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) |
| Molecular Weight | 29000 |
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 | No adequate studies in pregnant women. Animal reproduction studies not conducted. Use only if clearly needed. |
| 2nd trimester | No adequate studies in pregnant women. Use only if clearly needed. |
| 3rd trimester | No adequate studies in pregnant women. Use only if clearly needed. |
Clinical note
Comprehensive clinical and safety monograph for VIOKACE (VIOKACE).
| Placental transfer | Unknown; molecular weight suggests potential for placental transfer. |
| Breastfeeding | Excretion in human milk unknown. Caution advised. |
| Lactation Rating | L3 - No data available; risk cannot be ruled out. |
■ 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 any componentAcute 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 |
| Food/Dietary | Viokace should be taken with food; do not take on an empty stomach. Avoid high-fat meals unless recommended by a dietitian, as fat content may require dose adjustment. No specific food interactions, but alcohol may increase risk of pancreatitis. |
Loading safety data…
| 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. |
| 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. |
| Clinical Pearls | Viokace (pancrelipase) must be taken with food; do not crush or chew capsules. Use with caution in patients with gout or hyperuricemia due to potential for increased uric acid. Monitor for fibrosing colonopathy with high doses in cystic fibrosis patients. Adjust dose based on steatorrhea and nutritional status. |
| Patient Advice | Take exactly as prescribed with every meal or snack. · Swallow capsules whole; do not crush, chew, or hold in mouth. · Drink plenty of fluids to prevent constipation. · Do not change dose without consulting your doctor. · Report new joint pain, skin rash, or changes in urination. |