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For the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF)PERTZYE® (pancrelipase) dosing and administration

Each delayed-release capsule contains enteric-coated pancreatic enzymes1

Lipase
Dose by lipase units
4,000
USP Units
8,000
USP Units
16,000
USP Units
24,000
USP Units
Protease 14,375
USP Units
28,750
USP Units
57,500
USP Units
86,250
USP Units
Amylase 15,125
USP Units
30,250
USP Units
60,500
USP Units
90,750
USP Units
Bicarbonate
Buffer
0.625 mEq
(0.625 mmol)
1.25 mEq
(1.25 mmol)
2.5 mEq
(2.5 mmol)
3.75 mEq
(3.75 mmol)

How to dose PERTZYE1

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 unit capsule of PERTZYE via a gastrostomy tube (G-tube)

Gastrostomy tube administration1
  • Gastrostomy 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 gastrostomy tube with a diameter of 14 French or larger

Gastrostomy tube administration instructions1

  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 gastrostomy tube feeding port.
  7. Push the syringe contents into the gastrostomy tube feeding port using steady pressure until empty.
  8. Draw up approximately 10 mL of water with the slip tip syringe and flush the gastrostomy 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.
Download and print patient-friendly Instructions of use with G-tube and contents of the 4,000 USP lipase unit capsule.
Limitations on dosing
  • Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines