PERTZYE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PERTZYE (PERTZYE).
Pancreatic enzyme replacement therapy: provides lipase, amylase, and protease to digest fats, carbohydrates, and proteins in the duodenum, compensating for deficient exocrine pancreatic secretion.
| Metabolism | Not absorbed systemically; acts locally in the gastrointestinal tract; degraded by proteolytic enzymes in the gut. |
| Excretion | PERTZYE (pancrelipase) is not absorbed systemically; it acts locally in the gastrointestinal tract. After oral administration, the enzymes are degraded and excreted primarily in feces as inactive metabolites. No significant renal or biliary elimination occurs. |
| Half-life | Not applicable; PERTZYE is not absorbed systemically and does not exhibit a systemic half-life. Its activity is confined to the gut lumen. |
| Protein binding | Not applicable; PERTZYE is not absorbed systemically, so protein binding is not relevant. |
| Volume of Distribution | Not applicable; PERTZYE is not absorbed systemically, thus has no volume of distribution. |
| Bioavailability | Oral: Bioavailability is zero because the enzymes are not absorbed. Therapeutic effect is local, measured by improved fat absorption in the gut. |
| Onset of Action | Oral: Onset of clinical effect (improvement in fat digestion) occurs within minutes of administration, corresponding to gastric dissolution and delivery of enzymes to the duodenum. |
| Duration of Action | Oral: Duration of action lasts approximately 1-2 hours after ingestion, corresponding to the time enzymes remain active in the small intestine. Dosing is timed with meals and snacks. |
500 to 2500 lipase units/kg per meal orally, with snacks at 50% of meal dose; maximum 2500 lipase units/kg per meal or 10,000 lipase units/kg/day.
| Dosage form | CAPSULE, DELAYED RELEASE |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Infants: 2000-4000 lipase units per 120 mL formula or per breast-feeding. Children: 500-2500 lipase units/kg per meal, not to exceed 2500 units/kg per meal or 10,000 units/kg/day. |
| Geriatric use | No specific geriatric dose adjustments; titrate to minimize steatorrhea while maintaining nutritional status. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PERTZYE (PERTZYE).
| Breastfeeding | Not expected to be excreted into breast milk due to large molecular size and lack of systemic absorption. Caution recommended due to lack of human data. M/P ratio not available. |
| Teratogenic Risk | No teratogenic effects reported in animal studies; no adequate human studies. FDA Pregnancy Category C. Theoretical risk of fetal harm is low as enzymes are not systemically absorbed. Use only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to porcine-derived products","Acute pancreatitis","Acute flare of chronic pancreatitis"]
| Precautions | ["Fibrosing colonopathy (with high doses, especially in cystic fibrosis patients)","Hyperuricemia","Allergic reactions (porcine protein hypersensitivity)","Irritation of oral mucosa if capsules are chewed or held in mouth","Potential for viral transmission from porcine-derived product"] |
Loading safety data…
| Routine prenatal care; no specific monitoring required related to drug. Monitor maternal nutritional status and pancreatic insufficiency management. |
| Fertility Effects | No adverse effects on fertility reported in animal studies. No human data available. |