TM Owner Aimmune Therapeutics, Inc. (Nestle)
Zenpep 25000 USP Delayed-release capsule
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Indications & Clinical Uses
- Zenpep 25000 USP delayed-release capsules each contain 25,000 USP units of lipase with 79,000 units of protease and 105,000 units of amylase.
- Pancrelipase is a porcine-derived pancreatic enzyme replacement that helps digest fat, protein and starch.
- In the US it is indicated for the treatment of exocrine pancreatic insufficiency (the pancreas does not release enough digestive enzymes) in adults and children.
- Zenpep comes in eight strengths from 3,000 to 60,000 USP units of lipase, so check the strength on the bottle and take the number of capsules your healthcare provider prescribes; dosing is calculated per kilogram of body weight.
- The current US label is held by Aimmune Therapeutics, a Nestle company, rather than the Allergan/AbbVie named on the sheet.
- The label carries no boxed warning.
Side Effects
- In a small clinical study (34 patients aged 7 to 23 years), the most frequent effects were headache (15%), bruising, cough and early feeling of fullness (6% each).
- In young children aged 1 to 6 years, abdominal pain and fatty stools were the most common.
- After marketing, reports include fibrosing colonopathy (narrowing of the colon, linked to high doses, mostly in children with cystic fibrosis), distal intestinal obstruction syndrome, various stomach and bowel symptoms, allergic reactions including anaphylaxis, asthma, hives, itching and rash, muscle pain or spasm, blurred vision and raised liver enzymes.
- The label has no boxed warning.
- Tell your healthcare provider about new or worsening abdominal symptoms, and seek urgent help for signs of a severe allergic reaction.
Precautions & Warnings
- The label lists no contraindications.
- Take Zenpep with meals or snacks.
- The usual starting dose is 500 lipase units/kg per meal in patients aged 4 and over, or 1,000 units/kg per meal from 12 months to under 4 years; do not exceed 2,500 units/kg per meal, 10,000 units/kg per day or 4,000 units per gram of fat eaten daily.
- Doses above 6,000 units/kg per meal have been linked to colon strictures in children under 12.
- Swallow capsules whole; never crush or chew them, as this can irritate the mouth.
- If swallowing is difficult, the contents may be sprinkled on a little acidic soft food (pH 4.5 or lower) such as applesauce, banana or pear.
- High doses may raise uric acid, so tell your provider if you have gout or kidney problems.
- Pork allergy is a concern, and porcine viruses cannot be fully excluded.
- Pregnancy data show no identified risk; systemic absorption is minimal.
- Store at 20°C to 25°C, protected from moisture.
Avoid Interactions
- Increase risk or effect: the label states that interactions mediated by CYP enzymes or transporters are not expected, and lists no specific interacting drugs.
- Reduce efficacy: crushing or chewing the capsules, or mixing the contents with foods that are not acidic (pH above 4.5), can damage the protective coating and reduce effectiveness.
- Keep the desiccant packet in the bottle and close the bottle tightly after each use.
- Tell your healthcare provider about all prescription and over-the-counter medicines, other enzyme products, and supplements you use, and do not switch between pancreatic enzyme brands or strengths without their advice.
References
Frequently Asked Questions
Zenpep (pancrelipase) replaces digestive enzymes in adults and children whose pancreas does not make enough, a condition called exocrine pancreatic insufficiency. The capsules help you digest fat, protein and starch from food. Zenpep 25000 contains 25,000 USP units of lipase per capsule.
Take Zenpep (pancrelipase) with meals or snacks, swallowing the capsules whole with enough liquid. Do not crush or chew them. If you cannot swallow capsules, sprinkle the contents on a little applesauce, banana or pear. Your provider sets the dose per kilogram, up to 2,500 lipase units/kg per meal.
Zenpep (pancrelipase) side effects in studies included headache, bruising, cough and early fullness, plus abdominal pain and fatty stools in young children. Rarely it causes fibrosing colonopathy (bowel narrowing) at high doses or serious allergic reactions. Report new or worsening stomach symptoms. It has no boxed warning.
Do not crush or chew Zenpep (pancrelipase) capsules or their contents, as this can irritate the mouth and reduce effectiveness. Mix sprinkled contents only with acidic soft foods (pH 4.5 or lower). Avoid it if you have a known allergy to pork proteins, and do not exceed the dose your provider sets.
If you miss a dose of Zenpep (pancrelipase), take your next dose with the next meal or snack, as the label directs. Do not double up. Because the capsules work only while food is being digested, you do not normally take them between meals.
Yes. Zenpep (pancrelipase) is approved for children, including toddlers from 12 months, with starting doses of 1,000 lipase units/kg per meal under age 4 and 500 units/kg from age 4. Doses above 6,000 units/kg per meal have been linked to colon strictures in children under 12.
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