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Pancrelipase

Pronunciation

Pronunciation

(pan kre LYE pase)

Index Terms

  • Amylase, Lipase, and Protease
  • Digestive Enzyme
  • Lipancreatin
  • Lipase, Protease, and Amylase
  • Pancrease MT
  • Pancreatic Enzymes
  • Pancrecarb MS-16
  • Pangestyme
  • Panocaps
  • Panokase
  • Protease, Lipase, and Amylase
  • Ultrase

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, delayed release, bicarbonate buffered enteric coated microspheres, oral [porcine derived]:

Pertzye: Lipase 8,000 USP units, protease 28,750 USP units, and amylase 30,250 USP units

Pertzye: Lipase 16,000 USP units, protease 57,500 USP units, and amylase 60,500 USP units

Capsule, delayed release, enteric coated beads, oral [porcine derived]:

Pancrelipase (Lip-Prot-Amyl): Lipase 5000 USP units, protease 17,000 USP units, amylase 27,000 USP units

Zenpep: Lipase 3000 USP units, protease 10,000 USP units, and amylase 16,000 USP units

Zenpep: Lipase 5000 USP units, protease 17,000 USP units, and amylase 27,000 USP units

Zenpep: Lipase 10,000 USP units, protease 34,000 USP units, and amylase 55,000 USP units

Zenpep: Lipase 15,000 USP units, protease 51,000 USP units, and amylase 82,000 USP units

Zenpep: Lipase 20,000 USP units, protease 68,000 USP units, and amylase 109,000 USP units

Zenpep: Lipase 25,000 USP units, protease 85,000 USP units, and amylase 136,000 USP units

Zenpep: Lipase 40,000 USP units, protease 136,000 USP units, and amylase 218,000 USP units

Capsule, delayed release, enteric coated microspheres, oral [porcine derived]:

Creon: Lipase 3000 USP units, protease 9500 USP units, and amylase 15,000 USP units

Creon: Lipase 6000 USP units, protease 19,000 USP units, and amylase 30,000 USP units

Creon: Lipase 12,000 USP units, protease 38,000 USP units, and amylase 60,000 USP units

Creon: Lipase 24,000 USP units, protease 76,000 USP units, and amylase 120,000 USP units

Creon: Lipase 36,000 USP units, protease 114,000 USP units, and amylase 180,000 USP units

Capsule, delayed release, enteric coated microtablets, oral [porcine derived]:

Pancreaze: Lipase 4200 USP units, protease 10,000 USP units, and amylase 17,500 USP units

Pancreaze: Lipase 10,500 USP units, protease 25,000 USP units, and amylase 43,750 USP units

Pancreaze: Lipase 16,800 USP units, protease 40,000 USP units, and amylase 70,000 USP units

Pancreaze: Lipase 21,000 USP units, protease 37,000 USP units, and amylase 61,000 USP units

Capsule, delayed release, enteric coated minitablets, oral [porcine derived]:

Ultresa: Lipase 13,800 USP units, protease 27,600 USP units, and amylase 27,600 USP units

Ultresa: Lipase 20,700 USP units, protease 41,400 USP units, and amylase 41,400 USP units

Ultresa: Lipase 23,000 USP units, protease 46,000 USP units, and amylase 46,000 USP units

Tablet, oral [porcine derived]:

Viokace: Lipase 10,440 USP units, protease 39,150 USP units, and amylase 39,150 USP units

Viokace: Lipase 20,880 USP units, protease 78,300 USP units, and amylase 78,300 USP units

Brand Names: U.S.

  • Creon
  • Pancreaze
  • Pancrelipase (Lip-Prot-Amyl)
  • Pertzye
  • Ultresa
  • Viokace
  • Zenpep

Pharmacologic Category

  • Enzyme

Pharmacology

Pancrelipase is a natural product harvested from the porcine pancreatic glands. It contains a combination of lipase, amylase, and protease. Products are formulated to dissolve in the more basic pH of the duodenum so that they may act locally to break down fats, protein, and starch.

Absorption

None; acts locally in GI tract

Excretion

Feces

Use: Labeled Indications

Pancreatic insufficiency (exocrine): Treatment of exocrine pancreatic insufficiency caused by cystic fibrosis or other conditions. Creon is also approved for patients with chronic pancreatitis or pancreatectomy. Viokace, in combination with a proton-pump inhibitor, is approved for use in adults with exocrine pancreatic insufficiency caused by chronic pancreatitis or pancreatectomy.

Note: Viokace must be administered with a proton pump inhibitor (PPI) since it is not enteric coated.

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Dosing: Adult

Note: Dosing should not exceed recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines. Adjust dose based on body weight, clinical symptoms, and stool fat content. Allow several days between dose adjustments. Total daily dose reflects ~3 meals per day and 2 to 3 snacks per day, with half the mealtime dose given with a snack. Doses of lipase >2,500 units/kg/meal, lipase >10,000 units/kg/day, or lipase >4,000 units/g fat daily should be used with caution and only with documentation of 3-day fecal fat measures. Doses of lipase >6,000 units/kg/meal are associated with colonic stricture and should be decreased.

Pancreatic insufficiency due to conditions such as cystic fibrosis: Oral (Creon, Pancreaze, Pertzye, Ultresa, Zenpep): Initial: Lipase 500 units/kg/meal. Dosage range: Lipase 500 to 2,500 units/kg/meal. Maximum: Lipase ≤2,500 units/kg/meal or lipase ≤10,000 units/kg/day or lipase <4,000 units/g of fat daily

Pancreatic insufficiency due to chronic pancreatitis or pancreatectomy: Oral:

Creon: Initial: Lipase 500 units/kg/meal with individualized dosage titrations. In one clinical trial, 72,000 units/meal while consuming ≥100 g of fat daily was used. Usually, half the prescribed dose for an individualized full meal should be given with each snack. Maximum: Lipase ≤2,500 units/kg/meal or lipase ≤10,000 units/kg/day or lipase <4,000 units/g of fat daily

Viokace (administer in combination with a proton pump inhibitor): Initial: Lipase 500 units/kg/meal with individualized dosage titration. In one clinical trial, 125,280 units/meal while consuming ≥100 g of fat daily was used. Usually, half the prescribed dose for an individualized full meal should be given with each snack. Maximum: Lipase ≤2,500 units/kg/meal or lipase ≤10,000 units/kg/day or lipase <4,000 units/g of fat daily.

Pancreatic insufficiency (exocrine) due to pancreatic cancer (off-label dosing): Oral: Initial: 25,000 to 50,000 units (lipase) per meal or 1,000 units (lipase)/kg/day or 4,000 units/5 to 7 g fat at each meal; escalate dose based on relief of symptoms; maximum dose: 2,500 units (lipase)/kg/meal (Damerla 2008).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Dosing should not exceed recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines. Adjust dose based on body weight, clinical symptoms, and stool fat content. Allow several days between dose adjustments. Total daily dose reflects ~3 meals per day and 2 to 3 snacks per day, with half the mealtime dose given with a snack. Doses of lipase >2,500 units/kg/meal, lipase >10,000 units/kg/day, or lipase >4,000 units/g fat daily should be used with caution and only with documentation of 3-day fecal fat measures. Doses of lipase >6,000 units/kg/meal are associated with colonic stricture and should be decreased.

Pancreatic insufficiency due to conditions such as cystic fibrosis:

Infants ≤1 year (Creon, Pancreaze, Pancrelipase, Ultresa, Zenpep): Oral: Manufacturer's labeling: Lipase 2,000 to 4,000 units per 120 mL of formula or per breast-feeding based on available dosage form:

Creon 3,000 units per 120 mL formula or per breast-feeding

Pancreaze 2,600 units per 120 mL or per breast-feeding

Pancrelipase 2,000 to 4,000 units per 120 mL or per breast-feeding

Ultresa 4,000 units per 120 mL or per breast-feeding

Zenpep: 3,000 units per 120 mL or per breast-feeding

Note: CF Guidelines recommend a dose of 2,000 to 5,000 units per feeding of formula, breast milk, or per breast-feeding (even if volume is <120 mL) for up to 2 years of age. Maximum daily dose: 10,000 lipase units/kg/day (Borowitz, 2009; Borowitz 2013).

Children >1 and <4 years (Pertzye [and weight ≥8 kg], Ultresa, Creon, Pancreaze, Zenpep): Oral: Initial: Lipase 1,000 units/kg/meal. Dosage range: Lipase 1,000 to 2,500 units/kg/meal. Maximum: Lipase ≤2,500 units/kg/meal or lipase ≤10,000 units/kg/day or lipase <4,000 units/g of fat daily

Children ≥4 years and Adolescents (Pertzye [and weight ≥16 kg], Ultresa, Creon, Pancreaze, Zenpep): Oral: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in manufacturer’s labeling. Use with caution.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in manufacturer’s labeling.

Administration

Oral: Administer with meals or snacks and swallow whole with a generous amount of liquid. Do not crush or chew; retention in the mouth before swallowing may cause mucosal irritation and stomatitis.

Capsules, delayed release: If necessary, capsules may also be opened and contents added to a small amount of an acidic food (pH ≤4.5), such as applesauce. The food should be at room temperature and swallowed immediately after mixing. The contents of the capsule should not be crushed or chewed. Follow with water or juice to ensure complete ingestion and that no medication remains in the mouth.

When administering to infants <1 year of age, do not mix with breast milk or infant formula. Open capsule and place the contents directly into the mouth or mix with a small amount of acidic soft food (pH ≤4.5), such as applesauce or other acidic commercially prepared baby food (pears or bananas) at room temperature. Administer immediately after mixing (or within 15 minutes of mixing using Pancreaze). Follow with infant formula or breast milk to ensure complete ingestion and that no medication remains in the mouth.

Tablets: Viokace: Tablets are not enteric coated and should be taken with a proton pump inhibitor.

Administration via gastrostomy (G) tube: An in vitro study demonstrated that Creon delayed-release capsules sprinkled onto a small amount of baby food (pH <4.5; applesauce or bananas manufactured by both Gerber and Beech-Nut) stirred gently and after 15 minutes was administered through the following G-tubes without significant loss of lipase activity: Kimberly-Clark MIC Bolus size 18 Fr, Kimberly-Clark MIC-KEY size 16 Fr, Bard Tri-Funnel size 18 Fr, and Bard Button size 18 Fr (Shlieout, 2011).

Dietary Considerations

Take with meals or snacks and swallow whole with a generous amount of liquid. Capsule contents may be sprinkled on a soft acidic food with pH <4.5. Vitamin supplementation should be per current guidelines for patients with cystic fibrosis.

Storage

Avoid heat. Protect from moisture. After opening, keep the container tightly closed between uses to protect from moisture.

Creon: Store at room temperature up to 25°C (77°F); excursions are permitted between 25°C and 40°C (77°F and 104°F) for ≤30 days. Discard if moisture conditions are >70%. Bottles of 3,000 USP units of lipase must be stored and dispensed in the original container.

Pancreaze: Store at ≤25°C (77°F). Store in the original container.

Pancrelipase: Store at 20°C to 25°C (68°F to 77°F); brief excursions are permitted between 15°C and 40°C (59°F and 104°F).

Pertzye: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 40°C (59°F and 104°F). Store in the original container.

Ultresa: Store at 20°C to 25°C (68°F to 77°F). Store in the original container.

Viokace: Store at 20°C to 25°C (68°F to 77°F); brief excursions are permitted up to 40°C (104°F) for up to 24 hours.

Zenpep:

Original glass container: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 40°C (59°F and 104°F).

Repackaged HDPE container: Store at ≤30°C (86°F) for up to 6 months; excursions are permitted between 15°C and 40°C (59°F and 104°F) for ≤30 days.

Drug Interactions

Iron Salts: Pancrelipase may decrease the absorption of Iron Salts. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Gluconate; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): Pancrelipase may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, pancrelipase may decrease absorption of iron in iron-containing multivitamin products. Monitor therapy

Adverse Reactions

The following adverse reactions were reported in a short-term safety studies; actual frequency varies with different products; adverse events, particularly gastrointestinal events, were often greater with placebo.

>10%:

Central nervous system: Headache (3% to 15%)

Gastrointestinal: Abdominal pain (3% to 18%)

Hematologic & oncologic: Lymphadenopathy (11%)

Infection: Streptococcal infection (beta-hemolytic streptococcus: 11%)

Neuromuscular & skeletal: Neck pain (14%)

Otic: Otalgia (11%)

Respiratory: Nasal congestion (14%)

1% to 10%:

Cardiovascular: Peripheral edema (3%)

Central nervous system: Dizziness (4% to 6%)

Dermatologic: Skin rash (3%)

Endocrine & metabolic: Hyperglycemia (4% to 8%), weight loss (3% to 6%), exacerbation of diabetes mellitus (4%), hypoglycemia (4%)

Gastrointestinal: Dyspepsia (10%), diarrhea (≤10%), flatulence (3% to 9%), choledocholithiasis (7%), pruritus ani (7%), early satiety (6%), vomiting (6%), upper abdominal pain (≤5%), abnormal stools (≤4%)

Hematologic & oncologic: Anemia (3%)

Hepatic: Ascites (3%), hydrocholecystis (3%)

Infection: Viral infection (3%)

Renal: Renal cyst (3%)

Respiratory: Cough (4% to 10%), epistaxis (7%), pharyngolaryngeal pain (7%), nasopharyngitis (4%)

<1% (Limited to important or life-threatening; reported with various formulations of pancrelipase): Anaphylaxis, asthma, blurred vision, carcinoma (recurrence), constipation, duodenitis, fibrosing colonopathy, gastritis, hyperuricemia, increased serum transaminases (asymptomatic), intestinal obstruction (distal intestinal obstruction syndrome [DIOS]), muscle spasm, myalgia, nausea, neutropenia (transient), pruritus, severe hypersensitivity, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Fibrosing colonopathy: Fibrosing colonopathy advancing to colonic strictures have been reported (rarely) with doses of lipase >6,000 units/kg/meal usually over long periods of time and most commonly in children <12 years of age with cystic fibrosis. Patients taking doses of lipase >6,000 units/kg/meal should be examined and the dose decreased. Doses of lipase >2,500 units/kg/meal, lipase >10,000 units/kg/day, or lipase >4,000 units/g fat daily should be used with caution and only with documentation of 3-day fecal fat measures.

• Hypersensitivity: Severe, allergic reactions (eg anaphylaxis, asthma, hives, pruritus) have rarely been observed; use with caution in patients hypersensitive to pork proteins, taking into consideration the patient's overall clinical needs.

• Mucosal irritation: Crushing or chewing the contents of the capsules or tablets, or mixing the capsule contents with foods outside of product labeling, may cause early release of the enzymes, causing irritation of the oral mucosa and/or loss of enzyme activity. When mixing the contents of capsules with food, the mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion. Pancrelipase should not be mixed in foods with pH >4.5.

• Pork: Products are derived from porcine pancreatic glands. Transmission of porcine viruses, and diseases caused by novel or unidentified viruses, is theoretically a risk; however, testing and/or inactivation or removal of certain viruses, reduces the risk. There have been no cases of transmission of an infectious illness reported.

Disease-related concerns:

• Gout, hyperuricemia: Use caution in patients with gout or hyperuricemia; porcine-derived products contain purines which may increase uric acid concentrations.

• Pancreatic cancer: According to guidelines from the American Society of Clinical Oncology, patients with pancreatic cancer (potentially curable, locally advanced, or metastatic) who experience exocrine pancreatic insufficiency may require pancreatic enzyme replacement therapy to improve digestion and nutrient absorption (Balaban 2016; Khorana 2016; Sohal 2016). A retrospective study in patients with metastatic pancreatic cancer suggests that pancreatic enzyme replacement therapy is underutilized (Landers 2016).

• Renal impairment: Use caution in patients with renal impairment; porcine-derived products contain purines which may increase uric acid concentrations.

Dosage form specific issues:

• Brand interchangeability: Available brand products are not interchangeable.

• Lactose: Viokace tablets contain lactose; use with caution in patients with lactose intolerance.

Monitoring Parameters

Abdominal symptoms, nutritional intake, weight, growth (in children), stool character, fecal fat

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. Nutrition should be optimized in pregnancy; in cystic fibrosis patients with malabsorption, pancreatic enzyme replacement is not considered to cause a risk to the pregnancy.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience abdominal pain, headache, flatulence, constipation, pharyngitis, diarrhea, nausea, vomiting, neck pain, rhinitis, ear pain, heartburn, dizziness, or nosebleed. Have patient report immediately to prescriber joint pain, joint edema, mouth irritation, tongue irriation, or signs of fibrosing colonopathy (abnormal or severe abdominal pain; bloating; difficulty passing stools; nausea; vomiting; or diarrhea) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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