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Enzalutamide, sold under the brand name Xtandi, is a nonsteroidal antiandrogen (NSAA) medication which is used in the treatment of prostate cancer. It is indicated for use in conjunction with castration in the treatment of metastatic castration-resistant prostate cancer (mCRPC), nonmetastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer (mCSPC). It is taken by mouth.
Read the full article on WikipediaCastration resistant metastatic carcinoma of the prostate Clinical criteria: The treatment must not be used in combination with chemotherapy, AND Patient must have a WHO performance status of 2 or less, 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; OR Patient must have been receiving PBS-subsidised treatment with abiraterone or abiraterone plus methylprednisolone for castration resistant metastatic prostate cancer prior to being associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation. Treatment criteria: 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.
Castration 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.
“Enzalutamide acts as a selective silent antagonist of the androgen receptor (AR), the biological target of androgens like testosterone and dihydrotestosterone (DHT). Unlike the first-generation NSAA bicalutamide, enzalutamide does not promote translocation of AR to the cell nucleus and in addition prevents binding of AR to deoxyribonucleic acid (DNA) and AR to coactivator proteins. As such, it has been described as an AR signaling inhibitor in addition to antagonist. The drug is described as a "second-generation" NSAA because it has greatly increased efficacy as an antiandrogen relative to so-called "first-generation" NSAAs like flutamide and bicalutamide. The drug has only 2-fold lower affinity for the AR than DHT, the endogenous ligand of the AR in the prostate gland.”
“Enzalutamide: 5.8 days (range 2.8–10.2 days)NDME: 7.8–8.6 days”
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