Frequently Asked Questions

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

Over the last decade, we have answered hundreds if not thousands of questions about Glytactin, Glycomacropeptide (GMP), Amino Acid products, and transition strategies. This continues to be a popular "go to" resource for helpful advice. These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


The Orphan Drug Act of 1988 defines a medical food as "a food which is formulated to be consumed or administered enterally (or orally) under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."
Medical foods are specially formulated foods intended for the dietary management of certain medical conditions with distinctive nutritional requirements, which cannot be managed by altering a normal diet. The term "medical food" does not include all foods recommended by a physician, or fed to sick patients. Medical foods must be uniquely formulated for particular dietary conditions created by certain diseases.
Medical foods must be used under the supervision of a physician. Medical food must comply with Good Manufacturing Practice regulations and adhere to labeling practices for protection against major food allergens.

Phenylketonuria is a rare genetic disorder which afflicts approximately 1 in every 10,000-15,000 newborns in the United States.[4] Detection of PKU typical occurs shortly after birth through a standard screening process. The disease is caused by a mutation in the gene that produces the enzyme phenylalanine hydroxylase. The enzyme is needed to breakdown the essential amino acid Phenylalanine (Phe), which is found in protein-based foods and some artificial sweeteners. Without proper management, phenylalanine increases to physiologically harmful levels.[4]
PKU varies in severity from benign PKU, with limited signs and symptoms, to what is known as classic PKU, which is likely to result in the development of serious disability and a variety of additional health problems if left untreated. Classic PKU is caused by nearly absent or completely absent activity of the enzyme phenylalanine hydroxylase (<5% compared to normal levels). This enzyme is required for the normal breakdown of Phe, and its limited activity in PKU patients causes the unhealthy buildup of Phe.[5] Poor management of PKU can result in both physical and neurologic developmental delays. If PKU remains untreated for a prolonged period, patients can progress to severe intellectual disabilities. Patients who are non-adherent to dietary management at early ages are more susceptible Attention Deficit and Hyperactivity Disorder (ADHD), seizure disorders, and a number of other mental health conditions. Other significant long-term complications include bone mineral disease, Vitamin B12 deficiency, and impaired growth.[6-9]

A Phe restricted diet paired with Phe free amino acid supplementation remains the gold standard for the management of PKU.[6] The diet and supplementation is individualized dependent on the severity of the disorder and nutritional need. The goal of treating PKU is to maintain a phenylalanine blood level between 2 and 6 mg/dl for children under 12 years old and between 2 and 15 mg/dl for those over 12 years old.[6] Those with benign forms of PKU may be able to manage the condition with little to no alterations to their diet. Those with mild, moderate, or severe disorders require adherence to diets that significantly limit the consumption of products containing phenylalanine, particularly high protein foods.[6]
Instead, PKU patients must rely on low Phe containing cereals, starches, fruits, and vegetables, along with protein substitutes to provide all nutritional needs. These foods are allowed in quantities that suit the individual's tolerance for Phe and each individual’s diet is determined with the help of their healthcare providers. Such restrictive diets make it impossible for individuals to obtain the necessary daily nutrition thru diet alone.[10]
In order to ensure these nutritional needs are met, medical foods and supplements are incorporated into the diet. These products become a critical component of most PKU patients’ daily nutritional support.[6] Adherence to the diet and supplementation is crucial for managing the disorder; however, most diets are very difficult and onerous for patients and their families to follow.[10] In addition, many of the standard low Phe containing amino acid supplementation products have historically been troubled by poor taste, smell and demanding consumption schedules.[5] Following these restrictive diets have been shown to have significant psychosocial burden and can result in lowered quality of life.
For patients who are unable to maintain safe Phe levels through diet restriction and supplementation alone, a prescription product, Kuvan (sapropterin dihydrochloride), is also available.[11] Kuvan is recommended for use only in patients who have failed to properly manage PKU with diet and supplementation.[11] Kuvan is thought to work by activating residual phenylalanine hydroxylase enzymes, which improves the normal metabolism of phenylalanine. This helps to lower the levels of Phe in the blood stream.
The clinical effects of Kuvan can be highly variable and has not been shown to return phenylalanine hydroxylase activity to normal levels.[12] Hence, Kuvan is prescribed in addition to a Phe restricted diet and is not intended to maintain goals of treatment for PKU on prescription drug therapy alone. The diet recommended for patients taking Kuvan is typically similar to those managing PKU with diet alone.

As previously mentioned, patients diagnosed with PKU must adhere to a very strict diet that significantly limits the foods they are able to eat. In addition, patients must also supplement this diet with products that provide the necessary amino acids multiple times throughout each day. Patients are typically started on the restricted diet and supplementation at a very early age and must follow the diet throughout their life. In addition, patients must have their Phe levels monitored regularly to ensure blood levels are within the recommended values.
Adherence to the diet alone is problematic for most patients, and the added need to consume supplements multiple times each day makes complete adherence very difficult. Adherence to low Phe protein supplementation is further complicated by the poor taste and smell of many of the available products. It is extremely important for providers to work with patients and dieticians to develop a diet and supplementation plan that will promote the highest level of adherence for each individual patient. Inclusion of protein substitutes, which are more palatable and offer a variety of formulations, has the potential to significantly impact individual adherence and prevent further complications from the disease.

Products available to supplement PKU patients managing the disorder through diet restrictions have historically been composed primarily of synthetic essential amino acid formulations. It is often a challenge for patients to remain adherent to diets supplemented strictly with amino acid based formulations due in part to poor taste and smell, as well as, an inability of these formulas to encourage satiety. In addition, supplementation products containing only amino acid formulations are available primarily as powders with very few reconstituting options or as pre-made liquids with extremely limited flavor selections.
Glytactin differs from those products through its inclusion of both a formula of essential large neutral amino acids (LNAAs) and glycomacropeptide (GMP), which is the only naturally occurring, low-phenylalanine whole protein. Production of GMP is accomplished through a process similar to that used in cheese making.[2] GMP is one of several proteins, which make up whey and can be isolated during procurement. The isolated GMP is then incorporated into the Glytactin line of products. The production, isolation, and inclusion of GMP into the Glytactin products does come with an increase in production costs over the standard amino acid replacement products; however, this increased production costs results in only a modest price premium for the Glytactin products compared to amino acid only formulations.
The essential amino acid and GMP formulation found in Glytactin offers a variety of patient benefits. First, the formulation helps to stabilize Phe levels throughout the day, eliminating the spikes and troughs seen with alternative PKU preparations.[14] This leads to increased energy levels and improved concentration. Second, it reduces the Phe absorption across the blood brain barrier through its use of LNAAs, reducing the risk of disease progression.[15] Third, it returns the level of the hunger hormone, grehlin, closer to that seen in individuals on a normal diet.[16] This helps patients feel full longer, which improves the overall experience of PKU patients.
In addition, many patients believe Glytactin products have a more appealing taste, smell, and appearance than other products currently available.[17] The available product line includes a powder that makes a flavored milk-like substitute, a pre-made citrus drink, chewy chocolate bars, and a powder that can be made as a smoothie or a pudding. Multiple flavors are available for each formulation and reconstitution options for each product allows patients to customize their protein substitutes. In addition, each formulation is made up of 10 or 15 grams of protein, making it easy for patients to tailor their supplementation to their determined protein needs and personal preferences.



Frequently Asked Questions

BetterMilk

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

Over the last decade, we have answered hundreds if not thousands of questions about Glytactin, Glycomacropeptide (GMP), Amino Acid products, and transition strategies. This continues to be a popular "go to" resource for helpful advice. These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


Yes. BetterMilk is a formula designed to provide an easily absorbed protein source for PKU patients and has been fortified with essential amino acids, vitamins and minerals.

Once prepared, BetterMilk should be consumed entirely. However, prepared BetterMilk can be refrigerated for up to 24 hours. Unopened product packets have a one year recommended use by date.

To prepare, mix one packet of BetterMilk with four ounces of cold water or more/less to taste. BetterMilk can also be incorporated into recipes.

Yes. Please contact your dietitian or Cambrooke Therapeutics directly. Cambrooke Therapeutics can facilitate the delivery of sample kit, once approved by a dietitian.



Frequently Asked Questions

BetterMilk Orange Creme and Strawberry Creme

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

Over the last decade, we have answered hundreds if not thousands of questions about Glytactin, Glycomacropeptide (GMP), Amino Acid products, and transition strategies. This continues to be a popular "go to" resource for helpful advice. These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


BetterMilk Orange Creme and Strawberry Creme are different than original BetterMilk because they contain flavor boosters and have higher levels of some nutrients formulated for different age ranges.

Yes, flavored BetterMilk can fully replace amino acid formula intake. Flavored BetterMilk is designed to provide PKU patients with a safe whole protein source that is fortified with essential amino acids, vitamins and minerals.

Once prepared, flavored BetterMilk should be consumed entirely. However, prepared BetterMilk can be refrigerated for up to 24 hours, though we recommended drinking within 1–3 hours. Unopened product packets have a one year recommended use by date.

To prepare, mix one packet of flavored BetterMilk with four ounces of cold water or more to taste.

Yes. Please contact your dietitian or Cambrooke Therapeutics directly. Cambrooke Therapeutics can facilitate the delivery of sample kit, once approved by a dietitian.



Frequently Asked Questions

COMPLETE

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

Over the last decade, we have answered hundreds if not thousands of questions about Glytactin, Glycomacropeptide (GMP), Amino Acid products, and transition strategies. This continues to be a popular "go to" resource for helpful advice. These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


COMPLETE with Glytactin™ is a metabolic formula product for PKU patients in the form of a great tasting bar. Variety of flavors and age segmented for protein, vitamins and minerals.

Once bar is opened, COMPLETE should be consumed completely or stored appropriately to maintain freshness.

No, just open bar wrapper and enjoy!

COMPLETE is a great tasting alternative to liquid formula for the use of dietary management of PKU and is a complete formula product.

The bars are designed with age specific optimized vitamins and minerals, e.g. the 3-12 bars contain more Vitamins A and C than the 12+ bars. The COMPLETE 3-12 bar is fortified with a special blend of vitamins and minerals that is optimized for those ages 3-12. While the COMPLETE 12+ bar is fortified with a special blend of vitamins and minerals that is optimized for those 12 and older. Both bars can be enjoyed by anyone with PKU.

Yes. Please contact your dietitian or Cambrooke Therapeutics directly. Cambrooke Therapeutics can facilitate the delivery of sample kit, once approved by a dietitian.



Frequently Asked Questions

RESTORE

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

Over the last decade, we have answered hundreds if not thousands of questions about Glytactin, Glycomacropeptide (GMP), Amino Acid products, and transition strategies. This continues to be a popular "go to" resource for helpful advice. These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


You may have noticed that Glytactin Restore is not as clear as it used to be. We have been working with our supplier to improve the low Phe protein source (GMP) used in all of our products. On occasion, the prior Glytactin Restore would settle out over time. A quick shake fixed this in many cases, but in the spirit of continual improvement, we wanted to minimize the need for doing this. One visible impact is the liquid will not look as clear. It is important to note that this change has absolutely no effect on the safety, taste, or nutritional value of the product. It is the same great tasting hydration drink with an improved source of natural protein.

RESTORE with Glytactin™ is a metabolic formula for PKU patients in the form of a great tasting beverage.

No refrigeration is required for RESTORE prior to opening; however the product should be stored in a cool place (e.g. basement, kitchen). We recommend chilling it in the refrigerator before enjoying.

No. RESTORE can be enjoyed by anyone with a confirmed diagnosis of PKU.

Yes. RESTORE is a great substitute for other sports drinks as it provides electrolytes and other key nutrients PKU patients typically get from their metabolic formula. Most importantly, RESTORE contains 10 grams of protein (Glytactin™) suitable for PKU patients, which is not available from a typical sports drink.

Once open, RESTORE should be consumed within two hours if it is not refrigerated and within one to two days if it is refrigerated.

The shelf life of RESTORE is one year.

No preparation for RESTORE is required. Simply shake the bottle, twist the cap and drink.

RESTORE is designed to provide an easily absorbed protein source for PKU patients. While RESTORE contains a good number of water soluble vitamins, it does not contain the fat soluble vitamins: A, D, E, and K or some of the minerals required as part of a complete diet. You will need to get these from your diet or a vitamin supplement. It can be used in conjunction with the patient's current metabolic formula, COMPLETE or BetterMilk. Patients should talk to their physician/dietician to determine the appropriate combination of RESTORE, other metabolic formula, and foods that should be taken daily for complete nutrition.

Yes. Please contact your dietitian or Cambrooke Therapeutics directly. Cambrooke Therapeutics can facilitate the delivery of sample kit, once approved by a dietitian.



Frequently Asked Questions

RESTORE LITE

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

Over the last decade, we have answered hundreds if not thousands of questions about Glytactin, Glycomacropeptide (GMP), Amino Acid products, and transition strategies. This continues to be a popular "go to" resource for helpful advice. These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


You may have noticed that Glytactin Restore Lite is not as clear as it used to be. We have been working with our supplier to improve the low Phe protein source (GMP) used in all of our products. On occasion, the prior Glytactin Restore Lite would settle out over time. A quick shake fixed this in many cases, but in the spirit of continual improvement, we wanted to minimize the need for doing this. One visible impact is the liquid will not look as clear. It is important to note that this change has absolutely no effect on the safety, taste, or nutritional value of the product. It is the same great tasting hydration drink with an improved source of natural protein.

RESTORE LITE with Glytactin™ is a low calorie (70 calories) metabolic formula for PKU patients in the form of a great tasting beverage.

No refrigeration is required for RESTORE LITE prior to opening; however the product should be stored in a cool place (e.g. basement, kitchen). We recommend chilling it in the refrigerator before enjoying.

RESTORE has 170 calories per serving and RESTORE LITE has 70 calories per serving because we use a zero calorie sweetener.

Once open, RESTORE LITE should be consumed within two hours if it is not refrigerated and within one to two days if it is refrigerated.

The shelf life of RESTORE LITE is one year.

No preparation for RESTORE LITE is required. Simply shake the bottle, twist the cap and drink.

Yes. Please contact your dietitian or Cambrooke Therapeutics directly. Cambrooke Therapeutics can facilitate the delivery of sample kit, once approved by a dietitian.



Frequently Asked Questions

RESTORE Powder

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

Over the last decade, we have answered hundreds if not thousands of questions about Glytactin, Glycomacropeptide (GMP), Amino Acid products, and transition strategies. This continues to be a popular "go to" resource for helpful advice. These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


Glytactin™ RESTORE Powder with is a metabolic formula for PKU patients in a convenient powder packet for easy mixing.

No. RESTORE Powder can be enjoyed by anyone with a confirmed diagnosis of PKU.

Yes. RESTORE Powder is a great substitute for other sports drinks as it provides electrolytes and other key nutrients PKU patients typically get from their metabolic formula. Most importantly, RESTORE Powder contains 5 grams of protein (Glytactin™) suitable for PKU patients, which is not available from a typical sports drink.

Once mixed, RESTORE Powder should be consumed within two hours if it is not refrigerated and within one to two days if it is refrigerated.

The shelf life of RESTORE Powder is one year.

Yes. Pour powder into 6-12 oz of water. Mix well and enjoy.

RESTORE Powder is designed to provide an easily absorbed protein source for PKU patients. While RESTORE Powder contains a good number of water soluble vitamins, it does not contain the fat soluble vitamins: A, D, E, and K or some of the minerals required as part of a complete diet. You will need to get these from your diet or a vitamin supplement. It can be used in conjunction with the patient's current metabolic formula, COMPLETE, BetterMilk, or GLytactin RTD. Patients should talk to their physician/dietician to determine the appropriate combination of RESTORE Powder, other metabolic formula, and foods that should be taken daily for complete nutrition.

Yes. Please contact your dietitian or Cambrooke Therapeutics directly. Cambrooke Therapeutics can facilitate the delivery of sample kit, once approved by a dietitian.


Frequently Asked Questions

Glytactin RTD 10 (10g of Protein Equivalent [PE])

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

Over the last decade, we have answered hundreds if not thousands of questions about Glytactin, Glycomacropeptide (GMP), Amino Acid products, and transition strategies. This continues to be a popular "go to" resource for helpful advice. These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


Yes. Glytactin RTD 10, a convenient ready-to-drink formula, is designed to provide PKU patients with an easily absorbed protein source that is fortified with essential amino acids, vitamins and minerals.

Unopened Glytactin RTD 10 has a one year recommended use by date.

Store Glytactin RTD 10 in a cool, dry place and refrigerate after opening. Ideal temperature for storing is 59-77 degrees F.

No preparation for Glytactin RTD 10 is required. Glytactin RTD 10 comes in a convenient ready-to drink-format. Simply shake the carton, peel open the foil seal from the bottom or pop in the straw and enjoy.

Yes. Please contact your dietitian or Cambrooke Therapeutics directly. Cambrooke Therapeutics can facilitate the delivery of a sample kit, once approved by a dietitian.



Frequently Asked Questions

Glytactin RTD 15 (15g of Protein Equivalent [PE])

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

Over the last decade, we have answered hundreds if not thousands of questions about Glytactin, Glycomacropeptide (GMP), Amino Acid products, and transition strategies. This continues to be a popular "go to" resource for helpful advice. These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


Yes. Glytactin RTD 15, a convenient ready-to-drink formula, is designed to provide PKU patients with an easily absorbed protein source that is fortified with essential amino acids, vitamins and minerals.

Unopened Glytactin RTD 15 has a one year recommended use by date.

Store Glytactin RTD 15 in a cool, dry place and refrigerate after opening. Ideal temperature for storing is 59-77 degrees F.

No preparation for Glytactin RTD 15 is required. Glytactin RTD 15 comes in a convenient ready-to-drink format. Simply shake the carton, peel open the foil seal from the bottom or pop in the straw and enjoy.

Yes. Please contact your dietitian or Cambrooke Therapeutics directly. Cambrooke Therapeutics can facilitate the delivery of a sample kit, once approved by a dietitian.



Frequently Asked Questions

SWIRL

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

Over the last decade, we have answered hundreds if not thousands of questions about Glytactin, Glycomacropeptide (GMP), Amino Acid products, and transition strategies. This continues to be a popular "go to" resource for helpful advice. These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


SWIRL is a great tasting, unique formula that can be prepared however you want to take it – with a spoon or with a straw! SWIRL provides 15 grams of Glytactin protein, a blend of GMP and essential amino acids, plus vitamins and minerals.

SWIRL and BetterMilk are both made from Glytactin; however SWIRL has a slightly different formulation that gives it a unique preparation profile.

Yes. SWIRL is designed to provide PKU patients with a safe whole protein source that is fortified with essential amino acids, vitamins and minerals.

For optimal taste, once prepared, SWIRL should be consumed entirely within 15-30 minutes.

The unique thing about SWIRL is that it can be mixed however you want to take it! For a thicker formula, to be eaten with a spoon, combine SWIRL with 3 ounces of very cold water in a cup with a tight lid, shake for 30-45 seconds and enjoy. For a thinner formula, to be drunk with a straw, combine SWIRL with 6-8 ounces of cold water in a cup with a tight lid, shake for 30 seconds and enjoy.

Yes. Please contact your dietitian or Cambrooke Therapeutics directly. Cambrooke Therapeutics can facilitate the delivery of sample kit, once approved by a dietitian.



Frequently Asked Questions

CAMINO PRO Amino Acid Formulas

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

Over the last decade, we have answered hundreds if not thousands of questions about Glytactin, Glycomacropeptide (GMP), Amino Acid products, and transition strategies. This continues to be a popular "go to" resource for helpful advice. These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


The shelf life is one year when stored properly. All unopened products should be stored in a cool, dry environment.

No preparation is required. Simply shake the pouch, twist the cap and drink.

No. All CAMINO PRO Amino Acid Formula products come in pre-measured portions.

Yes. Please contact your dietitian or Cambrooke Therapeutics directly. Cambrooke Therapeutics can facilitate the delivery of sample kit, once approved by a dietitian.



Frequently Asked Questions

TYROSINEMIA

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


The Orphan Drug Act of 1988 defines a medical food as "a food which is formulated to be consumed or administered enterally (or orally) under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."
Medical foods are specially formulated foods intended for the dietary management of certain medical conditions with distinctive nutritional requirements, which cannot be managed by altering a normal diet. The term "medical food" does not include all foods recommended by a physician, or fed to sick patients. Medical foods must be uniquely formulated for particular dietary conditions created by certain diseases.
Medical foods must be used under the supervision of a physician. Medical food must comply with Good Manufacturing Practice regulations and adhere to labeling practices for protection against major food allergens.

Tyrosinemia is a rare genetic disorder (autosomal recessive trait) characterized by elevated blood levels of the amino acid tyrosine, a building block of most proteins. There are 3 different types of Tyrosinemia: Type I which affects 1 out of every 100,000 newborns in the United States, Type II which affects 1 out of every 250,000 newborns in the United States and Type III which has only been reported in a few cases in the United States. Tyrosinemia Type I is more common in Quebec, Canada where 1 out of every 16,000 newborns are diagnosed with Tyrosinemia. Detection of TYR typically occurs shortly after birth through a standard screening process. The disease is caused by the shortage (deficiency) of one of the enzymes required for the multi-step process that breaks down tyrosine. If untreated, tyrosine and its by products build up in tissues and organs, which leads to serious medical problems and depending on the type, neurological disorders.

Products available to supplement TYR patients managing the disorder through diet restrictions have historically been composed primarily of synthetic essential amino acid formulations. It is often a challenge for patients to remain adherent to diets supplemented strictly with amino acid based formulations due in part to poor taste and smell, as well as, an inability of these formulas to encourage satiety. In addition, supplementation products containing only amino acid formulations are available primarily as powders with very few reconstituting options or as pre-made liquids with extremely limited flavor selections.
Tylactin differs from those products through its inclusion of both a formula of certain essential large neutral amino acids (LNAAs) and glycomacropeptide (GMP), which is the only naturally occurring, low-phenylalanine, low-tyrosine whole protein. Production of GMP is accomplished through a process similar to that used in cheese making.[2] GMP is one of several proteins, which make up whey and can be isolated during procurement. The isolated GMP is then incorporated into the Tylactin line of products. The production, isolation, and inclusion of GMP into the Tylactin products does come with an increase in production costs over the standard amino acid replacement products; however, this increased production costs results in only a modest price premium for the Tylactin products compared to amino acid only formulations.
The essential amino acid and GMP formulation found in Tylactin, similar to our PKU formula Glytactin, offers a variety of patient benefits. GMP improves protein retention, increases protein synthesis and throughout the day, and returns the level of the hunger hormone, grehlin, closer to that seen in individuals on a normal diet.[14,16] This helps patients feel full longer, which improves the overall experience of TYR patients.
In addition, many patients believe the Glytactin products have a more appealing taste, smell, and appearance than other products currently available[17]. Tylactin is made of the same GMP which will have the same great taste and appearance as Glytactin. The available product line includes a ready to drink complete formula and a hydration formula similar to a Gatorade-like sports drink. Having options makes it easy for patients to tailor their supplementation to their determined protein needs and personal preferences.



Frequently Asked Questions

Tylactin RTD 15 (15g of Protein Equivalent [PE])

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


Yes. Tylactin RTD 15, a convenient ready-to-drink formula, is designed to provide TYR patients with an easily absorbed protein source that is fortified with essential amino acids, vitamins and minerals.

Unopened Tylactin RTD 15 has a one year recommended use by date. If opened,and refrigerated, Tylactin RTD 15 should be consumed within 24 hours. If opened and not refrigerated, Tylactin RTD 15 should be consumed within 2 hours.

Store Tylactin RTD 15 in a cool, dry place and refrigerate after opening. Ideal temperature for storing is 59-77 degrees F.

No preparation for Tylactin RTD 15 is required. Tylactin RTD 15 comes in a convenient ready-to-drink format. Simply shake the carton, peel open the foil seal from the bottom or pop in the straw and enjoy.

Yes. Please contact your dietitian or Cambrooke Therapeutics directly. Cambrooke Therapeutics can facilitate the delivery of a sample kit, once approved by a dietitian.



Frequently Asked Questions

Tylactin RESTORE

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


You may have noticed that Tylactin Restore is not as clear as it used to be. We have been working with our supplier to improve the low Phe and Tyr protein source (GMP) used in all of our products. On occasion, the prior Tylactin Restore would settle out over time. A quick shake fixed this in many cases, but in the spirit of continual improvement, we wanted to minimize the need for doing this. One visible impact is the liquid will not look as clear. It is important to note that this change has absolutely no effect on the safety, taste, or nutritional value of the product. It is the same great tasting hydration drink with an improved source of natural protein.

Tylactin RESTORE is a metabolic formula for TYR patients in the form of a great tasting beverage.

No refrigeration is required for Tylactin RESTORE prior to opening; however the product should be stored in a cool place (e.g. basement, kitchen). Ideal temperature for storing is 59-77 degrees F. We recommend chilling it in the refrigerator before enjoying.

No. Tylactin RESTORE can be enjoyed by anyone with a confirmed diagnosis of TYR.

Yes. Tylactin RESTORE is a great substitute for other sports drinks as it provides electrolytes and other key nutrients TYR patients typically get from their metabolic formula. Most importantly, Tylactin RESTORE contains 10 grams of protein (Tylactin) suitable for TYR patients, which is not available from a typical sports drink.

Once open, Tylactin RESTORE should be consumed within two hours if it is not refrigerated and within one to two days if it is refrigerated.

The shelf life of Tylactin RESTORE is one year.

No preparation for Tylactin RESTORE is required. Simply shake the bottle, twist the cap and drink.

Tylactin RESTORE is designed to provide an easily absorbed protein source for TYR patients. While Tylactin RESTORE contains a good number of water soluble vitamins, it does not contain the fat soluble vitamins: A, D, E, and K or some of the minerals required as part of a complete diet. You will need to get these from your diet or a vitamin supplement. It can be used in conjunction with the patient's current metabolic formula or Tylactin RTD. Patients should talk to their physician or dietician to determine the appropriate combination of Tylactin RESTORE, other metabolic formula, and foods that should be taken daily for complete nutrition.

Yes. Please contact your dietitian or Cambrooke Therapeutics directly. Cambrooke Therapeutics can facilitate the delivery of sample kit, once approved by a dietitian.



Frequently Asked Questions

KetoVie

Do you have questions about medical foods (formula) or are you simply looking for a source for answers to the most frequently asked questions about medical foods products?

These FAQs are intended to be supplemental reference material and are intended solely for the general information of the reader. They are not intended to diagnose health problems or to take the place of professional medical care. Always consult with your health care provider. If you cannot find the answer to your question, we ask that you contact us.


KetoVie is a liquid ready to use medical food for the dietary management of individuals who are prescribed a ketogenic diet for intractable epilepsy and other conditions requiring a ketogenic diet.

The KetoVie 4:1 products are ready-to-drink ketogenic formulas for the dietary management of intractable epilepsy and other disorders where a ketogenic diet is indicated. It may be used as sole source nutrition or as a supplement. It must be prescribed by a physician and monitored by a registered dietitian.

The Orphan Drug Act of 1988 defines a medical food as "a food which is formulated to be consumed or administered enterally (or orally) under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." Medical foods are specially formulated foods intended for the dietary management of certain medical conditions with distinctive nutritional requirements, which cannot be managed by altering a normal diet. The term "medical food" does not include all foods recommended by a physician, or fed to sick patients. Medical foods must be uniquely formulated for particular dietary conditions created by certain diseases. Medical foods must be used under the supervision of a physician. Medical food must comply with Good Manufacturing Practice regulations and adhere to labeling practices for protection against major food allergens.

KetoVie products contain a 4:1 ketogenic ratio by fat grams to combined protein and net carbohydrate grams. Net carbohydrate is the total carbohydrate grams minus grams of total fiber.

  • 4:1 Ketogenic Ratio
  • Lowest net carbohydrates
  • Ready to feed liquid appropriate for oral and tube feeding
  • Complete nutrition source
  • 100% Whey protein
  • Higher in protein than other ketogenic formulas
  • Contains 25% of calories as medium chain triglycerides (MCTs)
  • Supplemented with essential fatty acids
  • Supplemented with selenium and carnitine
  • Blend of soluble and insoluble fiber
  • Trans fat free
  • Aspartame free
  • Low lactose (0.2 g/250 mL)
  • Enhanced vitamin and mineral content for bone health
  • More vitamin D than any other ketogenic formulas

KetoVie 4:1 protein source is 100% whey protein. Whey protein is derived from milk. Cow and human milk contain both whey and casein protein fractions. Whey protein has been shown to empty out of the stomach faster than casein dominant milk proteins. Slow gastric motility can be common for those on a ketogenic diet.

KetoVie 4:1 – Vanilla is sweetened with a blend of sucralose and acesulfame potassium, sugar substitutes that contribute little to the carbohydrate total and do not add significant calories. Sucralose (more commonly known as SPLENDA® No Calorie Sweetener) is a non-caloric sweetener that is approved by the FDA and has a large body of evidence demonstrating it safe for use in foods. Acesulfame potassium is also a non-caloric sweetener often used with sucralose in commercial products to create a taste more like sucrose (or table sugar.) Acesulfame potassium is also deemed safe by the FDA. KetoVie 4:1 – Chocolate is sweetened with sucralose only. Both KetoVie 4:1 Vanilla and Chocolate flavors are aspartame free.

Unopened KetoVie has a one year recommended use by date.

Store KetoVie in a cool, dry place and refrigerate after opening. Ideal storage temperature is 59 – 77 degrees Fahrenheit. Opened cartons may be stored covered in the refrigerator for up to 24 hours.

Caregiver's and patients can purchase direct after medical consent has been received.

Contact our CAMBROOKEcare full service reimbursement team to determine coverage.


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