PERTZYE (Page 6 of 6)

INSTRUCTIONS FOR USE

Important information:

Always take PERTZYE with a meal or snack and plenty of fluid.

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.

Throw away the PERTZYE capsule contents-food mixture that is not used. Do not save this mixture for later use.

Giving PERTZYE to infants (up to 12 months of age) by mouth:

Give the contents of 1 PERTZYE capsule right before each feeding of formula or breast milk.

Do not mix PERTZYE capsule contents directly into formula or breast milk.

PERTZYE capsule contents may be given directly into your infant’s mouth or mixed with food.

Giving PERTZYE capsule contents directly into your infant’s mouth:

1. 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.

2. Give your infant 4 ounces (120 mL) of formula or breastfeed right away.

3. 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.

4. Throw away the empty PERTZYE capsule.

Giving PERTZYE capsule contents mixed in food:

1. 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.

2. 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.

3. Carefully mix the capsule contents evenly through the food. Be careful not to crush the PERTZYE capsule contents when mixing.

4. Give the PERTZYE capsule contents-food mixture to your infant right away.

5. Give your infant 4 ounces (120 mL) of formula or breastfeed your infant right away.

6. 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.

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.

3. Carefully mix the capsule contents evenly through the food. Be careful not to crush the PERTZYE capsule contents when mixing.

4. Swallow all of the PERTZYE capsule contents-food mixture right away.

5. 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).

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).

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).

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).

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.

How should I store 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 air tight 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.

This Medication Guide and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: March 2020

Manufactured in the USA by:

Digestive Care, Inc.

Bethlehem, PA 18017

© 2019 Digestive Care, Inc.

PERTZYE pancrelipase capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59767-008 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 8000 [USP’U] PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 30250 [USP’U] PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 28750 [USP’U]

Product Characteristics Color blue (Clear capsule shell with blue band) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code DCI;8 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59767-008-01 1 BOTTLE in 1 CARTON contains a BOTTLE 1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59767-008-01) 2 NDC:59767-008-02 1 BOTTLE in 1 CARTON contains a BOTTLE 2 250 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59767-008-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA022175 05/17/2012

PERTZYE pancrelipase capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59767-004 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 4000 [USP’U] PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 15125 [USP’U] PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 14375 [USP’U]

Product Characteristics Color green (Clear capsule shell with green band) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code DCI;4 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59767-004-01 1 BOTTLE in 1 CARTON contains a BOTTLE 1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59767-004-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA022175 10/06/2016

PERTZYE pancrelipase capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59767-016 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 16000 [USP’U] PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 60500 [USP’U] PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 57500 [USP’U]

Product Characteristics Color red (Clear capsule shell with red band) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code DCI;16 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59767-016-01 1 BOTTLE in 1 CARTON contains a BOTTLE 1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59767-016-01) 2 NDC:59767-016-02 1 BOTTLE in 1 CARTON contains a BOTTLE 2 250 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59767-016-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA022175 05/17/2012

PERTZYE pancrelipase capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59767-024 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 24000 [USP’U] PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 90750 [USP’U] PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 86250 [USP’U]

Product Characteristics Color purple (Clear capsule shell with purple band) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code DCI;24 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59767-024-01 1 BOTTLE in 1 CARTON contains a BOTTLE 1 80 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59767-024-01) 2 NDC:59767-024-02 1 BOTTLE in 1 CARTON contains a BOTTLE 2 250 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59767-024-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA022175 05/17/2012

Labeler — Digestive Care, Inc. (831065214)

Establishment
Name	Address	ID/FEI	Operations
Digestive Care, Inc.		831065214	manufacture (59767-008), manufacture (59767-016), manufacture (59767-004), manufacture (59767-024)

Revised: 01/2022 Digestive Care, Inc.