dose is missed, give the next dose with the next feeding.
Giving PANCREAZE to Adults and Children Older than 12 Months of Age:
What are the possible side effects of PANCREAZE?
PANCREAZE may cause serious side effects, including:
The most common side effects of PANCREAZE include:
Other possible side effects of PANCREAZE:
PANCREAZE 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 does not go away.
These are not all the possible side effects of PANCREAZE. 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.
You may also report side effects to VIVUS LLC at 1-888-998-4887.
How should I store PANCREAZE?
Keep PANCREAZE and all medicines out of the reach of children.
General information about PANCREAZE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PANCREAZE for a condition for which it was not prescribed. Do not give PANCREAZE to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or doctor for information about PANCREAZE that is written for healthcare professionals.
What are the ingredients in PANCREAZE?
Active Ingredient: lipase, protease, amylase
Inactive ingredients in all strengths of PANCREAZE: colloidal silicon dioxide, crospovidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, microcrystalline cellulose, montan glycol wax, simethicone emulsion, talc and triethyl citrate. The capsule shell contains hypromellose, titanium dioxide and iron oxide.
Imprint ink for PANCREAZE 2600 contains black iron oxide, shellac, propylene glycol, strong ammonia solution, potassium hydroxide.
Imprint ink for PANCREAZE 4200, 10500 and 16800 contains black iron oxide, shellac-glaze45%, ammonium hydroxide, propylene glycol.
Imprint ink for PANCREAZE 21000 contains yellow iron oxide, shellac, strong ammonia solution, propylene glycol. Imprint ink for PANCREAZE 37000 contains black iron oxide, shellac-glaze-45%, ammonium hydroxide, propylene glycol.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
