Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase
FDA Drug Information • Also known as: Zenpep
- Brand Names
- Zenpep
- Route
- ORAL
- Dosage Form
- CAPSULE, DELAYED RELEASE
- Product Type
- HUMAN PRESCRIPTION DRUG
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 pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1 . 8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2 . 2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows: 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint "APTALIS 3". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint "APTALIS 5". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint "APTALIS 10". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint "APTALIS 15". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium...
What Is Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase Used For?
1 INDICATIONS AND USAGE ZENPEP ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ZENPEP ® 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 ) ZENPEP 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 ZENPEP. When switching from another pancreatic enzyme product to ZENPEP, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed. Recommended Dosage ( 2.2 ) Adult 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 of age to less than 4 years of age. Titrate 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 effective by fecal fat measures or improvement in malabsorption. Pediatric Patients Birth to 12 Months: The recommended dosage is 3,000 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, bananas, pears). Do not crush or chew ZENPEP capsules or capsule contents. Consume sufficient liquids to ensure complete swallowing of ZENPEP. ( 5.2 ) See the full prescribing information for additional information on administering to pediatric patients birth to 12 months. ( 2.3 ) 2.1 Important Dosing Information ZENPEP is a mixture of enzymes including lipases, proteases, and amylases. ZENPEP 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...
Side Effects (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 (≥6%) are: headache, contusion, cough, and early satiety. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics, Inc at 1-833-AIM2KNO (1-833-246-2566) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 ZENPEP in 53 adult and pediatric patients with exocrine pancreatic insufficiency due to cystic fibrosis in two clinical trials conducted [see Clinical Studies (14) ] . In both trials, ZENPEP was administered at dosages of approximately 5,000 lipase units/kg/day for 19 to 42 days. Study 1 was a randomized, double-blind, placebo-controlled, crossover study of 34 adult and pediatric patients, aged 7 to 23 years. Adverse reactions that were reported in at least 2 ZENPEP-treated patients (greater than or equal to 6%) and at a higher rate than in placebo-treated patients in Study 1 are shown in Table 1. Table 1: Adverse Reactions Reported in at least 2 ZENPEP-treated patients (greater than or equal to 6%) and at a higher rate than placebo-treated patients. in a Clinical Trial of Adult and Pediatric Patients 7 Years of Age and Older with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis (Study 1) Adverse Reaction ZENPEP N=34 n (%) Placebo N=32 n (%) Headache 5 (15%) 0 Contusion 2 (6%) 0 Cough 2 (6%) 0 Early Satiety 2 (6%) 0 Study 2 was an open-label, uncontrolled study of ZENPEP in 19 pediatric patients aged 1 to 6 years. The most commonly reported adverse reactions were gastrointestinal, including abdominal pain and steatorrhea. The type and incidence of adverse reactions in Studies 1 and 2 were similar between pediatric patients and adults. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ZENPEP 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 and distal intestinal obstruction syndrome abdominal distension, abdominal pain, diarrhea, flatulence, constipation, and nausea Immune System Disorders anaphylaxis, asthma, hives and pruritis Investigations asymptomatic elevations of liver enzymes Musculoskeletal System myalgia, muscle spasm Skin and Subcutaneous Tissue Disorders urticaria and rash
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Pregnancy and Breastfeeding
8.1 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.
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) ] .
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING ZENPEP (pancrelipase) delayed-release capsules containing light, brown-colored delayed-release pancrelipase are supplied as follows: Strength Description Supplied As NDC Number 3,000 USP units of lipase; 10,000 USP units of protease; 14,000 units of amylase two-piece hypromellose capsule with white opaque cap and white body with a red radial print and printed with "APTALIS 3" Bottles of 100 73562-113-01 5,000 USP units of lipase; 17,000 USP units of protease; 24,000 units of amylase two-piece hypromellose capsule with a white opaque cap and white body with a blue radial print and printed with "APTALIS 5" Bottles of 100 73562-115-01 10,000 USP units of lipase; 32,000 units of protease; 42,000 units of amylase two-piece hypromellose capsule with a yellow opaque cap and white body with a blue radial print and printed with "APTALIS 10" Bottles of 100 73562-110-01 15,000 USP units of lipase; 47,000 units of protease; 63,000 units of amylase two-piece hypromellose capsule with a red opaque cap and white body with a blue radial print and printed with "APTALIS 15" Bottles of 100 73562-111-01 20,000 USP units of lipase; 63,000 units of protease; 84,000 units of amylase two-piece hypromellose capsule with a green opaque cap and white body with a blue radial print and printed with "APTALIS 20" Bottles of 100 73562-112-01 25,000 USP units of lipase; 79,000 units of protease; 105,000 units of amylase two-piece hypromellose capsule with a blue opaque cap and white body with a blue radial print and printed with "APTALIS 25" Bottles of 100 73562-116-01 40,000 USP units of lipase; 126,000 units of protease; 168,000 units of amylase two-piece hypromellose capsule with an orange opaque cap and white body with a blue radial print and printed with "APTALIS 40" Bottles of 100 73562-114-01 60,000 USP units of lipase; 189,600 units of protease; 252,600 units of amylase two-piece hypromellose capsule with powder blue opaque cap with two black stripes...
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.