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On the other side, each subject washed their hands with liquid soap and warm tap water immediately after drug application, then wipe the index finger using dry sponges to collect residual testosterone. Prior to application of FORTESTA, each index finger and each intended application site (left and right front and inner thighs) was wiped using dry sponges to assess baseline skin testosterone. In an open-label, single-dose study, the amount of residual testosterone on the application finger and application site after washing was evaluated in 12 healthy male subjects. In a 2-way crossover study, the effects of showering on the pharmacokinetics of total testosterone following application of FORTESTA (30 mg testosterone to each thigh; total 60 mg testosterone) were assessed in 7 hypogonadal males.
Pump this medication directly onto the thigh(s). Follow the instructions for priming the pump if you are using it for the first time. Read the dosing instructions carefully for each product.
There is a single report of acute overdosage after parenteral administration of an approved testosterone product in the literature. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH. There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing FORTESTA to determine whether efficacy in those over 65 years of age differs from younger subjects.
There were two 7-day treatment phases, with showering 2 hours post FORTESTA application, and without showering on Day 7 of each treatment phase. The potential for testosterone transfer from healthy males dosed with FORTESTA to healthy females was evaluated in a placebo-controlled, 3-way crossover study. About 90% of a dose of testosterone given intramuscularly is excreted in the urine as glucuronic acid and sulfuric acid conjugates of testosterone and its metabolites. There is considerable variation in the half-life of testosterone concentration as reported in the literature, ranging from 10 to 100 minutes. Circulating testosterone is primarily bound in the serum to sex hormone-binding globulin (SHBG) and albumin. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has 2 main etiologies.
In developmental studies conducted in rats, rabbits, pigs, sheep, and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis. These studies did not meet current standards for nonclinical development toxicity studies. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma.
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