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:

1. 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 levels and gonadotropins (FSH, LH) above the normal range.
2. 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 levels but have gonadotropins in the normal or low range.

Testim^® has not been clinically evaluated in males under 18 years of age.

DOSAGE AND ADMINISTRATION

The recommended starting dose of Testim^® is 5 g of gel (one tube) containing 50 mg of testosterone applied once daily (preferably in the morning) to clean, dry intact skin of the shoulders and/or upper arms. Morning serum testosterone levels should then be measured approximately 14 days after initiation of therapy to ensure proper serum testosterone levels are achieved. If the serum testosterone concentration is below the normal range, or if the desired clinical response is not achieved, the daily Testim^® dose may be increased from 5 g (one tube) to 10 g (two tubes) as instructed by the physician.

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. 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.

In order to prevent transfer to another person, clothing should be worn 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.

In order to maintain serum testosterone levels in the normal range, the sites of application should not be washed for at least two hours after application of Testim^®.

Do not apply Testim^® to the genitals or to the abdomen.

HOW SUPPLIED

Testim^® contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. 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	Strength	Package Size
66887-001-05	1% (50 mg)	30 tubes: 5 g per tube

Storage

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

Disposal

Used Testim^® tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.

RX Only

Manufactured for:

Auxilium Pharmaceuticals, Inc.

Norristown, PA, 19401 USA

By: Contract Pharmaceuticals Limited

Mississauga, Ontario, Canada L5N 6L6

Labeling Code: AA2500.09

Issued: January 2005

0105-001.a

127997