PERTZYE- pancrelipase 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 AMYLASE (UNII: YOJ58O116E) (PANCRELIPASE AMYLASE - UNII:YOJ58O116E), PANCRELIPASE PROTEASE (UNII: 3560D81V50) (PANCRELIPASE PROTEASE - UNII:3560D81V50)

Available from:

Digestive Care, Inc.

INN (International Name):

PANCRELIPASE LIPASE

Composition:

PANCRELIPASE LIPASE 8000 [USP'U]

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PERTZYE® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. 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 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 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 PERTZYE and any potential adverse effects on the breastfed infant from PERTZYE or from the underlying maternal condition. The safety and effectiveness of PERTZYE for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of PERTZYE for this indication is supported by a randomized, double-blind, placebo-controlled, crossover study of 24 pediatric patients, 8 years and older with exocrine pancreatic insufficiency due to cystic fibrosis. The safety in pediatric patients was 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 PERTZYE 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 (2.1) and Warnings and Precautions (5.1)] . Crushing or chewing PERTZYE 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 PERTZYE 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. INSTRUCTIONS FOR USE PERTZYE (pert-zye) (pancrelipase) delayed-release capsules This Instructions for Use contains information on how to give PERTZYE by mouth and through a gastrostomy tube. Important Information You Need to Know Before Taking PERTZYE: - Always take PERTZYE with a meal or snack. - PERTZYE capsules should be swallowed whole. Do not crush or chew the PERTZYE capsules or their contents, and do not hold the capsule or capsule contents in your mouth. - Drink plenty of liquid to ensure complete swallowing of PERTZYE capsules or PERTZYE capsule contents-food mixture. - Throw away the PERTZYE capsule contents-food mixture that is not used. Do not save this mixture for later use. Giving PERTZYE to infants (Children from Birth to 12 Months of Age) by mouth: The two methods to give PERTZYE to Infants (Children from Birth to 12 Months of Age) are described below: a) Giving with Applesauce Before Breast or Formula Feeding - Place about 2 teaspoons of applesauce, the kind found in baby food jars that you buy at the store, or other food recommended by your doctor, into a clean container. - Carefully open the PERTZYE capsule by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart. Pour the capsule contents onto the food in the clean container. Throw away the empty PERTZYE capsule. - Carefully mix the capsule contents evenly through the food. Be careful not to crush the PERTZYE capsule contents when mixing. - Give the PERTZYE capsule contents-food mixture to your infant right away. - Give your infant 4 ounces (120 mL) of formula or breastfeed your infant right away . - Look in your infant's mouth to make sure that all of the medicine is swallowed and there is no PERTZYE capsule contents-food mixture left in your infant's mouth. b) Giving Directly into the Infant's Mouth Before Breast or Formula Feeding - Carefully open the PERTZYE capsule by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart. Empty the capsule contents into your infant's mouth. - Give your infant 4 ounces (120 mL) of formula or breastfeed right away. - Look in your infant's mouth to make sure that all of the medicine is swallowed and there is no PERTZYE capsule contents left in your infant's mouth. - Throw away the empty PERTZYE capsule. Do not mix the PERTZYE capsule contents directly into a bottle of breast milk or formula. Giving PERTZYE to children and adults by mouth: - Swallow PERTZYE capsules whole and take them with enough liquid to swallow them right away. - If you have trouble swallowing capsules, follow these instructions for taking PERTZYE with food: Place about 2 teaspoons of applesauce, or other food recommended by your doctor, into a clean container. Carefully open the capsules that you will need for the prescribed dose by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart. Pour the capsule contents onto the food in the clean container. Throw away the empty PERTZYE capsules. Carefully mix the capsule contents evenly through the food. Be careful not to crush the PERTZYE capsule contents when mixing. Swallow all of the PERTZYE capsule contents-food mixture right away. Drink plenty of water or juice to make sure that all of the medicine is swallowed and there is no PERTZYE capsule contents-food mixture left in the mouth. - Place about 2 teaspoons of applesauce, or other food recommended by your doctor, into a clean container. - Carefully open the capsules that you will need for the prescribed dose by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart. Pour the capsule contents onto the food in the clean container. - Throw away the empty PERTZYE capsules. - Carefully mix the capsule contents evenly through the food. Be careful not to crush the PERTZYE capsule contents when mixing. - Swallow all of the PERTZYE capsule contents-food mixture right away. - Drink plenty of water or juice to make sure that all of the medicine is swallowed and there is no PERTZYE capsule contents-food mixture left in the mouth. Giving PERTZYE through a gastrostomy tube: - PERTZYE 4,000 lipase units capsule contents may be given through a gastrostomy tube that is size 14 French or larger. Do not give PERTZYE through a gastrostomy tube smaller than size 14 French. - Do not give more than the contents of 2 PERTZYE 4,000 lipase units capsules through a gastrostomy tube at a time. - Give the PERTZYE capsule contents-food mixture right away after it is prepared. 1. Place at least 2 teaspoons of applesauce, or other food recommended by your doctor, into a clean container. 2. Carefully open 1 or 2 of the PERTZYE capsules, depending on your prescribed dose, by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart. Pour the capsule contents onto the food in the clean container. Throw away the empty PERTZYE capsules (See Figure A ).      Figure A 3. Carefully mix the capsule contents evenly through the food. Be careful not to crush the PERTZYE capsule contents when mixing. 4. Remove the plunger from a 35 mL slip tip syringe. Cover the tip of the syringe with your finger. 5. Carefully spoon the PERTZYE capsule contents-food mixture into the slip tip syringe (See Figure B ).      Figure B 6. Replace the plunger partially back into the slip tip syringe. 7. Turn the slip tip syringe so the syringe tip is facing upward. Remove your finger from the tip of the slip tip syringe. 8. Gently shake or tap the slip tip syringe so that the PERTZYE capsule contents-food mixture moves down towards the plunger. 9. Carefully push up slowly on the plunger until the PERTZYE capsule contents-food mixture fills the syringe tip (See Figure C ).      Figure C 10. Connect the slip tip syringe directly into the gastrostomy tube feeding port. 11. Press on the plunger of the slip tip syringe using steady pressure to push all of the PERTZYE capsule contents-food mixture into the gastrostomy tube feeding port over 10 seconds to 12 seconds (See Figure D ).      Figure D 12. Flush the gastrostomy tube feeding port with about 10 mL of water. 13. If your prescribed dose is more than 2 capsules of PERTZYE, repeat steps 1 through 12, using only 1 or 2 PERTZYE capsules at a time, until the prescribed dose is given. Storing PERTZYE: - Store PERTZYE at room temperature between 68ºF to 77ºF (20°C to 25°C). - Keep PERTZYE in a dry place and in the original container or equivalent airtight container. - After opening the bottle, keep it tightly closed between uses to keep your medicine dry (protect it from moisture). - The PERTZYE bottle contains a desiccant packet to help keep your medicine dry. Do not eat or throw away the desiccant packet in your medicine bottle. Keep PERTZYE and all medicines out of the reach of children. Manufactured by: Digestive Care, Inc. 1120 Win Drive Bethlehem, PA 18017 U.S. License No. 2184 Product of USA © 2024 Digestive Care, Inc. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 02/2024

Product summary:

PERTZYE (pancrelipase) delayed-release capsules, containing light tan/cream-colored delayed-release microspheres are supplied as follows: Storage and Handling

Authorization status:

Biologic Licensing Application

Patient Information leaflet

PERTZYE- PANCRELIPASE CAPSULE, DELAYED RELEASE
Digestive Care, Inc.
----------
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Revised: 02/2024
MEDICATION GUIDE
PERTZYE (pert-zye)
(pancrelipase)
delayed-release capsules
What is the most important information I should know about PERTZYE?
PERTZYE may increase the risk 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 gives you.
Call your doctor right away if you have any unusual or severe:
•
stomach area (abdominal) pain
•
bloating
•
trouble passing stool (constipation)
•
nausea
•
vomiting
•
diarrhea
Take PERTZYE exactly as prescribed by your doctor. Do not take more
PERTZYE than directed by
your doctor.
What is PERTZYE?
•
PERTZYE is a prescription medicine used to treat people who cannot
digest food normally
because their pancreas does not make enough enzymes.
•
PERTZYE capsules contain a mixture of digestive enzymes including
lipases, proteases and
amylases from pig pancreas.
•
PERTZYE is safe and effective in adults and children.
Before taking PERTZYE, tell your doctor about all of 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 PERTZYE
passes into your breast milk.
Talk to your doctor about the best way to feed your baby if you take
PERTZYE.
Tell your doctor about all the medicines you take, including
prescription and over-the-counter medicines,
vitamins, and

Summary of Product characteristics

PERTZYE- PANCRELIPASE CAPSULE, DELAYED RELEASE
DIGESTIVE CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PERTZYE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PERTZYE.
PERTZYE (PANCRELIPASE) DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
PERTZYE is indicated for the treatment of exocrine pancreatic
insufficiency in adult and pediatric patients.
(1)
DOSAGE AND ADMINISTRATION
Important Dosing Information (2.1)
PERTZYE 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 PERTZYE. When
switching from another
pancreatic enzyme product to PERTZYE, monitor patients for clinical
symptoms of exocrine pancreatic
insufficiency and titrate the dosage as needed.
Recommended Dosage (2.2)
_Adults 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 to less than 4 years of age.
Titrate the dosage to either 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 to be effective by fecal
fat mea