| CPC A61K 38/168 (2013.01) [A61K 9/0053 (2013.01)] | 20 Claims |
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1. A method of continuing an oral immunotherapy for the treatment of a peanut allergy in a patient after missing a scheduled administration of one or more consecutive doses of a pharmaceutical composition comprising peanut protein, wherein the patient began an oral immunotherapy and missed one or more doses of the up-dosing phase or the maintenance phase of the oral immunotherapy, the oral immunotherapy comprising:
(i) an up-dosing phase comprising orally administering to the patient a series of escalating doses of the pharmaceutical composition with a single dose administered on a daily basis, wherein the series of escalating doses administered during the up-dosing phase comprises doses of 3 mg to 300 mg peanut protein, and wherein a given dose is administered to the patient for at least a predetermined period of time before the dose is escalated, and
(ii) a maintenance phase comprising orally administering to the patient a plurality of maintenance doses of the pharmaceutical composition after completion of the up-dosing phase, wherein the maintenance dose of the pharmaceutical composition comprise about 300mg peanut protein and are administered daily;
the method comprising:
orally administering to the patient a dose of the pharmaceutical composition after missing the scheduled one or more consecutive doses, wherein:
(1) if one or two consecutive doses are missed, the dose administered to the patient is the same as the most recently administered dose;
(2) if three or four consecutive doses are missed, the dose administered to the patient is reduced compared to the most recently administered dose, wherein the dose is reduced by:
(i) 25% or more, and the dose is administered to the patient under medical supervision, or without medical supervision; or
(ii) 50% or more and the dose is administered under medical supervision, or without medical supervision;
(3) if five to seven consecutive doses are missed during the up-doing phase, the dose administered to the patient is reduced by 50% or more compared to the most recently administered dose;
(4) if eight to fourteen consecutive doses are missed during the up-dosing phase, the dose administered to the patient is reduced by 75% or more compared to the most recently administered dose;
(5) if five to fourteen consecutive doses are missed during the maintenance phase, the dose administered to the patient is 120 mg; and
(6) if more than fourteen consecutive doses are missed, the dose administered to the patient is an initial dose of the up-dosing phase.
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