Iron-fortified infant formula and medical food powder for infants and toddlers with documented tyrosinemia.
Last Updated: Monday, October 5, 2015
Metabolic clinicians can contact the Mead Johnson Medical Department at firstname.lastname@example.org to find out about receiving a starter case of TYROS 1 for a newly diagnosed infant.
Indication: TYROS 1 is an iron-fortified infant formula and medical food powder that is free of the essential amino acids phenylalanine and tyrosine for infants and toddlers with documented tyrosinemia. This product provides all other essential amino acids as well as nonessential amino acids, carbohydrate, fat, essential fatty acids, vitamins and minerals. Use under direct and continuing supervision of a doctor.
DHA and ARA
Phenylalanine- and tyrosine-free
Vitamin and mineral levels meet the U.S. Infant Formula Act requirements per 100 Calories
Increased levels of B vitamins, compared to routine infant formulas, for cofactor production
Mixes easily and stays in suspension well
Choline, an essential nutrient important for brain development and the normal functioning of cells1-2
|Per 100 grams Powder|
|Protein equivalent, g†||16.7|
|Linoleic acid, mg||4000|
|Per 100 grams Powder|
|Vitamin A, IU||1520|
|Vitamin D, IU||380|
|Vitamin E, IU||10|
|Vitamin K, mcg||40|
|Thiamin (Vitamin B1), mcg||1000|
|Riboflavin (Vitamin B2), mcg||1000|
|Vitamin B6, mcg||1000|
|Vitamin B12, mcg||2|
|Folic acid (Folacin), mcg||100|
|Pantothenic acid, mcg||3800|
|Vitamin C (Ascorbic acid), mg||60|
|Per 100 grams Powder|
* Product nutrient values and ingredients are subject to change. Please see product label for current information. † Protein is incomplete since it does not contain the essential amino acids tyrosine and phenylalanine. NA = None Added
|Protein Equivalent (% Calories)†||13|
|Fat (% Calories)||47|
|Carbohydrate (% Calories)||40|
|Potential Renal Solute Load (mOsm/100 g powder)3||148|
|Osmolality (mOsm/kg water)‡||360|
|Lactose-Free||Suitable for someone with lactose intolerance|
† Protein is incomplete since it does not contain the essential amino acids tyrosine and phenylalanine. ‡ Determined at 20 Cal/fl oz dilution.
TYROS 1 is available in powder.
Item #: 893001
Unit Size: 1 lb can
Prod. Yield / Unit (fl oz): Varies
Case: 6 cans per case
HCPCS Code: B4162
Reimbursement Code: 00087-510191
Ingredients: Corn syrup solids, vegetable oil (palm olein oil, coconut oil, soy oil, high oleic sunflower oil), amino acids (L-glutamine, L-leucine, potassium aspartate, L-lysine hydrochloride, L-proline, L-valine, L-alanine, L-isoleucine, L-arginine, L-threonine, L-serine, glycine, L-histidine, L-methionine, L-tryptophan, L-cystine), modified corn starch, sugar, calcium phosphate, and less than 1%: Mortierella alpina oil§, Crypthecodinium cohnii oil||, ethyl vanillin, sodium citrate, potassium citrate, magnesium oxide, ferrous sulfate, potassium chloride, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite, choline chloride, inositol, ascorbic acid, niacinamide, calcium pantothenate, vitamin B6 hydrochloride, thiamin hydrochloride, riboflavin, vitamin D3, folic acid, biotin, vitamin K1, vitamin E acetate, vitamin A palmitate, vitamin B12, taurine, L-carnitine.
§ A source of arachidonic acid (ARA).
|| A source of docosahexaenoic acid (DHA).
The child's health depends on carefully following the instructions. Proper hygiene, preparation, dilution, use and storage are important when preparing product. Powdered products are not sterile and should not be fed to premature infants or those persons who might have immune problems unless directed and supervised by a medical professional.
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.
Metabolic clinician should advise parents about the correct amounts of water and powder. Pour the required amount of water into the bottle. Add the correct amount of powder, cap the bottle and shake vigorously.
If instructed to use the scoop in the can, each scoop (unpacked and leveled) delivers approximately 4.5 g of powder. Store DRY scoop in can.
Failure to follow these instructions could result in severe harm. Once prepared, product 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 product if it is unrefrigerated for more than a total of 2 hours. Do not freeze prepared product. After feeding begins, use within 1 hour or discard.
Powder Storage (cans)
Store cans at room temperature. After opening can, keep tightly covered, store in a dry area and use contents within 1 month. Do not freeze powder, and avoid excessive heat.
To be used only under the supervision of a doctor.
This product is nutritionally incomplete. Care must be taken to provide enough phenylalanine and tyrosine to support growth, using other foods with these amino acids as required. Medical professionals must carefully and constantly supervise the use of TYROS 1 with other foods and liquids and adjust the diet based on frequent blood tests.
Use by date on bottom of can.
Nutritional powders are not sterile.
WARNING: Do not use a microwave oven to warm product. Serious burns may result.
Not for parenteral (I.V.) use.
Fat provides 47% of total calories in TYROS 1. The fat content is similar to the fat content of human milk¶ and consists of a four-oil vegetable blend of palm olein oil (44%), soy oil (19.5%), coconut oil (19.5%) and high oleic sunflower oil (14.5%), along with ARA and DHA from single cell oils (2.5%). This fat blend provides a fatty acid profile similar to the fatty acid profile of breast milk¶.
¶ Comparison based on fatty acid profile of typical mature U.S. breast milk.
Protein equivalents provide 13% of total calories in TYROS 1. The product provides the essential amino acids (except phenylalanine and tyrosine) as well as nonessential amino acids (see Amino Acids table); 47% of the amino acids are essential amino acids. Since the product contains no tyrosine or phenylalanine, care must be taken to provide enough tyrosine and phenylalanine from breast milk, infant formula, or other foods to support growth.
|Essential Amino Acids||Per 100 g Powder|
|Nonessential Amino Acids||Per 100 g Powder|
|Aspartic acid, mg||1450|
|Glutamic acid, mg||2900#|
# Added as glutamine.
Carbohydrate provides 40% of the total calories in TYROS 1. The carbohydrate blend is corn syrup solids, modified corn starch, and sucrose (table sugar). The sucrose in the product helps neutralize the taste of the amino acids. TYROS 1 is suitable for someone with lactose intolerance.
Vitamins and Minerals
Vitamin and mineral levels in TYROS 1 meet U.S. Food and Drug Administration requirements per 100 Calories for vitamins and minerals as mandated by the U.S. Infant Formula Act and the associated Code of Federal Regulations 21 C.F.R. part 107.1004. Amounts of B vitamins have been increased above levels in routine infant formulas for cofactor production. An increased level of choline, an essential nutrient important for brain development and the normal functioning of cells1-2, is provided. Calcium, iron, zinc, manganese, and copper levels are higher in order to help meet the needs for these minerals when low-protein solid foods are introduced.
1. Food and Nutrition Board, Institute of Medicine, Choline. In: Dietary References Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington, DC: National Academy Press; 1998:390-422.
2. Zeisel SH, da Costa KA. Nutr Rev. 2009;67:615-623.
3. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11–14.
4. Nutrient Requirements for Infant Formulas. Code of Federal Regulations 21, C.F.R. 107.100.