VIOKACE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VIOKACE (VIOKACE).
Pancrelipase is a pancreatic enzyme replacement therapy that provides lipase, amylase, and protease to hydrolyze fats, starches, and proteins into absorbable forms in the small intestine, compensating for exocrine pancreatic insufficiency.
| Metabolism | Pancrelipase is not absorbed systemically; it acts locally in the gastrointestinal tract. There is no significant metabolism; enzymes are degraded by proteolytic activity in the gut. |
| Excretion | Primarily fecal via degradation in GI tract; minimal renal excretion (<2% unchanged) |
| Half-life | 2-3 hours (enzymatic degradation in GI tract; clinical relevance: frequent dosing for exocrine pancreatic insufficiency) |
| Protein binding | <10% (minimal binding due to rapid proteolytic digestion) |
| Volume of Distribution | Not applicable (restricted to GI lumen; no systemic absorption) |
| Bioavailability | Not applicable (no systemic absorption; acts locally in GI tract) |
| Onset of Action | Oral: 30-60 minutes (lipolysis and proteolysis begin after meal ingestion) |
| Duration of Action | 4-6 hours (during gastric emptying and small intestinal transit; requires administration with all meals/snacks) |
500 lipase units/kg per meal orally, with snacks at half the meal dose. Maximum 2500 lipase units/kg per meal or 10,000 lipase units/kg per day.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Infants: 1000 lipase units per 120 mL formula or per breast-feeding; Children: 500 lipase units/kg per meal, with snacks at half the meal dose. Dosing based on lipase content. |
| Geriatric use | Use same dosing as adults; monitor for gastrointestinal adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VIOKACE (VIOKACE).
| Breastfeeding | No data on excretion in human milk. M/P ratio unknown. Due to high molecular weight and protein structure, entry into breast milk is expected to be minimal. Use with caution during breastfeeding; safety likely compatible. |
| Teratogenic Risk | VIOKACE (pancrelipase) is a pancreatic enzyme replacement. Given its high molecular weight (enzymes ~30-50 kDa) and protein nature, significant placental transfer is unlikely. No well-controlled studies in pregnant women. Animal studies show no teratogenic effects. Use during pregnancy generally considered low risk; fetal risks not established in any trimester. |
■ FDA Black Box Warning
WARNING: RISK OF FIBROSING COLONOPATHY. Fibrosing colonopathy has been reported following high-dose use of pancreatic enzyme products in patients with cystic fibrosis. Exercise caution when doses exceed 10,000 lipase units/kg/day.
| Serious Effects |
["Hypersensitivity to pork proteins or any component of the formulation","Acute pancreatitis"]
| Precautions | ["Fibrosing colonopathy risk, especially with high doses","Allergic reactions (e.g., anaphylaxis) in patients with hypersensitivity to pork proteins","Potential for irritation of oral mucosa if capsules are chewed or held in mouth","May exacerbate gout due to increased purine absorption from protein digestion","Risk of hyperuricemia"] |
Loading safety data…
| Fetal Monitoring | Monitor maternal nutritional status including fat-soluble vitamin levels (A, D, E, K). No specific fetal monitoring required. |
| Fertility Effects | No known effect on fertility. Not studied for reproductive toxicity. |