Fortesta

Fortesta^® was a prescription testosterone gel medication used to treat men with hypogonadism, or low testosterone. As a topical gel, Fortesta delivered testosterone transdermally (i.e., through the skin) to help restore normal hormone levels. 

Fortesta improved symptoms of hypogonadism, such as fatigue, decreased libido, muscle loss, and mood disturbances. Clinical studies have shown that testosterone replacement therapy (TRT) with medications like Fortesta can enhance energy levels, bone density, and overall well-being in men with confirmed testosterone deficiency.

While Fortesta is no longer available in the United States, other testosterone gels can treat hypogonadism as well as other forms of TRT, including testosterone patches, injections, pellets, and oral pills. 

Overall, TRT, including in gel form, should only be used as prescribed by a healthcare provider in order to ensure proper dosing and to minimize risks.

Fortesta (testosterone) is indicated for:

• Replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

  • Primary hypogonadism (congenital or acquired)

  • Hypogonadotrophic hypogonadism (congenital or acquired)

Androgen

The most common adverse reaction (incidence ≥3%) is:

• Skin reactions at the application site (16.1%)

Fortesta has been discontinued in the US and is no longer available to purchase.

• Men with carcinoma of the breast or known or suspected prostate cancer

• Pregnant or breastfeeding women. Testosterone may cause fetal harm

• Drug interactions: Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients, changes in anticoagulant activity may be seen with androgens, use of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention

• Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH

• Avoid unintentional exposure of women or children to Fortesta

• Exogenous administration of androgens may lead to azoospermia

• Edema with or without congestive heart failure (CHF) may be a complication in patients with pre-existing cardiac, renal, or hepatic disease

• Sleep apnea may occur in those with risk factors

• Monitor serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests and lipid concentrations periodically

• Fortesta is flammable until dry

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

Virilization has been reported in children who were secondarily exposed to testosterone gel.

Children should avoid contact with unwashed or unclothed application sites in men using Fortesta.

Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

*This information is from the label for brand name Fortesta^®. See the Full Prescribing Information for more complete information. Testosterone, the active ingredient in Fortesta, may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient testosterone.