These Highlights Do Not Include All The Information Needed To Use Viokace Safely And Effectively. See Full Prescribing Information For Viokace

Adult Patients:

The recommended oral initial starting dosage of VIOKACE is 500 lipase units/kg/meal.

If signs and symptoms of malabsorption persist, increase the dosage. Titrate to a maximum of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/grams of fat ingested/day.

Storage and Handling

• Store VIOKACE at room temperature 20°C to 25°C (68°F to 77°F), and protect from moisture. Brief excursions permitted up to 40°C (104°F) for 24 hours. After opening, keep the container tightly closed between uses to protect from moisture.
• Store and dispense VIOKACE in the original container.
• VIOKACE is dispensed in bottles containing a desiccant.

Chronic high dosages of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see Warnings and Precautions (5.1)]. High dosages of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia [see Warnings and Precautions (5.3)].

Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands.

VIOKACE (pancrelipase) tablets are for oral administration and available as follows:

• 10,440 USP units of lipase; 39,150 USP units of protease; and 39,150 USP units of amylase as a tan, round biconvex tablet and have VIO9111 engraved on one side and 9111 on the other side.
• 20,880 USP units of lipase; 78,300 USP units of protease; and 78,300 USP units of amylase as a tan, oval, biconvex tablet with V¹⁶ engraved on one side and 9116 on the other side.

Inactive ingredients in VIOKACE include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, stearic acid and talc.

Pancreatic enzyme products contain purines that may increase blood uric acid levels. High dosages have been associated with hyperuricosuria and hyperuricemia [see Overdosage (10)].

Consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia during treatment with VIOKACE.

The safety and effectiveness of VIOKACE in pediatric patients have not been established.

Use of VIOKACE in pediatric patients may increase the risk of inadequate treatment of pancreatic insufficiency and result in suboptimal weight gain, malnutrition and/or need for larger doses of pancreatic enzyme replacement due to tablet degradation in the gastric environment of the stomach.

High dosages of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age [see Warnings and Precautions (5.1)].

Clinical studies of VIOKACE did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between patients aged 65 years and over and younger adult patients.

A randomized, double-blind, placebo-controlled, parallel group study was conducted in 50 adult patients, aged 24 to 70 years, with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy. Eighteen patients had a history of pancreatectomy (11 were treated with VIOKACE). All patients were maintained on a controlled high fat diet of 100 grams of fat per day. After a washout period (6 to 7 days), patients were randomized to a fixed dose of VIOKACE or placebo, in combination with a proton pump inhibitor: 125,280 lipase units per meal (3 meals) and 41,760 lipase units per snack (2 snacks) (6 tablets per meal and 2 tablets per snacks). Forty-nine patients completed the double-blind treatment period (6 to 7 days); 29 patients received VIOKACE, and 20 patients received placebo. Duration of exposure to VIOKACE ranged from 6 to 7 days. The majority of the subjects were White (96%) and male (82%).

None.

The following serious or otherwise important adverse reactions are described elsewhere in the labeling:

• Fibrosing Colonopathy [see Warnings and Precautions (5.1)]
• Irritation of the Oral Mucosa [see Warnings and Precautions (5.2)]
• Hyperuricemia [see Warnings and Precautions (5.3)]
• Risk of Viral Transmission [see Warnings and Precautions (5.4)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.5)]
• Potential for Exacerbation of Symptoms of Lactose Intolerance [see Warnings and Precautions (5.6)]

For patients consuming a high fat diet in the clinical trial, the coefficient of fat absorption (CFA) was higher in patients who received VIOKACE compared to the placebo treatment group, indicating improved fat absorption [see Clinical Studies (14)].

Following oral administration, the lipases, proteases, and amylases released from VIOKACE are not absorbed from the gastrointestinal tract in appreciable amounts.

VIOKACE, in combination with a proton pump inhibitor, is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in adults.

Pancreatic enzyme products contain a mixture of lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglycerides, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

Fibrosing colonopathy has been reported following treatment with pancreatic enzyme products. Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with use of high-dose pancreatic enzyme products, usually over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. Pancreatic enzyme products exceeding 6,000 lipase units/kg/meal have been associated with colonic stricture, a complication of fibrosing colonopathy, in pediatric patients less than 12 years of age. The underlying mechanism of fibrosing colonopathy remains unknown.

If there is a history of fibrosing colonopathy, monitor patients during treatment with VIOKACE because some patients may be at risk of progressing to colonic stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs. Do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day without further investigation. Higher dosages may be administered if they are documented to be effective by fecal fat measures or an improvement in signs or symptoms of malabsorption including measures of nutritional status. Patients receiving dosages higher than 6,000 lipase units/kg/meal should frequently monitored for symptoms of fibrosing colonopathy and the dosage decreased or titrated downward to a lower range if clinically appropriate [see Dosage and Administration (2.1)].

• Fibrosing Colonopathy: Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated. (2.1, 5.1)
• Irritation of the Oral Mucosa: May occur if tablets are crushed or chewed. (5.2)
• Hyperuricemia: Reported with high dosages, consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia. (5.3)
• Risk of Viral Transmission: The presence of porcine viruses that might infect humans cannot be definitely excluded. (5.4)
• Hypersensitivity Reactions: Monitor patients with known reactions to proteins of porcine origin. If symptoms occur, initiate appropriate medical management; consider the risks and benefits of continued treatment. (5.5)
• Potential for Exacerbation of Symptoms of Lactose Intolerance: tablets contain lactose monohydrate. Patients who have lactose intolerance may not be able to tolerate VIOKACE. (5.6)

Important Dosing Information (2.1)

• VIOKACE is a mixture of enzymes including lipases, proteases, and amylases and dosing is based on lipase units. Dosing scheme based on actual body weight or fat ingestion.
• Individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.
• Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day without further investigation. (5.1)
• The total daily dosage should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed dose for a meal.
• Do not substitute other pancreatic enzyme products for VIOKACE. When switching from another pancreatic enzyme product to VIOKACE, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed.

Recommended Dosage

• Adult Patients: The recommended initial starting dosage is 500 lipase units/kg/meal.
• Titrate the dosage to 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day. Higher dosages may be administered if documented effective by fecal fat measures or improvement in malabsorption.

Preparation and Administration Instructions

• Swallow tablets whole; do not crush or chew VIOKACE tablets. (2.3)
• Consume sufficient liquids to ensure complete swallowing of VIOKACE tablets. (2.3, 5.2)

Tablets are available in the following strengths:

• 10,440 USP units of lipase; 39,150 USP units of protease; and 39,150 USP units of amylase as a tan, round, biconvex tablet with VIO9111 engraved on one side and 9111 on the other side.
• 20,880 USP units of lipase; 78,300 USP units of protease; and 78,300 USP units of amylase as a tan, oval, biconvex tablet with V¹⁶ engraved on one side and 9116 on the other side.

The following adverse reactions have been identified during post-approval use of VIOKACE or other pancreatic enzyme products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye Disorders

• blurred vision

Gastrointestinal Disorders

• fibrosing colonopathy and distal intestinal obstruction syndrome
• abdominal pain, diarrhea, flatulence, constipation, and nausea

Immune System Disorders

• anaphylaxis, asthma, hives and pruritis

Investigations

• asymptomatic elevations of liver enzymes

Musculoskeletal System

• myalgia, muscle spasm

Skin and Subcutaneous Tissue Disorders

• urticaria and rash

• Pediatrics: VIOKACE use in pediatric patients may result in suboptimal weight gain, malnutrition and/or need for larger doses. The safety and effectiveness of VIOKACE in pediatric patients have not been established. (8.4)

VIOKACE is sourced from pancreatic tissue from pigs used for food consumption. Although the risk that VIOKACE will transmit an infectious agent to humans has been reduced by testing for certain viruses during manufacturing and by inactivating certain viruses during manufacturing, there is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. Thus, the presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.

Severe hypersensitivity reactions including anaphylaxis, asthma, hives, and pruritus have been reported with pancreatic enzyme products [see Adverse Reactions (6.2)]. If symptoms occur, initiate appropriate medical management.

Monitor patients with a known hypersensitivity reaction to proteins of porcine origin for hypersensitivity reactions during treatment with VIOKACE. The risks and benefits of continued VIOKACE treatment in patients with severe hypersensitivity reactions should be taken into consideration with the overall clinical needs of the patient.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to VIOKACE in 30 adult patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in a single, multicenter, randomized, parallel, placebo-controlled, double-blind study [see Clinical Studies (14)].

Adverse reactions that were reported in at least 2 VIOKACE-treated patients (greater than or equal to 7%) are shown in Table 1. There were no adverse reactions reported in two or more patients in the placebo group (N=20).

The following adverse reactions were reported in one VIOKACE-treated patient each: anemia, abdominal pain, ascites, flatulence, headache, hydocholecystis, peripheral edema, rash, renal cyst, and viral infection.

VIOKACE is a mixture of enzymes including lipases, proteases, and amylases. VIOKACE dosing is based on lipase units.

• Administer VIOKACE with a proton pump inhibitor.
• Use either an actual body weight or fat ingestion-based dosing scheme.
• Start at the lowest recommended dosage and individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Changes in dosage may require an adjustment period of several days.
• Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day without further investigation [see Warnings and Precautions (5.1)]. Higher dosages may be administered if they are documented to be effective by fecal fat measures or an improvement in signs or symptoms of malabsorption including measures of nutritional status.
• The total daily dosage should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed VIOKACE dose for a meal.
• Do not substitute other pancreatic enzyme products for VIOKACE. When switching from another pancreatic enzyme product to VIOKACE, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed.

Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide).

Crushing or chewing VIOKACE tablets can result in irritation of the oral mucosa, and/or loss of enzyme activity. Instruct the patient to swallow tablets whole. Do not crush or chew VIOKACE tablets. Consume sufficient liquids immediately following administration of VIOKACE to ensure complete swallowing [see Dosage and Administration (2.3)].

VIOKACE (pancrelipase) tablets are supplied as follows:

NDC# 73562-104-10

pancrelipase

Viokace^®

TABLETS

Rx only

Each tablet contains:

10,440 USP Units Lipase

39,150 USP Units Amylase

39,150 USP Units Protease

VIOKACE^® is dosed based on

lipase units.

VIOKACE^® tablets should be

swallowed whole. Do not crush

or chew tablets.

Dispense the enclosed Medication

Guide to each patient.

100 TABLETS

NDC# 73562-208-10

pancrelipase

Viokace^®

TABLETS

Rx only

Each tablet contains:

20,880 USP Units Lipase

78,300 USP Units Amylase

78,300 USP Units Protease

VIOKACE^® is dosed based on

lipase units.

VIOKACE^® tablets should be

swallowed whole. Do not crush

or chew tablets.

Dispense the enclosed Medication

Guide to each patient.

100 TABLETS

NDC# 73562-104-10

pancrelipase

Viokace^®

TABLETS

Rx only

Each tablet contains:

10,440 USP Units Lipase

39,150 USP Units Amylase

39,150 USP Units Protease

VIOKACE^® is dosed based

on lipase units.

Contains no preservatives.

Contains pork proteins.

VIOKACE^® tablets should

be swallowed whole. Do not

crush or chew tablets.

Dispense the enclosed Medication

Guide to each patient.

Nestlé

HealthScience _®

100 TABLETS

NDC# 73562-208-10

pancrelipase

Viokace^®

TABLETS

Rx only

Each tablet contains:

20,880 USP Units Lipase

78,300 USP Units Amylase

78,300 USP Units Protease

VIOKACE^® is dosed based

on lipase units.

Contains no preservatives.

Contains pork proteins.

VIOKACE^® tablets should

be swallowed whole. Do not

crush or chew tablets.

Dispense the enclosed Medication

Guide to each patient.

Nestlé

HealthScience _®

100 TABLETS

VIOKACE tablets contain lactose monohydrate [see Description (11)]. Patients who have lactose intolerance may not be able to tolerate VIOKACE.

Adult Patients:

The recommended oral initial starting dosage of VIOKACE is 500 lipase units/kg/meal.

If signs and symptoms of malabsorption persist, increase the dosage. Titrate to a maximum of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/grams of fat ingested/day.

Storage and Handling

• Store VIOKACE at room temperature 20°C to 25°C (68°F to 77°F), and protect from moisture. Brief excursions permitted up to 40°C (104°F) for 24 hours. After opening, keep the container tightly closed between uses to protect from moisture.
• Store and dispense VIOKACE in the original container.
• VIOKACE is dispensed in bottles containing a desiccant.

Chronic high dosages of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see Warnings and Precautions (5.1)]. High dosages of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia [see Warnings and Precautions (5.3)].

Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands.

VIOKACE (pancrelipase) tablets are for oral administration and available as follows:

• 10,440 USP units of lipase; 39,150 USP units of protease; and 39,150 USP units of amylase as a tan, round biconvex tablet and have VIO9111 engraved on one side and 9111 on the other side.
• 20,880 USP units of lipase; 78,300 USP units of protease; and 78,300 USP units of amylase as a tan, oval, biconvex tablet with V¹⁶ engraved on one side and 9116 on the other side.

Inactive ingredients in VIOKACE include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, stearic acid and talc.

Pancreatic enzyme products contain purines that may increase blood uric acid levels. High dosages have been associated with hyperuricosuria and hyperuricemia [see Overdosage (10)].

Consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia during treatment with VIOKACE.

The safety and effectiveness of VIOKACE in pediatric patients have not been established.

Use of VIOKACE in pediatric patients may increase the risk of inadequate treatment of pancreatic insufficiency and result in suboptimal weight gain, malnutrition and/or need for larger doses of pancreatic enzyme replacement due to tablet degradation in the gastric environment of the stomach.

High dosages of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age [see Warnings and Precautions (5.1)].

Clinical studies of VIOKACE did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between patients aged 65 years and over and younger adult patients.

A randomized, double-blind, placebo-controlled, parallel group study was conducted in 50 adult patients, aged 24 to 70 years, with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy. Eighteen patients had a history of pancreatectomy (11 were treated with VIOKACE). All patients were maintained on a controlled high fat diet of 100 grams of fat per day. After a washout period (6 to 7 days), patients were randomized to a fixed dose of VIOKACE or placebo, in combination with a proton pump inhibitor: 125,280 lipase units per meal (3 meals) and 41,760 lipase units per snack (2 snacks) (6 tablets per meal and 2 tablets per snacks). Forty-nine patients completed the double-blind treatment period (6 to 7 days); 29 patients received VIOKACE, and 20 patients received placebo. Duration of exposure to VIOKACE ranged from 6 to 7 days. The majority of the subjects were White (96%) and male (82%).

None.

The following serious or otherwise important adverse reactions are described elsewhere in the labeling:

• Fibrosing Colonopathy [see Warnings and Precautions (5.1)]
• Irritation of the Oral Mucosa [see Warnings and Precautions (5.2)]
• Hyperuricemia [see Warnings and Precautions (5.3)]
• Risk of Viral Transmission [see Warnings and Precautions (5.4)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.5)]
• Potential for Exacerbation of Symptoms of Lactose Intolerance [see Warnings and Precautions (5.6)]

For patients consuming a high fat diet in the clinical trial, the coefficient of fat absorption (CFA) was higher in patients who received VIOKACE compared to the placebo treatment group, indicating improved fat absorption [see Clinical Studies (14)].

Following oral administration, the lipases, proteases, and amylases released from VIOKACE are not absorbed from the gastrointestinal tract in appreciable amounts.

VIOKACE, in combination with a proton pump inhibitor, is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in adults.

Pancreatic enzyme products contain a mixture of lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglycerides, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

Fibrosing colonopathy has been reported following treatment with pancreatic enzyme products. Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with use of high-dose pancreatic enzyme products, usually over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. Pancreatic enzyme products exceeding 6,000 lipase units/kg/meal have been associated with colonic stricture, a complication of fibrosing colonopathy, in pediatric patients less than 12 years of age. The underlying mechanism of fibrosing colonopathy remains unknown.

If there is a history of fibrosing colonopathy, monitor patients during treatment with VIOKACE because some patients may be at risk of progressing to colonic stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs. Do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day without further investigation. Higher dosages may be administered if they are documented to be effective by fecal fat measures or an improvement in signs or symptoms of malabsorption including measures of nutritional status. Patients receiving dosages higher than 6,000 lipase units/kg/meal should frequently monitored for symptoms of fibrosing colonopathy and the dosage decreased or titrated downward to a lower range if clinically appropriate [see Dosage and Administration (2.1)].

• Fibrosing Colonopathy: Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated. (2.1, 5.1)
• Irritation of the Oral Mucosa: May occur if tablets are crushed or chewed. (5.2)
• Hyperuricemia: Reported with high dosages, consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia. (5.3)
• Risk of Viral Transmission: The presence of porcine viruses that might infect humans cannot be definitely excluded. (5.4)
• Hypersensitivity Reactions: Monitor patients with known reactions to proteins of porcine origin. If symptoms occur, initiate appropriate medical management; consider the risks and benefits of continued treatment. (5.5)
• Potential for Exacerbation of Symptoms of Lactose Intolerance: tablets contain lactose monohydrate. Patients who have lactose intolerance may not be able to tolerate VIOKACE. (5.6)

Important Dosing Information (2.1)

• VIOKACE is a mixture of enzymes including lipases, proteases, and amylases and dosing is based on lipase units. Dosing scheme based on actual body weight or fat ingestion.
• Individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.
• Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day without further investigation. (5.1)
• The total daily dosage should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed dose for a meal.
• Do not substitute other pancreatic enzyme products for VIOKACE. When switching from another pancreatic enzyme product to VIOKACE, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed.

Recommended Dosage

• Adult Patients: The recommended initial starting dosage is 500 lipase units/kg/meal.
• Titrate the dosage to 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day. Higher dosages may be administered if documented effective by fecal fat measures or improvement in malabsorption.

Preparation and Administration Instructions

• Swallow tablets whole; do not crush or chew VIOKACE tablets. (2.3)
• Consume sufficient liquids to ensure complete swallowing of VIOKACE tablets. (2.3, 5.2)

Tablets are available in the following strengths:

• 10,440 USP units of lipase; 39,150 USP units of protease; and 39,150 USP units of amylase as a tan, round, biconvex tablet with VIO9111 engraved on one side and 9111 on the other side.
• 20,880 USP units of lipase; 78,300 USP units of protease; and 78,300 USP units of amylase as a tan, oval, biconvex tablet with V¹⁶ engraved on one side and 9116 on the other side.

The following adverse reactions have been identified during post-approval use of VIOKACE or other pancreatic enzyme products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye Disorders

• blurred vision

Gastrointestinal Disorders

• fibrosing colonopathy and distal intestinal obstruction syndrome
• abdominal pain, diarrhea, flatulence, constipation, and nausea

Immune System Disorders

• anaphylaxis, asthma, hives and pruritis

Investigations

• asymptomatic elevations of liver enzymes

Musculoskeletal System

• myalgia, muscle spasm

Skin and Subcutaneous Tissue Disorders

• urticaria and rash

• Pediatrics: VIOKACE use in pediatric patients may result in suboptimal weight gain, malnutrition and/or need for larger doses. The safety and effectiveness of VIOKACE in pediatric patients have not been established. (8.4)

VIOKACE is sourced from pancreatic tissue from pigs used for food consumption. Although the risk that VIOKACE will transmit an infectious agent to humans has been reduced by testing for certain viruses during manufacturing and by inactivating certain viruses during manufacturing, there is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. Thus, the presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.

Severe hypersensitivity reactions including anaphylaxis, asthma, hives, and pruritus have been reported with pancreatic enzyme products [see Adverse Reactions (6.2)]. If symptoms occur, initiate appropriate medical management.

Monitor patients with a known hypersensitivity reaction to proteins of porcine origin for hypersensitivity reactions during treatment with VIOKACE. The risks and benefits of continued VIOKACE treatment in patients with severe hypersensitivity reactions should be taken into consideration with the overall clinical needs of the patient.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to VIOKACE in 30 adult patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in a single, multicenter, randomized, parallel, placebo-controlled, double-blind study [see Clinical Studies (14)].

Adverse reactions that were reported in at least 2 VIOKACE-treated patients (greater than or equal to 7%) are shown in Table 1. There were no adverse reactions reported in two or more patients in the placebo group (N=20).

The following adverse reactions were reported in one VIOKACE-treated patient each: anemia, abdominal pain, ascites, flatulence, headache, hydocholecystis, peripheral edema, rash, renal cyst, and viral infection.

VIOKACE is a mixture of enzymes including lipases, proteases, and amylases. VIOKACE dosing is based on lipase units.

• Administer VIOKACE with a proton pump inhibitor.
• Use either an actual body weight or fat ingestion-based dosing scheme.
• Start at the lowest recommended dosage and individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Changes in dosage may require an adjustment period of several days.
• Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day without further investigation [see Warnings and Precautions (5.1)]. Higher dosages may be administered if they are documented to be effective by fecal fat measures or an improvement in signs or symptoms of malabsorption including measures of nutritional status.
• The total daily dosage should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed VIOKACE dose for a meal.
• Do not substitute other pancreatic enzyme products for VIOKACE. When switching from another pancreatic enzyme product to VIOKACE, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed.

Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide).

Crushing or chewing VIOKACE tablets can result in irritation of the oral mucosa, and/or loss of enzyme activity. Instruct the patient to swallow tablets whole. Do not crush or chew VIOKACE tablets. Consume sufficient liquids immediately following administration of VIOKACE to ensure complete swallowing [see Dosage and Administration (2.3)].

VIOKACE (pancrelipase) tablets are supplied as follows:

NDC# 73562-104-10

pancrelipase

Viokace^®

TABLETS

Rx only

Each tablet contains:

10,440 USP Units Lipase

39,150 USP Units Amylase

39,150 USP Units Protease

VIOKACE^® is dosed based on

lipase units.

VIOKACE^® tablets should be

swallowed whole. Do not crush

or chew tablets.

Dispense the enclosed Medication

Guide to each patient.

100 TABLETS

NDC# 73562-208-10

pancrelipase

Viokace^®

TABLETS

Rx only

Each tablet contains:

20,880 USP Units Lipase

78,300 USP Units Amylase

78,300 USP Units Protease

VIOKACE^® is dosed based on

lipase units.

VIOKACE^® tablets should be

swallowed whole. Do not crush

or chew tablets.

Dispense the enclosed Medication

Guide to each patient.

100 TABLETS

NDC# 73562-104-10

pancrelipase

Viokace^®

TABLETS

Rx only

Each tablet contains:

10,440 USP Units Lipase

39,150 USP Units Amylase

39,150 USP Units Protease

VIOKACE^® is dosed based

on lipase units.

Contains no preservatives.

Contains pork proteins.

VIOKACE^® tablets should

be swallowed whole. Do not

crush or chew tablets.

Dispense the enclosed Medication

Guide to each patient.

Nestlé

HealthScience _®

100 TABLETS

NDC# 73562-208-10

pancrelipase

Viokace^®

TABLETS

Rx only

Each tablet contains:

20,880 USP Units Lipase

78,300 USP Units Amylase

78,300 USP Units Protease

VIOKACE^® is dosed based

on lipase units.

Contains no preservatives.

Contains pork proteins.

VIOKACE^® tablets should

be swallowed whole. Do not

crush or chew tablets.

Dispense the enclosed Medication

Guide to each patient.

Nestlé

HealthScience _®

100 TABLETS

VIOKACE tablets contain lactose monohydrate [see Description (11)]. Patients who have lactose intolerance may not be able to tolerate VIOKACE.