FOR MEDICAL PROFESSIONALS

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Products”TAMAKONA” &” MILKONA”

1. What is Tamakona and Milkona powder

These products can be used for three purposes:

  1. Oral food challenge at medical institutions
  2. Simple and easy daily intake at home for children with egg and/or milk allergies
  3. Baby food for introducing small amounts of egg and/or milk from 6 months of age

2. Oral food challenge (OFC)

Tamakona and Milkona were developed based on published evidences and the Japanese guidelines for food allergy to make OFC easier and more reliable. Tamakona and Milkona are particularly useful for stepwise OFC (Figure1)reducing the risk of allergic reactions. With a reaction rate of less than 20%, Tamakona and Milkona make OFC safer and less of a burden for children. By starting with small amounts, stepwise OFC also allows early exposure to small quantities, which can prevent the complete elimination of egg and/or milk for children with allergies to these foods.

Figure1. Stepwise oral food challenge
Figure 2. Our products and the Japanese guidelines for food allergy

3. The product information

Tamakona 25

Tamakona 25 contains 25mg of egg protein (Kjeldahl method).

It is equivalent to approximately 0.2g of whole egg boiled for at least 15 minutes which includes 0.13g of boiled egg white.

Tamakona 250
Tamakona 750
Milkona 100
Table. Product information

4. Evidences of Tamakona and Milkona powder

【Oral food challenge】

Egg
  • Stepwise single-dose oral egg challenge: a multicenter prospective study. Yanagida et al. J Allergy Clin Immunol Pract 2019; 7: 716-8.e6.
    (Further information is provided below)
  • Timing of onset of allergic symptoms following low-dose milk and egg challenges. Yanagida et al. Pediatr Allergy Immunol 2021; 32: 612-5
    (Further information is provided below)
  • Threshold and safe ingestion dose among infants sensitized to hen’s egg. Mitomori et al. Pediatr Allergy Immunol 2022; 33: e13830.
    (Further information is provided below)
Milk
  • Increasing specific immunoglobulin E levels correlate with the risk of anaphylaxis during an oral food challenge. Yanagida et al. Pediatr Allergy Immunol 2018; 29: 417-24
  • Relationship between serum allergen-specific immunoglobulin E and threshold dose in an oral food challenge. Yanagida et al. Pediatr Allergy Immunol 2023; 34: e13926.

【Daily intake at home and oral immunotherapy】

Egg
  • Safe egg yolk consumption after a negative result for low-dose egg oral food challenge. Yanagida et al. Pediatr Allergy Immunol 2021; 32: 170-6
    (refer to the information below for further details)
  • Long-term outcomes of oral immunotherapy for anaphylactic egg allergy in children. Sasamoto et al. Journal of Allergy and Clinical Immunology: Global 2022;1: 138-144.
Milk
  • Safe consumption of processed foods after negative medium-dose cow’s milk oral food challenge. Vanlaya et al. Allergology Int 2023 (in press)
  • A randomized trial of oral immunotherapy for pediatric cow’s milk-induced anaphylaxis: Heated vs unheated milk. Nagakura et al. Pediatric Allergy and Immunology 2021; 32: 161-9
    (Further information is provided below)

【Baby food and prevention】

Egg
  • Two-step egg introduction for prevention of egg allergy in high-risk infants with eczema (PETIT): a randomized, double-blind, placebo-controlled trial. Natsume et al. Lancet 2017; 389: 276-286
    (Further information is provided below)
Evidence 1 : Stepwise single-dose oral egg challenge: a multicenter prospective study. Yanagida et al. J Allergy Clin Immunol Pract 2019; 7: 716-8.e6
Evidence 2 : Timing of onset of allergic symptoms following low-dose milk and egg challenges. Yanagida et al. Pediatr Allergy Immunol 2021; 32: 612-5

We conducted an observational study of OFC with Tamakona 250 and Milkona 100 on children with a history of reaction or sensitization proven by elevated IgE level. Out of 563 children, 53 (9.4%) passed the OFC using Tamakona 250, while 20 out of 103 (19%) passed the OFC using Milkona 100. The symptoms appeared after 60 minutes (median) and 30 minutes (median) after loading Tamakona 250 and Milkona 100, respectively. In conclusion, during OFC, allergic reactions to milk appear and resolve sooner than reactions to hen’s egg, regardless of the total amount of food protein ingested and its form (unbaked vs. baked in a grain matrix). Our findings can help improve the safety of OFCs. We also confirmed that the test can be safely administered to children with or suspected of having hen’s egg or cow’s milk allergy.

Evidence 3 : Threshold and safe ingestion dose among infants sensitized to hen’s egg. Mitomori et al. Pediatr Allergy Immunol 2022; 33: e13830

The study analyzed the outcome of a stepwise OFC in infants who had not eaten hen’s eggs but who were sensitized to egg white-specific IgE. The enrolled infants had a median age of 9.9 months, 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 low dose OFC as part of the stepwise OFC was performed using with Tamakona 250. Out of the 87 patients, 12 (14%) failed the low dose OFC, and one patient (1.1%) required an adrenaline intramuscular injection. Subsequently, a moderate dose OFC with Tamakona 750 was performed on 75 patients, and 9 (12%) failed. The study showed that a stepwise OFC performed on infants who were not fed and had IgE sensitization was relatively safe, with many children avoiding complete elimination.

Evidence 4 : Safe egg yolk consumption after a negative result for low-dose egg oral food challenge. Yanagida et al. Pediatr Allergy Immunol 2021; 32: 170-6

A clinical study was conducted with 276 subjects, who had a median age of 1.2 years, a total IgE of 104 IU/mL, egg white-specific IgE of 14.7 kUA/L, and obomucoid-specific IgE 5.3 kUA/L. he subjects were instructed to consume egg yolk splice at home after a low dose OFC with Tamakona 250 was negative. Out of the 276 subjects, only 6 (2.1%) experienced minor symptoms at home. Among these, 5 were able to continue consuming the egg yolk binder without any issues, while 1 patient experienced mild respiratory symptoms, resulting in the complete elimination of the egg yolk binder. Based on the above findings, it is considered that egg yolk bridges can be safely consumed if the Tamakona 250 OFC is negative.

Evidence 5 : Two-step egg introduction for prevention of egg allergy in high-risk infants with eczema (PETIT): a randomized, double-blind, placebo-controlled trial. Natsume et al. Lancet 2017; 389: 276-286

5. Note

These products can be used in OFC as well as other egg- and milk-containing foods. Allergic symptoms may be induced if they are ingested by a person suffering from an allergy. OFC is a medical procedure conducted by physician experts at a medical institution under the clinical guidelines and should not be conducted by parents or guardians at home. If parents or guardians have any concerns about food allergies, please consult your home doctor or a specialist nearby.

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