These highlights do not include all the information you need to use ZENPEP safely and effectively. See complete prescribing information for ZENPEP. ZENPEP® (pangrelipase) delayed-release capsules. Initial approval in the US: 2009 (2023)

Pharmacy GUIDE
delayed release capsules

Read this Medication Guide before you start taking ZENPEP and every time you get a refill. There may be new information. This information is not a substitute for talking with your doctor about your medical condition or treatment.

What is the most important information I should know about ZENPEP?

ZENPEP may make you more likely to get a rare bowel disease called fibrotic colonopathy. This condition is serious and may require surgery. The risk of developing this condition can be reduced by following the dosage instructions provided by your doctor.Call your doctor right away if you haveunusual or serious:

Pain in the stomach (abdominal) region.
Difficulty defecating (with bowel movements)
Nausea, vomiting or diarrhea

Take ZENPEP exactly as prescribed.Chorustake more or less ZENPEP than your doctor tells you to.

What is ZENPEP?

ZENPEP is a medication prescribed for people who cannot digest food normally because their pancreas does not produce enough enzymes. ZENPEP can help your body use fats, proteins and sugars from food.
ZENPEP contains a blend of digestive enzymes including lipases, proteases and amylases from porcine pancreas.
ZENPEP is safe and effective for children.

What should I tell my doctor before taking ZENPEP?

Before taking ZENPEP, tell your doctor about all of your medical conditions, including if you:

are allergic to pork products.
you have a history of bowel obstruction or scarring or thickening of the bowel wall (fibrous colonic disease)
you have gout, kidney disease, or high uric acid in your blood (hyperukaemia)
you have difficulty swallowing the capsules
have any other medical condition
you are pregnant or planning to become pregnant
are breastfeeding or planning to breastfeed. It is not known whether ZENPEP passes into breast milk. Talk to your doctor about the best way to feed your baby if you are taking ZENPEP.

Tell your doctor about all medications you take, including prescription and over-the-counter drugs, vitamins, and dietary or herbal supplements.

Know the medication you are taking. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take ZENPEP?

Take ZENPEP exactly as your doctor has told you.
Do not take more capsules per day than the amount prescribed by your doctor. (total daily dose).
Always take ZENPEP with a meal or snack. If you have several meals or snacks a day, be careful not to exceed your total daily intake.
Do not crush or chew ZENPEP capsules or their contents and do not hold the capsule or its contents in your mouth.Crushing, chewing, or holding ZENPEP capsules in your mouth can cause irritation in your mouth or change the way ZENPEP works in your body.

Administration of ZENPEP to children and adults

Swallow the ZENPEP capsules whole and take them with enough liquid to swallow them immediately.
If you have difficulty swallowing the capsules, open them and sprinkle the spheres on a small amount of acidic foods, such as applesauce, mashed bananas or pears. Ask your doctor about other foods you can mix with ZENPEP.
If you sprinkle ZENPEP on food, swallow it immediately after mixing. Do not store ZENPEP mixed with food.
Swallow ZENPEP and the food mixture immediately afterwards with water or juice. Make sure the medicine is swallowed completely.
If you forget to take ZENPEP, contact your doctor or wait until your next meal and take the usual amount of capsules.Do not take missed doses.Take the next dose at the usual time.

Administration of ZENPEP to Infants(children up to 12 months):

Administer ZENPEP immediately before each feeding of formula or breast milk.
Do not mix the contents of the ZENPEP capsule directly into formula or breast milk.
Open the capsule and sprinkle the contents over a small amount of applesauce, mashed banana or pear. These foods should be those found in jars of store-bought baby food or other foods recommended by your doctor. You can also spray the contents directly into your child's mouth.
If you sprinkle ZENPEP on food, give ZENPEP and the food mixture to your child immediately.
Give your child enough liquid to completely swallow the contents of ZENPEP or the mixture of ZENPEP and food.
Look into your child's mouth to make sure all of the medicine has been swallowed.

What are the possible side effects of ZENPEP?

ZENPEP can cause serious side effects, including:

I see"What is the most important information I should know about ZENPEP?"
Worsening of swollen and painful joints (gout) caused by increased levels of uric acid in the blood
allergic reactionsincluding breathing problems, rash or swollen lips.

Call your doctor right away if you have any of these symptoms.

The most common ZENPEP side effects include;

pain in your abdomen

Other possible side effects

ZENPEP and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs that humans eat pork. These pigs can transmit viruses. Although it has never been reported, it may be possible for a person to contract a viral infection from consuming porcine pancreatic enzyme products.

Tell your doctor if you have any side effects that bother you or do not go away.

These are not all possible side effects of ZENPEP. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You can report side effects to the FDA by calling 1-800-FDA-1088.

You may also report side effects to Nestlé HealthCare Nutrition at 1-833-920-2178.

How should I store ZENPEP?

Store ZENPEP at room temperature (68º to 77ºF, 20º to 25ºC). Avoid the heat.
After opening the bottle, keep it tightly closed between doses.
DO NOT eat or throw away the packet (desiccant) from the medicine bottle. This package will protect your medicine from moisture.
Store ZENPEP in a dry place.

Keep ZENPEP and all medicines out of the reach of children.

General information about ZENPEP

Medications are sometimes prescribed for purposes other than those listed in a medication guide. Do not use ZENPEP for a condition for which it was not prescribed. Do not give ZENPEP to other people, even if they have the same symptoms as you. It can hurt them.

This medication guide summarizes the most important information about ZENPEP. If you want more information, talk to your doctor. You can ask your pharmacist or doctor for information about ZENPEP intended for healthcare professionals. For more information, visit or call 1-833-920-2178.

What are the ingredients in ZENPEP?

Active ingredient:lipase, protease, amilase

Inactive Ingredients:colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc and triethyl citrate in hypromellose capsules.

Red radial print on capsule with 3000 strength Contains, DC 1510 Antifoam, Industrial Methylated Alcohol, Iron Oxide Red C.I. 77491-E172, n-butyl alcohol, shellac and soy lecithin.

Blue radial print on 5,000, 10,000, 15,000, 20,000, 25,000 and 40,000 capsule strengths contains dehydrated alcohol, FD&C Blue #2 C.I. 73015-E132 aluminum lake, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac and strong ammonia solution.

Capsule Ingredients:

3,000 USP Units and 5,000 USP Units of Lipase contain Carnauba Wax or Talc, Carrageenan, Hypromellose, Potassium Chloride, Titanium Oxide, and Water.
10,000 Lipase USP Units contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water, and yellow iron oxide.
15,000 USP units of lipase contain carnauba wax or talc, carrageenan, hypromellose potassium chloride, red iron oxide, titanium oxide and water.
20,000 Lipase USP Units contains Carnauba Wax or Talc, Carrageenan, FD&C Blue #2, Hypromellose, Potassium Chloride, Titanium Oxide, Water, and Yellow Iron Oxide.
25,000 USP Units of Lipase contains carnauba wax or talc, carrageenan, hypromellose FD&C Blue #2, potassium chloride, titanium oxide and water.
40,000 Lipase USP Units contain FD&C Yellow #6, hypromellose, titanium oxide and water.

Distributed by:
Nestlé HealthCare Nutrition, Inc.
Bridgewater, Nova Jersey 08807

For more information, call Nestlé HealthCare Nutrition at 1-833-920-2178.

©2020 Nestlé

All trademarks are owned by Société des Produits Nestlé S.A., Vevey, Switzerland or used under license.


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