A Medical Food for the dietary management of Phenylketonuria (PKU)

A second generation of Large Neutral Amino Acids (LNAA) for the dietary management of PKU.

NeoPhe is the clinically proven LNAA tablet that blocks Phenylalanine from entering the blood, thus reducing blood Phe levels. NeoPhe is the only preparation of LNAA clinically proven to lower blood Phe.

Clinically Proven

• Data from pilot studies conducted in Ukraine, Russia and the US revealed a decrease in blood Phe concentration of 52%-55% form baseline. When NeoPhe was discontinued, blood Phe concentrations increased to pre-trial levels. ¹
• Double blind studies performed in seven (7) different centers indicate that LNAA can compete with Phe on the transporter in the GI tract, resulting in a decrease in the blood phe-level in patients on NeoPhe, averaging 39% from baseline levels. ²

Indications

• Adults, teenagers and children who are able to swallow whole tablets.
• Non compliant, untreated or late-diagnosed PKU patients.

Warning

• NeoPhe should not be used when planning a pregnancy or during a pregnancy.

Benefits

• Monitor blood Phe levels for tolerance.
• NeoPhe tablets are tasteless and odorless.
• NeoPhe results in liberalization of the diet for most PKU patients.
• Diet can consist up to 80% regular food and only 20% medical foods.
• Decrease in consumption of low protein foods.
  

Nutrition Information Per Tablet Energy, kcal   2.1 Carbohydrate, g   0.09 Fat, g   0.009 Trans, g   0 Protein equivalent, g   0.41 Vitamins   Biotin, µg   1.0 Vitamin B6, µg   50 Vitamin B12, µg   0.09 Folic acid, µg   13

Ingredients: L-Tyrosine, L-Leucine, Tricalcium Phosphate, L-Tryptophan, Potato Starch, L-Isoleucine, L-Valine, L-Lysine, L-Threonine, L-Arginine, L-Histidine, Colloidal Hydrated Silica, Rice Starch, L-Methionine, Shellac, Titanium Dioxide, Magnesium Stearate, Olive Oil, Macrogol 6000, Vitamin B₆, Folic Acid, Biotin, Vitamin B₁₂.

 

Suggested Intake: 1 tablet per kg of body weight per day (1 tablet/kg/d).

 

Daily intake to be determined by your healthcare professional specialized in metabolic disorders. The dosage is dependant on the age, body weight, medical condition and individual Phe tolerance. NeoPhe is not suitable as a sole source of nutrition.

 

Tablets must always be taken with food. NeoPhe must be supplemented with a moderately restricted PKU diet containing other sources of protein, vitamins and minerals. An individualized diet plan must be followed at all times.

 

The total number of NeoPhe tablets to be taken at 1 meal can be divided so that they are taken at the beginning, middle or end of a meal. For example: 20 tablets at breakfast – 7 tablets at the beginning of the meal, 7 during breakfast and 6 at the end.

Tablets must always be taken with food. NeoPhe must be supplemented with a moderately restricted PKU diet containing other sources of protein, vitamins and minerals. An individualized diet plan must be followed at all times.

 

 

References

1) R. Matalon, K.  Michals-Matalon, G. Bhatia, E. Grechanina, P. Novikov, D. J. McDonald, J. Grady, S.K. Tyring, F. Guttler, Large Neutral Amino Acids in the Treatment of Phenylketonuria (PKU), J Inherit Metab Dis. 2006 Dec;29(6):732-8. 

2) R. Matalon, K. Michals-Matalon, G. Bhatia, A.B. Burlina, A.P. Burlina, C. Braga, L. Fiori, M. Giovannini, E. Grechanina, P. Novikov, J. Grady, S.K. Tyring,  F.Guttler, Double blind placebo control trial of large neutral amino acids in treatment of PKU: Effect on blood phenylalanine. J Inherit Metab Dis. 2007, Feb 27.

 

Ordering NeoPhe - (888) 876-5223

Reimbursement code (NDC)*:

57771-0050-01

Contact Solace Nutrition
(888) 8-SOLACE (876-5223)
Fax: 401 633-6066
www.solacenutrition.com

 

*National Drug Codes (NDC) Format Codes: Products sold by Solace Nutrition are classified as Medical Foods by the US Food and Drug Administration (FDA). NDC format codes are product codes adjusted according to standard industry practice to meet the format requirements of pharmacy and health insurance computer systems.

Patent Pending: US - 10/826112