Pancreaze
(amylase / lipase / protease)Dosage & Administration
Important Dosing Information ( 2.1)
Recommended Dosage ( 2.2):
Adult and Pediatric Patients Greater than 12 Months: The recommended initial starting dosage is:
Pediatric Patients Birth to 12 Months:The recommended dosage is 2,600 lipase units (one capsule) per 120 mL of formula or per breastfeeding.
Preparation and Administration Instructions ( 2.3)
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Pancreaze Prescribing Information
PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
Important Dosing Information
PANCREAZE is a mixture of enzymes including lipases, proteases, and amylases. PANCREAZE 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 PANCREAZE dose for a meal.
- Do not substitute other pancreatic enzyme products for PANCREAZE. When switching from another pancreatic enzyme product to PANCREAZE, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed.
Recommended Dosage
Adult 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 lipase units/kg/meal, 10,000 lipase units/kg/day, or less than 4,000 lipase units/grams of fat ingested/day.
- 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.
Pediatric Patients Birth to 12 Months of Age
The recommended oral dosage is 2,600 lipase units per 120 mL of formula or per breast-feeding.
Preparation and Administration Instructions
Instruct adult and pediatric patients greater than 12 months of age, or their caregivers, of the following:
- Take PANCREAZE with meals or snacks. If a dose is missed, take the next dose with the next meal or snack.
- Swallow capsules whole.
- For patients who are unable to swallow intact capsules, carefully open the capsules and sprinkle the entire contents on a small amount of acidic soft food with a pH of 4.5 or less (e.g., applesauce). Consume the entire mixture immediately.
- Do not crush or chew PANCREAZE capsules or capsule contents.
- Consume sufficient liquids (water or juice) to ensure complete swallowing of PANCREAZE capsules [see Warnings and Precautions (5.2)] .
Instruct caregivers of pediatric patients birth to 12 months of age of the following:
- Immediately prior to each breast-feeding session or each administration of 120 mL of formula, carefully open one PANCREAZE capsule (containing 2,600 USP units of lipase) and administer the entire contents using one of the following two methods:
- Sprinkle on a small amount of acidic soft food with a pH of 4.5 or less (e.g., applesauce) being careful not to crush the capsule contents. The entire mixture should be given to the infant immediately.
- Sprinkle the capsule contents directly into the infant's mouth.
- Immediately administer additional breast milk or formula after PANCREAZE to ensure complete swallowing of the capsule contents.
- Do not mix PANCREAZE capsule contents directly into a bottle of breast milk or formula.
- Do not crush PANCREAZE capsule contents, and visually inspect the infant's mouth to ensure that no drug is retained in the mouth [see Warnings and Precautions (5.2)] .
- If a dose is missed, administer the next dose with the next feeding.
Delayed-release capsules are available in the following strengths:
- 2,600 USP units of lipase; 8,800 USP units of protease; and 15,200 USP units of amylase in a two-piece hypromellose capsule with a light orange opaque body and clear cap, printed with "VIVUS" and "MT 2"
- 4,200 USP units of lipase; 14,200 USP units of protease; and 24,600 USP units of amylase in a two-piece hypromellose capsule with a yellow opaque body and clear cap, printed with "VIVUS" and "MT 4"
- 10,500 USP units of lipase; 35,500 USP units of protease; and 61,500 USP units of amylase in a two-piece hypromellose capsule with a flesh opaque body and clear cap, printed with "VIVUS" and "MT 10"
- 16,800 USP units of lipase; 56,800 USP units of protease; and 98,400 USP units of amylase in a two-piece hypromellose capsule with a flesh opaque body and clear cap, printed with "VIVUS" and "MT 16"
- 21,000 USP units of lipase; 54,700 USP units of protease; and 83,900 USP units of amylase in a two-piece hypromellose capsule with a white opaque body and cap, printed with "VIVUS" and "MT 20"
- 37,000 USP units of lipase; 97,300 USP units of protease; and 149,900 USP units of amylase in a two-piece hypromellose capsule with an iron grey opaque body and white opaque cap, printed with "VIVUS" and "MT 37"
Pregnancy
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.
Lactation
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 PANCREAZE and any potential adverse effects on the breastfed infant from PANCREAZE or from the underlying maternal condition.
Pediatric Use
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 (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 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 (2.2)and Warnings and Precautions (5.1)] .
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 (2.3)and Warnings and Precautions (5.2)].
Geriatric Use
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.
None.
Fibrosing 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 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 (2.1)] .
Irritation of the Oral Mucosa
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:
- 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).
- Do not crush or chew PANCREAZE capsules or capsule contents.
- Consume sufficient liquids (juice, water, breast milk, or formula) immediately following administration of PANCREAZE 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 that no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see Dosage and Administration (2.3)] .
Hyperuricemia
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 PANCREAZE.
Risk of Viral Transmission
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.
Hypersensitivity Reactions
Serious 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 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.