Abiraterone acetate
Abiraterone acetate is an oncology treatment for metastatic prostate cancer in adult men.
Source:
EMA
Active Ingredients:
Indications
Representation
Accurate sex representation in patient population
Efficacy
No sex-specific efficacy data
Posology
No sex-specific posology data
Potential Side Effects
No sex differences in potential side effects
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
100%
0%
Clinical study participation by sex
100%
0%
Representation Gap
Accurate sex representation
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-based efficacy comparison was reported; the pivotal efficacy data were generated in male prostate cancer populations only.
Sex-specific posology
No sex-specific data
No sex-specific dose adjustment is described; standard dosing applies to the indicated male population.
The medicine is not for use in women.
Sex-specific differences in possible side effects
No sex differences in data
No sex-based differences in adverse event frequency or severity were reported; safety data come from male prostate cancer populations only.
Pregnancy / lactation
N / A
The medicine is not for use in women and is contraindicated in women who are or may potentially be pregnant. There are no human data on use in pregnancy; breast-feeding is not applicable because the medicine is not for use in women.
Sex-specific non-clinical findings
In nonclinical studies, abiraterone acetate affected fertility in male rats, and these effects were fully reversible; it is also not known whether abiraterone or its metabolites are present in semen.
In nonclinical studies, abiraterone acetate affected fertility in female rats, and these effects were fully reversible.
Disease prevalence by sex
Men
100%
Women
0%
Clinical study participation by sex
Men
100%
Women
0%
Representation Gap
Accurate sex representation
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-based efficacy comparison was reported; the pivotal efficacy data were generated in male prostate cancer populations only.
Sex-specific posology
No sex-specific data
Men
No sex-specific dose adjustment is described; standard dosing applies to the indicated male population.
Women
The medicine is not for use in women.
Sex-specific differences in possible side effects
No sex differences in data
No sex-based differences in adverse event frequency or severity were reported; safety data come from male prostate cancer populations only.
Pregnancy / lactation
Men
N / A
Women
The medicine is not for use in women and is contraindicated in women who are or may potentially be pregnant. There are no human data on use in pregnancy; breast-feeding is not applicable because the medicine is not for use in women.
Sex-specific non-clinical findings
Men
In nonclinical studies, abiraterone acetate affected fertility in male rats, and these effects were fully reversible; it is also not known whether abiraterone or its metabolites are present in semen.
Women
In nonclinical studies, abiraterone acetate affected fertility in female rats, and these effects were fully reversible.
General information
General Efficacy
Primary endpoints: Overall survival (OS) and radiographic progression-free survival (rPFS) were the co-primary efficacy endpoints in studies 3011 and 302; overall survival was the primary efficacy endpoint in study 301. Secondary endpoints: Important supportive endpoints included time to skeletal-related event, time to subsequent therapy for prostate cancer, time to initiation of chemotherapy or cytotoxic chemotherapy, time to pain progression, time to PSA progression, time to opiate use for cancer pain, time to deterioration in ECOG performance status by ≥ 1 point, objective response, pain palliation/progression, time to degradation in FACT-P total score, total PSA response rate, and radiographic progression-free survival in study 301.
General Posology
1 000 mg orally once daily as a single daily dose on an empty stomach. It is given with prednisone or prednisolone: 5 mg daily for mHSPC and 10 mg daily for mCRPC. In patients not surgically castrated, an LHRH analogue should be continued. The dose must be taken at least two hours after eating, with no food for at least one hour afterward; tablets are swallowed whole with water.
Further Dose Adjustments
Contraindicated in severe hepatic impairment (Child-Pugh Class C) and in combination with Ra-223 when used with prednisone or prednisolone.
Possible Side Effects
Very common adverse reactions were peripheral oedema, hypokalaemia, hypertension, urinary tract infection, alanine aminotransferase increased and/or aspartate aminotransferase increased, and diarrhoea. Important serious reactions included cardiac disorders, hepatotoxicity, fractures, allergic alveolitis, sepsis, anaphylactic reactions, adrenal insufficiency, acute hepatic failure/hepatitis fulminant, myocardial infarction and QT prolongation. Marked increases in liver enzymes led to treatment discontinuation or dose modification; discontinuations due to ALT/AST increases or abnormal hepatic function occurred in 1.1% of abiraterone acetate-treated patients.
Contraindications
Hypersensitivity to the active substance or any excipient; women who are or may potentially be pregnant; severe hepatic impairment (Child-Pugh Class C); and combination with Ra-223 when used with prednisone or prednisolone.
Clinical Trial Type and Population
The safety and efficacy were evaluated in three randomised placebo-controlled multicentre Phase 3 studies in men with mHSPC or mCRPC. Study 3011: n=1199, median age 67 years, 0% women/girls. Study 302: n=1088, median age 71 years in the abiraterone acetate arm and 70 years in the placebo arm, 0% women/girls. Study 301: n=1195, median age 69 years, 0% women/girls.
Representation
Accurate sex representation in patient population
Efficacy
No sex-specific efficacy data
Posology
No sex-specific posology data
Potential Side Effects
No sex differences in potential side effects
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
100%
0%
Clinical study participation by sex
100%
0%
Representation Gap
Accurate sex representation
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-based efficacy comparison was reported; the pivotal efficacy data were generated in male prostate cancer populations only.
Sex-specific posology
No sex-specific data
No sex-specific dose adjustment is described; standard dosing applies to the indicated male population.
The medicine is not for use in women.
Sex-specific differences in possible side effects
No sex differences in data
No sex-based differences in adverse event frequency or severity were reported; safety data come from male prostate cancer populations only.
Pregnancy / lactation
N / A
The medicine is not for use in women and is contraindicated in women who are or may potentially be pregnant. There are no human data on use in pregnancy; breast-feeding is not applicable because the medicine is not for use in women.
Sex-specific non-clinical findings
In nonclinical studies, abiraterone acetate affected fertility in male rats, and these effects were fully reversible; it is also not known whether abiraterone or its metabolites are present in semen.
In nonclinical studies, abiraterone acetate affected fertility in female rats, and these effects were fully reversible.
Disease prevalence by sex
Men
100%
Women
0%
Clinical study participation by sex
Men
100%
Women
0%
Representation Gap
Accurate sex representation
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-based efficacy comparison was reported; the pivotal efficacy data were generated in male prostate cancer populations only.
Sex-specific posology
No sex-specific data
Men
No sex-specific dose adjustment is described; standard dosing applies to the indicated male population.
Women
The medicine is not for use in women.
Sex-specific differences in possible side effects
No sex differences in data
No sex-based differences in adverse event frequency or severity were reported; safety data come from male prostate cancer populations only.
Pregnancy / lactation
Men
N / A
Women
The medicine is not for use in women and is contraindicated in women who are or may potentially be pregnant. There are no human data on use in pregnancy; breast-feeding is not applicable because the medicine is not for use in women.
Sex-specific non-clinical findings
Men
In nonclinical studies, abiraterone acetate affected fertility in male rats, and these effects were fully reversible; it is also not known whether abiraterone or its metabolites are present in semen.
Women
In nonclinical studies, abiraterone acetate affected fertility in female rats, and these effects were fully reversible.
General information
General Efficacy
Primary endpoints: Overall survival (OS) and radiographic progression-free survival (rPFS) were the co-primary efficacy endpoints in studies 3011 and 302; overall survival was the primary efficacy endpoint in study 301. Secondary endpoints: Important supportive endpoints included time to skeletal-related event, time to subsequent therapy for prostate cancer, time to initiation of chemotherapy or cytotoxic chemotherapy, time to pain progression, time to PSA progression, time to opiate use for cancer pain, time to deterioration in ECOG performance status by ≥ 1 point, objective response, pain palliation/progression, time to degradation in FACT-P total score, total PSA response rate, and radiographic progression-free survival in study 301.
General Posology
1 000 mg orally once daily as a single daily dose on an empty stomach. It is given with prednisone or prednisolone: 5 mg daily for mHSPC and 10 mg daily for mCRPC. In patients not surgically castrated, an LHRH analogue should be continued. The dose must be taken at least two hours after eating, with no food for at least one hour afterward; tablets are swallowed whole with water.
Further Dose Adjustments
Contraindicated in severe hepatic impairment (Child-Pugh Class C) and in combination with Ra-223 when used with prednisone or prednisolone.
Possible Side Effects
Very common adverse reactions were peripheral oedema, hypokalaemia, hypertension, urinary tract infection, alanine aminotransferase increased and/or aspartate aminotransferase increased, and diarrhoea. Important serious reactions included cardiac disorders, hepatotoxicity, fractures, allergic alveolitis, sepsis, anaphylactic reactions, adrenal insufficiency, acute hepatic failure/hepatitis fulminant, myocardial infarction and QT prolongation. Marked increases in liver enzymes led to treatment discontinuation or dose modification; discontinuations due to ALT/AST increases or abnormal hepatic function occurred in 1.1% of abiraterone acetate-treated patients.
Contraindications
Hypersensitivity to the active substance or any excipient; women who are or may potentially be pregnant; severe hepatic impairment (Child-Pugh Class C); and combination with Ra-223 when used with prednisone or prednisolone.
Clinical Trial Type and Population
The safety and efficacy were evaluated in three randomised placebo-controlled multicentre Phase 3 studies in men with mHSPC or mCRPC. Study 3011: n=1199, median age 67 years, 0% women/girls. Study 302: n=1088, median age 71 years in the abiraterone acetate arm and 70 years in the placebo arm, 0% women/girls. Study 301: n=1195, median age 69 years, 0% women/girls.
Representation
Accurate sex representation in patient population
Efficacy
No sex-specific efficacy data
Posology
No sex-specific posology data
Potential Side Effects
No sex differences in potential side effects
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
100%
0%
Clinical study participation by sex
100%
0%
Representation Gap
Accurate sex representation
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-based efficacy comparison was reported; the pivotal efficacy data were generated in male prostate cancer populations only.
Sex-specific posology
No sex-specific data
No sex-specific dose adjustment is described; standard dosing applies to the indicated male population.
The medicine is not for use in women.
Sex-specific differences in possible side effects
No sex differences in data
No sex-based differences in adverse event frequency or severity were reported; safety data come from male prostate cancer populations only.
Pregnancy / lactation
N / A
The medicine is not for use in women and is contraindicated in women who are or may potentially be pregnant. There are no human data on use in pregnancy; breast-feeding is not applicable because the medicine is not for use in women.
Sex-specific non-clinical findings
In nonclinical studies, abiraterone acetate affected fertility in male rats, and these effects were fully reversible; it is also not known whether abiraterone or its metabolites are present in semen.
In nonclinical studies, abiraterone acetate affected fertility in female rats, and these effects were fully reversible.
Disease prevalence by sex
Men
100%
Women
0%
Clinical study participation by sex
Men
100%
Women
0%
Representation Gap
Accurate sex representation
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-based efficacy comparison was reported; the pivotal efficacy data were generated in male prostate cancer populations only.
Sex-specific posology
No sex-specific data
Men
No sex-specific dose adjustment is described; standard dosing applies to the indicated male population.
Women
The medicine is not for use in women.
Sex-specific differences in possible side effects
No sex differences in data
No sex-based differences in adverse event frequency or severity were reported; safety data come from male prostate cancer populations only.
Pregnancy / lactation
Men
N / A
Women
The medicine is not for use in women and is contraindicated in women who are or may potentially be pregnant. There are no human data on use in pregnancy; breast-feeding is not applicable because the medicine is not for use in women.
Sex-specific non-clinical findings
Men
In nonclinical studies, abiraterone acetate affected fertility in male rats, and these effects were fully reversible; it is also not known whether abiraterone or its metabolites are present in semen.
Women
In nonclinical studies, abiraterone acetate affected fertility in female rats, and these effects were fully reversible.
General information
General Efficacy
Primary endpoints: Overall survival (OS) and radiographic progression-free survival (rPFS) were the co-primary efficacy endpoints in studies 3011 and 302; overall survival was the primary efficacy endpoint in study 301. Secondary endpoints: Important supportive endpoints included time to skeletal-related event, time to subsequent therapy for prostate cancer, time to initiation of chemotherapy or cytotoxic chemotherapy, time to pain progression, time to PSA progression, time to opiate use for cancer pain, time to deterioration in ECOG performance status by ≥ 1 point, objective response, pain palliation/progression, time to degradation in FACT-P total score, total PSA response rate, and radiographic progression-free survival in study 301.
General Posology
1 000 mg orally once daily as a single daily dose on an empty stomach. It is given with prednisone or prednisolone: 5 mg daily for mHSPC and 10 mg daily for mCRPC. In patients not surgically castrated, an LHRH analogue should be continued. The dose must be taken at least two hours after eating, with no food for at least one hour afterward; tablets are swallowed whole with water.
Further Dose Adjustments
Contraindicated in severe hepatic impairment (Child-Pugh Class C) and in combination with Ra-223 when used with prednisone or prednisolone.
Possible Side Effects
Very common adverse reactions were peripheral oedema, hypokalaemia, hypertension, urinary tract infection, alanine aminotransferase increased and/or aspartate aminotransferase increased, and diarrhoea. Important serious reactions included cardiac disorders, hepatotoxicity, fractures, allergic alveolitis, sepsis, anaphylactic reactions, adrenal insufficiency, acute hepatic failure/hepatitis fulminant, myocardial infarction and QT prolongation. Marked increases in liver enzymes led to treatment discontinuation or dose modification; discontinuations due to ALT/AST increases or abnormal hepatic function occurred in 1.1% of abiraterone acetate-treated patients.
Contraindications
Hypersensitivity to the active substance or any excipient; women who are or may potentially be pregnant; severe hepatic impairment (Child-Pugh Class C); and combination with Ra-223 when used with prednisone or prednisolone.
Clinical Trial Type and Population
The safety and efficacy were evaluated in three randomised placebo-controlled multicentre Phase 3 studies in men with mHSPC or mCRPC. Study 3011: n=1199, median age 67 years, 0% women/girls. Study 302: n=1088, median age 71 years in the abiraterone acetate arm and 70 years in the placebo arm, 0% women/girls. Study 301: n=1195, median age 69 years, 0% women/girls.
EQUAL CARE® Evaluations
EQUAL CARE® Evaluation
Medication
Source
Source:
EMA
Date of first authorisation:
05 September 2011
Source URL:
Prevalence Source: