Nutramigen® (Liquids)

Nutramigen® (Liquids)

Last Updated: Wednesday, September 30, 2015

For Cow’s Milk Allergy

  • Indication
    • Nutramigen is an iron-fortified, hypoallergenic infant formula designed for newborns and infants who are allergic to the intact proteins in cow’s milk and soy formulas, as well as other foods. Nutramigen contains 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 severe and multiple food allergies or intolerances, Nutramigen is sometimes continued as a milk substitute in the diet of children. This and similar supplemental use of Nutramigen in the diet beyond 12 months of age may make a significant contribution to maintenance of good nutrition in such patients. When Nutramigen is used as a milk substitute, 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, with attention to developmental as well as nutritional implications of such a dietary regimen.

  • Product Features
      • Hypoallergenic and suitable for someone with lactose intolerance
      • Clinically proven to effectively manage colic due to cow's milk protein allergy in 48 hours1,2,*
      • Nutritionally complete
      • Has 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,†

      Fatty Acid Nutrients

      • DHA – 17 mg
      • ARA – 34 mg

      * Studied before the addition of DHA and ARA. † Comparison based on fatty acid profile of typical mature U.S. breast milk. ‡ Per 100 Calories.

  • Nutrients§
    • (Normal Dilution) Per 100 Calories (5 fl oz)
      Protein, g 2.8
      Fat, g 5.3
      Linoleic acid, mg 860
      Carbohydrate, g 10.3
      Water, g 133
      (Normal Dilution) Per 100 Calories (5 fl oz)
      Vitamins/Other Nutrients
      Vitamin A, IU 300
      Vitamin D, IU 50
      Vitamin E, IU 2
      Vitamin K, mcg 8 (13 fl oz Conc) 9 (8 fl oz Conc; 2, 6, 8 & 32 fl oz RTU)
      Thiamin (Vitamin B1), mcg 80
      Riboflavin (Vitamin B2), mcg 90
      Vitamin B6, mcg 60
      Vitamin B12, mcg 0.3
      Niacin, mcg 1000
      Folic acid (Folacin), mcg 16
      Pantothenic acid, mcg 500
      Biotin, mcg 3
      Vitamin C (Ascorbic acid) mg 12
      Choline, mg 24
      Inositol, mg 17
      (Normal Dilution) Per 100 Calories (5 fl oz)
      Minerals
      Calcium, mg 94
      Phosphorus, mg 52
      Magnesium, mg 11 (13 fl oz Conc) 8 (8 fl oz Conc; 2, 6, 8 & 32 fl oz RTU)
      Iron, mg 1.8
      Zinc, mg 1
      Manganese, mcg 25
      Copper, mcg 75
      Iodine, mcg 15
      Selenium, mcg 2.8
      Sodium, mg 47
      Potassium, mg 110
      Chloride, mg 86

      § Product nutrients 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)13 25
      Potential Renal Solute Load (mOsm/100 mL)13 16.9
      Osmolality (mOsm/kg water) 260 (8 & 13 fl oz Conc)
      270 (8 & 32 fl oz RTU)
      320 (2 & 6 fl oz RTU)
      Osmolarity (mOsm/L) 230 (13 fl oz Conc; 6 fl oz RTU)
      240 (8 and 32 fl oz RTU)
      290 (2 fl oz RTU)
      Lactose-Free Suitable for someone with lactose intolerance
      Galactose-Free Yes||

      ||Some metabolic clinicians recommend liquid formulas even though question have been raised about the availability of galactose bound in the carrageenan in liquid formulas.

  • Product Forms
    • Nutramigen® is available in ready-to-use liquid and concentrate.

    • Item #: 148601
      Description: Concentrate
      Unit Size: 8 fl oz bottle
      Cal./Unit: 320
      Prod. Yield / Unit (fl oz): 16
      Case: 24 bottles per case
      Reimbursement Code: 0087-510248

    • Item #: 049811
      Description: Concentrate
      Unit Size: 13 fl oz can
      Cal./Unit: 520
      Prod. Yield / Unit (fl oz): 26
      Case: 12 cans per case
      Reimbursement Code: 0087-049801

    • Item #: 049911
      Description: RTU
      Unit Size: 32 fl oz can
      Cal./Unit: 640
      Prod. Yield / Unit (fl oz): 32
      Case: 6 cans per case
      Reimbursement Code: 0087-049901

    • Item #: 143701
      Description: RTU
      Unit Size: 2 fl oz bottle
      Cal./Unit: 40
      Prod. Yield / Unit (fl oz): 2
      Case: 48 bottles per case
      Reimbursement Code: 0087-143741

    • Item #: 429704
      Description: RTU
      Unit Size: 6 fl oz bottle
      Cal./Unit: 120
      Prod. Yield / Unit (fl oz): 6
      Case: 24 bottles per case
      Reimbursement Code: 0087-510517

    • Item #: 148501
      Description: RTU
      Unit Size: 8 fl oz bottle
      Cal./Unit: 160
      Prod. Yield / Unit (fl oz): 8
      Case: 24 bottles per case
      Reimbursement Code: 0087-510246

      HCPCS Code

  • Composition
    • Ingredients: Ready To Use (2 & 6 fl oz Nursette® bottles, 32 fl oz can): Water (87%), corn syrup solids (5%), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) (3%), casein hydrolysate (from 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 (8 fl oz bottle): Water (87%), corn syrup solids (5%), vegetable oil (palm olein, coconut, soy and high oleic sunflower oils) (3%), casein hydrolysate (from 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: Concentrated Liquid (8 fl oz bottle): Water (75%), corn syrup solids (10%), vegetable oil (palm olein, coconut, soy and high oleic sunflower oils) (7%), casein hydrolysate (from milk) (4%), modified corn starch (3%) and less than 2%: 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, acetylated monoglycerides, citric acid, choline chloride, ascorbic acid, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, vitamin D3, L‑cystine, carrageenan, inositol, L‑tyrosine, L‑tryptophan, vitamin B12, taurine, L‑carnitine.

      Ingredients: Concentrated Liquid (13 fl oz can): Water (75%), corn syrup solids (10%), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) (7%), casein hydrolysate (from 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.

  • Preparation of Feedings
    • The baby’s health depends on carefully following these instructions. Proper hygiene, preparation, dilution, use and storage are important when preparing infant formula.

      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.

      Ready To Use

      1. Wash hands thoroughly with soap and water before preparing bottle for feeding.

      2. Clean can lid, SHAKE CAN WELL, and open; or SHAKE BOTTLE WELL and remove cap and foil seal.

      3. Pour into feeding bottle(s).

      Failure to follow these instructions could result in severe harm. Opened cans and prepared bottles 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 can and/or prepared bottle if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared bottle. After feeding begins, use within 1 hour or discard.

      Ready To Use Storage

      Store unopened cans/bottles at room temperature. Avoid excessive heat. Do not freeze. Use by date on top of can or on bottle.

      Nutramigen® does not look or taste like milk or soy formulas. It may separate in the refrigerator. Shake well before feeding.

      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).

      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 48 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 within 1 hour or discard.

      Nursette Bottle Storage

      Store unopened bottles at room temperature. Avoid excessive heat and prolonged exposure to light. Do not freeze. Use by date on carton and bottle label.

      Nutramigen does not look or taste like milk or soy formulas. It may separate in the refrigerator. Shake well before feeding.

      Concentrate

      1. Wash hands thoroughly with soap and water before preparing formula.

      2. Clean can lid, SHAKE CAN WELL, and open; or SHAKE BOTTLE WELL and remove cap and foil seal.

      3. Pour desired amount of water into feeding bottle. Add an equal amount of concentrated liquid. SHAKE OR STIR WELL.

      Failure to follow these instructions could result in severe harm. Opened 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 can 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 within 1 hour or discard.

      Concentrate Storage

      Store unopened cans/bottles at room temperature. Avoid excessive heat. Do not freeze. Use by date on top of can or on bottle. Nutramigen does not look or taste like milk or soy formulas. It may separate in the refrigerator. Shake well before feeding.

      CAUTION

      Use product by date on container.

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

      This product is not recommended for routine use in very low-birth-weight infants. Some of these infants may be at increased risk of developing gastrointestinal complications.

  • 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 polyun-saturated 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.

  • Insurance Reimbursement Request for Nutramigen® (Liquids)

    
Insurance companies are not required to cover 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.