Testim (Testosterone) - Indications and Dosage

INDICATIONS AND USAGE

Testim^® is indicated for testosterone 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 cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], 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 testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitations of use:

• Safety and efficacy of Testim in males less than 18 years old have not been established [see Use in Specific Populations ].
• Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Dosage and Administration and Clinical Pharmacology].

DOSAGE AND ADMINISTRATION

Dosing and Dose Adjustment

The recommended starting dose of Testim^® is 50 mg of testosterone (one tube) applied once daily (preferably in the morning) to clean, dry intact skin of the shoulders and/or upper arms.

Dose Adjustment

To ensure proper dosing, serum testosterone concentrations should be measured. Morning, pre-dose serum testosterone concentrations should be measured approximately 14 days after initiation of therapy to ensure proper serum testosterone concentrations are achieved.  If the serum testosterone concentration is below the normal range (300 ng/dL to 1,000 ng/dL), the daily Testim dose may be increased from 50 mg testosterone (one tube) to 100 mg testosterone (two tubes) once daily.

The maximum recommended dose of Testim is 100 mg once daily.

The application site and dose of Testim are not interchangeable with other topical testosterone products.

Administration Instructions

Upon opening the tube the entire contents should be squeezed into the palm of the hand and immediately applied to the shoulders and/or upper arms (area of application should be limited to the area that will be covered by the patient’s short sleeve T-shirt (see figure below). Do not apply Testim to the genitals or to the abdomen.

Application sites should be allowed to dry for a few minutes prior to dressing.  Hands should be washed thoroughly with soap and water after Testim has been applied. Avoid fire, flame or smoking during the application of Testim until the Testim has dried [see Warnings and Precautions].

In order to prevent transfer to another person, wear clothing to cover the application sites. If direct skin-to-skin contact with another person is anticipated, the application sites must be washed thoroughly with soap and water [see Warnings and Precautions and Clinical Pharmacology].

The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application [see Clinical Pharmacology].

Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from Testim-treated skin:

• Children and women should avoid contact with unwashed or unclothed application site(s) of men using Testim.
• Testim should only be applied to the upper arms and shoulders. The area of application should be limited to the area that will be covered by a short sleeve T-shirt.
• Patients should wash their hands with soap and water immediately after applying Testim.
• Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the gel has dried.
• Prior to situations in which direct skin-to-skin contact 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 Testim 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.

DOSAGE FORMS AND STRENGTHS

Testim® (testosterone gel) for topical use is available in a unit-dose tube. Each tube contains 50 mg testosterone in 5 g of gel.

HOW SUPPLIED/STORAGE AND HANDLING

Repackaged by A-S Medication Solutions - Libertyville, IL See REPACKAGING INFORMATION for available configurations.

Testim is supplied in unit-dose tubes in cartons of 30.  Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:

NDC Number	Package Size
66887-001-05	30 tubes: 50 mg testosterone in 5 g of gel per tube

Store at 20° to 25°C (68°F to 77°F). Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Discard used Testim tubes in household trash in a manner that prevents accidental exposure of women, children, or pets [see Boxed Warning and Warnings and Precautions ]. Contents are flammable [see Warnings and Precautions].