JP-2022514645-A5 -

Dates

Publication Date

20221213

Application Date

20191219

Description

[0168] During the maintenance period, the patient informs their healthcare provider that they have missed the last 15 consecutive doses. The patient is then advised by their healthcare provider to return to the clinic. The patient's healthcare provider evaluates the patient. If no significant aggravating or comorbid factors are present, the patient is then administered a 3 mg peanut protein dose at the clinic, in accordance with the guidelines. The patient is observed for 60 minutes. The patient is then given a further dose of 3 mg peanut protein and instructed to resume dose increases by completing the 3 mg dose level through self-administration at home. After completing the 3 mg dose level, the patient is instructed to return to the clinic and again progress to the 6 mg peanut protein dose level. Further embodiments are as follows: [Embodiment 1] A method for continuing oral immunotherapy to treat peanut allergy in a patient after a planned administration of one or more consecutive doses of a pharmaceutical composition containing peanut protein has been missed, wherein the oral immunotherapy is (i) A dose-increase period comprising the step of orally administering a series of gradually increasing doses of the pharmaceutical composition to the patient once daily, wherein a given dose is administered to the patient for at least a predetermined period before the dose is gradually increased, (ii) A maintenance period comprising the step of orally administering a plurality of maintenance doses of the pharmaceutical composition to the patient, Including; The aforementioned method, The step includes administering a single dose of the pharmaceutical composition orally to the patient after the planned series of administrations has been missed, in which case, (1) If one or two consecutive doses are missed, the dose administered to the patient shall be the same as the most recent dose; (2) If three or four consecutive doses are missed, (i) the dose administered to the patient shall be the same as the most recent dose administered, and said dose shall be administered to the patient under medical supervision, or (ii) the dose administered to the patient shall be reduced compared to the most recent dose administered; (3) If 5 to 14 consecutive doses are missed, the dose administered to the patient shall be reduced by approximately 50% or more; and (4) If more than 14 consecutive doses are missed, the dose administered to the patient shall be the initial dose of the dose increase period. method. [Embodiment 2] The method according to Embodiment 1, wherein one or two consecutive doses are omitted, and the dose administered to the patient is the same as the most recently administered dose. [Embodiment 3] The method according to Embodiment 2, wherein the aforementioned dose is administered to the patient without medical supervision. [Embodiment 4] The method according to Embodiment 2, wherein the aforementioned dose is administered to the patient under medical supervision. [Embodiment 5] The method according to Embodiment 1, wherein three or four consecutive doses are omitted, and the dose administered to the patient is reduced compared to the most recent dose administered. [Embodiment 6] The method according to Embodiment 5, wherein the dose administered to the patient is reduced by 25% or more. [Embodiment 7] The method according to Embodiment 5, wherein the dose administered to the patient is reduced by 50% or more. [Embodiment 8] The method according to any one of Embodiments 5 to 7, wherein the aforementioned dose is administered to the patient under medical supervision. [Embodiment 9] The method according to any one of Embodiments 5 to 7, wherein the aforementioned dose is administered to the patient without medical supervision. [Embodiment 10] The method according to Embodiment 1, wherein three or four consecutive doses are missing, the dose administered to the patient is the same as the most recently administered dose, and the dose is administered to the patient under medical supervision. [Embodiment 11] The method according to Embodiment 1, wherein 5 to 14 consecutive doses are omitted, and the dose administered to the patient is reduced by approximately 50% or more. [Embodiment 12] The method according to any one of Embodiments 1 to 11, wherein if five to seven consecutive doses are missed, the dose administered to the patient is reduced by approximately 50% or more compared to the most recent dose administered. [Embodiment 13] The method according to Embodiment 12, wherein five to seven consecutive doses are omitted, and the dose administered to the patient is reduced by approximately 50% or more compared to the most recently administered dose. [Embodiment 14] The method according to any one of Embodiments 1 to 13, wherein if eight to fourteen consecutive doses are missed during the dose-increasing period, the dose administered to the patient is reduced by approximately 75% or more. [Embodiment 15] The method ac