AXIRON is applied to the axilla, preferably at the same time each morning, to clean, dry, intact skin. Do not apply AXIRON to other parts of the body including to the scrotum, penis, abdomen, shoulders or upper arms. After applying the solution, the application site should be allowed to dry completely prior to dressing. Avoid fire, flames or smoking until the solution has dried since alcohol based products, including AXIRON, are flammable. 

AXIRON is applied to the axilla using an applicator. When using AXIRON for the first time, patients should be instructed to prime the pump by depressing the pump three (3) times, discard any product dispensed directly into a basin, sink, or toilet and then wash the liquid away thoroughly. This priming should be done only prior to the first use of each pump. After priming, patients should completely depress the pump one time (one pump actuation) to dispense 30 mg of testosterone. To dispense the solution, position the nozzle over the applicator cup and carefully depress the pump fully once. Ensure that the liquid is directed into the cup. The cup should be filled with no more than 30 mg (1 pump actuation) of testosterone. Dosing that requires greater than one pump actuation must be applied in increments of 30 mg as is shown in Table 1. 

Keeping the applicator upright, patients should place it up into the axilla and wipe steadily down and up into the axilla. If the solution drips or runs, it can be wiped back up with the applicator cup. The solution should not be rubbed into the skin with fingers or hand. The process is then repeated with application of 30 mg of testosterone (1 pump actuation) to the other axilla to achieve a total of 60 mg of testosterone applied. For patients prescribed the 90 mg dose of testosterone, the procedure is the same, but three applications are required. To dose 120 mg of testosterone, four applications are required alternating left and right for each application as shown in Table 1. When repeat application to the same axilla is required, the axilla should be allowed to dry completely before more AXIRON is applied. 

After use, the applicator should be rinsed under room temperature, running water and then patted dry with a tissue. The applicator and cap are then replaced on the bottle for storage. 

When deodorants or antiperspirants are used as part of a regular program for personal hygiene, they should not interfere with the efficacy of AXIRON in treating hypogonadism. If patients use an antiperspirant or deodorant (stick or roll-on) then it should be applied prior to the application of AXIRON to avoid contamination of the stick or roll-on product. 

Patients should be advised to avoid swimming or washing the application site until two hours following application of AXIRON [see Clinical Pharmacology (12.3)]. 

To reduce the likelihood of interpersonal transfer of testosterone, the application site should always be washed prior to any skin-to-skin contact regardless of the length of time since application. [See Warnings and Precautions (5.2)]. 

Hands should be washed thoroughly with soap and water after AXIRON has been applied [see Warnings and Precautions (5.2)]. 

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

  * Children and women should avoid contact with the unclothed or unwashed application sites on the skin of men using AXIRON. 
  * Patients should wash their hands immediately with soap and water after application of AXIRON. 
  * Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the solution has dried. 
  * Prior to any 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 AXIRON 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. 



While interpersonal testosterone transfer can occur with a T-shirt on, it has been shown that transfer can be substantially reduced by wearing a T-shirt and the majority of residual testosterone is removed from the skin surface by washing with soap and water.