Viokace (Page 3 of 4)
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.
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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 * * [%] | ||
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 wash-out period CFA values than in patients with higher wash-out 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 wash-out 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 wash-out period and a mean CFA of 86% at the end of the double-blind period.
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 V16 engraved on one side and 9116 on the other side | bottles of 100 | 73562-208-10 |
Storage and Handling
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- 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.
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- Store and dispense VIOKACE in the original container.
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- VIOKACE is dispensed in bottles containing a desiccant.
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 increase 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:
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- Take VIOKACE with meals or snacks.
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- Swallow tablets whole. Do not crush or chew VIOKACE tablets.
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- Consume sufficient liquids (water) to ensure complete swallowing of VIOKACE tablets.
Storage
Instruct the patient or caregiver as follows:
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- Keep VIOKACE in a dry place and protect from moisture and heat.
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- After opening, keep the container tightly closed between uses to protect from moisture.
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- Keep VIOKACE in the original bottle.
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- The desiccant packet should not be eaten or thrown away.
Manufactured by:
Viokace, LLC
1007 US Highway 202/206,
Bridgewater, NJ 08807, USA
US License No. 2196
Manufactured for:
Aimmune Therapeutics, Inc.Bridgewater, NJ 08807, USA
©2024 Nestlé. All trademarks are owned by Société des Produits Nestlé S.A., Vevey, Switzerland or used with permission.
Medication Guide
MEDICATION GUIDEVIOKACE ® (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:
Take VIOKACE exactly as prescribed by your doctor. Do not take more VIOKACE than directed by your doctor. |
What is VIOKACE?
|
Before taking VIOKACE, tell your doctor about all your medical conditions, including if you:
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?
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What are the possible side effects of VIOKACE? VIOKACE may cause serious side effects, including:
The most common side effects of VIOKACE include:
Other Possible Side Effects: VIOKACE and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possibleside effects of VIOKACE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Aimmune Therapeutics, Inc at 1-833-AIM2KNO (1-833-246-2566) |
How should I store VIOKACE?
Keep VIOKACE and all medicines out of the reach of children. |
General information about the safe and effective use of VIOKACE. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VIOKACE for a condition for which it was not prescribed. Do not give VIOKACE to other people to take, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about VIOKACE that is written for health professionals. |
What are the ingredients in VIOKACE? Active ingredients: lipase, protease and amylase Inactive ingredients: colloidal silicon dioxide, crosscarmellose sodium, lactose monohydrate, microcrystalline cellulose, stearic acid and talc. |
Manufactured by: Viokace LLC1007 US Highway 202/206, Bridgewater, NJ 08807, USA US License No. 2196 Manufactured for: Aimmune Therapeutics, Inc.Bridgewater, NJ 08807, USA For more information, please call Aimmune Therapeutics, Inc at 1-833-AIM2KNO (1-833-246-2566). All trademarks are owned by Société des Produits Nestlé S.A., Vevey, Switzerland or used with permission. ©2024 Nestlé. |
This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: 02/2024
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.