pancrelipase (Rx)

Brand and Other Names:Creon, Pancreaze, more...Pertzye, Ultresa, Viokace, Zenpep
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lipase/protease/amylase

(KU=1000 units)

capsule, delayed-release (contains enteric-coated microspheres)

  • Creon
  • 6KU/19KU/30KU
  • 12KU/38KU/60KU
  • 24KU/76KU/120KU
  • 36KU/114KU/180KU

capsule, delayed-release (contains enteric-coated microtablets)

  • Pancreaze
  • 4.2KU/10KU/17.5KU
  • 10.5KU/25KU/43.75KU
  • 16.8KU/40KU/70KU
  • 21KU/37KU/61KU

capsule, delayed-release (contains enteric-coated minitablets)

  • Ultresa
  • 13.8KU/27.6KU/27.6KU
  • 20.7KU/41.4KU/41.4KU
  • 23KU/46KU/46KU

tablet

  • Viokace
  • 10.44KU/39.15KU/39.15KU
  • 20.88KU/78.3KU/78.3KU

capsule, delayed-release (contains enteric-coated microspheres)

  • Pertzye
  • 8KU/28.75KU/30.25KU
  • 16KU/57.5KU/60.5KU
  • 24KU/86.25KU/90.75KU

capsule, delayed-release (contains enteric-coated beads)

  • Zenpep
  • 5KU/17KU/27KU
  • 10KU/34KU/55KU
  • 15KU/51KU/82KU
  • 20KU/68KU/109KU
  • 25KU/85KU/136KU

Exocrine Pancreatic Insufficiency

Creon, Ultresa, Pertzye, Zenpep, Pancreaze are indicated for pancreatic insufficiency due to cystic fibrosis, pancreatitis, pancreatectomy, or other conditions

  • Cystic fibrosis guidelines: Generally, start 500 lipase units/kg PO per meal; can titrate up to 2500 units/kg/meal based on response; not to exceed 10,000 lipase units/kg/day or <4000 lipase units/g fat ingested per day  
  • Administer 50% of meal dose with snacks
  • High-dose Creon: In 1 clinical trial described in the prescribing information, adults received a dose of 72,000 lipase units/meal while consuming at least 100 g of fat/day for chronic pancreatitis or pancreatectomy; lower starting doses (ie, 500 lipase units/kg/meal) are consistent with Cystic Fibrosis guidelines

Viokace

  • Only indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy (and not cystic fibrosis)
  • Generally, start 500 lipase units/kg PO per meal; can titrate up to 2500 units/kg/meal based on response; not to exceed 10,000 lipase units/kg/day or <4000 lipase units/g fat ingested per day  
  • Administer 50% of meal dose with snacks
  • Viokace should be administered with a PPI

Dosing Considerations

For patients who are unable to swallow intact capsules, may carefully open capsules and contents mixed with a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce, or administered with applesauce via a gastrostomy tube with a diameter of 14 French or larger (only for the 4,000 USP lipase unit capsule strength); if administered orally, the mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion

Dosage Forms & Strengths

lipase/protease/amylase

(KU=1000 units)

capsule, delayed-release (enteric-coated microspheres)

  • Creon
  • 3KU/9.5KU/15KU
  • 6KU/19KU/30KU
  • 12KU/38KU/60KU
  • 24KU/76KU/120KU

capsule, delayed-release (enteric-coated microtablets)

  • Pancreaze
  • 4.2KU/10KU/17.5KU
  • 10.5KU/25KU/43.75KU
  • 16.8KU/40KU/70KU
  • 21KU/37KU/61KU

capsule, delayed-release (contains enteric-coated minitablets)

  • Ultresa
  • 13.8KU/27.6KU/27.6KU
  • 20.7KU/41.4KU/41.4KU
  • 23KU/46KU/46KU

tablet

  • Viokace
  • 10.44KU/39.15KU/39.15KU
  • 20.88KU/78.3KU/78.3KU

capsule, delayed-release (contains enteric-coated microspheres)

  • Pertzye
  • 4KU/14.375KU/15.125KU
  • 8KU/28.75KU/30.25KU
  • 16KU/57.5KU/60.5KU
  • 24KU/86.25KU/90.75KU

capsule, delayed-release (contains enteric-coated beads)

  • Zenpep
  • 3KU/10KU/16KU
  • 5KU/17KU/27KU
  • 10KU/34KU/55KU
  • 15KU/51KU/82KU
  • 20KU/68KU/109KU
  • 25KU/85KU/136KU

Exocrine Pancreatic Insufficiency

Creon, Ultresa, Pertzye, Zenpep, Pancreaze are indicated for pancreatic insufficiency due to cystic fibrosis, pancreatitis, pancreatectomy, or other conditions

Creon/Zenpep

  • ≤12 months: 3000 lipase units/kg/120 mL of formula or per breastfeeding; administer prior to feeding; capsule contents should not be mixed directly in formula or breast milk  
  • 1-3 years: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
  • ≥4 years: Initiate at 500 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day

Pancreaze

  • ≤12 months: 2000-4000 lipase units/kg/120 mL of formula or per breastfeeding; administer prior to feeding; capsule contents should not be mixed directly in formula or breast milk  
  • 1-3 years: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
  • ≥4 years: Initiate at 500 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
  • Not to exceed 10,000 unit lipase/kg/day or <4,000 lipase unites/g fat ingested daily

Pertzye

  • ≤12 months: 4000 lipase units/kg/120 mL of formula or per breastfeeding; administer prior to feeding; capsule contents should not be mixed directly in formula or breast milk  
  • 1-4 years and weight ≥8 kg: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
  • ≥4 years and weight ≥16 kg: Initiate at 500 lipase units/kg per meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day

Ultresa

  • 1-4 years and weight >14 kg: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day  
  • ≥4 years and weight >28 kg: Initiate at 500 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day

Viokace

  • Safety and effectiveness not established

Recommendations from Cystic Fibrosis Foundation Consensus Report

  • Infants <2 years is 2000-5000 lipase units/120 mL feeding; as infant grows, adjust dose not to exceed 2500 lipase units/kg/feeding (or 10,000 lipase units/kg/day)
  • In general, daily requirements of 500-4000 lipase units/g of fat are required
  • J Pediatr 2009;155(6 Suppl):S73-S93
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Interactions

Interaction Checker

and pancrelipase

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (10)

                • acarbose

                  pancrelipase decreases effects of acarbose by pharmacodynamic antagonism. Use Caution/Monitor. Antihyperglycemic action of acarbose results from a competitive, reversible inhibition of pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside hydrolase enzymes.

                • calcium carbonate

                  calcium carbonate decreases effects of pancrelipase by pharmacodynamic antagonism. Use Caution/Monitor. Antacids may negate beneficial effects of enzymes.

                • ferric maltol

                  pancrelipase decreases levels of ferric maltol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Levels of iron salts may decrease with concomitant administration of digestive enzymes.

                • ferrous fumarate

                  pancrelipase decreases levels of ferrous fumarate by enhancing GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Levels of iron salts may decrease with concomitant administration of digestive enzymes.

                • ferrous gluconate

                  pancrelipase decreases levels of ferrous gluconate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Levels of iron salts may decrease with concomitant administration of digestive enzymes.

                • ferrous sulfate

                  pancrelipase decreases levels of ferrous sulfate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Levels of iron salts may decrease with concomitant administration of digestive enzymes.

                • folic acid

                  pancrelipase decreases levels of folic acid by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. folic deficiency may occur.

                • magnesium hydroxide

                  magnesium hydroxide decreases effects of pancrelipase by pharmacodynamic antagonism. Use Caution/Monitor. Antacids may negate beneficial effects of enzymes.

                • miglitol

                  pancrelipase decreases levels of miglitol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Digestive enzymes may reduce levels of miglitol when administered concomitantly.

                • polysaccharide iron

                  pancrelipase decreases levels of polysaccharide iron by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Levels of iron salts may decrease with concomitant administration of digestive enzymes.

                Minor (0)

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                  Adverse Effects

                  >10%

                  Abdominal pain/cramping (3-18% )

                  Headache (3-15% )

                  1-10%

                  Dyspepsia (10%)

                  Cough (4-10%)

                  Diarrhea (0-10%)

                  Hyperglycemia (8%)

                  Pharyngolaryngeal pain (7%)

                  Epistaxis (7%)

                  Anal pruritus (7%)

                  Biliary tract stones (7%)

                  Vomiting (6%)

                  Contusion (6%)

                  Weight loss (6%)

                  Early satiety (6%)

                  Flatulence (5-6%)

                  Dizziness (4%)

                  Hypoglycemia (4%)

                  Abnormal Feces (4%)

                  Frequent bowel movements (4%)

                  Nasopharyngitis (4%)

                  Anemia (3%)

                  Ascites (3%)

                  Flatulence (3%)

                  Peripheral edema (3%)

                  Hydrocholecystis (3%)

                  Viral infection (3%)

                  Renal cyst (3%)

                  Rash (3%)

                  Postmarketing Reports

                  Severe allergic reactions including anaphylaxis, asthma and hives

                  Skin disorders including pruritus, rash and urticaria

                  Asymptomatic elevations of liver enzymes

                  Gastrointestinal disorders: Abdominal distension, abdominal pain, diarrhea, flatulence, constipation and nausea; rare reports of fibrosing colonopathy and distal intestinal obstruction syndrome

                  Endocrine: May affect glycemic control in susceptible individuals

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                  Warnings

                  Contraindications

                  Documented hypersensitivity

                  Cautions

                  Avoid exceeding maximum dose due to risk of fibrosing colonopathy; ≥6,000 lipase units/kg per meal associated with colonic stricture, indicative of fibrosing colonopathy, particularly in children ≤12 years

                  Swallow pills as chewing or retaining in mouth may cause oral mucosa irritation; do not chew, crush or mixed in foods having a pH ≥4.5

                  Monitor uric acid levels in patients with gout, hyperuricemia or renal impairment due to risk of hyperuricemia

                  Caution in patients with known allergy or porcine proteins

                  Do not exceed ≥2,500 units/kg per meal (or ≥10,000 lipase units/kg per day or ≥ 4000 lipase units/g fat ingested per day)

                  Avoid inhalation of powder

                  Theoretical risk of viral transmission

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                  Pregnancy & Lactation

                  Pregnancy Category: C

                  Lactation: unknown

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Product contains a combination of lipase, protease, and amylase that replace endogenous pancreatic enzymes and catalyze the hydrolysis of starches into dextrins and short chain sugars such as maltose and maltotriose, fats to monoglycerides, glycerol and free fatty acids and proteins into peptides and amino acids in the duodenum and proximal small intestine

                  Pharmacokinetics

                  Absorption: not absorbed, acts locally in GI tract

                  Excretion: feces

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                  Administration

                  Oral Administration

                  Pancrelipase products are not interchangeable

                  Initiate therapy at lowest recommended dose and increase gradually

                  Individualize therapy based on symptoms, degree of steatorrhea, fat content of diet, and patient response

                  Children and adults

                  • Usually, 50% of the full meal dose should be administered with snacks; total daily dosage should reflect approximately 3 meals plus 2-3 snacks per day
                  • Decrease dose in geriatric patients as, on average, they weigh more but tend to ingest less fat per kilogram of body weight
                  • Capsule should be swallowed whole with sufficient fluid; do not crush, chew, or retain in the mouth, to avoid irritation of the oral mucosa
                  • Unable to swallow capsule: Capsule contents may be sprinkled on applesauce, yogurt, or acidic soft food with pH <4.5 and consumed without chewing; follow with water or juice to ensure complete ingestion and to ensure nothing is retained in the mouth to avoid mucosal irritation
                  • Gastrostomy tube administration (Pertzye)
                    • Contents of one or two 4000-unit lipase capsules can be administered with soft foods via gastrostomy tube (G-tube) with a diameter ≥14 French
                    • Note: The 4000-unit Pertzye capsules were developed with reduced size microspheres to meet requirements needed to administer via G-tube
                    • Flush G-tube with 10 mL of water
                    • Discard any unused portion of pancrelipase-soft food mixture; do not save for later use
                    • If dose requires >two 4000-unit lipase capsules, repeat process until prescribed dose is reached

                  Infants aged ≤12 months

                  • Do not mix capsule contents directly into formula or breast milk (may decrease efficacy)
                  • Administered to infants immediately prior to each feeding
                  • Capsule contents may be mixed with ~10 mL of soft acidic food with a pH ≤4.5 (eg, applesauce) or directly to the mouth
                  • Administration should be followed by breast milk or formula
                  • Contents of the capsule should not be mixed directly into
                  • Do not crush, chew, or retain in the mouth, to avoid irritation of the oral mucosa
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.