Once-a-day gel for low testosterone
Once-a-day gel for low testosterone
Pharmacologic class: Androgen
Active ingredient: Testosterone 10 mg/0.5 g actuation; metered-dose pump; topical gel.
Indication: Primary hypogonadism. Hypogonadotropic hypogonadism.
Pharmacology: Fortesta is a topical gel formulation of the androgen testosterone, indicated as replacement therapy in men for conditions associated with a deficiency or absence of the endogenous hormone. When applied correctly, it provides a continuous delivery of testosterone for 24 hours. Daily dosing supplies a physiologic amount of testosterone, producing serum concentrations that approximate those levels seen in healthy men.
Primary hypogonadism, or testicular failure, associated with conditions such as cryptorchidism, bilateral torsion, orchiectomy, chemotherapy, or heavy metal toxicity, as well as idiopathic gonadotropin or luteinizing hormone-releasing hormone deficiency and pituitary-hypothalamic injury, can be treated with testosterone replacement.
Clinical trials: A multicenter, open-label, noncomparative 90-day trial was conducted involving 149 hypogonadal men between ages 18 and 75 years. A starting dose of 40 mg/day was used, which was subsequently adjusted to between 10 mg/day and 70 mg/day based on serum testosterone levels obtained two hours after application on Days 14, 35, and 60. The primary endpoint was the percentage of patients with average serum concentrations within the normal range (≥300 ng/dL to ≤1,140 ng/dL) on Day 90. In patients treated with the study drug, 77.5% had average serum concentrations within the normal range on Day 90.
The secondary endpoint was the percentage of patients with maximum serum concentrations above three predetermined limits. On Day 90, 5.4% of patients had maximum serum concentrations greater than 1,500 ng/dL, and 1.6% of patients had maximum serum concentrations between 1,800 ng/dL and 2,499 ng/dL.
Mean serum levels were observed to remain above the lower limit of normal for the 24-hour dosing interval.
Adults: Patients should be advised to strictly adhere to the recommended instructions. ≥18 years: Apply to clean, dry, intact skin on front and inner thighs only. Initially 40 mg (four pump actuations) once daily in the am. Adjust based on serum testosterone levels (see literature); minimum: 10 mg/day, maximum: 70 mg/day. Wash hands after application; do not wash site for two hours after application; cover site with clothing. Prime pump before first use. Not interchangeable with other testosterone products.
Children: <18 years: not recommended.
Contraindications: Known or suspected prostate or breast cancer. Pregnancy (Cat. X). Nursing mothers.
Warnings/Precautions: Secondary exposure to testosterone; promptly discontinue if signs of virilization in children and women occur until cause is identified. Children and women must avoid contact with unwashed or unclothed application sites. Evaluate for prostate cancer before starting therapy. Monitor for worsening benign prostatic hyperplasia. Pre-existing cardiac, renal, or hepatic disease. Periodically monitor serum testosterone, prostate-specific antigen, hemoglobin, hematocrit, liver function, lipid profile, prothrombin time/ international normalized ratio. Monitor serum calcium if risk of hypercalcemia. Product is flammable.
Interactions: Antidiabetic drugs may need adjustment. Adrenocorticotropic hormone, corticosteroids: increased fluid retention.
Adverse reactions: Application site reactions, androgenic effects, fluid retention, azoospermia, gynecomastia, sleep apnea, abnormal dreams.
How supplied: Pump (120 actuations)—1, 2, 3.
For more information, call 800.462.3636 or visit www.Fortestagel.com.