![Viokace Pancrelipase 20880 [USP'U]/1; 78300 [USP'U]/1; 78300 [USP'U]/1 Tablet, 100-count — NDC 73562-0208-10 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=58bdb8de-582d-44e6-9b72-8d5a42fdf501&name=viokace-03.jpg)
Viokace Pancrelipase 20880 [USP'U]/1; 78300 [USP'U]/1; 78300 [USP'U]/1 Tablet, 100-count — NDC 73562-208-10 (Billing 73562-0208-10)
This is a package of 100 tablets of Viokace Pancrelipase 20880 [USP'U]/1; 78300 [USP'U]/1; 78300 [USP'U]/1 Tablet from Aimmune Therapeutics, Inc., marketed since Mar 2021 and currently FDA-listed; retail pharmacies pay about $8.21 per tablet (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 73562-208-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 73562 labeler · 208 product · 10 package
- Package marketed since
- Mar 1, 2021
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 100 EA per package
- Barcode (UPC-A, from the NDC)
- 3 7356220810 9
- Medicaid fills, this package
- 210 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 068743
- GCN: 31582
- GPI-14 (Medi-Span): 51200024000360
- HICL (First Databank): 008060
- AHFS class code: 56:16.00.00
- RxCUI (RxNorm): 1247379
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Pancrelipase capsules are used to improve digestion of food in infants, children, and adults who have pancreatic insufficiency (a condition in which the pancreas does not have enough pancreatic enzymes (substances needed to break down food so it can be digested) because they have a condition that affects the pancreas (a gland that produces several important substances including enzymes needed to digest food). Pancrelipase tablets are used along with another medication (proton pump inhibitor; PPI) to improve digestion of foods in adults who cannot digest food normally because they have chronic...
Read the full MedlinePlus article ↗- The enzymes in pancrelipase only work when there's food for them to digest — so timing really does matter. Even a small snack needs about half your usual meal dose. Skipping doses...
- Why do I have to take this with every meal? Can I skip it if I'm not very hungry?
- Yes, but carefully. You can sprinkle the contents onto a small amount of soft, acidic food like applesauce — just make sure to swallow it right away without chewing. What you absol...
- Can I open the capsule if I have trouble swallowing it?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Pancrelipase (prescription drug) — tap one for details:
Pancrelipase (prescription drug) may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $8.213 | $821.25 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $8.02 | $802.00 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $8.35 | $834.96 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 73562-0208-10 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE | 2021-03-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Viokace 20880 [USP'U]/1; 78300 [USP'U]/1; 78300 [USP'U]this 73562-0208-10 | Aimmune | 100 tablets | $8.213 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Pancrelipase inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Aimmune Therapeutics, Inc. labeler code 73562
- Zenpep pancrelipase lipase, pancrelipase protease, pancrelipase amylase 20000 [USP'U]/1; 63000 [USP'U]/1; 84000 [USP'U]/1 Capsule, Delayed Release NDC 73562-112-01
- Zenpep pancrelipase lipase, pancrelipase protease, pancrelipase amylase 3000 [USP'U]/1; 10000 [USP'U]/1; 14000 [USP'U]/1 Capsule, Delayed Release NDC 73562-113-01
- Zenpep pancrelipase lipase, pancrelipase protease, pancrelipase amylase 40000 [USP'U]/1; 126000 [USP'U]/1; 168000 [USP'U]/1 Capsule, Delayed Release NDC 73562-114-01
- Zenpep pancrelipase lipase, pancrelipase protease, pancrelipase amylase 5000 [USP'U]/1; 17000 [USP'U]/1; 24000 [USP'U]/1 Capsule, Delayed Release NDC 73562-115-01
- Zenpep pancrelipase lipase, pancrelipase protease, pancrelipase amylase 25000 [USP'U]/1; 79000 [USP'U]/1; 105000 [USP'U]/1 Capsule, Delayed Release NDC 73562-116-01
- Zenpep pancrelipase lipase, pancrelipase protease, pancrelipase amylase 60000 [USP'U]/1; 189600 [USP'U]/1; 252600 [USP'U]/1 Capsule, Delayed Release NDC 73562-117-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1. INDICATIONS AND USAGE 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. 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. ( 1 )
⏱️ Dosage and Administration ▾
2. DOSAGE AND ADMINISTRATION 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 ) 2.1.
Important Dosing Information 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.
2.2. Recommended Dosage 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. 2.3. Preparation and Administration Instructions Adult Patients: Take VIOKACE with meals or snacks.
If a dose is missed, take the next dose with the next meal or snack. Swallow tablets whole. Do not crush or chew VIOKACE tablets.
Consume sufficient liquids (water) to ensure complete swallowing of VIOKACE tablets [see Warnings and Precautions (5.2) ] .
💊 Dosage Forms and Strengths ▾
3. DOSAGE FORMS AND STRENGTHS 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 V 16 engraved on one side and 9116 on the other side.
Tablets ( 3 ): 10,440 USP units of lipase; 39,150 USP units of protease; and 39,150 USP units of amylase 20,880 USP units of lipase; 78,300 USP units of protease; and 78,300 USP units of amylase
⛔ Contraindications ▾
4. CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5. WARNINGS AND PRECAUTIONS 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 ) 5.1. Fibrosing Colonopathy 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) ] . 5.2. Irritation of the Oral Mucosa 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) ] .
5.3. Hyperuricemia 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. 5.4. Risk of Viral Transmission 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 inf… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6. ADVERSE REACTIONS 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) ] Most common adverse reactions (≥7%) are: anal pruritus and biliary tract stones.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics, Inc at 1-833-AIM2KNO (1-833-246-2566) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1. Clinical Trials Experience 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).
Table 1: Adverse Reactions Reported in at least 2 VIOKACE-treated patients (greater than or equal to 7%) and at a higher rate than placebo-treated patients. in a Clinical Trial of Adult Patients with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy Adverse Reaction VIOKACE N = 30 (%) Anal pruritus 2 (7%) Biliary tract stones 2 (7%) 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.
6.2. Postmarketing Experience 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
👥 Use in Specific Populations ▾
8. USE IN SPECIFIC POPULATIONS 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 ) 8.1. Pregnancy Risk Summary Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug.
Animal reproduction studies have not been conducted with pancrelipase. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 8.2. Lactation Risk Summary There are no data on the presence of pancrelipase in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.
Pancrelipase is minimally absorbed systemically following oral administration, therefore maternal use is not expected to result in clinically relevant exposure of breastfed infants to the drug. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VIOKACE and any potential adverse effects on the breastfed child from VIOKACE or from the underlying maternal conditions. 8.4.
Pediatric Use 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) ] .
8.5. Geriatric Use 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.
🤰 Pregnancy ▾
8.1. Pregnancy Risk Summary Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug.
Animal reproduction studies have not been conducted with pancrelipase. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
🧒 Pediatric Use ▾
8.4. Pediatric Use 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) ] .
🧓 Geriatric Use ▾
8.5. Geriatric Use 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.
🆘 Overdosage ▾
10. OVERDOSAGE 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) ] .
🧬 Clinical Pharmacology ▾
12. CLINICAL PHARMACOLOGY 12.1. Mechanism of Action 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.
12.2. Pharmacodynamics 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) ] . 12.3.
Pharmacokinetics Following oral administration, the lipases, proteases, and amylases released from VIOKACE are not absorbed from the gastrointestinal tract in appreciable amounts. Drug Interactions The lipases, proteases, and amylases of VIOKACE are not substrates of CYP enzymes or transporters. CYP enzymes or transporters mediated drug interactions are not expected.
🧬 Mechanism of Action ▾
12.1. Mechanism of Action 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.
📦 How Supplied / Storage and Handling ▾
16. HOW SUPPLIED/STORAGE AND HANDLING VIOKACE (pancrelipase) tablets are supplied as follows: Strength Description Supplied As NDC Number 10,440 USP units of lipase; 39,150 USP units of protease; 39,150 USP units of amylase tan, round, biconvex tablet with VIO9111 engraved on one side and 9111 on the other side bottles of 100 73562-104-10 20,880 USP units of lipase; 78,300 USP units of protease; 78,300 USP units of amylase tan, oval, biconvex tablet with V 16 engraved on one side and 9116 on the other side bottles of 100 73562-208-10 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.
📦 Storage and Handling ▾
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.
📋 Description ▾
11. DESCRIPTION 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 V 16 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.
💬 Information for Patients ▾
17. PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). Fibrosing Colonopathy Advise patients that if signs and symptoms of colon stricture formation occur (e.g., stomach area (abdominal) pain, bloating, trouble passing stool (constipation), nausea, vomiting, diarrhea) to immediately contact their healthcare provider [see Warnings and Precautions (5.1) ].
Hyperuricemia Advise the patient that hyperuricemia may occur in patients with gout or renal impairment and to contact the healthcare provider if they experience pain, stiffness, redness or swelling of their joints [see Warnings and Precautions (5.3) ]. Hypersensitivity Reactions Inform the patient that severe hypersensitivity reactions, including anaphylaxis asthma, hives, and pruritus, have been reported with use of pancreatic enzyme products. Seek medical attention if signs or symptoms of a hypersensitivity reaction develop [see Warnings and Precautions (5.5) ] .
Dosage Advise the patient to take VIOKACE as prescribed, and to contact the healthcare provider if signs and symptoms of malabsorption persist [see Dosage and Administration (2.1) ] . Administration Instruct the patient to: Take VIOKACE with meals or snacks. Swallow tablets whole.
Do not crush or chew VIOKACE tablets. Consume sufficient liquids (water) to ensure complete swallowing of VIOKACE tablets. Storage Instruct the patient or caregiver as follows: Keep VIOKACE in a dry place and protect from moisture and heat.
After opening, keep the container tightly closed between uses to protect from moisture. Keep VIOKACE in the original bottle. The desiccant packet should not be eaten or thrown away.
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 07/2025 MEDICATION GUIDE VIOKACE ® (vye-oh-kase) (pancrelipase) tablets, for oral use What is the most important information I should know about VIOKACE?
VIOKACE may increase your chance of having a rare bowel disorder called fibrosing colonopathy especially if taken at a high dose for a long time in children with cystic fibrosis. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you.
Call your doctor right away if you have any unusual or severe: stomach area (abdominal) pain bloating trouble passing stool (having bowel movements) nausea, vomiting, or diarrhea Take VIOKACE exactly as prescribed by your doctor. Do not take more VIOKACE than directed by your doctor. What is VIOKACE?
VIOKACE is a prescription medicine used with a proton pump inhibitor medicine (PPI) to treat adults who cannot digest food normally. Adults with swelling of the pancreas that lasts a long time (chronic pancreatitis), or who have had some or all of their pancreas removed (pancreatectomy) may not digest food normally because their pancreas does not make enough enzymes. VIOKACE contains a mixture of digestive enzymes (including lipases, proteases, and amylases) from pig pancreas.
It is not known if VIOKACE is safe and effective in children. Use of VIOKACE in children may result in poor nutrition and slowing of growth. Before taking VIOKACE, tell your doctor about all your medical conditions , including if you: are allergic to pork (pig) products. have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy). have gout, kidney disease, or a condition called high blood uric acid (hyperuricemia). have trouble swallowing tablets. are lactose intolerant. have any other medical condition. are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed.
It is not known if VIOKACE passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take VIOKACE. Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. How should I take VIOKACE?
Take VIOKACE tablets exactly as your doctor tells you. Contact your doctor if you continue to have signs and symptoms of malabsorption (not absorbing nutrients from food) such as abdominal pain, abdominal distention, bloating, fatty stools, or weight loss. Your dose may need to be changed.
You should not switch VIOKACE with any other pancreatic enzyme product without first talking to your doctor. Do not take more tablets in a day than the number your doctor tells you to take (total daily dose). Always take VIOKACE with a meal or a snack and enough liquid (water) to swallow VIOKACE completely.
If you eat a lot of meals or snacks in a day, be careful not to go over your total daily dose. Your doctor may change your dose based on the amount of fatty foods you eat or based on your weight. Your doctor should also prescribe a medicine for you called a proton pump inhibitor (PPI) to decrease stomach acid.
VIOKACE should be taken with a PPI to help prevent VIOKACE from breaking down in your stomach. Swallow VIOKACE tablets whole. Do not crush or chew the tablets.
Be careful to make sure that no VIOKACE is left in your mouth. Crushing or chewing the VIOKACE tablets may cause irritation in your mouth, or change the way VIOKACE works in your body. If you forget to take VIOKACE, wait until your next meal and take your usual number of tablets.
Take your next dose at your usual time. Do not take two doses at one time. What are the possible side effects of VIOKACE?
VIOKACE may cause serious side effects, including: See " What is the most importa… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3. Pharmacokinetics Following oral administration, the lipases, proteases, and amylases released from VIOKACE are not absorbed from the gastrointestinal tract in appreciable amounts. Drug Interactions The lipases, proteases, and amylases of VIOKACE are not substrates of CYP enzymes or transporters. CYP enzymes or transporters mediated drug interactions are not expected.
🧬 Pharmacodynamics ▾
12.2. Pharmacodynamics 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) ] .
🔬 Clinical Studies ▾
14. CLINICAL STUDIES 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%). Coefficient of Fat Absorption Endpoint and Results The coefficient of fat absorption (CFA) was determined by a 72-hour stool collection during both the washout period and end of double-blind period when both fat excretion and fat ingestion were measured.
The mean change in CFA at the end of the double-blind treatment period in the VIOKACE and placebo groups is shown in Table 2. Table 2: Change in Coefficient of Fat Absorption in Adults with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy - Intent to Treat Population VIOKACE n = 30 Placebo n = 20 CFA [%] Washout Period (Mean, SD) 48 (24) 57 (22) End of Double-Blind Period (Mean, SD) 86 (9) 58 (24) Change in CFA p<0.0001 [%] Treatment Difference (95% CI) 28 (18, 37) Subgroup analyses of the CFA results showed that mean change in CFA with VIOKACE treatment (from the washout period to the end of the double-blind period) was greater in patients with lower washout period CFA values than in patients with higher washout period CFA values.
Only 2 of the patients with a history of total pancreatectomy were treated with VIOKACE. One of these patients had a CFA of 12% during the washout period and a CFA of 90% at the end of the double-blind period; the other patient had a CFA of 38% during the wash-out period and a CFA of 77% at the end of the double-blind period. The remaining 9 patients with a history of partial pancreatectomy treated with VIOKACE had a mean CFA of 56% during the washout period and a mean CFA of 86% at the end of the double-blind period.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton - 104-10 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 PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton - 104-10
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label - 104-10 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 PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label - 104-10
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton - 208-10 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 PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton - 208-10
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label - 208-10 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 PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label - 208-10