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2 dosage strengths available1
- Each VIOKACE® tablet strength contains the specified amounts of lipase, protease, and amylase as follows:
Significant improvement in fat absorption1
- In the pivotal trial of adult patients with EPI due to chronic pancreatitis or pancreatectomy*, patients treated with VIOKACE in combination with a PPI at the end of the double-blind treatment period achieved a mean coefficient of fat absorption (CFA) of 86% vs 58% for patients treated with placebo. The mean difference in CFA at the end of the double-blind treatment period was 28 percentage points in favor of VIOKACE treatment with 95% Confidence Interval of (21,37) and P≤0.0001
|*||A multicenter, randomized, parallel-group, placebo-controlled, double-blind study of 50 patients, ages 24 to 70 years, with EPI due to chronic pancreatitis or pancreatectomy. Eighteen patients had a history of pancreatectomy (11 were treated with VIOKACE). After a wash-out period (6-7 days), patients were randomized to a fixed dose of VIOKACE, 22 tablets per day (6 tablets with 3 meals and 2 tablets with 2 of 3 snacks) or placebo, in combination with a proton pump inhibitor. Duration of exposure ranged from 6 to 7 days. All patients were maintained on a controlled high-fat diet of 100 grams of fat per day. Forty-nine patients completed the double-blind treatment period. The CFA was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured. The wash-out period mean CFA was 48% in the VIOKACE treatment group and 57% in the placebo group.1|
Established tolerability in adults with EPI due to chronic pancreatitis or pancreatectomy1
- The most common adverse reactions occurring in at least 2 chronic pancreatitis or pancreatectomy patients (≥7%) receiving VIOKACE were biliary tract stones and anal pruritus
- Adverse reactions occurring in at least 1 patient (≥3%) at a higher rate than placebo in chronic pancreatitis or pancreatectomy were anal pruritus, biliary tract stones, anemia, abdominal pain, ascites, flatulence, edema peripheral, hydrocholecystis, viral infection, headache, renal cyst, and rash
- See additional Important Safety Information below