Testim

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.

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 (5.2), (5.14)].

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 (5.2) and Clinical Pharmacology (12.3)].

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)].

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

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.

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 (area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt). 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 (area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt). 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.

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 (area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt). 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 (area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt). 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.

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 (area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt). 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 (area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt). 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.

Prior to initiating, Testim confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

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.

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 (5.2), (5.14)].

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 (5.2) and Clinical Pharmacology (12.3)].

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)].

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