ZENPEP- pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release

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:

Allergan, Inc.

INN (International Name):

PANCRELIPASE LIPASE

Composition:

PANCRELIPASE LIPASE 3000 [USP'U]

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. None. 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. Risk Summary There are no data on the presence of pancrelipase in either human or animal milk, the effects

Product summary:

ZENPEP ® (pancrelipase) Delayed-Release Capsules 3,000 USP units of lipase; 10,000 USP units of protease; 14,000 units of amylase. Each ZENPEP capsule is available as a two piece hypromellose capsule with white opaque cap and white body with a red radial print and printed with “APTALIS 3”, that contains 1.8-1.9mm enteric-coated beads.  Capsules are supplied in bottles of: ZENPEP ® (pancrelipase) Delayed-Release Capsules 5,000 USP units of lipase; 17,000 USP units of protease; 24,000 units of amylase. Each ZENPEP capsule is available as a two piece hypromellose capsule with white opaque cap and white body with a blue radial print and printed with “APTALIS 5”, that contains 1.8-1.9mm enteric-coated beads.  Capsules are supplied in bottles of: ZENPEP ® (pancrelipase) Delayed-Release Capsules 10,000 USP units of lipase; 32,000 units of protease; 42,000 units of amylase. Each ZENPEP capsule is available as a two piece hypromellose capsule with yellow opaque cap and white body with a blue radial print and printed with “APTALIS 10”, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of: ZENPEP ® (pancrelipase) Delayed-Release Capsules 15,000 USP units of lipase; 47,000 units of protease; 63,000 units of amylase. Each ZENPEP capsule is available as a two piece hypromellose capsule with red opaque cap and white body with a blue radial print and printed with “APTALIS 15”, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of: ZENPEP ® (pancrelipase) Delayed-Release Capsules   20,000 USP units of lipase; 63,000 units of protease; 84,000 units of amylase. Each ZENPEP capsule is available as a two piece hypromellose capsule with green opaque cap and white body with a blue radial print and printed with “APTALIS 20”, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of: ZENPEP ® (pancrelipase) Delayed-Release Capsules   25,000 USP units of lipase; 79,000 units of protease; 105,000 units of amylase. Each ZENPEP capsule is available as a two piece hypromellose capsule with blue opaque cap and white body with a blue radial print and printed with “APTALIS 25”, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of:  ZENPEP ® (pancrelipase) Delayed-Release Capsules 40,000 USP units of lipase; 126,000 units of protease; 168,000 units of amylase. Each ZENPEP capsule is available as a two piece hypromellose capsule with orange opaque cap and white body with a blue radial print and printed with “APTALIS 40”, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of: Storage and Handling Original   container: Avoid excessive heat. Store at room temperature (68-77°F; 20-25°C), brief excursions permitted to 15-40°C (59-104°F). Protect from moisture. AFTER OPENING, KEEP BOTTLE TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Repackaged HDPE container: Avoid excessive heat. Store at up to 30°C (86°F) for up to 6 months. Brief excursions permitted to 15-40°C (59-104°F) for up to 30 days. Protect from moisture. AFTER OPENING, KEEP BOTTLE TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Dispense in tight container (USP). Keep out of reach of children. DO NOT CRUSH ZENPEP delayed-release capsules.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Allergan, Inc.
----------
MEDICATION GUIDE
ZENPEP® (ZEN-pep)
(pancrelipase)
delayed-release capsules
Read this Medication Guide before you start taking ZENPEP and each
time you get a refill. There
may be new information. This information does not take the place of
talking to your doctor about
your medical condition or treatment.
What is the most important information I should know about ZENPEP?
ZENPEP may increase your chance of having a rare bowel disorder called
fibrosing colonopathy.
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 ZENPEP exactly as prescribed. Do not take more or less ZENPEP
than directed by your
doctor.
What is ZENPEP?
•
ZENPEP is a prescription medicine for people who cannot digest food
normally because
their pancreas does not make enough enzymes. ZENPEP may help your body
use fats,
proteins and sugars from food.
•
ZENPEP contains a mixture of digestive enzymes including lipases,
proteases, and amylases
from pig pancreas.
•
ZENPEP is safe and effective in children.
What should I tell my doctor before taking ZENPEP?
Before taking ZENPEP, 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 high blood uric acid (hyperuricemia)
•
have trouble swallowing capsules
•
have any other medical condition
•
are pregnant or plan to become pregnant
•
are breastfeeding or plan to breastfeed. It is not known if ZENPEP
passes into your breast
milk. Talk to your doctor about the best way to feed your baby if you
take ZENPEP.
Tell your doctor about all the medicines you take, i

Summary of Product characteristics

ZENPEP- PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE
AMYLASE CAPSULE, DELAYED
RELEASE
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZENPEP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZENPEP.
ZENPEP (PANCRELIPASE) DELAYED RELEASE CAPSULES
INITIAL U.S. APPROVAL: 2009
INDICATIONS AND USAGE
ZENPEP is a combination of porcine-derived lipases, proteases, and
amylases indicated for the treatment of exocrine
pancreatic insufficiency due to cystic fibrosis, or other conditions
(1)
DOSAGE AND ADMINISTRATION
_Dosage_
ZENPEP is not interchangeable with any other pancrelipase product.
_Infants (up to 12 months) _
Infants may be given 3,000 lipase units (one capsule) per 120 mL of
formula or per breast-feeding. (2.1)
Do not mix ZENPEP capsule contents directly into formula or breast
milk prior to administration. (2.2)
_Children Older than 12 Months and Younger than 4 Years_
Enzyme dosing should begin with 1,000 lipase units/kg of body weight
per meal to a maximum of 2,500 lipase units/kg
of body weight per meal (or less than or equal to 10,000 lipase
units/kg of body weight per day), or less than 4,000
lipase units/g fat ingested per day. (2.1)
_Children 4 Years and Older and Adults_
Enzyme dosing should begin with 500 lipase units/kg of body weight per
meal to a maximum of 2,500 lipase units/kg of
body weight per meal (or less than or equal to 10,000 lipase units/kg
of body weight per day), or less than 4,000 lipase
units/g fat ingested per day. (2.1)
_Limitations on Dosing_
Dosing should not exceed the recommended maximum dosage set forth by
the Cystic Fibrosis Foundation Consensus
Conferences Guidelines (2.1)
_Administration_
ZENPEP should be swallowed whole. For infants or patients unable to
swallow intact capsules, the contents may be
sprinkled on soft acidic food, e.g., applesauce. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 3,000 USP units of lipase; 10,000 USP units of protease;
14,000 USP units of amylase. C