What updates were made to Pepticate?
The key updates include:
– An updated nutrient profile
– A change to the product codes
– Updated label design
– The net weight of each can is now 375 g of powder. This new fill amount makes approximately 86 fl oz per can which increases the monthly allocation under the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
Pepticate continues to be a nutritionally complete, hypoallergenic extensively hydrolyzed infant formula for use under medical supervision and is indicated for the dietary management of cow milk allergy.
Why was Pepticate updated?
Pepticate was initially introduced to the United States (US) to help increase the availability of specialized formulas to those in need. Nutricia has modified the Pepticate formulation not only to meet the US Food & Drug Administration’s (FDA) nutrient and labeling requirements, but to also optimize the formulation to best serve our consumers. Pepticate was and continues to be a safe, nutritionally complete, hypoallergenic extensively hydrolyzed infant formula for the dietary management of cow milk allergy.
Will the updated Pepticate be hypoallergenic?
Yes, Pepticate remains a nutritionally complete, hypoallergenic extensively hydrolyzed infant formula which consists of free amino acids and short-chain peptides as the source of protein. It has been shown to be hypoallergenic in a clinical trial. The clinical trial by Giampietro et al demonstrated that Pepticate was well tolerated (i.e. did not elicit an allergic reaction) in 97% of infants with proven cow milk allergy (CMA).¹ In addition, Pepticate has been shown to be well tolerated in other Pepticate trials investigating infants with CMA.¹,²
Exactly what nutrients were updated?
You’ll notice most of the nutrient levels have been updated. Please visit our website to see the updated nutrient profile.
Have any of the ingredients changed?
While some of the ingredients and amounts have changed, all ingredients in Pepticate meet the US Food & Drug Administration’s (FDA) requirements for permitted use in infant formulas as well as our own strict internal standards. Pepticate remains a nutritionally complete, hypoallergenic extensively hydrolyzed infant formula.
Please visit our website to see the updated ingredient list.
Will my patient tolerate the new update?
The updated Pepticate remains a nutritionally complete, hypoallergenic extensively hydrolyzed infant formula. The hypoallergenicity of Pepticate has been established according to the American Academy of Pediatrics’ (AAP) criteria. In one clinical study, Pepticate was well tolerated (i.e., did not elicit an allergic reaction) in 97% of subjects with proven cow milk allergy.1
Can I use my previous scoop for the updated Pepticate formula?
No, the scoops are NOT interchangeable. Only use the scoop provided in the can to ensure accurate mixing.
The scoop found in the current Pepticate is yellow and has a scoop weight of 4.5 g. The updated formula will have a pink scoop and will have a scoop weight of 4.8 g.
Have the mixing instructions changed?
The 1:1 mixing ratio (1 unpacked, level scoop to 1 fl oz of water) remains the same.
Here are the mixing instructions for the updated Pepticate:
1. Wash hands thoroughly and clean the preparation area.
2. To make the standard dilution (20 calories/fl oz), add 1 unpacked, level scoop (4.8 g) of powder to each 1 fl oz of water.
3. Cap bottle; shake well until powder dissolves. Freshly prepared formula is best. Once feeding begins, use within 1 hour or discard. Only if necessary, refrigerate freshly prepared formula between 35-40°F (2-4°C) and use within 24 hours.
Why did the amount of powder in the can decrease?
The total gram weight per can now results in a reconstituted volume of approximately 86 fl oz per can. With this change, infants receiving Pepticate through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) will receive an increase in the total volume of formula per month. The price per can has decreased to account for the decrease in the amount of powder per can.
When will the previous version no longer be available?
We anticipate the previous Pepticate formulation to be available until May 2024 or until supplies last.
Will the product codes be the same as the previous formulation?
No, the product codes have been updated. Please refer to the below table for the updated codes.
Pepticate Update | |
Product Code (Case) | 199359 |
Product Code (Can) | 197602 |
UPC – Case | 749735101025 |
UPC – Unit | 749735001011 |
HCPCS Category | B4161 |
How can I tell if my patients have the updated Pepticate?
Along with the updated formula, the Pepticate label will have a new look which will distinguish between the current formula and the updated formula.
Where can my patients find Pepticate?
Pepticate is readily available. Please see below for ways in which Pepticate can be obtained.
In addition to the retailers listed below, you can also use our “Where to Buy” page to find Pepticate near you.
Pepticate may be covered under WIC (Special Supplemental Nutrition Program for Women, Infants, and Children) or SNAP (Supplemental Nutrition Assistance Program). It may also be available through National & Regional Home Health Care & Durable Medical Equipment (DME).
Will I need to write a new order for the updated Pepticate?
Possibly. Orders will need to be updated if written as the number of cans. Orders will NOT need to be updated if written as volume (e.g., fl oz).
For patients who are receiving Pepticate through a durable medical equipment (DME) company or home healthcare company (HHC) where an order has number of cans per month versus volume (e.g. fl oz) per day or month, you may need to send an updated order to the DME or HHC due to the reconstituted fluid ounces per can changing. Patients will most likely require more cans per month to meet their recommended nutrient intake levels.
WIC is a registered service mark of the U.S. Department of Agriculture for USDA’s Special Supplemental Nutrition Program for Women, Infants, and Children.
References:
1. Giampietro PG, Kjellman NI, Oldaeus G, et al. Hypoallergenicity of an extensively hydrolyzed whey formula. Pediatr Allergy Immunol. 2001;12:83-6.
2. Abrahamse-Berkeveld M, Alles M, Franke-Beckmann E, et al. Infant formula containing galacto-and fructo-oligosaccharides and Bifidobacterium breve M-16V supports adequate growth and tolerance in healthy infants in a randomised, controlled, double-blind, prospective, multicentre study. J Nutr Sci. 2016;5:e42.