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Pancrelipase

Class
Digestive enzymes
Subclass
Pancreatic enzymes
Generic name
Pancrelipase, pancreatin
Brand names
Viokace®
Common formulations
Tablet
See also
Pancrelipase DR (Pertzye®, Creon®, Zenpep®)
Indications for use
Labeled indications
Adults
•
Treatment of pancreatic insufficiency in patients with chronic pancreatitis
•
Treatment of pancreatic insufficiency, after pancreatectomy
Safety risks
Warnings and precautions
Drug hypersensitivity reaction
•
Use caution in patients with hypersensitivity to porcine protein.
Exacerbation of lactose intolerance
•
Use caution in patients with lactose intolerance, as pancrelipase tablets contain lactose monohydrate.
Hyperuricemia
•
Use caution in patients taking high dosages, especially those with gout, renal impairment, or hyperuricemia.
Intestinal stricture
•
Use caution in patients on high doses, with prolonged use, and in pediatric patients with cystic fibrosis.
Oral mucosal erythema
•
Maintain a high level of suspicion, as pancrelipase is associated with an increased risk of oral mucosal irritation and/or loss of enzyme activity.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use with caution. No guidance available. Monitor blood uric acid.
Renal replacement therapy
Any modality
•
Use with caution. No guidance available.
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Use only if benefits outweigh potential risks. Patients with EPI should receive adequate nutritional support (including adequate caloric intake) during pregnancy to ensure normal maternal weight gain and fetal growth.
•
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.
Breastfeeding
Acceptable for use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Headache
Common 1-10%
•
Anemia, ascites, cholelithiasis, contusion, ↓ blood glucose, duodenal injury, gastritis, ↑ blood glucose, nasopharyngitis, peripheral edema, renal cysts, abdominal pain, anal itching, cough, diarrhea, dizziness, early satiety, flatulence, indigestion, irritability, loss of appetite, vomiting
Rare < 0.1%
•
Intestinal stricture
Unknown frequency
•
Anaphylaxis, distal intestinal obstruction syndrome, ↑ liver enzymes, ↑ serum uric acid, ↑ urine uric acid, blurred vision, muscle spasms, myalgia, skin rash, steatorrhea, urolithiasis, urticaria
Interactions
Drug(s)
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