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.

Table 2: Change in Coefficient of Fat Absorption in Adults with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy — Intent to Treat Population
*
p<0.0001

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

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.

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:

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.

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:

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 important information I should know about VIOKACE?”
Irritation of the inside of your mouth. This can happen if VIOKACE is not swallowed completely.
Increase in blood uric acid levels (hyperuricemia). This may happen in people with gout, kidney problems, or those who take high doses of pancrelipase, the active ingredient in VIOKACE. Call your doctor if you have pain, stiffness, redness or swelling of your joints.
Severe allergic reactions. Severe allergic reactions have happened in people taking pancreatic enzyme products like VIOKACE. Stop taking VIOKACE and get emergency treatment right away if you have any of these symptoms: trouble with breathing, skin rashes, swollen lips or itching.

The most common side effects of VIOKACE include:

you can develop stones that form in your gallbladder and the tubes that carry bile to your small intestines.
anal itching

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?

Store VIOKACE at room temperature between 68°F to 77°F (20°C to 25°C). Avoid heat.
Keep VIOKACE in a dry place and in its original container.
After opening the bottle, keep it closed tightly between uses to protect from moisture.
The VIOKACE bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not eat or throw away the desiccant packet.

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

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