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Darolutamide, sold under the brand name Nubeqa, is an antiandrogen medication which is used in the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) in men. It is specifically approved to treat nmCRPC in conjunction with surgical or medical castration. The medication is taken by mouth twice per day with food.
Read the full article on WikipediaCastration resistant non-metastatic carcinoma of the prostate Clinical criteria: The condition must have evidence of an absence of distant metastases on the most recently performed conventional medical imaging used to evaluate the condition, AND The condition must be associated with a prostate-specific antigen level that was observed to have at least doubled in value in a time period of within 10 months anytime prior to first commencing treatment with this drug, AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation, AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug, AND Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation. Treatment criteria: Patient must be undergoing concurrent treatment with androgen deprivation therapy, AND Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine. Prescribing instructions: Retain the results of all investigative imaging and prostate-specific antigen (PSA) level measurements on the patient's medical records - do not submit copies of these with this authority application. The PSA level doubling time must be based on at least three PSA levels obtained within a time period of 10 months any time prior to first commencing a novel hormonal drug for this condition. The third reading is to demonstrate that the doubling was durable and must be at least 1 week apart from the second reading.
Metastatic castration sensitive carcinoma of the prostate Clinical criteria: The treatment must be/have been initiated within 6 months of treatment initiation with androgen deprivation therapy, AND Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation, AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug. Treatment criteria: Patient must be undergoing concurrent androgen deprivation therapy, AND Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
“Darolutamide is a second- or third-generation nonsteroidal antiandrogen (NSAA). It acts as a selective competitive silent antagonist of the androgen receptor (AR), the biological target of androgens like testosterone and dihydrotestosterone (DHT). Its affinity (Ki) for the AR is 11 nM and its functional inhibition (IC50Tooltip half-maximal inhibitory concentration) of the AR is 26 nM. The major metabolite of darolutamide, ketodarolutamide, has similar antiandrogenic activity relative to darolutamide (Ki = 8 nM; IC50 = 38 nM). In addition to its actions as an AR antagonist, darolutamide has been found to act as a silent antagonist of the progesterone receptor (PR), with approximately 1% of the potency of its AR antagonism.”
“16–20 hours”
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