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New FORTESTA(R) (testosterone) Gel
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INDICATION
FORTESTA® (testosterone) Gel is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
  • Primary hypogonadism (congenital or acquired) – testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol, heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH)) above the normal range
  • Hypogonadotropic hypogonadism (congenital or acquired) – idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations but have gonadotropins in the normal or low range
Important limitations of use: Safety and efficacy of FORTESTA Gel in males <18 years old have not been established.
IMPORTANT SAFETY INFORMATION
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 Gel
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use
  • FORTESTA Gel is contraindicated in men with carcinoma of the breast or known or suspected prostate cancer and in women who are, or may become pregnant, or who are breast-feeding. FORTESTA Gel may cause fetal harm and serious adverse reactions to nursing infants
  • Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Patients treated with androgens may be at an increased risk for prostate cancer. Evaluation of the patients for the presence of prostate cancer prior to initiating and during treatment with androgens is appropriate
  • Avoid unintentional exposure of women or children to FORTESTA Gel. Secondary exposure to testosterone can produce signs of virilization. Signs of virilization and the possibility of secondary exposure should be brought to the attention of the HCP. FORTESTA Gel should be discontinued until the cause of virilization is identified
  • To minimize the potential for transfer to others, strict adherence to the following is advised:
    • Children and women should avoid contact with unwashed or unclothed application site(s) in men using FORTESTA Gel
    • To minimize the potential for transfer to others, patients using FORTESTA Gel should apply the product as directed and strictly adhere to the following: 1) Wash hands with soap and water after application; 2) Cover the application site with clothing after the gel has dried; 3) Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated
    • If unwashed or uncovered skin to which FORTESTA Gel was applied comes in direct contact with the skin of another person, the area of contact should be washed with soap and water as soon as possible
  • Increases of hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. An increase in red blood cell mass may increase the risk of thromboembolic events
  • Due to lack of controlled evaluations in women and potential virilizing effects, FORTESTA Gel is not indicated for use in women
  • Exogenous administration of androgens, including FORTESTA Gel, may lead to azoospermia through suppression of spermatogenesis, gynecomastia, sleep apnea (especially in those with risk factors such as obesity and chronic lung diseases), decreased concentrations of thyroxin-binding globulins, changes in insulin sensitivity or glycemic control (that may decrease insulin requirements in diabetic patients), and changes in anticoagulant activity
  • Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease
  • Use of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal or hepatic disease
  • Monitor serum testosterone, prostate-specific antigen, hemoglobin, hematocrit, liver function tests, serum calcium concentrations, INR and prothrombin time, and lipid concentrations periodically. Changes may require dose adjustment or discontinuation of FORTESTA Gel
  • Use FORTESTA Gel with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria)
  • FORTESTA Gel is flammable until dry
  • There are insufficient long-term data in geriatric patients using FORTESTA Gel to assess potential risks of cardiovascular disease and prostate cancer
  • Do not apply FORTESTA Gel to the genitals
  • The most common adverse reaction (incidence ≥3%) is skin reactions at the application site (16.1%)
Please see the full Prescribing Information including the Boxed Warning.