Products

    Nutramigen® with EnfloraLGG®*

    Hypoallergenic formula with extensively hydrolyzed protein and LGG probiotic for infants with food allergies including cow’s milk allergy

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

    Indication

    Nutramigen with Enflora LGG is a 20 Cal/fl oz, iron-fortified, lactose-free, hypoallergenic infant formula designed for infants who have food allergies including cow’s milk allergy. 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.

    Product 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.

    Ingredients

    Ingredients: Corn syrup solids (47%), vegetable oil (palm olein, coconut, soy and high oleic sunflower oils) (26%), casein hydrolysate (milk) (17%)††, modified corn starch (4%) and less than 2%: Mortierella alpina oil‡‡, Schizochytrium sp. 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 K1, biotin, vitamin B12, 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 (DHA).

    |||| 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.

    Nutrients

    (Normal Dilution)

    Per 100 Calories (5 fl oz)

    Per 100 mL

    Per 100 grams Powder (500 Cal)

    Protein, g

    2.8

    1.89

    14

    Fat, g

    5.3

    3.6

    27

    Linoleic acid, mg

    780

    530

    3900

    Carbohydrate, g

    10.3

    7

    52

    Water, g

    131

    89

    2.3

    Vitamins/Other Nutrients

         

    Vitamin A, IU

    300

    200

    1500

    Vitamin D, IU

    60

    41

    300

    Vitamin E, IU

    2

    1.35

    10

    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

    1.5

    Niacin, mcg

    1000

    680

    5000

    Folic acid (Folacin), mcg

    16

    10.8

    80

    Pantothenic acid, mcg

    500

    340

    2500

    Biotin, mcg

    3

    2

    15

    Vitamin C (Ascorbic acid), mg

    12

    8.1

    60

    Choline, mg

    24

    16.2

    120

    Inositol, mg

    24

    16.2

    120

    Minerals

         

    Calcium, mg

    94

    64

    470

    Phosphorus, mg

    52

    35

    260

    Magnesium, mg

    8

    5.4

    40

    Iron, mg

    1.8

    1.22

    9

    Zinc, mg

    1

    0.68

    5

    Manganese, mcg

    25

    16.9

    125

    Copper, mcg

    75

    51

    380

    Iodine, mcg

    15

    10.1

    75

    Selenium, mcg

    2.8

    1.89

    14

    Sodium, mg

    47

    32

    240

    Potassium, mg

    110

    74

    550

    Chloride, mg

    86

    58

    430

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

    Nutrient Density

    20 Calories/fl oz

    Protein (% Calories)

    11

    Fat (% Calories)

    48

    Carbohydrate (% Calories)

    41

    Potential Renal Solute Load (mOsm/100 Calories)15

    25

    Potential Renal Solute Load (mOsm/100 mL)15

    16.9

    Osmolality (mOsm/kg water)

    300

    Osmolarity (mOsm/L)

    270

    Lactose-free

    Yes

    AMINO ACID COMPOSITION

    ESSENTIAL AMINO ACIDS

    mg/100 Cal

    mg/100 g Pwd

    Histidine

    84

    420

    Isoleucine

    162

    810

    Leucine

    270

    1370

    Lysine

    240

    1180

    Methionine

    73

    360

    Cysteine

    48

    240

    Phenylalanine

    137

    690

    Tyrosine

    59

    290

    Threonine

    129

    640

    Tryptophan

    46

    230

    Valine

    200

    1010

    NONESSENTIAL AMINO ACIDS

    mg/100 kcal

    mg/100 g Pwd

    Arginine

    148

    740

    Alanine

    270

    1350

    Aspartic Acid

    560

    2800

    Glutamic Acid

    168

    830

    Glycine

    73

    360

    Proline

    280

    1390

    Serine

    171

    850

    Product Forms and Ordering Information

    NUTRAMIGEN LGG IS AVAILABLE IN POWDER

    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

    Nutramigen® with Enflora LGG®, Powder
    Item #: 897301
    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

    Nutramigen® with Enflora LGG®, Powder
    Item #: 897302
    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

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

    PRODUCT BENEFITS

    Nutramigen LGG provides fast relief today* and fewer allergies tomorrow

    Fast on colic due to cow’s milk allergy (CMA)

    • Starts to manage as early as the first feeding, with ~90% of infants improving within 48 hours‡1

    Fast on GI health

    • 0% occult blood in stool after 4 weeks of feeding2

    Fast return to milk protein

    • Helps infants consume milk protein without an allergic reaction in as little as 6 months of feeding3

    Nutramigen LGG is the only formula with a published study showing the reduction in the incidence of allergic manifestations like asthma and eczema†,4

    Additional product features:

    • Hypoallergenic protein source (extensively hydrolyzed casein)
    • Nutramigen with Enflora LGG works fast and is clinically proven to:
      • Start to manage colic due to cow's milk allergy in as early as the first feeding, with 90% of infants improving within 48 hours1,†
      • Result in 0% blood in stool after 4 weeks of feeding2
      • Help infants consume milk protein without an allergic response in as early as 6 months of feeding3
    • Helps reduce the likelihood of other allergic manifestations at 3 years of age4,‡
    • Contains the probiotic brand LGG:
      • LGG promotes a healthy GI and immune system by supporting a balanced immune response, colonizing the infant's gut to support a healthy microflora and promoting normal gut barrier function
    • DHA and ARA to support brain and eye development5-12
      • DHA at the clinically proven§ amount of 0.32% of total fatty acids, the same amount as the worldwide breast milk average13,||, and double the amount found in the leading competitor's product
    • Nutramigen protein clinically researched in over 75 studies
    • Lactose-free
    • Has no sucrose# as a carbohydrate source
    • No artificial growth hormones**

    Some studies were prior to the addition of DHA, ARA and LGG.
    Rhinoconjunctivitis, urticaria, eczema and asthma at 3 years compared to Nutramigen without LGG. Feeding began at 4 months or older in the study.
    § Studies compared infants fed Enfamil® with DHA and ARA vs. discontinued Enfamil without DHA and ARA; studied before the addition of prebiotics.
    || Average amount of DHA in worldwide breast milk is 0.32% ± 0.22% (mean ± standard deviation of total fatty acids) based on an analysis of 65 studies of 2,474 women13.
    Nutramigen with Enflora LGG has not been shown superior to the leading competitor in promoting brain and eye development. The level of DHA in Similac Pro-Advance™ is ~0.15% of total fatty acids.
    # When hereditary fructose intolerance is a concern.
    ** No significant difference has been shown between milk derived from rbST-treated and non-rbST-treated cows.

    A deeper look at how Nutramigen LGG can change outcomes for infants with food allergies

    Infants with food allergies are up to 4x more likely to exhibit other allergies as they grow4

    In a study evaluating the occurrence of allergic manifestations in babies with CMA, 46% experienced eczema, hives, asthma, and nasal allergies at a 3-year follow-up.*4

    ACTIVE MANAGEMENT OF CMA POSITIVELY IMPACTS THE ALLERGIC MARCH

    Watch to gain a deeper understanding of CMA, the allergic march, and how active management with Nutramigen LGG can change outcomes for infants with food allergies.

    Clinical study

    OCCURRENCE OF OTHER ALLERGIC MANIFESTATIONS IN CHILDREN WITH CMA

    COW'S MILK ALLERGY INDICATIONS

    *Published study showing fewer incidences of asthma, rhinoconjunctivitis, urticaria, and eczema at 3 years in infants with CMA compared to Nutramigen without LGG. Feeding began at 4 months of age or older in the study.

    The latest food allergy research

    Review the prevalence and impact of CMA, and the research Mead Johnson has supported to manage food allergies for infants and young children.

    Nutramigen LGG works fast to supports GI health2

    0% occult blood in stool after 4 weeks of feeding*

    Infants fed Nutramigen LGG also experienced significantly larger decreases in fecal calprotectin, a marker of gut inflammation, than those fed an extensively hydrolyzed formula without LGG.*2

    Clinical study

    LGG IMPROVES RECOVERY IN INFANTS WITH BLOOD IN THE STOOL

    *Compared to Nutramigen without LGG

    Proven to help more CMA babies consume milk proteins*

    After 6 months of feeding Nutramigen LGG, 59% of infants could consume cow’s milk protein without an allergic response*3

    Clinical study

    EFFECT OF LGG ON TOLERANCE ACQUISITION IN INFANTS WITH CMA

    Significantly more infants could consume cow’s milk protein after 1 year of feeding Nutramigen LGG*14

    79% of infants of infants could consume cow’s milk protein without an allergic response

    *Compared to other formulas used in the study. Formulas included: extensively hydrolyzed casein: Nutramigen and Nutribén hydrolyzed®; rice hydrolysate: Risolac®; soy: Isomil®, Sinelac®, Nutrilon Soya®; amino acid: Neocate®, Nutramigen AA®, Sineall®.

    Clinical study

    FORMULA INFLUENCES RATE OF ACQUISITION OF TOLERANCE FOR INFANTS WITH CMA

    Canani R et al. The Journal of Pediatrics. 2013;163(3):771-777.

    HELPING INFANTS WITH COW'S MILK ALLERGY BUILD TOLERANCE

    Watch a clinical presentation and commentary by Dr. Michael Hart, a professor of pediatrics on managing cow’s milk protein allergy and helping infants and toddlers build tolerance to cow's milk protein.

    LETTER OF MEDICAL NECESSITY FOR NUTRAMIGEN

    This letter establishes a medical need for Nutramigen and might help parents get reimbursed by their insurance company for the product.

    Layout:
    A solution for severe CMA
    Infants with severe CMA may benefit from an amino acid-based formula. PurAmino™ is made for infants with food protein allergies, severe CMA...
    Nutramigen LGG is Women, Infant and Children Program®* approved in all 50 states
    Access your state’s medical documentation form to help your WIC infants and toddlers receive the formula they need.
    Additional products for cow’s milk allergy
    Mead Johnson has a complete portfolio for infants and toddlers with CMA and food allergies.

    *WIC is a registered trademark of the United States Department of Agriculture (USDA) for the
    Women, Infants, & Children Program. No endorsement of any brand or product by the USDA is implied
    or intended.

    Contact Mead Johnson

    Contact a Mead Johnson representative to request information and samples

    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.
    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.
    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.