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Products for Medical Institutions (for load testing)

Purpose

Oral food load test at medical institutions

Dietary guidance for those who have negative tolerance test (only some products)

Allergen information

Tamakona 25

Contains 25mg of egg protein (Kjeldahl method).

 Equivalent to about 0.2g of boiled egg (whole egg) boiled for 15 minutes or 0.13g of hard-boiled egg white.

 Contains egg yolk and egg white ingredients.

Tamakona 250

 Meets the “small amount” tolerance test of the medical guidelines.

 Contains 250 mg of egg protein (Kjeldahl method).

 Contains about 2 g of boiled egg (whole egg) boiled for 15 minutes and 1.3 g of hard-boiled egg white, equivalent to 1/32-1/25 of a whole egg.

 Contains egg yolk and egg white ingredients.

Tamakona 750

 This product corresponds to the “moderate” loading test of the medical guideline.

 Contains 750 mg of egg protein (Kjeldahl method).

 Equivalent to approximately 6 g of boiled egg (whole egg) boiled for 15 minutes, 4 g of hard-boiled egg white, or 1/8 of a whole egg.

 Includes egg yolk and egg white ingredients.

Mirukona 100

 This product corresponds to the “small amount” loading test in the medical guideline.

 Contains 100mg of milk protein (Kjeldahl method).

 Equivalent to 3ml of milk.

 Because it is made from skimmed milk powder, its antigenicity may be slightly lower than that of 3ml of raw cow’s milk.

Clinical Studies list

Clinical Study, 1 [Tamakona 250 and Tamakona 750]

 We conducted a food oral load test using the same powder as Tamakona 250 and Tamakona 750 at 4 hospitals and 3 clinics in Japan. The subjects were 252 patients with a history of egg allergy, median age 1.7 years (median, interquartile range 1.2-4.6 years), total IgE 172IU/mL (53-611), egg white specific IgE 14.3 kUA/L (4.3-33.8), obomucoid specific IgE 7.5 kUA/L (1.6-24.5). (24.5) .

 Of the 252 patients, 200 (79.3%) had negative (asymptomatic) food oral load tests with this powder. Of the 52 positive subjects, 13 (25%) had mild severity as defined by anaphylaxis guidelines, 38 (73%) had moderate severity, and 1 (2%) had severe severity. Onset of symptoms ranged from 61 minutes (25 to 102), peak from 80 minutes (20 to 138), and resolution from 120 minutes (84 to 180). Oral antihistamines were administered in 34 patients (65%), oral steroids in 15 patients (29%), and inhaled beta2-stimulants in 5 patients (10%), with no severe cases requiring intramuscular adrenaline injection.

 Of the 154 patients, 148 (96%) had negative (asymptomatic) food oral load tests with this powder. Of the 16 positive cases, 4 (25%) were mild in severity as defined by anaphylaxis guidelines, 12 (75%) were moderate, and 0 (0%) were severe. Onset of symptoms ranged from 48 minutes (28-90), peak from 65 minutes (49-100), and resolution from 133 minutes (86-153). Oral antihistamines were administered in 13 patients (81%), oral steroids in 6 patients (38%), beta2-stimulant inhalation in 4 patients (25%), and no severe cases required intramuscular adrenaline injection.

 References : Yanagida N, Sato S, Takahashi K, et.al.:J Allergy Clin Immunol Pract. 2019 Feb;7(2):716-718.(Open Access)

Clinical Study, 2 [Tamakona 250 and Tamakona 750]

 Results of a stepwise loading test in infants who had not eaten chicken eggs and who were sensitized to egg white-specific IgE were reported. Eighty-seven subjects included in the analysis were suspected of having eczema or other food allergies, so specific IgE antibody titers associated with chicken eggs were measured. The subjects were 9.9 months of age (median, same below), with a total IgE level of 101 IU/mL, egg white-specific IgE level of 18.0 kUA/L, and obomucoid-specific IgE level of 0.99 kUA/L. A small loading test with a powder equivalent to Tamakona 250 was performed, and 12 (14%) were positive and Adrenaline intramuscular injection was required for 1 patient (1.1%). A moderate-dose challenge test with a powder equivalent to Tamakona 750® was performed on 75 patients who tested negative, and 9 (12%) tested positive. A stepwise loading test on unfed and IgE-sensitized children was found to be relatively safe, with many children escaping complete elimination.

 References : Mitomori et al. Threshold and safe ingestion dose among infants sensitized to hen’s egg

Clinical Study, 3 [Tamakona 250 and Tamakona 750]

 conducted on children with a history of triggering symptoms or sensitization, resulted in 53 of 563 (9.4%) and 20 of 103 (19%) positives, respectively (Yanagida et al. Timing of onset of allergic symptoms…). Similar to the above study, the triggering symptoms started to appear about 60 minutes (median) after the chicken egg powder was loaded. On the other hand, the triggering symptoms of cow’s milk powder started to appear about 30 minutes (median) after loading. It was confirmed that the test can be safely administered to children with or suspected of having chicken egg or cow’s milk allergy.

 References : Yanagida et al. Timing of onset of allergic symptoms following low-dose milk and egg challenges

Clinical Study, 4 [Tamakona 250]

 In a clinical study in which 276 subjects (median age 1.2 years, total IgE 104 IU/mL, egg white-specific IgE 14.7 kUA/L, obomucoid-specific IgE 5.3 kUA/L) were instructed to consume egg yolk splice at home with a negative tolerance test, 6 subjects (2.1%) ) only had minor triggering symptoms; 5 of the 6 patients were able to continue the egg yolk binder thereafter, and 1 patient had mild respiratory symptoms, resulting in complete elimination of the egg yolk binder. Based on the above, it is considered that egg yolk bridges can be safely consumed if the Tamakona 250® loading test is negative.

 References : Yanagida et al. Safe egg yolk consumption after a negative result for low-dose egg oral food challenge

Clinical Study, 5 [Tamakona 25]

 Study subjects Babies who had itchy eczema or atopic dermatitis from within a few months of birth and whose eczema was cured by 6 months of age with appropriate skin care and topical steroids
Egg intake method: A very small amount of heated whole egg powder for research purposes (about 0.2 g of egg, equivalent to 25 tamakona) is taken once a day from 6 months of age, and from 9 months of age, the amount is increased about 5 times (equivalent to half of 250 tamakona). Safety was confirmed by a loading test at the beginning and when increasing the amount of food. As a comparison, the same number of babies were asked to eat the powder without chicken eggs.
Results: Comparing the number of children who showed allergic reactions to the equivalent of about half a cooked whole egg at the age of 1 year, the percentage of children who showed allergic reactions was lower in the group that ate the powder (intervention group).
*In response to the publication of this study, in 2017, the Japanese Society of Pediatric Allergy issued a “Recommendation on the Prevention of the Development of Egg Allergy” and recommended that, in order to prevent the onset of egg allergy, the consumption of eggs in weaning food should not be delayed, but rather that a small amount should be started as early as possible. This information can be found on the Society’s website.
Modified from Natsume O, Kabashima S, et.al.Lancet. 2017 Jan 21;389(10066):276-286より改変

Positioning of this product in medical practice guidelines

Modified from “Food Allergy Clinical Practice Guidelines 2021”

Use in Food Oral Load Tests

 This product can be used in food oral load tests as well as other egg- and milk-containing foods. Allergic symptoms may be induced if this product is ingested by a person suffering from an allergy. The oral load test is a medical procedure performed at a medical institution under the guidance of a physician and should not be performed by the general public at home. The general public should contact their local medical institution.

 Medical institutions that use this product for oral load testing need to be prepared to handle the symptoms of allergy when they appear, such as drugs and personnel. For more information on the specific method and details of the oral load test, please refer to the official document, guidelines, etc., or contact us using the Inquiry Form.

 References : Guide to the Treatment of Food Allergy 2020

Detailed product information

Stepwise oral food challenge is safer and easier

Tamakona and Milkona make your clinicalpractice reliable and simple

Quality and quantity of allergen are designed based on evidences. The products are available for stepwise oral food challenge at hospitals and daily use at home.

Why is stepwise approach of oral food challenge (OFC) important?

A stepwise approach of OFC is recommended to avoid complete elimination of causative foods.

Ebisawa M, Ito K, Fujisawa T. Japanese guidelines for food allergy 2020. Allergol Int, 2020

Which paper shows that stepwise OFC with Tamakona is effective and safe?

The stepwise single-dose OFC, starting with a low dose (Tamakona250) and progressing to medium doses (Tamakona750), is an effective and safe approach that enables children with egg allergies to avoid complete elimination and contributes to improving daily food allergy management. The positive rates of OFC with Tamakona250 and Tamakona750 were 20.6% and 9.8%, respectively.

Yanagida N, Sato S, Takahashi K, et.al. Stepwise single-dose oral egg challenge: a multicenter prospective study. J Allergy Clin Immunol Pract, 2019

How about stepwise OFC for infant with Tamakona?

Stepwise oral food challenges starting from a low dose are relatively safe to introduce egg and effective in determining the threshold and safe ingestion dose for such infants for whom egg consumption was completely avoided owing to sensitization. The positive rates of OFC with Tamakona250 and Tamakona750 were 14% and 12%, respectively.

Mitomori M, Yanagida N, Nishino M, et.al. Threshold and safe ingestion dose among infants sensitized to hen’s egg. Pediatr Allergy Immunol. 2022

Is there any evidence of Tamakona about oral immunotherapy?

Long-term OIT with Tamakona enabled ingestion of 1/2 of a boiled egg in half of the participants with anaphylactic egg allergy.

Sasamoto S, Yanagida N, Nagakura K, et.al. Long-term outcomes of oral immunotherapy for anaphylactic egg allergy in children. J Allergy Clin Immunol Glob. 2022

Which product is optimal for prevention?

Introduction of heated egg in a stepwise manner along with aggressive eczema treatment is a safe and efficacious way to prevent hen’s egg allergy in high-risk infants. Tamakon25 is equivalent to the first step in this study.

Sasamoto S, Yanagida N, Nagakura K, et.al. Long-term outcomes of oral immunotherapy for anaphylactic egg allergy in children. J Allergy Clin Immunol Glob. 2022

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