FORTESTA- testosterone gel, metered
Endo Pharmaceuticals Inc.
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
- Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].
- Children should avoid contact with unwashed or unclothed application sites in men using FORTESTA [see Dosage and Administration (2.2) and Warnings and Precautions (5.2)].
- Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration (2.2), Warnings and Precautions (5.2), and Patient Counseling Information (17)].
1 INDICATIONS AND USAGE
FORTESTA is indicated for replacement therapy in 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) – 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.
Limitations of Use
- Safety and efficacy of FORTESTA in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
- Safety and efficacy of FORTESTA in males <18 years old have not been established [see Use in Specific Populations (8.4)].
2 DOSAGE AND ADMINISTRATION
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.
2.1 Dosing and Dose Adjustment
The recommended starting dose of FORTESTA is 40 mg of testosterone (4 pump actuations) applied once daily to the thighs in the morning. The dose can be adjusted between a minimum of 10 mg of testosterone and a maximum of 70 mg of testosterone. To ensure proper dosing, the dose should be titrated based on the serum testosterone concentration from a single blood draw 2 hours after applying FORTESTA at approximately 14 days and 35 days after starting treatment or following dose adjustment. In addition, serum testosterone concentration should be assessed periodically thereafter. Table 1 describes the dose adjustments required at each titration step.
|Total Serum Testosterone Concentration 2 hours Post FORTESTA Application||Dose Titration|
|Equal to or greater than 2,500 ng/dL||Decrease daily dose by 20 mg (2 pump actuations)|
|Equal to or greater than 1,250 and less than 2,500 ng/dL||Decrease daily dose by 10 mg (1 pump actuation)|
|Equal to or greater than 500 and less than 1,250 ng/dL||No change: continue on current dose|
|Less than 500 ng/dL||Increase daily dose by 10 mg (1 pump actuation)|
The application site and dose of FORTESTA are not interchangeable with other topical testosterone products.
2.2 Administration Instructions
FORTESTA should be applied directly to clean, dry, intact skin of the front and inner thighs. Do not apply FORTESTA to the genitals or other parts of the body. Patients should be instructed to use one finger to gently rub FORTESTA evenly onto the front and inner area of each thigh as directed in Table 2.
|Total Dose of Testosterone||Total Pump Actuations||Pump Actuations per Thigh|
|Thigh #1||Thigh #2|
Once the application site is dry, the site should be covered with clothing [see Clinical Pharmacology (12.3)]. Wash hands thoroughly with soap and water. Avoid applying the gel to the thigh adjacent to the scrotum. Avoid fire, flames, or smoking until the gel has dried since alcohol based products, including FORTESTA, are flammable.
The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application [see Clinical Pharmacology (12.3)].
To obtain a full first dose, it is necessary to prime the canister pump. To do so, with the canister in the upright position, slowly and fully depress the actuator eight times. The first 3 actuations may result in no discharge of gel. Safely discard the gel from the first 8 actuations. It is only necessary to prime the pump before the first dose.
Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from FORTESTA-treated skin:
- Children and women should avoid contact with unwashed or unclothed application site(s) of men using FORTESTA.
- FORTESTA should only be applied to the front and inner thighs (area of application should be limited to the area that will be covered by the patient’s shorts or pants).
- Patients should wash their hands immediately with soap and water after applying FORTESTA.
- Patients should cover the application site(s) with clothing (eg, shorts of sufficient length or pants) after the gel has dried.
- Prior to any situation in which skin-to-skin contact with the application site is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue.
- In the event that unwashed or unclothed skin to which FORTESTA has been applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.
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