How to take PERTZYE® (pancrelipase)
A treatment for EPI due to cystic fibrosis that offers flexibility in dosing and delivery options
To help you start and stay on PERTZYE from infancy to adulthood, PERTZYE offers flexibility in dosing options for managing EPI due to CF.
Capsule illustrations are not actual size and do not represent exact color.
- Standard oral administration
- FDA-approved gastrostomy tube (G‑tube) administration for the contents of the 4,000 USP lipase units capsule
Dosing instructions for infants up to 12 months old
One dosing strength option: 4,000 USP lipase units per 120 mL of formula or per breastfeeding. It’s important to give your baby PERTZYE right before each feeding of formula or breast milk!
Instructions for dosing
- Open the capsule and mix the contents with a soft, acidic food (for example, applesauce)
- Contents of the capsule may also be given directly to your baby’s mouth
- Always give your baby breast milk or formula right after you give them their medicine
- Look inside your baby’s mouth to see if all of the contents of the capsule have been swallowed
- Make sure the contents of the capsule are not crushed, chewed, or retained in the mouth
Important do’s and don’ts
- Do check the inside of your baby’s mouth to ensure they have swallowed all the medicine
- Do not crush or chew the PERTZYE capsule or microspheres
- Do not mix PERTZYE with breast milk or formula, or administer from a bottle
- Do not save or store extra PERTZYE/applesauce mixture
- Do not change the dose without talking to your CF dietitian or doctor
Soft, acidic foods like applesauce help the medicine work where it’s supposed to. This way, the enzymes won’t be released too early or irritate the mouth.
Dosing instructions for children (older than 12 months) and adults
Four dosing strength options: 4,000, 8,000, 16,000, and 24,000 USP lipase units capsules. Dosing is based on your age, body weight, and diet. Take PERTZYE capsules exactly as your doctor tells you. Read the Medication Guide for instructions on how to take PERTZYE if you have trouble swallowing capsules.
- You should not switch PERTZYE with any other pancreatic enzyme product without first talking with your doctor
- Don’t take more capsules in a day than the number your doctor tells you to take (total daily enzyme dose)
- If you eat a lot of meals or snacks in a day, be careful not to go over your total daily enzyme dose
- PERTZYE capsules should be swallowed whole. Crushing, chewing, or holding the capsules in your mouth may cause irritation in your mouth or change the way PERTZYE works in your body
- Do not crush or chew the PERTZYE capsules or their contents, and do not hold the capsule contents in your mouth
Always take PERTZYE with a meal or snack and plenty of fluid.
How to give the contents of the 4,000 USP lipase units capsule of PERTZYE through a gastrostomy tube (G-tube)
PERTZYE 4,000 lipase units capsule contents may be given through a G-tube that is size 14 French or larger. Do not give PERTZYE through a G-tube smaller than size 14 French.
- Do not give more than the contents of 2 PERTZYE 4,000 lipase units capsules through a G-tube at a time
- Give the PERTZYE capsule contents-food mixture right away after it is prepared
- Place at least 2 teaspoons of applesauce, or other food recommended by your doctor, into a clean container.
- 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.
- Carefully mix the capsule contents evenly through the food. Be careful not to crush the PERTZYE capsule contents when mixing.
- Remove the plunger from a 35 mL slip tip syringe. Cover the tip of the syringe with your finger.
- Carefully spoon the PERTZYE capsule contents-food mixture into the slip tip syringe.
- Replace the plunger partially back into the slip tip syringe.
- Turn the slip tip syringe so the syringe tip is facing upward. Remove your finger from the tip of the slip tip syringe.
- Gently shake or tap the slip tip syringe so that the PERTZYE capsule contents-food mixture moves down towards the plunger.
- Carefully push up slowly on the plunger until the PERTZYE capsule contents-food mixture fills the syringe tip.
- Connect the slip tip syringe directly into the G-tube feeding port.
- Press on the plunger of the slip tip syringe using steady pressure to push all of the PERTZYE capsule contents-food mixture into the G-tube feeding port over 10 seconds to 12 seconds.
- Flush the gastrostomy feeding port tube with about 10 mL of water.
- 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.
*For use with the contents of the 4,000 USP lipase units capsule.
PERTZYE® (pancrelipase) may increase the risk of having a rare bowel disorder called fibrosing colonopathy, especially if taken at a high dose in children with cystic fibrosis who are less than 12 years of age. This condition is serious and may require surgery. The risk of having fibrosing colonopathy 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 stools (constipation), nausea, vomiting, or diarrhea.
Take PERTZYE capsules exactly as your doctor tells you. You should not switch PERTZYE with any other pancreatic enzyme product without first talking with your doctor. Don’t take more capsules in a day than the number your doctor tells you to take (total daily dose). Always take PERTZYE with a meal or snack and plenty of fluid. If you eat a lot of meals or snacks in a day, be careful not to go over your total daily enzyme dose. 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. Read the Medication Guide for instructions on how to take PERTZYE if you have trouble swallowing capsules.
The most common side effects of PERTZYE include diarrhea, upset stomach (indigestion), and cough. Other potential serious side effects are irritation of the inside of your mouth; increase in blood uric acid levels, which may cause worsening of swollen, painful joints (gout); and allergic reactions, including trouble swallowing or breathing, skin rash, itching, or swelling of your face, eyes, lips, tongue, or throat. Call your doctor right away if you have any of these symptoms.
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, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your doctor about all the medicines you take.
PERTZYE and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.
PERTZYE is a prescription medicine used to treat people who can’t digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions.
PERTZYE capsules contain a mixture of digestive enzymes, including lipases, proteases, and amylases, from pig pancreas. PERTZYE is safe and effective in children and adults when taken as prescribed by your doctor.
Click here to read the Full Prescribing Information and Medication Guide before you start taking PERTZYE. You should also read the insert that comes with each prescription refill because there may be new information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.