Check with your physician for additional information about side effects. This document does not contain all possible side effects and others may occur. Get medical help right away, if you have any of the symptoms listed above. These are not all the possible side effects of FORTESTA. Other side effects include more erections than are normal for you or erections that last a long time. Call your healthcare provider right away if you have any of the serious side effects listed above. 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. Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for the maintenance of secondary sex characteristics. There were no reports of overdose in the FORTESTA clinical trial. This subject had serum testosterone concentrations of up to 11,400 ng/dL, which were implicated in a cerebrovascular accident. The Food and Drug Administration (FDA or Agency) has determined that FORTESTA (testosterone) gel, 10 milligrams (mg)/0.5 gram (gm) actuation, was not withdrawn from sale for reasons of safety or effectiveness. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where FORTESTA has been applied to your skin. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. Keep all medications away from children and pets. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Apply the medication to clean, dry skin on the front and inner thigh(s) as directed by your doctor, usually once daily in the morning. Do not change products without asking your doctor or pharmacist. They may have different amounts of testosterone and may not have the same effects. Learn how to use the pump and how to apply the gel correctly. This medicated gel contains testosterone. You are encouraged to report negative side effects of prescription drugs to the FDA. Additionally, there were no clinically significant changes from baseline for SHBG (slight decrease), estradiol (slight increase), and ratio of DHT to total testosterone (slight increase) at Day 90. A mean (SD) of 0.24 (0.009) mg of residual testosterone (ie, 94.3% reduction compared to when application site was not washed) was recovered after application site washing.
