Androgen tablets

Treatment for proven androgen deficiency is based on testosterone replacement therapy. Testosterone can be administered by capsule or tablet, skin patch, gel, lotion or cream, or injection (short- or long-acting). 

If the cause of testosterone deficiency is located in the pituitary gland, and the man is also wishing to father a child, then gonadotrophin injections, several times a week for many months, are used to stimulate both testosterone and sperm production.

Men who receive testosterone replacement therapy will have regular reviews with their doctor. Prostate examinations are performed according to a man's age and other risk factors for prostate cancer. 

Older men need to be checked for prostate cancer before testosterone replacement therapy can be started, because increased levels of testosterone could make unrecognised prostate cancer grow. However, testosterone replacement therapy is not thought to increase the risk of a new prostate cancer above that of the general population.

Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (Adapted from refs. 2 and 3 with the author's permission). For further information, the reader is referred to a text on epidemiological methods.

As with other 5-alpha-reductase inhibitors, feminisation of male rat foetuses has been seen with administration of finasteride in the gestation period. Intravenous administration of finasteride to pregnant rhesus monkeys at doses up to 800 ng/day during the entire period of embryonic and foetal development resulted in no abnormalities in male foetuses. This dose is about 60-120 times higher than the estimated amount in semen of a man who have taken 5 mg finasteride, and to which a woman could be exposed via semen. In confirmation of the relevance of the Rhesus model for human foetal development, oral administration of finasteride 2 mg/kg/day (the systemic exposure (AUC) of monkeys was slightly higher (3x) than that of men who have taken 5 mg finasteride, or approximately 1-2 million times the estimated mount of finasteride in semen) to pregnant monkeys resulted in external genital abnormalities in male foetuses. No other abnormalities were observed in male foetuses and no finasteride-related abnormalities were observed in female foetuses at any dose.

The following CTCAE (version ) Grade 3 adverse reactions occurred in patients treated with abiraterone acetate: hypokalaemia 3%; urinary tract infection, alanine aminotransferase increased, hypertension, aspartate aminotransferase increased, fractures 2%; peripheral oedema, cardiac failure, and atrial fibrillation 1% each. CTCAE (version ) Grade 3 hypertriglyceridaemia and angina pectoris occurred in < 1% of patients. CTCAE (version ) Grade 4 peripheral oedema, hypokalaemia, urinary tract infection, cardiac failure and fractures occurred in < 1% of patients.

Androgen tablets

androgen tablets

The following CTCAE (version ) Grade 3 adverse reactions occurred in patients treated with abiraterone acetate: hypokalaemia 3%; urinary tract infection, alanine aminotransferase increased, hypertension, aspartate aminotransferase increased, fractures 2%; peripheral oedema, cardiac failure, and atrial fibrillation 1% each. CTCAE (version ) Grade 3 hypertriglyceridaemia and angina pectoris occurred in < 1% of patients. CTCAE (version ) Grade 4 peripheral oedema, hypokalaemia, urinary tract infection, cardiac failure and fractures occurred in < 1% of patients.

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