2 DOSAGE AND ADMINISTRATION Dosage and Administration for testosterone gel 1% differs from testosterone gel 1.62%. For dosage and administration of testosterone gel 1.62% refer to its full prescribing information. ( 2 ) Prior to initiating testosterone gel 1%, 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. Dosage and Administration for testosterone gel 1% differs from testosterone gel 1.62 %. For dosage and administration of testosterone gel 1.62% refer to its full prescribing information. ( 2 ) Prior to initiating testosterone gel 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2 ). Starting dose of testosterone gel 1% is 50 mg of testosterone (4 pump actuations, two 25 mg packets, or one 50 mg packet), applied once daily in the morning. ( 2.1 ) Apply to clean, dry, intact skin of shoulders and upper arms and/or abdomen. Do NOT apply testosterone gel 1% to any other parts of the body including the genitals, chest, armpits (axillae), knees, or back. ( 2.2 ) Dose adjustment: Testosterone gel 1% can be dose adjusted using 50 mg, 75 mg, or 100 mg of testosterone on the basis of total serum testosterone concentration. The dose should be titrated based on the serum testosterone concentration. Additionally, serum testosterone concentration should be assessed periodically. ( 2.1 ) Patients should wash hands immediately with soap and water after applying testosterone gel 1% and cover the application site(s) with clothing after the gel has dried. Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated. ( 2.2 ) 2.1 Dosing and Dose Adjustment The recommended starting dose of testosterone gel 1% is 50 mg of testosterone (4 pump actuations, two 25 mg packets, or one 50 mg packet), applied topically once daily in the morning to the shoulders and upper arms and/or abdomen area (preferably at the same time every day). Dose Adjustment To ensure proper dosing, serum testosterone concentrations should be measured at intervals. If the serum testosterone concentration is below the normal range, the daily testosterone gel 1% dose may be increased from 50 mg to 75 mg and from 75 mg to 100 mg for adult males as instructed by the physician (see Table 1, Dosing Information for testosterone gel 1%). If the serum testosterone concentration exceeds the normal range, the daily testosterone gel 1% dose may be decreased. If the serum testosterone concentration consistently exceeds the normal range at a daily dose of 50 mg, testosterone gel 1% therapy should be discontinued. In addition, serum testosterone concentrations should be assessed periodically. The application site and dose of testosterone gel 1% are not interchangeable with other topical testosterone products. 2.2 Administration Instructions Testosterone gel 1% should be applied to clean, dry, healthy, intact skin of the right and left upper arms/shoulders and/or right and left abdomen. Area of application should be limited to the area that will be covered by the patient’s short sleeve T-shirt. Do not apply testosterone gel 1% to any other part of the body including the genitals, chest, armpits (axillae), knees, or back. Testosterone gel 1% should be evenly distributed between the right and left upper arms/shoulders or both sides of the abdomen. The prescribed daily dose of testosterone gel 1% should be applied to the right and left upper arms/shoulders and/or right/left abdomen as shown in the shaded areas in the figure below. After applying the gel, the application site should be allowed to dry prior to dressing. Hands should be washed thoroughly with soap and water after application. Avoid fire, flames or smoking until the gel has dried since alcohol based products, including testosterone gel 1%, are flammable. The patient should be advised to avoid swimming or showering for at least 5 hours after the application of testosterone gel 1%. Multi-Dose Pump 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 three times. Safely discard the gel from the first three actuations. It is only necessary to prime the pump before the first dose. After the priming procedure, patients should completely depress the pump one time actuation for every 12.5 mg of testosterone required to achieve the daily prescribed dosage. The product should be delivered directly into the palm of the hand and then applied to the desired application sites. Alternatively, testosterone gel 1% can be applied directly to the application sites. Table 1 provides dosing information for adult males. Table 1: Dosing Information for Testosterone Gel 1% Amount of Testosterone Number of Pump Actuations 50 mg 4 (once daily) 75 mg 6 (once daily) 100 mg 8 (once daily) Packets The entire contents should be squeezed into the palm of the hand and immediately applied to the application sites. Alternately, patients may squeeze a portion of the gel from the packet into the palm of the hand and apply to application sites. Repeat until entire contents have been applied. Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from testosterone gel 1%-treated skin: Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel 1%. Patients should wash hands with soap and water immediately after application of testosterone gel 1%. Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the gel has dried. Prior to situation in which direct skin-to-skin contact is anticipated, patients should wash the application site thoroughly with soap and water to remove any testosterone residue. In the event that unwashed or unclothed skin to which testosterone gel 1% 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. The prescribed daily dose of testosterone gel 1% should be applied to the right and left upper arms/shoulders and/or right/left abdomen as shown in the shaded areas in the figure below.