Methods for administering pexidartinib
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.
Claims59
A method of administering pexidartinib, or a pharmaceutically acceptable salt thereof, to a patient while avoiding serious and potentially fatal liver injury, the method comprising:
- a) administering to the patient a dose of 400 mg equivalent of pexidartinib twice daily;
- b) monitoring the patient by measuring the patient's liver function;
- and
- c) reducing the dose or permanently discontinuing administration based on the patient's liver function.
A method for administering pexidartinib, or a pharmaceutically acceptable salt thereof, to a patient while minimizing a risk of serious and potentially fatal liver injury, the method comprising:
- a) 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;
- b) requiring the one or more healthcare providers to assess the patient's baseline liver functions;
- c) registering the patient in a database, wherein the patients has reviewed a patient guide and has had a baseline liver function assessed;
- and
- d) during treatment, re-assessing the patient's liver functions and modifying a dose of pexidartinib, or a pharmaceutically acceptable salt thereof, as needed.
A method of treating a patient with pexidartinib, or a pharmaceutically acceptable salt thereof, while avoiding 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) monitoring the patient by measuring the patient's liver function;
- and
- c) reducing the dose or permanently discontinuing administration based on the patient's liver function.
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.
Dependencies are inferred from the claim text.