EPI Due to CF
Don’t let patients with EPI due to cystic fibrosis fall through the cracks
About EPI in Patients With CF
Looking for information about EPI in patients without CF?
Up to 90% of patients diagnosed with CF have EPI.1
Early diagnosis and proper treatment can improve nutrient absorption and symptoms2
Left untreated, EPI can compromise a growing child in many ways3
- Malabsorption leading to vitamin and nutrient deficiencies
- Impaired height and weight
Symptoms of EPI develop when ~90% of
exocrine
function is lost2
Symptoms of EPI include3-5
Steatorrhea
Diarrhea
Malaise
Nausea
Frequent stools
Excessive flatulence
Bloating
Abdominal pain
Effective management of EPI
depends
on6:
- Pancreatic enzyme replacement therapy, such as ZENPEP
- Dietary modifications
- Regular nutritional assessment as a component of routine care
The Cystic Fibrosis Foundation states that patients with laboratory evidence of EPI should be started on PERT even in the absence of signs of fat malabsorption.7
Dosing in EPI Patients With CF
Looking for dosing in patients without CF?Flexible dosing for your
growing patients
Only ZENPEP offers 8 dosage strengths, which allows you to customize your treatment as needed and minimize pill burden8
Capsules not actual size.
- Do not substitute other pancreatic enzyme products for ZENPEP
- ZENPEP capsules and capsule contents should not be crushed or chewed
- ZENPEP should be taken with every meal and snack. Usually, half of the prescribed dose for an individualized full meal should be given with each snack
- Therapy should be initiated at the lowest recommended dosage and individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet
Remember to titrate as
your patients grow and
their needs change.8
Flexible Administration
ZENPEP capsules can be carefully opened and the contents mixed into soft acidic foods (eg, applesauce) for infants and those who are unable to swallow capsules whole.8
Dosing Calculator for ZENPEP
Use the app to calculate the per-meal dose of ZENPEP for your patients with EPI.
Do not substitute other pancreatic enzyme products for ZENPEP. Start at the lowest recommended dosage and individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.
DISCLAIMER: By using this dosing calculator, you agree to the following: The dosing calculator is being provided “AS IS” and is intended for healthcare professional (HCP) use only. The dosing calculator is to be used only in conjunction with ZENPEP (pancrelipase) delayed-release capsules. All calculations should be confirmed before use. The information being provided is not a substitute for clinical judgment. While the tool attempts to be as accurate as possible, it should not be relied upon as being comprehensive and error-free. Neither Nestlé Health Science, nor any party involved in the publication of this site, shall be liable to you or others for any decisions made or actions taken by you or others in reliance of this information. The user assumes all responsibility and risk for the use of this tool.
Safety
12-Month Safety Data of ZENPEP and Growth
Parameter Data in Infants With
CF9*
View additional safety information
Treatment-Related Adverse Events
(Primary Endpoint)
| Safety Population (n=15) | Relation to Study Treatment† | |
|---|---|---|
| Possible n (%) | Probable n (%) | |
| Any treatment-emergent adverse event | 4 (27%) | 1 (7%) |
| Gastrointestinal disorders | 4 (27%) | 1 (7%) |
| Diarrhea | 3 (20%) | 0 |
| Vomiting | 1 (7%) | 1 (7%) |
| Steatorrhea | 1 (7%) | 0 |
| Abnormal feces | 1 (7%) | 0 |
| Constipation | 1 (7%) | 1 (7%) |
| Abdominal distension | 1 (7%) | 0 |
| Flatulence | 1 (7%) | 0 |
| Metabolism and nutrition disorders | 2 (13%) | 0 |
| Decreased appetite | 1 (7%) | 0 |
| Poor weight gain | 1 (7%) | 0 |
Growth Curve Percentiles
(Secondary Endpoint)
- * A 12-month, open-label, follow-on study to gather data on the long-term safety of ZENPEP and to track growth parameters in infants 1 to 12 months of age with CF (N=15). The primary endpoints were the frequency, duration, and severity of treatment-emergent adverse events during long-term treatment with ZENPEP. The secondary endpoints were the effects of the long-term treatment with ZENPEP on growth parameters, including weight, length, weight-for-age percentile, length-for-age percentile, weight-for-length percentile, and z scores. The dose of ZENPEP was adjusted during the study to accommodate weight gain; ZENPEP capsules were opened, and the contents were mixed with a small amount of apple juice or applesauce and administered orally. Infants up to 12 months of age received 2,000 to 4,000 lipase U/120 mL of formula or per breast-feeding.
- † The table presents the number of distinct patients with possible or probable AEs. The study also captured unrelated AEs (not shown).
- AE=adverse event.
CF Coverage & Support
Looking for Coverage & Support for EPI patients without CF?
The Nestlé Health Science Cystic Fibrosis Pancreatic Enzyme Support Program offers eligible patients:
- Discounted out-of-pocket costs, as low as $0 per ZENPEP prescription fill‡
- Free nutritional supplements and vitamins delivered monthly§∥
- Age-specific educational content
- Interactive support
- ‡ This offer is valid only for ZENPEP prescriptions. Eligible patients may pay as low as $0 per ZENPEP 30-day prescription fill; up to 12 fills. Check with pharmacist for copay discount. Maximum savings limit applies; patient out-of-pocket expense may vary. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Please see CF Patient Support Program Terms, Conditions, and Eligibility Criteria at www.ZENPEPCFProgram.com.
- § These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
- ∥ Vitamins should be taken as directed on label or otherwise directed by a physician. Actual product, packaging, and materials may vary and are subject to substitution or replacement at any time. Always read labels, warnings, and directions before using or consuming a product.
ZENPEP insurance coverage is ~94% for patients with commercial insurance or Medicare Part D.** And 85% of those patients have no prior authorization or step edit requirements10,11
Insurance coverage is the same for all dosage strengths
- ¶ Analysis of MMIT coverage data includes commercial, Medicare, Medicaid, and health insurance exchange lives with coverage status of "covered" or better. Coverage data are based on publicly available plan-level data and may not reflect individual patient eligibility.
- ** Data are not a guarantee of coverage, or partial or full payment, by any payers listed. Actual benefits determined by respective plan administrators. Insurer plans, coverage criteria, and formularies are subject to change without notice. Check each patient's coverage with applicable insurer. Nestlé Health Science does not endorse any individual plans. Formulary coverage does not imply efficacy or safety.
