AXIRON is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
- Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as 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 (FSH, LH) above the normal range.
- Hypogonadotropic hypogonadism (congenital or acquired): 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 AXIRON in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
- Safety and efficacy of AXIRON in males < 18 years old have not been established [see Use In Specific Populations].
DOSAGE AND ADMINISTRATION
Prior to initiating AXIRON, 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.
Dosing And Dose Adjustment
The recommended starting dose of AXIRON (testosterone) topical solution is 60 mg of testosterone (2 pump actuations) applied once daily.
To ensure proper dosing, serum testosterone concentrations should be measured after initiation of therapy to ensure that the desired concentrations (300 ng/dL-1050 ng/dL) are achieved. The AXIRON dose can be adjusted based on the serum testosterone concentration from a single blood draw 2 – 8 hours after applying AXIRON and at least 14 days after starting treatment or following dose adjustment.
If the measured serum testosterone concentration is below 300 ng/dL, the daily testosterone dose may be increased from 60 mg (2 pump actuations) to 90 mg (3 pump actuations) or from 90 mg to 120 mg (4 pump actuations). If the serum testosterone concentration exceeds 1050 ng/dL, the daily testosterone dose should be decreased from 60 mg (2 pump actuations) to 30 mg (1 pump actuation) as instructed by a physician. If the serum testosterone concentration consistently exceeds 1050 ng/dL at the lowest daily dose of 30 mg (1 pump actuation), AXIRON therapy should be discontinued.
The application site and dose of AXIRON are not interchangeable with other topical testosterone products.
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].
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].
Table 1: Application
|Daily Prescribed Dose of Testosterone||Number of Pump Actuations||Application|
|30 mg||1 (once daily)||Apply once to one axilla only (left OR right)|
|60 mg||2 (once daily)||Apply once to the left axilla and then apply once to the right axilla.|
|90 mg||3 (once daily)||Apply once to the left and once to the right axilla, wait for the product to dry, and then apply once again to the left OR right axilla.|
|120 mg||4 (once daily)||Apply once to the left and once to the right axilla, wait for the product to dry, and then apply once again to the left AND once to the right axilla.|
Hands should be washed thoroughly with soap and water after AXIRON has been applied [see WARNINGS AND PRECAUTIONS].
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.
Dosage Forms And Strengths
AXIRON is a (testosterone) topical solution available as a metered-dose pump. One pump actuation delivers 30 mg of testosterone. Each metered-dose pump is supplied with an applicator.
AXIRON (testosterone) topical solution is available as a metered-dose pump containing 110 mL of solution. The pump is capable of dispensing 90 mL of solution in 60 metered pump actuations. One pump actuation delivers 30 mg of testosterone in 1.5 mL of solution. Each metered-dose pump is supplied with an applicator. The bottle and the applicator cup are not made with natural rubber latex.
Storage And Handling
Keep AXIRON out of reach of children.
Store at 25°C (77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.
Used AXIRON bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets.
Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA. Revised: May 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/8/2015
Additional Axiron Information
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