Nutramigen® (Liquids)

For Cow’s Milk Allergy

Last Updated: Thursday, December 14, 2017 - 19:00

Description/Indication

Nutramigen is an iron-fortified, hypoallergenic infant formula designed for infants who are allergic to the intact proteins in cow’s milk and soy formulas. Nutramigen has extensively hydrolyzed protein and is proven effective for managing colic due to cow's milk allergy.

Long-Term Usage: Nutramigen is designed to provide a sole source of nutrition for infants up to age 6 months, and provide a major source of nutrition through 12 months of age. Normally, in feeding infants, gradual introduction of solid foods after 4–6 months of age is an important developmental as well as nutritional step.

In cases of continued food allergies or intolerances, Nutramigen 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 (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
  • Clinically proven to effectively manage colic due to cow's milk allergy in 48 hours1,2,*
  • Nutritionally complete
  • DHA and ARA, important nutrients also found in breast milk that promote brain and eye development3-10
  • Fatty acid profile patterned after breast milk11,12,†
  • Lactose-free


* Studied before the addition of DHA and ARA.

† Comparison based on fatty acid profile of typical mature U.S. breast milk.

  • Nutrients
    • (Normal Dilution)

      Per 100 Cal (5 fl oz) 2 fl oz RTU

      Per 100 Cal (5 fl oz) 6 fl oz RTU

      Per 100 Cal (5 fl oz) 8 fl oz RTU

      Per 100 Cal (5 fl oz) 13 fl oz Conc

      Per 100 Cal (5 fl oz) 32 fl oz

      Per 100 mL 2 fl oz RTU

      Per 100 mL 6 fl oz RTU

      Per 100 mL 8 fl oz RTU

      Per 100 mL 13 fl oz Conc

      Per 100 mL 32 fl oz

      Protein, g

      2.8

      2.8

      2.8

      2.8

      2.8

      1.89

      1.89

      1.89

      1.89

      1.89

      Fat, g

      5.3

      5.3

      5.3

      5.3

      5.3

      3.6

      3.6

      3.6

      3.6

      3.6

      Linoleic acid, mg

      860

      860

      860

      860

      780

      580

      580

      580

      580

      530

      Carbohydrate, g

      10.3

      10.3

      10.3

      10.3

      10.3

      7

      7

      7

      7

      7

      Water, g

      133

      133

      133

      133

      133

      90

      90

      90

      90

      90

      Vitamins/Other Nutrients

      Vitamin A, IU

      300

      300

      300

      300

      300

      200

      200

      200

      200

      200

      Vitamin D, IU

      50

      50

      50

      50

      50

      34

      34

      34

      34

      34

      Vitamin E, IU

      2

      2

      2

      2

      2

      1.35

      1.35

      1.35

      1.35

      1.35

      Vitamin K, mcg

      9

      9

      9

      9

      8

      6.1

      6.1

      6.1

      6.1

      5.4

      Thiamin (Vitamin B1), mcg

      80

      80

      80

      80

      80

      54

      54

      54

      54

      54

      Riboflavin (Vitamin B2), mcg

      90

      90

      90

      90

      90

      61

      61

      61

      61

      61

      Vitamin B6, mcg

      60

      60

      60

      60

      60

      41

      41

      41

      41

      41

      Vitamin B12, mcg

      0.3

      0.3

      0.3

      0.3

      0.3

      0.2

      0.2

      0.2

      0.2

      0.2

      Niacin, mcg

      1000

      1000

      1000

      1000

      1000

      680

      680

      680

      680

      680

      Folic acid (Folacin), mcg

      16

      16

      16

      16

      16

      10.8

      10.8

      10.8

      10.8

      10.8

      Pantothenic acid, mcg

      500

      500

      500

      500

      500

      340

      340

      340

      340

      340

      Biotin, mcg

      3

      3

      3

      3

      3

      2

      2

      2

      2

      2

      Vitamin C (Ascorbic acid), mg

      12

      12

      12

      12

      12

      8.1

      8.1

      8.1

      8.1

      8.1

      Choline, mg

      24

      24

      24

      24

      24

      16.2

      16.2

      16.2

      16.2

      16.2

      Inositol, mg

      17

      17

      17

      17

      17

      11.5

      11.5

      11.5

      11.5

      11.5

      Minerals

      Calcium, mg

      94

      94

      94

      94

      94

      64

      64

      64

      64

      64

      Phosphorus, mg

      52

      52

      52

      52

      52

      35

      35

      35

      35

      35

      Magnesium, mg

      8

      8

      8

      11

      8

      5.4

      5.4

      5.4

      7.4

      5.4

      Iron, mg

      1.8

      1.8

      1.8

      1.8

      1.8

      1.22

      1.22

      1.22

      1.22

      1.22

      Zinc, mg

      1

      1

      1

      1

      1

      0.68

      0.68

      0.68

      0.68

      0.68

      Manganese, mcg

      25

      25

      25

      25

      25

      16.9

      16.9

      16.9

      16.9

      16.9

      Copper, mcg

      75

      75

      75

      75

      75

      51

      51

      51

      51

      51

      Iodine, mcg

      15

      15

      15

      15

      15

      10.1

      10.1

      10.1

      10.1

      10.1

      Selenium, mcg

      2.8

      2.8

      2.8

      2.8

      2.8

      1.89

      1.89

      1.89

      1.89

      1.89

      Sodium, mg

      47

      47

      47

      47

      47

      32

      32

      32

      32

      32

      Potassium, mg

      110

      110

      110

      110

      110

      74

      74

      74

      74

      74

      Chloride, mg

      86

      86

      86

      86

      86

      58

      58

      58

      58

      5

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

  • Nutrient Facts
    • Nutrient Density

      20 Cal/fl oz 2 & 6 fl oz

      20 Cal/fl oz 13 fl oz

      20 Cal/fl oz 8 & 32 fl oz

      RTU

      Concentrate

      RTU

      Protein (% Calories)

      11

      11

      11

      Fat (% Calories)

      48

      48

      48

      Carbohydrate (% Calories)

      41

      41

      41

      Potential Renal Solute Load (mOsm/100 Calories)13

      25

      25

      25

      Potential Renal Solute Load (mOsm/100 mL)13

      16.9

      16.9

      16.9

      Osmolality (mOsm/kg water)

      320

      260

      270

      Osmolarity (mOsm/L)

      290

      230

      240

      Lactose-Free

      Yes

      Yes

      Yes

  • Product Forms

      Nutramigen is available in ready-to-use liquid and concentrate.

      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®
      Item #: 049811
      Description: Concentrate
      Unit Size: 13 fl oz can
      Calories/Unit: 520
      Product Yield/Unit (fl oz): 26
      Case: 12 cans per case
      HCPCS Code: B4161
      NDC Format Code: 00087-0498-01
    • Product: Nutramigen
      Item #: 143701
      Description: RTU
      Unit Size: 2 fl oz bottle
      Calories/Unit: 40
      Product Yield/Unit (fl oz): 2
      Case: 48 bottles per case
      HCPCS Code: B4161
      NDC Format Code: 00087-1437-41
    • Product: Nutramigen
      Item #: 429704
      Description: RTU
      Unit Size: 6 fl oz bottle
      Calories/Unit: 120
      Product Yield/Unit (fl oz): 6
      Case: 24 bottles per case
      HCPCS Code: B4161
      NDC Format Code: 00087-5105-17
    • Product: Nutramigen
      Item #: 148501
      Description: RTU
      Unit Size: 8 fl oz bottle
      Calories/Unit: 160
      Product Yield/Unit (fl oz): 8
      Case: 24 bottles per case
      HCPCS Code: B4161
      NDC Format Code: 00087-5102-46
    • Product: Nutramigen
      Item #: 169101
      Description: RTU
      Unit Size: 32 fl oz bottle
      Calories/Unit: 640
      Product Yield/Unit (fl oz): 32
      Case: 6 bottles per case
      HCPCS Code: B4161
      NDC Format Code: 00087-5115-64
  • Composition
    • Ingredients: Ready To Use (2 fl oz Nursette® bottle): Water (87%), corn syrup solids (5%), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) (3%), casein hydrolysate* (milk) (2%), modified corn starch (2%) and less than 1%: Mortierella alpina oil, Crypthecodinium cohnii oil, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, citric acid, taurine, L-cystine, L-tyrosine, L-tryptophan, L-carnitine.

      Ingredients: Ready To Use (6 fl oz Nursette bottle): Water (87%), corn syrup solids (5%), vegetable oil (palm olein, coconut, soy and high oleic sunflower oils) (4%), casein hydrolysate* (milk) (2%), modified corn starch (2%) and less than 1%: Mortierella alpina oil, Crypthecodinium cohnii oil, calcium phosphate, potassium citrate, calcium carbonate, potassium chloride, sodium citrate, magnesium oxide, ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite, carrageenan, choline chloride, ascorbic acid, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, thiamin hydrochloride, riboflavin, vitamin D3, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, L-cystine, inositol, L-tyrosine, L-tryptophan, vitamin B12, taurine, L-carnitine.

      Ingredients: Ready To Use (8 fl oz bottle): Water (87%), corn syrup solids (5%), vegetable oil (palm olein, coconut, soy and high oleic sunflower oils) (3%), casein hydrolysate* (milk) (2%), modified corn starch (2%) and less than 1%: Mortierella alpina oil, Crypthecodinium cohnii oil, calcium phosphate, potassium citrate, calcium carbonate, potassium chloride, sodium citrate, magnesium oxide, ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite, carrageenan, citric acid, choline chloride, ascorbic acid, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, thiamin hydrochloride, riboflavin, vitamin D3, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, L-cystine, inositol, L-tyrosine, L-tryptophan, vitamin B12, taurine, L-carnitine.

      Ingredients: Ready To Use (32 fl oz bottle): Water (87%), corn syrup solids (5%), vegetable oil (palm olein, soy, coconut, and high oleic sunflower oils) (4%), casein hydrolysate* (milk) (2%), modified corn starch (2%) and less than 1%: Mortierella alpina oil, Crypthecodinium cohnii oil, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, potassium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, citric acid, taurine, L-cystine, L-tyrosine, L-tryptophan, L-carnitine.

      Ingredients: (13 fl oz can): Water (75%), corn syrup solids (10%), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) (7%), casein hydrolysate* (milk) (4%), modified corn starch (3%) and less than 1%: Mortierella alpina oil, Crypthecodinium cohnii oil, acetylated monoglycerides, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, citric acid, taurine, L-cystine, L-tyrosine, L-tryptophan, L-carnitine.

      * Modified to be better tolerated in milk-allergic babies.

      † A source of arachidonic acid (ARA).

      ‡ A source of docosahexaenoic acid (DHA).

  • Potential Allergens
    • Nutramigen contains milk and soy. Nutramigen is hypoallergenic. Rarely, however, allergic reactions to extensively hydrolyzed casein formulas have been reported.

  • Amino Acid Composition
    • ESSENTIAL AMINO ACIDS
      mg/100 Calmg/100 g Pwd
      Histidine84
      Isoleucine162
      Leucine270
      Lysine240
      Methionine73
      Cysteine48
      Phenylalanine137
      Tyrosine59
      Threonine129
      Tryptophan46
      Valine200
      NONESSENTIAL AMINO ACIDS
      mg/100 Calmg/100 g Pwd
      Arginine112
      Alanine95
      Aspartic Acid210
      Glutamic Acid640
      Glycine59
      Proline290
      Serine162
      Tyrosine59
      Threonine129
      Tryptophan46
      Valine200
  • Preparation of Feedings
    • Concentrate

      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. Discuss with parents which formula is appropriate for the baby.

      13 fl oz Cans

      1. Wash hands thoroughly with soap and water before preparing formula.
      2. Clean can lid, SHAKE CAN WELL and open.
      3. Pour desired amount of water into the bottle. Add an equal amount of concentrated liquid. Shake or stir well.

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



      Failure to follow these instructions could result in severe harm. Opened bottles or cans and prepared formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened containers and/or prepared formula if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use prepared formula within 1 hour or discard.

    • Nursette<sup>®</sup> Bottles

      The baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Proper hygiene, preparation, use and storage are important when preparing infant formula. Discuss with parents which formula is appropriate for the baby.

      2 & 6 fl oz Nursette® Bottles

      1. Inspect each bottle for signs of damage.
      2. Wash hands thoroughly with soap and water before preparing bottle for feeding.
      3. SHAKE BOTTLE WELL and remove cap.
      4. Attach nipple unit (not included).


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



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

    • Ready-to-Use

      The baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Proper hygiene, preparation, use and storage are important when preparing infant formula. Discuss with parents which formula is appropriate for the baby.

      8 fl oz Bottles

      1. Wash hands thoroughly with soap and water before preparing feeding bottles.
      2. SHAKE BOTTLE WELL, remove protective seal around cap, remove cap and foil seal.
      3. Pour into feeding bottle(s).


      32 fl oz Bottles

      1. Wash hands thoroughly with soap and water before preparing feeding bottles.
      2. SHAKE BOTTLE WELL, remove protective seal around cap, remove cap and foil seal. Replace cap.
      3. Pour into feeding bottle(s).


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



      Failure to follow these instructions could result in severe harm. Opened bottles and prepared formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened bottle and/or prepared formula if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use prepared formula within 1 hour or discard.

  • 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. Lothe L, Lindberg T, Jakobsson I. Cow’s milk formula as a cause of infantile colic: a double-blind study. Pediatrics. 1982;70:7-10.
      3. Birch EE, Hoffman DR, Uauy RD, 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.
      4. 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.
      5. 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.
      6. 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.
      7. 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.
      8. 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.
      9. 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.
      10. 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.
      11. Innis SM. Human milk and formula fatty acids. J Pediatr. 1992;120(suppl): S56-S61.
      12. Jensen RG, ed. Handbook of Milk Composition. San Diego, Calif: Academic Press;1995.
      13. 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.