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US 2022/0036993 A1Published application
Pexidartinib risk evaluation and mitigation strategy (rems)
AssigneeDaiichi Sankyo Company, Limited
InventorsDale Edward SHUSTER, Hamim ZAHIR, Ophelia Qiping YIN, Leonidas Daniel DROGARIS, Vikram Jeet DEV, Laurie DELEVE, James Hendricks LEWIS
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Abstract
The present disclosure relates generally to methods for using pexidartinib and related Risk Evaluation and Mitigation Strategy (REMS), while reducing the occurrence of hepatotoxic adverse events.
Claims82
A method comprising:
- receiving, by at least one computing device, data encapsulating a request to fill a prescription for pexidartinib, or a pharmaceutically acceptable salt thereof, for a patient, the request specifying a pharmacy initiating the request and including an identification of the patient;
- polling a server with the pharmacy identification and the patient identification to determine whether
- (i) the pharmacy is registered and pre-approved to fill prescriptions for pexidartinib, or a pharmaceutically acceptable salt thereof;
- (ii) the patient executed a consent form or other acknowledgement associated with the administration of pexidartinib, or a pharmaceutically acceptable salt thereof, and
- (iii) the patient has a patient status form prepared by a prescribing entity transmitted or prepared within a corresponding validity window thereby making such patient status form active, the validity windows increasing in length of days as treatment of the patient with pexidartinib, or a pharmaceutically acceptable salt thereof, progresses;
- transmitting data responsive to the request approving filling of the prescription by the pharmacy if it is determined that the pharmacy is registered and pre-approved to fill prescriptions for pexidartinib, or a pharmaceutically acceptable salt thereof, the patient has executed the consent form or other acknowledgment, and the patient has an active patient status form;
- and
- transmitting data responsive to the request rejecting filling of the prescription by the pharmacy if it is determined (a) that the pharmacy is not registered and pre-approved to fill prescriptions for pexidartinib, or a pharmaceutically acceptable salt thereof, (b) the patient has executed the form, or (c) the patient does not have an active patient status form.
5 more elements
A method for treating a patient with pexidartinib, or a pharmaceutically acceptable salt thereof, while minimizing a risk of serious and potentially fatal liver injury, wherein the patient having symptomatic tenosynovial giant cell tumor (TGCT), the method comprising:
- a) administering to the patient a dose of 400 mg equivalent of pexidartinib twice daily;
- b) registering one or more healthcare providers in a healthcare provider database in a non-transitory computer readable storage medium, wherein the one or more healthcare providers have completed a knowledge assessment regarding pexidartinib;
- c) requiring the one or more healthcare providers to assess the patient's baseline liver functions;
- d) registering the patient in a database, wherein the patient has reviewed a patient guide and has had a baseline liver function assessed;
- and
- e) during treatment, re-assessing a patient's liver function and reducing the dose or permanently discontinuing administration based on the patient's liver function.
3 more elements
Dependencies are inferred from the claim text.