Pancrelipase

FDA Drug Information • Also known as: Creon, Pertzye, Viokace

Brand Names: Creon, Pertzye, Viokace
Dosage Form: CAPSULE
Product Type: DRUG FOR FURTHER PROCESSING

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;...

What Is Pancrelipase Used For?

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. 2.1 Important 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...

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 (≥ 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 . 6.1 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 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% 6.2 Postmarketing 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

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 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.

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.