Nutramigen® with Enflora LGG®*

For the dietary management of cow's milk allergy. * LGG is a registered trademark of Chr. Hansen A/S

Last Updated: Wednesday, December 13, 2017 - 19:00

Description/Indication

Nutramigen with Enflora LGG is a 20 Cal/fl oz, iron-fortified, lactose-free, hypoallergenic infant formula designed for infants who are allergic to the intact proteins in cow's milk and soy formulas. Nutramigen with Enflora LGG has extensively hydrolyzed casein protein to help avoid an immune system response by reducing the allergen exposure, and the probiotic branded LGG to help support the strength of the intestinal barrier and support digestive health.

Long-Term Usage

In cases of continued food allergies or intolerances, Nutramigen with Enflora LGG is sometimes used as a milk substitute in the diet of children beyond 12 months of age. When Nutramigen is used as a milk substitute beyond 12 months of age, the total calcium content of the diet should be assessed. Extended use of Nutramigen with Enflora LGG (or other infant formulas) as a sole source of diet is most appropriately monitored by physicians and nutritionists on a case-by-case basis.

Product Features:

  • Hypoallergenic and suitable for someone with lactose intolerance
  • Starts to manage colic in as early as the first feeding, with 90% of infants improving within 48 hours1,†,‡
  • Nutritionally complete
  • Result in 0% blood in stool after 4 weeks of feedings2
  • Contains the probiotic LGG to help support the strength of the intestinal barrier and support digestive health
  • Has DHA and ARA, important nutrients also found in breast milk, that promote brain and eye development3-10
  • Nutramigen protein clinically researched in over 70 studies
  • Helps babies consume milk protein without an allergic response, in as early as 6 months of feeding11-12
  • Proven to promote skin health in infants through 18 months of age13,†
  • Proven to promote gastrointestinal (GI) health within 1 week of use14,†

† Some studies were prior to the addition of DHA, ARA and LGG.
‡ When managing colic due to cow's milk allergy. Studied before the addition of DHA, ARA and LGG.

  • Nutrients
    • (Normal Dilution)

      Per 100 Calories (5 fl oz)

      Per 100 mL

      Per 100 grams Powder (510 Cal)

      Protein, g

      2.8

      1.89

      14.1

      Fat, g

      5.3

      3.6

      27

      Linoleic acid, mg

      860

      580

      4300

      Carbohydrate, g

      10.3

      7

      52

      Water, g

      131

      89

      2.3

      Vitamins/Other Nutrients

      Vitamin A, IU

      300

      200

      1520

      Vitamin D, IU

      50

      34

      250

      Vitamin E, IU

      2

      1.35

      10.1

      Vitamin K, mcg

      9

      6.1

      45

      Thiamin (Vitamin B1), mcg

      80

      54

      400

      Riboflavin (Vitamin B2), mcg

      90

      61

      450

      Vitamin B6, mcg

      60

      41

      300

      Vitamin B12, mcg

      0.3

      0.2

      1.52

      Niacin, mcg

      1000

      680

      5100

      Folic acid (Folacin), mcg

      16

      10.8

      81

      Pantothenic acid, mcg

      500

      340

      2500

      Biotin, mcg

      3

      2

      15.2

      Vitamin C (Ascorbic acid), mg

      12

      8.1

      61

      Choline, mg

      24

      16.2

      121

      Inositol, mg

      17

      11.5

      86

      Minerals

      Calcium, mg

      94

      64

      470

      Phosphorus, mg

      52

      35

      260

      Magnesium, mg

      8

      5.4

      40

      Iron, mg

      1.8

      1.22

      9.1

      Zinc, mg

      1

      0.68

      5.1

      Manganese, mcg

      25

      16.9

      126

      Copper, mcg

      75

      51

      380

      Iodine, mcg

      15

      10.1

      76

      Selenium, mcg

      2.8

      1.89

      14.1

      Sodium, mg

      47

      32

      240

      Potassium, mg

      110

      74

      560

      Chloride, mg

      86

      58

      430

      Product nutrient values and ingredients are subject to change. Please see product label for current information.

  • Nutrient Facts
    • Nutrient Density

      20 Calories/fl oz

      Protein (% Calories)

      11

      Fat (% Calories)

      48

      Carbohydrate (% Calories)

      41

      Potential Renal Solute Load (mOsm/100 Calories)14

      25

      Potential Renal Solute Load (mOsm/100 mL)14

      16.9

      Osmolality (mOsm/kg water)

      300

      Osmolarity (mOsm/L)

      270

      Lactose-free

      Yes

  • Product Forms

      Nutramigen® with Enflora LGG® is available in powder.

      When using this information, please note the following:

      Coding systems and reimbursement allowable rates vary by payer:

      • Medicare Part B uses HCPCS (Healthcare Common Procedure Coding System) to group products
      • Medicaid systems vary by state; some use HCPCS while others use NDC format code or systems of their own—contact your state provider for more information
      • Private health insurance and managed care companies may use HCPCS, NDC format code or their own system—contact your provider for more information

    • Product: Nutramigen® with Enflora LGG®*
      Item #: 123905
      Description: Powder
      Unit Size: 19.8 oz can
      Calories/Unit: 2780
      Product Yield/Unit (fl oz): 139
      Case: 4 cans per case
      HCPCS Code: B4161
      NDC Format Code: 00087-1239-45
    • Product: Nutramigenwith Enflora LGG
      Item #: 123901
      Description: Powder
      Unit Size: 12.6 oz can
      Calories/Unit: 1740
      Product Yield/Unit (fl oz): 87
      Case: 6 cans per case
      HCPCS Code: B4161
      NDC Format Code: 00087-1239-41
  • Composition
    • Ingredients: Corn syrup solids (48%), vegetable oil (palm olein, coconut, soy and high oleic sunflower oils) (26%), casein hydrolysate (milk) (16%)#, modified corn starch (4%) and less than 2%:Mortierella alpina oil**, Crypthecodinium cohnii oil††, Lactobacillus rhamnosus GG‡‡, calcium citrate, calcium phosphate, potassium chloride, potassium citrate, sodium citrate, calcium hydroxide, magnesium oxide, ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite, choline chloride, ascorbic acid, niacinamide, calcium pantothenate, vitamin D3, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, folic acid, vitamin K,, biotin, vitamin B2, inositol, vitamin A palmitate, vitamin E acetate, L-cystine, L- tyrosine, L-tryptophan, taurine, L-carnitine.

      # Modified to be better tolerated in milk-allergic babies.
      ** A source of arachidonic acid (ARA).
      †† A source of docosahexaenoic acid (DMA).
      ‡‡ Branded as LGG, a registered trademark of Chr. Hansen A/S

  • Potential Allergens
    • Nutramigen with Enflora LGG contains milk and soy. Nutramigen with Enflora LGG is hypoallergenic. Allergic reactions to extensively hydrolyzed casein formulas are not commonly reported.

  • Amino Acid Composition
    • ESSENTIAL AMINO ACIDS
      mg/100 Calmg/100 g Pwd
      Histidine84420
      Isoleucine162810
      Leucine2701370
      Lysine2401180
      Methionine73360
      Cysteine48240
      Phenylalanine137690
      Tyrosine59290
      Threonine129640
      Tryptophan46230
      Valine2001010
      NONESSENTIAL AMINO ACIDS
      mg/100 Calmg/100 g Pwd
      Arginine112560
      Alanine95480
      Aspartic Acid2101060
      Glutamic Acid6403200
      Glycine59290
      Proline2901470
      Serine162810
      Tyrosine59290
      Threonine129640
      Tryptophan46230
      Valine2001010
  • Preparation of Feedings
    • Powder

      The baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Proper hygiene, preparation, dilution, use and storage are important when preparing infant formula. Powdered infant formulas are not sterile and should not be fed to premature infants or infants who might have immune problems unless directed and supervised by a doctor. Discuss with parents which formula is appropriate for the baby.

      Discuss with parents whether they need to use cooled, boiled water for mixing and whether they need to boil clean utensils, bottles and nipples in water before use.

      WARNING: Do not use a microwave oven to warm formula. Serious burns may result.

      Refer to the product label for the most accurate information.

      Failure to follow these instructions could result in severe harm. Once prepared, infant formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 24 hours. Do not use prepared formula if it is unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use formula within 1 hour or discard.

      1. Wash hands thoroughly with soap and water before preparing formula.
      2. Pour the desired amount of water into the bottle. Add powder.
      3. Cap bottle and SHAKE WELL.

      Use the charts below for correct amounts of water and powder. Use scoop in can to measure powder. Store DRY scoop in its original can.

      Nutramigen with Enflora LGG

      To Make¶¶

      Water

      Powder

      Weight

      2 fl oz bottle

      2 fl oz

      1 PACKED level scoop

      9 g

      4 fl oz bottle

      4 fl oz

      2 PACKED level scoops

      18 g

      6 fl oz bottle

      6 fl oz

      3 PACKED level scoops

      27 g

      8 fl oz bottle

      8 fl oz

      4 PACKED level scoops

      36 g

      1 quart

      28.5 fl oz

      1 1/4 PACKED level household measuring cups

      128 g

      WARNING: Do not warm. Warming may limit benefits of LGG culture.

      * LGG® is a registered trademark of Chr. Hansen A/S.

      ¶¶ Each scoop adds about 0.2 fl oz to the amount of prepared formula.

  • References
      1. Lothe L, Lindberg T. Cow’s milk whey protein elicits symptoms of infantile colic in colicky formula-fed infants: a double-blind crossover study. Pediatrics. 1989;83:262-266.
      2. Baldassarre ME, Laforgia N, Fanelli M, et al. Lactobacillus GG improves recovery in infants with blood in the stools and presumptive allergic colitis compared with extensively hydrolyzed formula alone. J Pediatr. 2010;156:397-401.
      3. Berni Canani R, Nocerino R, Terrin G, et al. Effect of Lactobacillus GG on tolerance acquisition in infants with cow’s milk allergy: a randomized trial. J Allergy Clin Immunol. 2012;129:580-582, 582 e1-5.
      4. Berni Canani R, Di Costanzo M, Bedogni G, et al. Extensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG reduces the occurrence of other allergic manifestations in children with cow’s milk allergy: 3-year randomized controlled trial. J Allergy Clin Immunol. 2017;139:1906-1913-e4. doi: 10.1016/j.jaci.2016.10.050.
      5. Birch EE, Hoffman DR, Uauy R, et al. Visual acuity and the essentiality of docosahexaenoic acid and arachidonic acid in the diet of term infants. Pediatr Res. 1998;44:201-209.
      6. Birch EE, Garfield S, Hoffman DR, et al. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol. 2000;42:174-181.
      7. Birch EE, Hoffman DR, Castañeda YS, et al. A randomized controlled trial of long-chain polyunsaturated fatty acid supplementation of formula in term infants after weaning at 6 wk of age. Am J Clin Nutr. 2002;75:570-580.
      8. Hoffman DR, Birch EE, Castañeda YS, et al. Visual function in breast-fed term infants weaned to formula with or without long-chain polyunsaturates at 4 to 6 months: a randomized clinical trial. J Pediatr. 2003;142:669-677.
      9. Hoffman DR, Birch EE, Castañeda YS, et al. Maturation of visual and mental function in 18-month old infants receiving dietary long-chain polyunsaturated fatty acids (LCPUFAs) [abstract]. FASEB J. 2003;17:A727-A728. Abstract 445.1.
      10. Hoffman DR, Birch EE, Birch DG, et al. Impact of early dietary intake and blood lipid composition of long-chain polyunsaturated fatty acids on later visual development. J Pediatr Gastroenterol Nutr. 2000;31:540-553.
      11. Birch EE, Castañeda YS, Wheaton DH, et al. Visual maturation of term infants fed long-chain polyunsaturated fatty acid-supplemented or control formula for 12 mo. Am J Clin Nutr. 2005;81:871-879.
      12. Morale SE, Hoffman DR, Castañeda YS, et al. Duration of long-chain polyunsaturated fatty acids availability in the diet and visual acuity. Early Hum Dev. 2005;81:197-203.
      13. Brenna JT, Varamini B, Jensen RG, et al. Docosahexaenoic and arachidonic acid concentrations in human breast milk worldwide. Am J Clin Nutr. 2007;85:1457-1464.
      14. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.
  • Consumer Reviews
  • Letter of Medical Necessity for Nutramigen® with Enflora™ LGG®*

    Insurance companies are not required to cover exempt infant formula or medical foods, but some do. This letter establishes a medical need for the product and might help get your patients insurance company to reimburse them for the product.