Pancrelipase (pan-kre-LYE-pase)

Treats patients who cannot digest food normally because their pancreas does not make enough enzymes.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Delayed Release Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Swallow the capsule or tablet whole with enough fluid (including water or juice) to prevent irritation of the mouth. Do not crush or chew it.
• If your child is unable to swallow the Creon® capsule whole:
  • Mixing with acidic soft food:
    • Open the capsule and sprinkle the entire contents onto small amount of soft food (including applesauce, bananas, or plain Greek yogurt. Mix the contents evenly. Do not crush the capsule contents while mixing.
    • Give the mixture right away. Do not store for later use.
    • Give your child plenty of water or juice to completely swallow the mixture.
    • Give your baby enough formula or breastfeed right away to completely swallow the mixture.
  • Giving directly into child's mouth before breast or formula feeding:
    • Open the capsule and sprinkle the entire contents directly into the child's mouth. Do not mix the contents of the capsule directly into a bottle of breast milk or formula.
    • Give your baby enough formula or breastfeed right away to completely swallow the contents of the capsule.
• If your child is unable to swallow the Pancreaze® capsule whole:
  • Mixing with acidic soft food:
    • Open the capsule and sprinkle the entire contents onto small amount of baby food applesauce. Mix the contents evenly. Do not crush the capsule contents while mixing.
    • Give the mixture right away. Do not store for later use.
    • Give your child plenty of water or juice to completely swallow the mixture.
    • Give your baby enough formula or breastfeed right away to completely swallow the mixture.
  • Giving directly into child's mouth before breast or formula feeding:
    • Open the capsule and sprinkle the entire contents directly into the child's mouth. Do not mix the contents of the capsule directly into a bottle of breast milk or formula.
    • Give your baby enough formula or breastfeed right away to completely swallow the mixture.
• If your child is unable to swallow the Pertzye® capsule whole:
  • Mixing with acidic soft food:
    • Place about 2 teaspoons of applesauce into a clean container. Grasp and slightly squeeze both ends of the capsule and then twist and pull it apart. Pour the contents onto the applesauce. Mix the contents evenly. Do not crush the capsule contents while mixing.
    • Give the mixture right away. Do not store for later use.
    • Give your child plenty of water or juice to completely swallow the mixture.
    • Give your baby 4 ounces (120 mL) of formula or breastfeed right away to completely swallow the mixture.
  • Giving directly into child's mouth before breast or formula feeding:
    • Grasp and slightly squeeze both ends of the capsule and then twist and pull it apart. Sprinkle the contents directly into the child's mouth. Do not mix the contents of the capsule directly into a bottle of breast milk or formula.
    • Give your baby 4 ounces (120 mL) of formula or breastfeed right away to completely swallow the mixture.
  • You may also give this medicine through a gastrostomy tube:
    • Place at least 2 teaspoons of applesauce into a clean container. Open 1 or 2 capsules, depending on your dose, by grasping and slightly squeezing both ends of the capsule and then twist and pull it apart. Pour the contents onto the applesauce. Mix the contents evenly. Do not crush the capsule contents while mixing.
    • Remove the plunger from a 35 mL slip tip syringe. Cover the tip of the syringe with your finger.
    • Carefully spoon the mixture into the slip tip syringe. Replace the plunger partially back into the slip tip syringe. Turn it so the syringe tip is facing upward. Remove your finger from the tip of the slip tip syringe.
    • Gently shake or tap the syringe to move the mixture down toward the plunger.
    • Push up slowly on the plunger until the mixture fills the syringe tip. Connect the slip tip syringe into the gastrotomy tube feeding port. Press on the plunger using steady pressure to push all of the mixture into the tube for 10 to 12 seconds.
    • Flush the tube with 10 mL of water.
• If your child is unable to swallow the Zenpep® capsule whole:
  • Mixing with acidic soft food:
    • Open the capsule and sprinkle the entire contents onto small amount of acidic soft food (including applesauce, bananas, or pears). Mix the contents evenly. Do not crush the capsule contents while mixing.
    • Give the mixture right away. Do not store for later use.
    • Give your child plenty of water or juice to completely swallow the mixture.
    • Give your baby enough formula or breastfeed right away to swallow the mixture.
  • Giving directly into child's mouth before breast or formula feeding:
    • Open the capsule and sprinkle the entire contents directly into the child's mouth. Do not mix the contents of the capsule directly into a bottle of breast milk or formula.
    • Give your baby enough formula or breastfeed right away to completely swallow the mixture.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and take your next dose at your usual time. Do not take 2 doses at the same time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not eat or throw away the drying agent (desiccant) in your medicine bottle. The drying agent will protect your medicine from moisture.
• You may store repacked Zenpep® for up to 6 months.
• Throw away unused Pertzye® mixture.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, gout, high uric acid in the blood or urine, lactose intolerant, severe pancreas disease, or a history of bowel problems. Tell your doctor if you have trouble swallowing capsules.
• This medicine may cause the following problems:
  • Fibrosing colonopathy (serious bowel disorder), especially if taken at a high dose for a long time in children with cystic fibrosis
  • High uric acid levels (hyperuricemia)
• This medicine is made from the pancreas of pigs. Some pig's organs have transmitted certain viruses to people who have received them, although the risk is low. All are tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Diarrhea, nausea, vomiting, decreased appetite, stomach pain or upset
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Shaking, trembling, sweating, fast or pounding heartbeat, faintness or lightheadedness, hunger, confusion
• Unusual bruising

If you notice these less serious side effects, talk with your doctor:

• Headache
• Joint pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088