Description
PKU sphere – GMP-Based Low-Phenylalanine Formula for Phenylketonuria (PKU)
PKU sphere is a specially formulated powdered medical food designed to support the dietary management of Phenylketonuria (PKU) using glycomacropeptide-(GMP) based protein—the first of its kind from Vitaflo®. Designed for use from age 3 years and up, it offers families and caregivers a more palatable, convenient protein substitute option under medical supervision.
Key Features & Benefits
- GMP-Dominant Protein Source: Uses glycomacropeptide (GMP) from whole protein sources—a protein naturally very low in phenylalanine—supplemented with essential and non-essential amino acids to meet nutritional needs in PKU management.
- Pre-Measured Packets for Easy Dosing: Available in sizes “15” (15 g protein equivalent) and “20” (20 g protein equivalent) with pre-measured packets. No weighing required makes preparation simpler for daily use.
- Low Volume, High Flexibility: The “20” packet, for example, mixes into a small volume (~120 mL/4 fl oz) while delivering 120 calories and 20 g protein equivalent—helpful for individuals managing fluid or portion size.
- Wide Variety of Flavours: Available in multiple flavours (Vanilla, Red Berry, Chocolate, Banana, Lemon) to enhance taste acceptance and dietary compliance.
- Micronutrient-Rich: Includes a broad spectrum of vitamins and minerals to address nutrient gaps common in low-protein PKU diets.
How to Use
- Choose the correct packet size (15 g or 20 g PE) and flavour as prescribed by your specialist.
- Mix one packet with the recommended volume of permitted fluid (as directed by your dietitian or clinician).
- Consume under medical supervision. Suitable for oral use and from age 3 years onward.
- Store unopened packets in a cool, dry place. Once prepared, follow instructions for consumption and discard any unused portion according to your clinician’s guidance.
Important Things to Know
- This product is a food for special medical purposes and must be used under the supervision of a healthcare professional experienced in PKU management.
- It is not intended as a sole source of nutrition, but as part of a comprehensive low-phenylalanine diet.
- Because each individual’s PKU dietary plan is unique (based on age, weight, metabolic control and phenylalanine tolerance), dosing and usage must be determined by a metabolic dietitian or physician.
- Individuals with allergies (e.g., milk or other protein sources) should check ingredient labels carefully.
- Flavoured options may contain small amounts of sugar—check with your dietitian if your plan limits sugars.
| SKU # | 1213389 |
| Manufacturer # | 812539025825 |
| Brand | PKU sphere® 20 |
| Manufacturer | Vitaflo USA LLC |
| Country of Origin | Netherlands |
| Administration Method | Oral |
| Application | Oral Supplement |
| Calories per Serving | 120 Calories |
| Calories per Serving Range | 101 to 200 Calories |
| Container Type | Individual Packet |
| Container Type Range | Individual Package |
| Flavor | Baa Flavor |
| Flavor Range | Fruit Flavor |
| Health Condition | PKU |
| Ingredients | Whey Protein Isolate (Milk), L-Leucine, Natural and Artificial Flavor, L-Tyrosine, Sugar, Modified Corn Starch, Soy Lecithin, L-Arginine, Calcium Lactate, Magnesium Phosphate, Calcium Phosphate, Dried Corn Syrup, L-Histidine, Choline Bitartrate, Glycine, Refined Tuna Oil (Fish), L-Tryptophan, L-Lysine L-Aspartate, L-Cystine, Sodium Ascorbate, Zinc Gluconate, Sucralose, Maltodextrin, Dipotassium Phosphate, Ferrous Sulfate, L-Methionine, DL-Alpha Tocopheryl Acetate, Potassium Iodide, Mono- and Diglycerides, Chromium Chloride, Sodium Selenite, Sodium Molybdate, Copper Gluconate, Niacinamide, Manganese Gluconate, Vitamin A Acetate, Calcium Pantothenate, Vitamin D3, Vitamin B12, Biotin, Folic Acid, Tocopherols (Preservative), Thiamine Hydrochloride, Pyridoxine Hydrochloride, Riboflavin, Vitamin K1 |
| Is_Active_Vendor | Y |
| Is_DSCSA | N |
| Is_Discontinued | N |
| Is_Medical_Device | N |
| Lot_Tracking_Flag | N |
| NDC Number | 12539002582 |
| Nutrient Type | Glycomacropeptide (GMP) |
| On_Allocation | N |
| Preparation | Powder |
| Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
| Serving Size | 35 Gram Serving Size |
| Supplier_ID | 60626581 |
| UNSPSC Code | 42231803 |
| User | Ages 3 Years and Up |
| User Group | Pediatric to Adult |
| Volume | 35 Gram |
Product Details
- Administration Method:
- Oral
- Application:
- Oral Supplement
- Calories per Serving:
- 120 Calories
- Calories per Serving Range:
- 101-200 Calories
- Container Type:
- Individual Packet
- Container Type Range:
- Individual Package
- Flavor:
- Banana Flavor
- Flavor Range:
- Fruit Flavor
- Health Condition:
- PKU
- Ingredients:
- Whey Protein Isolate (Milk), L-Leucine, Natural and Artificial Flavor, L-Tyrosine, Sugar, Modified Corn Starch, Soy Lecithin, L-Arginine, Calcium Lactate, Magnesium Phosphate, Calcium Phosphate, Dried Corn Syrup, L-Histidine, Choline Bitartrate, Glyc
- Manufacturer Number:
- 812539025825
- Manufacturer Name:
- VITAFLO USA LLC
- NDC Number:
- 12539002582
- Preparation:
- Powder
- Product Dating:
- McKesson Acceptable Dating: we will ship >= 90 days
- UNSPSC Code:
- 42231803
- User:
- Ages 3 Years and Up
- User Group:
- Pediatric to Adult
- Volume:
- 35 Gram