TESTOSTERONE- testosterone solution
Natco Pharma USA LLC
- Virilization has been reported in children who were secondarily exposed to topical testosterone products [see Warnings and Precautions (5.2)] .
- Children should avoid contact with unwashed or unclothed application sites in men using Testosterone Topical Solution [see Dosage and Administration (2.2) and Warnings and Precautions (5.2)] .
- Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration (2.2) and Warnings and Precautions (5.2) and Patient Counseling Information (17)] .
Testosterone Topical Solution 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 cryptor chidism, 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 concentrations and gonadotropins (FSH, LH) above the normal range.
- Hypogonadotropic hypogonadism (congenital or acquired): gonadotropic 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 Testosterone Topical Solution in men with “age-related hypogonadism’ (also referred to as “late-onset hypogonadism”) have not been established.
- Safety and efficacy of Testosterone Topical Solution in males < 18 years old have not been established [see Use in Specific Populations (8.4)].
Prior to initiating Testosterone Topical Solution, 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 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 to 1050 ng/dL) are achieved. The Testosterone Topical Solution dose can be adjusted based on the serum testosterone concentration from a single blood draw 2 to 8 hours after applying Testosterone Topical Solution 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), Testosterone Topical Solution therapy should be discontinued.
The application site and dose of Testosterone Topical Solution are not interchangeable with other topical testosterone products.
Testosterone Topical Solution is applied to the axilla, preferably at the same time each morning, to clean, dry, intact skin. Do not apply Testosterone Topical Solution 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 Testosterone Topical Solution, are flammable.
When deodorants or antiperspirants are used as part of a regular program for personal hygiene, they should not interfere with the efficacy of Testosterone Topical Solution in treating hypogonadism. If patients use an antiperspirant or deodorant (stick or roll-on) then it should be applied prior to the application of Testosterone Topical Solution 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 Testosterone Topical Solution [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)].
Testosterone Topical Solution is available as a pump actuated metered-dose pump.
Pump Actuated Metered-Dose Pump
Testosterone Topical Solution is applied to the axilla using an applicator. When using Testosterone Topical Solution 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 Testosterone Topical Solution 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.
|Daily Prescribed Dose Testosterone||Number of Pump of Application||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 Testosterone Topical Solution 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 Testosterone Topical Solution treated skin:
- Children and women should avoid contact with the unclothed or unwashed application sites on the skin of men using Testosterone Topical Solution.
- Patients should wash their hands immediately with soap and water after application of Testosterone Topical Solution.
- 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 Testosterone Topical Solution 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.
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