Version July 2025
Dosage guidance:
Safety: High doses of lipase >6,000 units/kg/meal for ≥6 months have been associated with fibrosing colonopathy; immediately decrease or titrate down to a lower dose (Ref). Refer to institutional policies and procedures.
Dosage form information: Do not substitute different brands; when switching from another brand for pancreatic insufficiency, monitor patients for clinical symptoms and titrate dose as needed. Refer to institutional policies and procedures.
Occluded enteral feeding tubes (off-label use): Note: Use of enteric-coated tablets/capsules may reduce effectiveness of clearing enteral tube (Ref).
Enteral feeding tube (not for oral administration): 1 tablet (nonenteric coated; lipase 10,440 units) mixed with sodium bicarbonate and warm water; instill in enteral feeding tube using light pressure and clamp for 5 to 15 minutes; then use warm sterile water to aspirate or flush the feeding tube; repeat if necessary (Ref).
Pancreatic insufficiency
Note: Dosing is based on lipase units and can be dosed based on grams of fat ingested (which is more likely to mimic normal pancreatic response) or by actual body weight. 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. Allow several days between dose adjustments.
Pancreatic insufficiency, cystic fibrosis:
Oral: Initial: Lipase 500 units/kg/meal, titrate dose based on individual response. For each snack, administer half the prescribed mealtime dose. Usual dose: Lipase 500 to 4,000 units/g of fat daily or lipase 500 to 2,500 units/kg/meal and lipase 250 to 1,250 units/kg/snack. Maximum dose: Lipase ≤2,500 units/kg/meal or lipase ≤10,000 units/kg/day or lipase <4,000 units/g of fat daily; higher dosages may be administered if documented to be effective by fecal fat measures or an improvement in signs and symptoms of malabsorption, including measures of nutritional status (Ref).
Pancreatic insufficiency, non-cystic fibrosis conditions (eg, chronic pancreatitis, pancreatectomy):
Note: Viokace must be administered with a proton pump inhibitor (PPI) since it is not enteric coated.
Oral: Initial: Lipase 500 to 1,000 units/kg/meal with individualized dosage titrations. For each snack, administer half the prescribed mealtime dose. Usual dose: 40,000 to 50,000 units/meal (Ref). Maximum dose: Lipase ≤2,500 units/kg/meal or lipase ≤10,000 units/kg/day or lipase <4,000 units/g of fat daily; higher dosages may be administered if documented to be effective by fecal fat measures or an improvement in signs and symptoms of malabsorption, including measures of nutritional status (Ref).
Pancreatic insufficiency, pancreatic cancer (off-label dosing):
Note: Viokace must be administered with a PPI because it is not enteric coated.
Oral: Initial: Lipase 25,000 to 50,000 units/meal or lipase 1,000 units/kg/day or 4,000 units per 5 to 7 g of fat at each meal; titrate dose based on relief of symptoms. For each snack, administer half the prescribed mealtime dose. Maximum dose: Lipase 2,500 units/kg/meal (Ref).
There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Pancrelipase: Pediatric drug information")
Note: Adjust dose based on body weight, clinical symptoms, and stool fat content. Allow several days between dose adjustments. Doses of lipase >6,000 units/kg/meal are associated with colonic stricture and should be decreased.
Pancreatic insufficiency due to cystic fibrosis:
General dosing recommendations:
Note: Dosage requirements may fluctuate as diet transitions to more solid foods.
Infants <6 months: Oral: Lipase: 2,000 to 5,000 units per feeding of formula or breast milk. Reported dose range: 492 to 3,727 units/kg per feeding. While a daily maximum of 10,000 units/kg/day was previously recommended based on limited evidence, this daily dose is insufficient for many patients; doses up to 28,139 units lipase/kg/day have been safely reported; in one evaluation, the average daily dose was 12,259 units lipase/kg/day (Ref).
Infants ≥6 months: Oral: Lipase: 2,000 to 5,000 units per feeding of formula or breast milk. Reported dose range: 313 to 3,612 units/kg per feeding. While a daily maximum of 10,000 units/kg/day was previously recommended based on limited evidence, this daily dose is insufficient for many patients; doses up to 26,388 units lipase/kg/day have been safely reported; in one evaluation, the average daily dose was 10,689 units lipase/kg/day (Ref).
Children <2 years: Oral: Initial dose: Lipase 1,000 units/kg/meal. Dosage range: Lipase 1,000 to 2,500 units/kg/meal. Maximum daily dose: Lipase 10,000 units/kg/day or lipase 4,000 units/g of fat/day. Higher dosing similar to infant dosing (Lipase: 2,000 to 5,000 units per feeding of formula, breast milk, or per breastfeeding) may be necessary in some patients (Ref).
Children ≥2 to <4 years: Oral: Initial dose: Lipase 1,000 units/kg/meal. Dosage range: Lipase 1,000 to 2,500 units/kg/meal. Maximum daily dose: Lipase 10,000 units/kg/day or lipase 4,000 units/g of fat/day.
Children ≥4 years and Adolescents: Oral: Initial dose: Lipase 500 units/kg/meal. Dosage range: Lipase 500 to 2,500 units/kg/meal. Maximum daily dose: Lipase 10,000 units/kg/day or lipase 4,000 units per g of fat/day.
Pancreatic enzyme supplementation, enteral tube feedings: Infants, Children, and Adolescents: Limited data available: Enteral: 1,000 to 4,000 units lipase/g of fat provided by feeds (Ref).
There are no dosage adjustments provided in the manufacturer's labeling. Use with caution; enzymes contain purines that may increase blood uric acid levels.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults and pediatric patients.
>10%: Nervous system: Headache
1% to 10%:
Cardiovascular: Peripheral edema
Dermatologic: Skin rash
Endocrine & metabolic: Hyperglycemia, hypoglycemia
Gastrointestinal: Choledocholithiasis, early satiety, gallbladder disease (hydrocholecystis), gastrointestinal signs and symptoms (including abdominal pain, abnormal stools, constipation, diarrhea, duodenitis, dyspepsia, flatulence, frequent bowel movements, gastritis, nausea, vomiting), pruritus ani
Hematologic & oncologic: Anemia
Hepatic: Ascites
Infection: Viral infection
Nervous system: Dizziness
Renal: Renal cyst
Respiratory: Cough, nasopharyngitis
Postmarketing:
Dermatologic: Pruritus, urticaria
Endocrine & metabolic: Hyperuricemia (Ferrone 2007)
Gastrointestinal: Intestinal obstruction (distal intestinal obstruction syndrome [DIOS])
Hematologic & oncologic: Neutropenia (Amoateng 2021)
Hepatic: Increased liver enzymes
Hypersensitivity: Anaphylaxis
Neuromuscular & skeletal: Muscle spasm, myalgia
Ophthalmic: Blurred vision
Respiratory: Asthma
Miscellaneous: Fibrosis (fibrosing colonopathy) (Ferrone 2007, Mack 2004)
There are no contraindications listed in the manufacturer’s US labeling.
Canadian labeling: Hypersensitivity to pancrelipase or any component of the formulation; acute pancreatitis; acute exacerbation of chronic pancreatitis.
Concerns related to adverse effects:
• Fibrosing colonopathy: Fibrosing colonopathy, advancing to colonic strictures, has been reported (rarely). Risk may be increased with high doses, prolonged use, and in pediatric patients with cystic fibrosis; however, the mechanism is unknown. Doses of lipase >6,000 units/kg/meal have been associated with colonic stricture in children <12 years. Do not exceed recommended dosages unless documented to be effective by fecal fat measures or an improvement in signs and symptoms of malabsorption, including measures of nutritional status.
• Hypersensitivity: Severe, allergic reactions (eg, anaphylaxis, asthma, hives, pruritus) have been observed; use with caution in patients hypersensitive to pork proteins, taking into consideration the patient's overall clinical needs. Initiate appropriate medical management if symptoms occur.
• 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 and limit weight loss (Balaban 2016; Khorana 2016; Sohal 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 may contain lactose; use with caution in patients with lactose intolerance.
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 4,000 USP units, protease 14,375 USP units, and amylase 15,125 USP units
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
Pertzye: Lipase 24,000 USP units, protease 86,250 USP units, and amylase 90,750 USP units
Capsule, delayed release, enteric-coated beads, oral [porcine derived]:
Zenpep: Lipase 3,000 USP units, protease 10,000 USP units, and amylase 14,000 USP units
Zenpep: Lipase 5,000 USP units, protease 17,000 USP units, and amylase 24,000 USP units
Zenpep: Lipase 10,000 USP units, protease 32,000 USP units, and amylase 42,000 USP units
Zenpep: Lipase 15,000 USP units, protease 47,000 USP units, and amylase 63,000 USP units
Zenpep: Lipase 20,000 USP units, protease 63,000 USP units, and amylase 84,000 USP units
Zenpep: Lipase 25,000 USP units, protease 79,000 USP units, and amylase 105,000 USP units
Zenpep: Lipase 40,000 USP units, protease 126,000 USP units, and amylase 168,000 USP units
Zenpep: Lipase 40,000 USP units, protease 136,000 USP units, and amylase 218,000 USP units [DSC]
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 [DSC]
Capsule, delayed release, enteric coated microtablets, oral [porcine derived]:
Pancreaze: Lipase 2600 USP units, protease 8800 USP units, and amylase 15,200 USP units
Pancreaze: Lipase 4200 USP units, protease 14,200 USP units, and amylase 24,600 USP units
Pancreaze: Lipase 10,500 USP units, protease 35,500 USP units, and amylase 61,500 USP units
Pancreaze: Lipase 16,800 USP units, protease 56,800 USP units, and amylase 98,400 USP units
Pancreaze: Lipase 21,000 USP units, protease 54,700 USP units, and amylase 83,900 USP units
Pancreaze: Lipase 37,000 USP units, protease 97,300 USP units, and amylase 149,900 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
No
Capsule, enteric pellets (Creon Oral)
3000-9500 unit (per each): $2.18
6000-19000 unit (per each): $2.58
12000-38000 unit (per each): $5.15
24000-76000 unit (per each): $10.21
36000-114000 unit (per each): $15.50
Capsule, enteric pellets (Pancreaze Oral)
2600-8800 unit (per each): $0.98
4200-14200 unit (per each): $1.59
10500-35500 unit (per each): $3.97
16800-56800 unit (per each): $6.38
21000-54700 unit (per each): $7.95
37000-97300 unit (per each): $18.11
Capsule, enteric pellets (Pertzye Oral)
4000-14375 unit (per each): $2.19
8000-28750 unit (per each): $3.26
16000-57500 unit (per each): $6.52
24000-86250 unit (per each): $9.78
Capsule, enteric pellets (Zenpep Oral)
3000-10000 unit (per each): $2.68
5000-24000 unit (per each): $2.55
10000-32000 unit (per each): $5.05
15000-47000 unit (per each): $7.29
20000-63000 unit (per each): $9.90
25000-79000 unit (per each): $12.26
40000-126000 unit (per each): $19.55
60000-189600 unit (per each): $29.32
Tablets (Viokace Oral)
10440-39150 unit (per each): $5.07
20880-78300 unit (per each): $10.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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. Administer half the prescribed dose at the start of a meal and the second half in the middle of the meal (Ref); for snacks, administer half the prescribed mealtime dose with each snack. The total daily dose should reflect ~3 meals plus 2 or 3 snacks per day.
Capsules, delayed release: If necessary, capsules may be opened and contents added to a small amount (~10 mL) of soft acidic food (pH ≤4.5), such as applesauce, bananas, plain Greek yogurt, pears; do not crush microspheres when mixing. The entire food content should be swallowed immediately after mixing (do not save for later use); do not chew. Follow with water or juice 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.
Occluded enteral feeding tubes (off-label use):
Tablet: Crush 1 nonenteric coated tablet (lipase 10,440 units) with 1 sodium bicarbonate 325 mg tablet to a fine powder, mix in 5 mL warm sterile water, then instill in occluded enteral tube using light pressure and clamp for 5 to 15 minutes. Then, use warm sterile water to aspirate or flush the tube; a light "back and forth" motion with the syringe plunger is suggested to dislodge the clog (Ref).
Enteral feeding tube:
The following recommendations are based upon the best available evidence and clinical expertise. Senior editorial team: Joseph I. Boullata, PharmD, RPh, CNS-S, FASPEN, FACN; Peggi A. Guenter, PhD, RN, FASPEN; Kathleen Gura, PharmD, BCNSP, FASHP, FASPEN, FPPA, FMSHP; Mark G. Klang, MS, RPh, BCNSP, PhD, FASPEN; Linda Lord, NP, ACNP-BC, CNSC, FASPEN; Lucas E. Orth, PharmD, BCPPS; Russel J. Roberts, PharmD, BCCCP, FCCM.
Note: Pancrelipase administration via enteral feeding tube (EFT) for the treatment of pancreatic insufficiency is not well-established (Ref); when selecting a formulation for EFT administration, take into consideration risks versus benefits, institutional protocols, availability of alternative therapy modalities (eg, Relizorb [immobilized lipase] cartridges connect for administration with compatible enteral formulas), and patient-specific factors (eg, indication, enteral nutrition [EN] formulation) and monitor for efficacy. Pancrelipase products may be administered prior to feeds, at the end of feeds, or divided and administered throughout feeding (Ref). When possible, patients with EFT should receive pancrelipase orally (Ref).
Capsule, delayed release, bicarbonate buffered enteric coated microspheres (Pertzye):
Note: Manufacturer’s labeling provides the following instructions for mixing with applesauce; however, this method may lead to EFT occlusion (Ref).
Gastric (eg, NG, G-tub e) tubes (≥14 French):
Note: Only 4,000 lipase unit capsules may be used for gastric tube administration.
Open capsule(s) and sprinkle entire contents on at least 10 mL of applesauce; do not administer more than two 4,000 lipase unit capsules at a time. Mix carefully to create a uniform suspension; avoid crushing capsule contents. Remove plunger from an enteral dosing syringe; transfer mixture to enteral dosing syringe and partially replace plunger back into syringe. Tap or shake syringe lightly with tip facing upward to move applesauce mixture toward plunger. Push plunger slowly and carefully until remaining air is removed from syringe tip. Administer immediately via EFT. Draw up 10 mL purified water into enteral dosing syringe and administer rinse via EFT. If dose requires more than two 4,000 unit capsules, repeat procedure until entire dose is administered (Ref).
General guidance: Hold EN during pancrelipase administration (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) before administration (Ref). Following administration process described above, flush feeding tube with an appropriate volume of purified water (eg, 15 mL) and restart EN (Ref).
Capsule, delayed release, enteric coated beads (Zenpep):
Note: EFT administration utilizing delayed release enteric coated pancrelipase beads (eg, Zenpep) is generally not recommended (Ref). When alternatives are not available and use is deemed necessary for feeding tube administration, some institutions have administered enteric coated pancrelipase products via feeding tubes; consider the risks versus benefits and monitor closely (Ref).
Gastric (eg, NG, G-tube) tubes (≥16 French): Open capsule and mix contents with 20 to 40 mL of 8.4% sodium bicarbonate solution; allow mixture to stand for 20 to 30 minutes; draw up mixture into enteral dosing syringe and administer via feeding tube (Ref). Alternatively, may mix capsule contents with a thickened (nectar-like consistency) fruit juice, stir gently, draw up mixture into enteral dosing syringe and administer via feeding tube (Ref).
General guidance: Hold EN during pancrelipase administration (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) before administration (Ref). Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) and restart EN (Ref).
Capsule, delayed release, enteric coated microspheres (Creon):
Note: EFT administration utilizing delayed release enteric coated pancrelipase microspheres (eg, Creon) is generally not recommended (Ref). The following method has been studied and is utilized by some centers; however, this method may lead to EFT occlusion (Ref).
Gastric (eg, NG, G-tube) tubes (≥18 French): Open capsule and sprinkle contents onto a ~15 mL commercially available baby food (pH <4.5; eg, applesauce or bananas). Stir gently and wait 15 minutes. Remove plunger from a ~35 mL capped enteral dosing syringe; pour mixture into syringe barrel. Insert syringe tip into EFT, insert plunger into syringe barrel, and administer slowly until all mixture has passed through EFT (Ref). Note: Study evaluated a single 12,000 lipase unit capsule via feeding tube; for higher doses and/or multiple capsules, may need larger baby food volumes and/or repeat the procedure to administer the entire dose (Ref).
General guidance: Hold EN during pancrelipase administration (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) before administration (Ref). Following administration, rinse container and syringe used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) and restart EN (Ref).
Capsule, delayed release, enteric coated microtablets (Pancreaze):
Note: EFT administration utilizing delayed release enteric coated pancrelipase microtablets (Pancreaze) is generally not recommended (Ref). When alternatives are not available and use is deemed necessary for feeding tube administration, some institutions have administered enteric coated pancrelipase products via feeding tubes; consider the risks versus benefits and monitor closely (Ref).
Gastric (eg, NG, G-tube) tubes (≥16 French): Open capsule(s) and mix contents in 20 to 40 mL of 8.4% sodium bicarbonate solution. Allow mixture to stand for 20 to 40 minutes. Draw up mixture into enteral dosing syringe and administer via feeding tube (Ref). Alternatively, capsule contents may be mixed with a thickened (nectar-like consistency) fruit juice; stir gently, draw up mixture into enteral dosing syringe, and administer via feeding tube (Ref).
General guidance: Hold EN during pancrelipase administration (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) before administration (Ref). Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) and restart EN (Ref).
Tablet, oral (Viokace):
Note: If administered gastrically, must be used in combination with proton pump inhibitor therapy (Ref).
Gastric (eg, NG, G-tube) or post-pyloric (eg, J-tube) tubes: Crush tablet(s) into a fine powder and disperse in ≥10 mL purified water immediately prior to administration; draw up mixture into enteral dosing syringe and administer via feeding tube (Ref).
General guidance: Hold EN during pancrelipase administration (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) before administration (Ref). Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) and restart EN (Ref).
Note: Recommendations may not account for differences in inactive ingredients, osmolality, or other formulation properties that may vary among products from different manufacturers.
The following recommendations are based upon the best available evidence and clinical expertise. Senior editorial team: Joseph I. Boullata, PharmD, RPh, CNS-S, FASPEN, FACN; Peggi A. Guenter, PhD, RN, FASPEN; Kathleen Gura, PharmD, BCNSP, FASHP, FASPEN, FPPA, FMSHP; Mark G. Klang, MS, RPh, BCNSP, PhD, FASPEN; Linda Lord, NP, ACNP-BC, CNSC, FASPEN; Lucas E. Orth, PharmD, BCPPS; Russel J. Roberts, PharmD, BCCCP, FCCM.
Note: Recommendations may not account for differences in inactive ingredients, osmolality, or other formulation properties that may vary among products from different manufacturers.
Oral: Administer with meals or snacks and swallow capsules or tablets whole with a generous amount of liquid, water, or juice. Do not crush or chew; retention in the mouth before swallowing may cause mucosal irritation and stomatitis.
Capsules:
Oral administration for patients unable to swallow capsule:
Infants: Avoid mixing 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 commercially prepared baby food (pears or bananas) at room temperature. Administer immediately after mixing. Follow with infant formula or breast milk to ensure complete ingestion and that no medication remains in the mouth.
Children and Adolescents: Capsules may be opened and contents added to a small amount of an acidic food (pH ≤4.5) (eg, applesauce, commercially available preparations of bananas or pears, or plain Greek yogurt). 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.
Administration via feeding tube: Note: Pancrelipase products may be administered prior to feeds, at the end of feeds, or divided and administered throughout feeding (Ref). When possible, patients with feeding tubes should receive pancrelipase orally (Ref). Pancrelipase administration via enteral feeding tube is not well established (Ref); when selecting a formulation for feeding tube administration, take into consideration risks versus benefits, institutional protocols, availability of alternative therapy modalities (eg, RELiZORB cartridges), and patient-specific factors (eg, indication, enteral nutrition formulation) and monitor for efficacy. Refer to product-specific instructions below.
Capsule, delayed release, bicarbonate-buffered enteric-coated microspheres (Pertzye): Note: Manufacturer's labeling provides the following instructions for mixing with applesauce; however, this may lead to feeding tube occlusion (Ref). Capsules contain bicarbonate-buffered enteric-coated microspheres which are 0.8 to 2.2 mm in diameter; size varies with capsule strength.
Gastric tubes (eg, NG, G-tube) (≥14 French): Note: Only 4,000 lipase unit capsules may be used for gastric tube administration.
Open capsule(s) and sprinkle entire contents on at least 10 mL of applesauce; do not administer more than two 4,000 lipase unit capsules at a time. Mix carefully to create a uniform suspension; avoid crushing capsule contents. Remove plunger from an enteral dosing syringe; transfer mixture to enteral dosing syringe and partially replace plunger back into syringe. Tap or shake syringe lightly with tip facing upward to move applesauce mixture toward plunger. Push plunger slowly and carefully until remaining air is removed from syringe tip. Administer immediately via enteral feeding tube. Draw up 10 mL purified water into enteral dosing syringe and administer rinse via enteral feeding tube. If dose requires more than two 4,000 unit capsules, repeat procedure until entire dose is administered (Ref).
General guidance: Hold enteral nutrition during pancrelipase administration (Ref). Flush feeding tube with the lowest volume of purified water necessary to clear the tube prior to administration based on size of patient and/or feeding tube (eg, neonates: 1 to 3 mL; infants and children: 2 to 5 mL; adolescents: 15 mL); refer to institutional policies and procedures (Ref). Following administration process described above, flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
Capsule, delayed release, enteric-coated beads (Zenpep): Enteral feeding tube administration utilizing delayed-release enteric-coated pancrelipase beads (Zenpep) is generally not recommended (Ref). When alternatives are not available and use is deemed necessary for feeding tube administration, some institutions have administered enteric-coated pancrelipase products via feeding tubes; consider the risks versus benefits and monitor closely (Ref). Capsules contain enteric-coated beads which are 1.8 to 2.5 mm in diameter; size varies with capsule strength.
Gastric tubes (eg, NG, G-tube) (≥16 French): Open capsule and mix contents with 20 to 40 mL 8.4% sodium bicarbonate solution; allow mixture to stand for 20 to 30 minutes; draw up mixture into enteral dosing syringe and administer via feeding tube (Ref). Alternatively, may mix capsule contents with a thickened (nectar like consistency) fruit juice; stir gently, draw up mixture into enteral dosing syringe, and administer via feeding tube (Ref).
General guidance: Hold enteral nutrition during pancrelipase administration (Ref). Flush feeding tube with the lowest volume of purified water necessary to clear the tube prior to administration based on size of patient and/or feeding tube (eg, neonates: 1 to 3 mL; infants and children: 2 to 5 mL; adolescents: 15 mL); refer to institutional policies and procedures (Ref). Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
Capsule, delayed release, enteric-coated microspheres (Creon): Note: Enteral feeding tube administration utilizing delayed-release enteric-coated pancrelipase microspheres (Creon) is generally not recommended (Ref). The following method has been studied and is utilized by some centers; however, this may lead to feeding tube occlusion (Ref). Capsules contain enteric-coated spheres which are 0.71 to 1.6 mm in diameter.
Gastric tubes (eg, NG, G-tube) (≥18 French): Open capsule and sprinkle contents onto ~15 mL commercially available baby food (pH <4.5; eg, applesauce or bananas). Stir gently and wait 15 minutes. Remove plunger from a ~35 mL capped enteral dosing syringe; pour mixture into syringe barrel. Insert syringe tip into enteral feeding tube, insert plunger into syringe barrel, and administer slowly until all mixture has passed through enteral feeding tube (Ref). Note: Study evaluated a single 12,000 lipase unit capsule; for higher doses and/or multiple capsules, may need larger baby food volumes and/or repeat the procedures to administer the entire dose (Ref).
General guidance: Hold enteral nutrition during pancrelipase administration (Ref). Flush feeding tube with the lowest volume of purified water necessary to clear the tube prior to administration based on size of patient and/or feeding tube (eg, neonates: 1 to 3 mL; infants and children: 2 to 5 mL; adolescents: 15 mL); refer to institutional policies and procedures (Ref). Following administration, rinse container and syringe used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
Capsule, delayed release, enteric-coated microtablets (Pancreaze): Note: Enteral feeding tube administration utilizing delayed-release enteric-coated pancrelipase microtablets (Pancreaze) is generally not recommended (Ref). When alternatives are not available and use is deemed necessary for feeding tube administration, some institutions have administered enteric-coated pancrelipase products via feeding tubes; consider the risks versus benefits and monitor closely (Ref). Capsules contain enteric-coated microtablets which are ~2 mm in diameter.
Gastric tubes (eg, NG, G-tube) (≥16 French): Open capsule(s) and mix contents in 20 to 40 mL of 8.4% sodium bicarbonate solution. Allow mixture to stand for 20 to 40 minutes. Draw up mixture into enteral dosing syringe and administer via feeding tube (Ref). Alternatively, capsule contents may be mixed with a thickened (nectar like consistency) fruit juice; stir gently, draw up mixture into enteral dosing syringe, and administer via feeding tube (Ref).
General guidance: Hold enteral nutrition during pancrelipase administration (Ref). Flush feeding tube with the lowest volume of purified water necessary to clear the tube prior to administration based on size of patient and/or feeding tube (eg, neonates: 1 to 3 mL; infants and children: 2 to 5 mL; adolescents: 15 mL); refer to institutional policies and procedures (Ref). Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
Tablets (Viokace): Tablets are not enteric coated and should be taken with a proton pump inhibitor.
Administration via feeding tube: Note: If administered gastrically, must be used in combination with proton pump inhibitor therapy (Ref).
Gastric (eg, NG, G-tube) or post-pyloric (eg, J-tube) tubes: Crush tablet(s) into a fine powder and disperse in ≥10 mL purified water immediately prior to administration; draw up mixture into enteral dosing syringe and administer via feeding tube (Ref).
General guidance: Hold enteral nutrition during pancrelipase administration (Ref). Flush feeding tube with the lowest volume of purified water necessary to clear the tube prior to administration based on size of patient and/or feeding tube (eg, neonates: 1 to 3 mL; infants and children: 2 to 5 mL; adolescents: 15 mL); refer to institutional policies and procedures (Ref). Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Creon: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020725s031lbl.pdf#page=12
Pancreaze: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf
Pertzye: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022175s008lbl.pdf
Viokace: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022542s007lbl.pdf
Zenpep: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210s024lbl.pdf
Pancreatic insufficiency: Treatment of exocrine pancreatic insufficiency in pediatric and adult patients. Viokace, in combination with a proton-pump inhibitor, is approved for use in adults with exocrine pancreatic insufficiency caused by chronic pancreatitis or pancreatectomy.
Occluded enteral feeding tubes
Pancrelipase may be confused with pancreatin
None known.
There are no known significant interactions.
Delayed release capsules: Enteric coated contents of delayed release capsules opened and sprinkled on alkaline foods may result in early release of pancrelipase followed by enzyme inactivation by gastric acid in the stomach after swallowing. Management: Avoid placing contents of opened capsules on alkaline food (using soft acidic foods with a pH of ≤4.5 is recommended for patients who cannot swallow capsules).
Systemic absorption of pancrelipase is limited; significant fetal exposure is not expected following maternal use.
Pancrelipase is considered compatible for use during pregnancy (Edenborough 2008; Panchaud 2016).
It is not known if pancrelipase is present in breast milk.
Systemic absorption of pancrelipase is limited; significant exposure to the breastfed infant is not expected following maternal use. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Maternal use of pancrelipase is considered compatible with breastfeeding (Edenborough 2008; Panchaud 2016).
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.
Abdominal symptoms, nutritional intake, weight, growth (in children), stool character, fecal fat; signs and symptoms of hypersensitivity; signs and symptoms of fibrosing colonopathy in patients receiving >6,000 lipase units/kg/meal; blood uric acid levels in patients with gout, renal impairment, or hyperuricemia.
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
