The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. There have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure (Table 4). Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In a letter dated December 1, 2023, Endo Operations Ltd., notified FDA that FORTESTA (testosterone) gel, 10 mg/0.5 gm actuation, was being discontinued, and FDA moved the drug product to the "Discontinued Drug Product List" section of the Orange Book. If this occurs, the child may have unwanted side effects due to testosterone gel. The dose was adjusted between a minimum of 10 mg and a maximum of 70 mg testosterone on the basis of total serum testosterone concentration obtained 2 hours post FORTESTA application on Days 14, 35, and 60 (± 3 days). Alcohol based products, including FORTESTA, are flammable; therefore, patients should be advised to avoid smoking, fire, or flame until the FORTESTA gel has dried.
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.
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.
Once the application site is dry, the site should be covered with clothing see CLINICAL PHARMACOLOGY. FORTESTA should be applied directly to clean, dry, intact skin of the front and inner thighs. Table 1 describes the dose adjustments required at each titration step. The active pharmacologic ingredient in Fortesta is testosterone. In pregnant or breastfeeding women, Fortesta may cause fetal harm.
Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease see ADVERSE REACTIONS. Androgens, including FORTESTA, may promote retention of sodium and water. Long-term therapy with testosterone enanthate has produced multiple hepatic adenomas. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids.
The safety and effectiveness of this drug in the pediatric population has not been studied; children and women should avoid topical contact on skin or clothing. Fortesta may cause adverse reactions if accidently contacted by women or children; it can even be transferred to others topically by clothing. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FORTESTA can transfer from your body to others including, children and women.
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.
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.