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

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Aimmune Therapeutics, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. 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 ZENPEP and any potential adverse effects on the breastfed infant from ZENPEP or from the underlying maternal conditions. The safety and effectiveness of ZENPEP for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of ZENPEP for this indication is supported by an adequate and well-controlled trial in adult and pediatric patients 7 to 17 years of age (Study 1) along with supportive data from an open-label, single arm study in 19 pediatric patients 1 to 6 years of age (Study 2). Both study populations consisted of patients with exocrine pancreatic insufficiency due to cystic fibrosis. The safety in pediatric patients in Studies 1 and 2 were similar to that observed in adult patients [see Adverse Reactions (6.1) and Clinical Studies (14)] . Dosages exceeding 6,000 lipase units/kg/meal have been reported postmarketing to be associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age. If there is a history of fibrosing colonopathy, monitor patients during treatment with ZENPEP because some patients may be at risk of progressing to stricture formation. 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 in pediatric patients greater than 12 months of age without further investigation. [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)] . Crushing or chewing ZENPEP capsules or mixing the capsule contents in foods having a pH greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity. Instruct the patient or caregiver of the following: consume sufficient liquids (juice, water, breast milk, or formula) to ensure complete swallowing, and visually inspect the mouth of pediatric patients less than 12 months of age to ensure that no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see Dosage and Administration (2.3) and Warnings and Precautions (5.2)] . Clinical studies of ZENPEP 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.

Produkt oppsummering:

ZENPEP (pancrelipase) delayed-release capsules containing light, brown-colored delayed-release pancrelipase are supplied as follows: Strength Description Supplied As NDC Number 3,000 USP units of lipase; 10,000 USP units of protease; 14,000 units of amylase two-piece hypromellose capsule with white opaque cap and white body with a red radial print and printed with “APTALIS 3” Bottles of 100 73562-113-01 5,000 USP units of lipase; 17,000 USP units of protease; 24,000 units of amylase two-piece hypromellose capsule with a white opaque cap and white body with a blue radial print and printed with “APTALIS 5” Bottles of 100 73562-115-01 10,000 USP units of lipase; 32,000 units of protease; 42,000 units of amylase two-piece hypromellose capsule with a yellow opaque cap and white body with a blue radial print and printed with “APTALIS 10” Bottles of 100 73562-110-01 15,000 USP units of lipase; 47,000 units of protease; 63,000 units of amylase two-piece hypromellose capsule with a red opaque cap and white body with a blue radial print and printed with “APTALIS 15” Bottles of 100 73562-111-01 20,000 USP units of lipase; 63,000 units of protease; 84,000 units of amylase two-piece hypromellose capsule with a green opaque cap and white body with a blue radial print and printed with “APTALIS 20” Bottles of 100 73562-112-01 25,000 USP units of lipase; 79,000 units of protease; 105,000 units of amylase two-piece hypromellose capsule with a blue opaque cap and white body with a blue radial print and printed with “APTALIS 25” Bottles of 100 73562-116-01 40,000 USP units of lipase; 126,000 units of protease; 168,000 units of amylase two-piece hypromellose capsule with an orange opaque cap and white body with a blue radial print and printed with “APTALIS 40” Bottles of 100 73562-114-01 60,000 USP units of lipase; 189,600 units of protease; 252,600 units of amylase two-piece hypromellose capsule with powder blue opaque cap with two black stripes and white body with a black radial print and printed with “APTALIS 60 ” Bottles of 100 73562-117-01 Storage and Handling Original container: Store at room temperature, 20°C to 25°C (68°F to 77°F) and protect from moisture. Brief excursions permitted to 15°C to 40°C (59°F to104°F) for 24 hours. After opening, keep bottle tightly closed between uses to protect from moisture. Repackaged HDPE container : Dispense in tight container (USP). Store at up to 30°C (86°F) for up to 6 months and protect from moisture. Brief excursions permitted to 15°C to 40°C (59°F to 104°F) for up to 30 days. Protect from moisture. After opening, keep bottle tightly closed between uses to protect from moisture. Zenpep is dispensed in bottles containing a desiccant.

Autorisasjon status:

Biologic Licensing Application

Informasjon til brukeren

Aimmune Therapeutics, Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
ZENPEP® (ZEN-pep)
(pancrelipase)
delayed-release capsules, for oral use
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
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 ZENPEP exactly as prescribed by your doctor. Do not take more
ZENPEP than directed by your
doctor.
What is ZENPEP?
•
ZENPEP is a prescription medicine used to treat people who cannot
digest food normally because
their pancreas does not make enough enzymes.
•
ZENPEP contains a mixture of digestive enzymes including lipases,
proteases, and amylases from
pig pancreas.
•
ZENPEP is safe and effective in adults and children.
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, 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

Preparatomtale

ZENPEP- PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE
AMYLASE CAPSULE, DELAYED RELEASE
AIMMUNE THERAPEUTICS, INC.
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
INDICATIONS AND USAGE
ZENPEP
is indicated for the treatment of exocrine pancreatic insufficiency in
adult and pediatric patients.
(1)
DOSAGE AND ADMINISTRATION
Important Dosing Information (2.1)
•
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Recommended Dosage (2.2)
_Adult and Pediatric Patients Greater than 12 Months_: The recommended
initial starting dosage is:
○ 500 lipase units/kg/meal for adult and pediatric patients 4 years
of age and older.
○ 1,000 lipase units/kg/meal for pediatric patients greater than 12
months of age to less than 4
years of age.
•
_Pediatric Patients Birth to 12 Months_: The recommended dosage is
3,000 lipase units (one capsule) per
120 mL of formula or per breastfeeding.
Preparation and Administration Instructions (2.3)
•
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DOSAGE FORMS AND STRENGTHS
Delayed-Release Capsules (3):
•
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®
®
ZENPEP 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 in adult and pediatric patients greater than 12 months of
age without further
investigation. (5.1)
The total daily dosage in adult and pediatric patients greater than 12
months of age 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 ZENPEP