With large doses of exogenous androgens, including FORTESTA, spermatogenesis may be suppressed through feedback inhibition of pituitary FSH which could possibly lead to adverse effects on semen parameters including sperm count. There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as FORTESTA. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel.
In at least 1 reported case, the reporter considered the possibility of secondary exposure from items such as the testosterone gel user's shirts and/or other fabric, such as towels and sheets see WARNINGS AND PRECAUTIONS. During the 90-day trial 5 patients (3.4%) discontinued treatment because of adverse reactions. The application site and dose of FORTESTA are not interchangeable with other topical testosterone products. To ensure proper dosing, the dose should be titrated based on the serum testosterone concentration from a single blood draw 2 hours after applying FORTESTA at approximately 14 days and 35 days after starting treatment or following dose adjustment.
On one side, the index finger was immediately wiped using dry sponges to collect residual testosterone. Subjects then used each index finger to rub FORTESTA (40 mg testosterone) onto each inner thigh. When transfer occurred with FORTESTA while covering a thigh with boxer shorts, mean Cavg decreased by 3% and mean Cmax increased by 2%, compared to direct skin-to-skin transfer with placebo see DOSAGE AND ADMINISTRATION. When direct skin-to-skin transfer occurred with FORTESTA mean average concentration (Cavg) increased by 134% and mean maximum concentration (Cmax) increased by 191%, compared to direct skin-toskin transfer with placebo. Serum concentrations of testosterone were monitored in females for 24 hours after the transfer procedure. At 2 hours after the application of FORTESTA to males, the females rubbed their forearms for 15 minutes on the thigh of the males. Six (6) males were treated with either FORTESTA (30 mg testosterone) or placebo to 1 thigh only.
The metered dose pump is capable of dispensing 120 metered pump actuations. To obtain a full first dose, it is necessary to prime the canister pump. In addition, serum testosterone concentration should be assessed periodically thereafter. The dose can be adjusted between a minimum of 10 mg of testosterone and a maximum of 70 mg of testosterone. Prior to initiating, FORTESTA confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least 2 separate days and that these serum testosterone concentrations are below the normal range.
The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product. Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented. Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. The concurrent administration of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal, or hepatic disease.

Gender: Female

Social links