pancrelipase (Rx)

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

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

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)

• acarbose

  Monitor Closely (1)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

  Monitor Closely (1)calcium carbonate decreases effects of pancrelipase by pharmacodynamic antagonism. Use Caution/Monitor. Antacids may negate beneficial effects of enzymes.

• ferric maltol

  Monitor Closely (1)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

  Monitor Closely (1)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

  Monitor Closely (1)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

  Monitor Closely (1)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

  Monitor Closely (1)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

  Monitor Closely (1)magnesium hydroxide decreases effects of pancrelipase by pharmacodynamic antagonism. Use Caution/Monitor. Antacids may negate beneficial effects of enzymes.

• miglitol

  Monitor Closely (1)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

  Monitor Closely (1)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.