Zenpep 24000 [USP'U]/1
pancrelipase lipase, pancrelipase protease, pancrelipase amylase · CAPSULE, DELAYED RELEASE · Aimmune Therapeutics, Inc.
Zenpep is a capsule, delayed release containing pancrelipase lipase, pancrelipase protease, pancrelipase amylase at 24000 [USP'U]/1, taken oral. Manufactured by Aimmune Therapeutics, Inc..
Key Facts
- Brand Name
- Zenpep
- Generic Name
- pancrelipase lipase, pancrelipase protease, pancrelipase amylase
- NDC Code (Product)
73562-115- Manufacturer
- Aimmune Therapeutics, Inc.
- Strength
- 24000 [USP'U]/1
- Dosage Form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- BLA022210
- Marketing Start
- 01/01/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ZENPEP ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ZENPEP ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Important Dosing Information ( 2.1 ) ZENPEP is a mixture of enzymes including lipases, proteases, and amylases and dosing is based on lipase units. Dosing scheme based on actual body weight or fat ingestion. Individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation. ( 5.1 ) The total daily dosage in adult and pediatric patients greater than 12 months of age should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed dose for a meal. Do not substitute other pancreatic enzyme products for ZENPEP. When switching from another pancreatic enzyme product to ZENPEP, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed. Recommended Dosage ( 2.2 ) Adult and Pediatric Patients Greater than 12 Months : The recommended initial starting dosage is: 500 lipase units/kg/meal for …
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Fibrosing Colonopathy [see Warnings and Precautions (5.1) ] Irritation of the Oral Mucosa [see Warnings and Precautions (5.2) ] Hyperuricemia [see Warnings and Precautions (5.3) ] Risk of Viral Transmission [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥6%) are: headache, contusion, cough, and early satiety. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics, Inc at 1-833-AIM2KNO (1-833-246-2566) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to ZENPEP in 53 adult and pediatric patients with exocrine pancreatic insufficiency due to cystic fibrosis in two clinical trials conducted [see Clinical Studies (…
Frequently Asked Questions
What is Zenpep used for?
Zenpep contains pancrelipase lipase, pancrelipase protease, pancrelipase amylase. It is a capsule, delayed release taken oral. Consult your doctor for specific uses.
Is Zenpep a controlled substance?
Zenpep is not classified as a controlled substance by the DEA.
What is the generic name for Zenpep?
The generic name for Zenpep is pancrelipase lipase, pancrelipase protease, pancrelipase amylase. There are no other listed brand versions of pancrelipase lipase, pancrelipase protease, pancrelipase amylase.
What is the NDC code for Zenpep 24000 [USP'U]/1?
The NDC (National Drug Code) for Zenpep 24000 [USP'U]/1 is 73562-115, listed by Aimmune Therapeutics, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)