For the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions

Flexibility in dosing and delivery options

The first and only FDA-approved PERT for gastrostomy tube (G-tube) administration with the contents of the 4,000 USP lipase units capsule

See G-tube administration instructions below

Dosage strengths1

Each PERTZYE® (pancrelipase) capsule contains enteric-coated pancreatic enzymes. Dose by lipase units.

 

Lipase

Protease

Amylase

Bicarbonate buffer*

Administration

PERTZYE (pancrelipase) has 4 dosing strengths

4,000
USP units

14,375
USP units

15,125
USP units

0.625 mEq
(0.625 mmol)

Oral or
G-tube

PERTZYE (pancrelipase) has 4 dosing strengths

8,000
USP units

28,750
USP units

30,250
USP units

1.25 mEq
(1.25 mmol)

Oral

PERTZYE (pancrelipase) has 4 dosing strengths

16,000
USP units

57,500
USP units

60,500
USP units

2.5 mEq
(2.5 mmol)

Oral

PERTZYE (pancrelipase) has 4 dosing strengths

24,000
USP units

86,250
USP units

90,750
USP units

3.75 mEq
(3.75 mmol)

Oral

*The PERTZYE formulation also contains other inactive ingredients.
Capsule illustrations are not actual size and do not represent exact color.

Infants up to 12 months old1

  • Infants may be given 4,000 USP lipase units (one capsule) per 120 mL of formula or per breastfeeding
    • Do not mix PERTZYE capsule contents directly into formula or breast milk prior to administration

Children older than 12 months and younger than 4 years1

  • Begin enzyme dosing with 1,000 USP lipase units/kg body weight per meal
  • Maximum of 2,500 USP lipase units/kg body weight per meal
    • ≤10,000 USP lipase units/kg body weight per day or < 4,000 USP lipase units/g fat ingested per day

Children 4 years and older and adults1

  • Begin enzyme dosing with 500 USP lipase units/kg body weight per meal
  • Maximum of 2,500 USP lipase units/kg body weight per meal
    • ≤10,000 USP lipase units/kg body weight per day or < 4,000 USP lipase units/g fat ingested per day

How to administer the contents of the 4,000 USP lipase units of PERTZYE via a G-tube1

  • G-tube administration should only be performed with the contents of one or two 4,000 USP lipase unit capsules
  • The contents of no more than two of the 4,000 USP lipase unit capsules may be administered at a time
  • Administer with soft foods with a pH of 4.0 or less (e.g., applesauce) via a G-tube with a diameter of 14 French or larger
Review step-by-step instructions for G-tube administration
         
1. Transfer a minimum of 10 mL of applesauce into a small bowl or medicine cup.
2. Carefully open one or two PERTZYE 4,000 lipase unit capsules.
3. Mix the capsule contents thoroughly with the transferred applesauce to create a uniform suspension. Once mixed, administer the suspension immediately. Care should be taken not to crush the enzyme microspheres. Discard the empty capsules.
4. Remove the plunger from a 35-mL slip tip syringe. Cover the tip of the syringe with your finger. Transfer the PERTZYE-applesauce mixture into the syringe. Replace the plunger partially back into the syringe.
5. Shake or tap the syringe lightly with the syringe tip facing upward so that the PERTZYE-applesauce mixture will move towards the plunger. Carefully push the plunger slowly until the residual air is removed from the syringe tip.
6. Once the residual air is removed, connect the syringe directly into the G-tube feeding port.
7. Push the syringe contents into the G-tube feeding port using steady pressure until empty.
8. Draw up approximately 10 mL of water with the slip tip syringe and flush the G-tube feeding port with the water.
9. Discard any unused portion of the PERTZYE-applesauce mixture. Do not save for later use.
10. If dose requires more than two capsules, repeat steps 1–9 until prescribed dose is reached.

For use with the contents of the 4,000 USP liapse units capsule.


Limitations on dosing

  • Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines

Important Safety Information

Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PERTZYE exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day).

To avoid irritation of oral mucosa, do not chew PERTZYE or retain in the mouth.

Hyperuricemia may develop. Consider monitoring uric acid levels in patients with hyperuricemia, gout, or renal impairment.

There is theoretical risk of viral transmission with all pancreatic enzyme products including PERTZYE.

Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

Most common adverse reactions (≥ 10%) are: diarrhea, dyspepsia, and cough.

Indication

PERTZYE® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Please click here for Full Prescribing Information and Medication Guide.



Reference: 1. PERTZYE (pancrelipase) Prescribing Information. Digestive Care, Inc., Bethlehem, PA: July 2017.