VIOKACE- pancrelipase tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PANCRELIPASE LIPASE (UNII: 8MYC33932O) (PANCRELIPASE LIPASE - UNII:8MYC33932O), PANCRELIPASE PROTEASE (UNII: 3560D81V50) (PANCRELIPASE PROTEASE - UNII:3560D81V50), PANCRELIPASE AMYLASE (UNII: YOJ58O116E) (PANCRELIPASE AMYLASE - UNII:YOJ58O116E)

Available from:

Aimmune Therapeutics, Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. None. 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. 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. 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.

Product summary:

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

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Aimmune Therapeutics, Inc
---------- MEDICATION GUIDE
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 kn

Summary of Product characteristics

VIOKACE- PANCRELIPASE TABLET
AIMMUNE THERAPEUTICS, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIOKACE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIOKACE.
VIOKACE (PANCRELIPASE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
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.
(1)
DOSAGE AND ADMINISTRATION
Important Dosing Information (2.1)
•
•
•
•
•
Recommended Dosage
•
•
Preparation and Administration Instructions
•
•
DOSAGE FORMS AND STRENGTHS
Tablets (3):
•
•
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
®
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.
_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.
Swallow tablets whole; do not crush or chew VIOKACE tablets