TM Owner Aimmune Therapeutics, Inc.
Viokace 20880 USP Tablet
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Indications & Clinical Uses
- Viokace 20,880 USP units (pancrelipase) is a tablet of pancreatic digestive enzymes (lipase, protease and amylase, from pig pancreas) used to replace enzymes the body no longer makes.
- It is indicated in adults for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, and must be used in combination with a proton pump inhibitor.
- Each 20,880 tablet contains 20,880 USP units of lipase, 78,300 units of protease and 78,300 units of amylase; a 10,440 unit tablet also exists, so the strength on the pack matters.
- The starting dose is 500 lipase units per kg per meal, adjusted by the prescriber to a maximum of 2,500 lipase units per kg per meal.
- Its safety and effectiveness in children have not been established.
- In the US the label holder is Aimmune Therapeutics, Inc.
Side Effects
- The most common reactions, seen in about 7% or more of people, were anal itching (pruritus) and biliary tract stones (gallstones).
- Serious problems include fibrosing colonopathy, a narrowing of the bowel reported with high doses of pancreatic enzymes; contact your healthcare provider about unusual abdominal symptoms or a change in bowel pattern.
- High doses may also raise uric acid (hyperuricaemia), and allergic reactions have been reported.
- If a tablet is crushed or chewed, it can irritate the mouth.
- Because the enzymes come from pig pancreas, there is a theoretical risk of transmitting viruses.
- The tablets contain lactose, which may worsen lactose intolerance symptoms.
- The current US label has no boxed warning.
- Report severe stomach pain, bloating or difficulty passing stools promptly.
Precautions & Warnings
- Swallow Viokace tablets whole with enough water during meals; do not crush or chew them, as this can irritate the lining of the mouth.
- Take about half the meal dose with snacks.
- It must be used together with a proton pump inhibitor.
- Do not exceed 2,500 lipase units per kg per meal without investigation, because of the risk of fibrosing colonopathy; report any unusual abdominal pain or bowel changes.
- Uric acid should be monitored in people with gout or kidney disease.
- Tell your provider if you are allergic to pork or have lactose intolerance.
- Safety and effectiveness in children are not established; use in children may lead to inadequate nutrition and stunted growth.
- Pancrelipase is minimally absorbed, and published data in pregnancy show no identified risk.
- Store at 20 to 25 degrees C in the original bottle with its desiccant, tightly closed, protected from moisture.
Avoid Interactions
- Viokace is not metabolised by CYP enzymes, so CYP-mediated or transporter-mediated drug interactions are not expected, and the label lists no specific interacting drugs.
- What increases or changes its effect: it is indicated only in combination with a proton pump inhibitor, which is part of the prescribed treatment, and the prescriber sets the dose according to your meals and symptoms.
- What may reduce its effect: chewing or crushing the tablets, taking doses away from meals, or switching to another pancrelipase product or tablet strength without advice, since doses are counted in lipase units.
- Tell your healthcare provider about all medicines and supplements you use.
References
Frequently Asked Questions
Viokace (pancrelipase) tablets replace digestive enzymes in adults whose pancreas does not make enough, called exocrine pancreatic insufficiency, due to chronic pancreatitis or pancreatectomy. It must be taken together with a proton pump inhibitor. Each 20,880 tablet contains 20,880 USP units of lipase.
Swallow Viokace whole with enough water during meals, and take about half the meal dose with snacks. The starting dose is 500 lipase units per kg per meal, adjusted by your provider up to 2,500 units per kg per meal. Take it together with a proton pump inhibitor.
The most common Viokace side effects, seen in at least 7% of people, are anal itching and gallstones (biliary tract stones). High doses can cause fibrosing colonopathy (bowel narrowing) and raised uric acid, and allergic reactions occur. Report severe abdominal pain, bloating or trouble passing stools. There is no boxed warning.
Do not crush or chew Viokace tablets, since this can irritate the mouth. Viokace (pancrelipase) is made from pig pancreas and contains lactose, so tell your provider if you are allergic to pork or lactose intolerant. Do not take more than 2,500 lipase units per kg per meal without investigation.
Store Viokace (pancrelipase) at 20 to 25 degrees C, protected from moisture. Keep it in the original bottle with the desiccant, and close the container tightly after each use. Brief excursions up to 40 degrees C for 24 hours are allowed.
Safety and effectiveness of Viokace in children have not been established, and use in children may cause inadequate nutrition and stunted growth. In pregnancy, pancrelipase is minimally absorbed and published data show no identified risk. Discuss use with your healthcare provider.
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