Got this from the ISSN listserv today:
December 30, 2010 â?? The US Food and Drug Administration (FDA) has approved a clear, odorless testosterone gel (Fortesta; Endo Pharmaceuticals) that is applied directly to the front and inner thigh â?? not the upper body â?? and rubbed in gently with 1 finger.
The product is indicated to treat hypogonadism, a condition that affects nearly 14 million American men, and will become available in early 2011.
"Declining blood levels of testosterone can occur in men beginning as early as age 40. The symptoms of low testosterone can be non-specific and often associated with other chronic medical problems," said Adrian Dobs, MD, MHS, professor of medicine and oncology, Division of Endocrinology and Metabolism, Johns Hopkins University School of Medicine in Baltimore, Maryland, in a company news release.
FDA approval was based on data from a phase 3 multicenter, open-label, 90-day clinical trial (n = 149) showing that 77.5% of men with hypogonadism achieved testosterone blood levels within the normal range (300 - 1140 ng/dL). Application site reactions were the most commonly reported adverse event (16.1%).
Testosterone topical gel is a schedule III controlled substance supplied in a travel-size 60-g metered-dose pump containing 120 actuations. The recommended initial dose is 4 pump actuations (40 mg) applied to clean, dry skin on the front and inner thighs once each morning; contact with the genital area should be avoided.
Dosing should be titrated based on serum testosterone concentrations obtained from a blood draw 2 hours after application and about 14 and 35 days after initiation of therapy or dose changes (dose range, 10 - 70 mg).
As with other topical testosterone preparations, the product's safety labeling includes a boxed warning regarding the potential for virilization in children with secondary exposure to treated skin. Because of the risk for fetal harm, women who are pregnant or may become pregnant should also avoid contact with the application site.
Patients should be instructed to wash their hands immediately with soap and water after applying testosterone gel, and to cover the application site with clothing after the alcohol-based gel has dried. The treated area should then be kept covered until washed; swimming and washing must be avoided for at least 2 hours.
Patients with benign prostatic hyperplasia should be monitored for worsening of associated signs and symptoms. All patients should be evaluated for prostate cancer at baseline and during treatment with testosterone gel.
Because polycythemia may require dose reductions or discontinuation of therapy, hematocrit should be obtained at baseline, 3 to 6 months after initiation of therapy, and annually thereafter.
Testosterone therapy can decrease blood glucose levels, potentially altering insulin requirements in diabetic patients. For those on anticoagulant therapy, testosterone can cause changes in activity, necessitating more frequent monitoring of international normalized ratio and prothrombin time on initiation and discontinuation of therapy. Concomitant use of corticosteroids may increase fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal, or hepatic disease.
Previously approved forms of testosterone replacement therapy include oral and buccal tablets, subcutaneous pellets, transdermal patches, injections, a topical solution applied to the underarm, and topical gels applied to the upper body.