Testosterone

TESTOSTERONE- testosterone gel
REMEDYREPACK INC.

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

  • Virilization has been reported in children who were secondarily exposed to testosterone gel [ see Warnings and Precautions (5.2) and Adverse Reactions (6.2) ] .
  • Children should avoid contact with any unwashed or unclothed application sites in men using testosterone gel [ see Dosage and Administration (2.2), Warnings and Precautions (5.2) ] .
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use [ see Dosage and Administration (2.2), Warnings and Precautions (5.2) and Patient Counseling Information (17) ] .

1 INDICATIONS AND USAGE

Testosterone gel is indicated for replacement therapy in adult 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 (follicle stimulating hormone (FSH), luteinizing hormone (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 testosterone gel in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
  • Safety and efficacy of testosterone gel in males less than 18 years old have not been established [ see Use in Specific Populations (8.4) ].
  • Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. (1, 12.3)

2 DOSAGE AND ADMINISTRATION

Prior to initiating testosterone gel, 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.

2.1 Dosing and Dose Adjustment

The recommended starting dose of testosterone gel 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 levels should be measured at intervals. If the serum testosterone concentration is below the normal range, the daily testosterone gel 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). If the serum testosterone concentration exceeds the normal range, the daily testosterone gel dose may be decreased. If the serum testosterone concentration consistently exceeds the normal range at a daily dose of 50 mg, testosterone gel therapy should be discontinued. In addition, serum testosterone concentration should be assessed periodically.

2.2 Administration Instructions

Testosterone gel 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 to any other part of the body including the genitals, chest, armpits (axillae), knees, or back. Testosterone gel 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 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.

Figure 1
(click image for full-size original)

After applying the gel, the application site should be allowed to dry prior to dressing. Hands should be washed with soap and water after testosterone gel has been applied. Avoid fire, flames or smoking until the gel has dried since alcohol based products, including testosterone gel, are flammable.

The patient should be advised to avoid swimming or showering for at least 5 hours after the application of testosterone gel.

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 can be applied directly to the application sites.

Table 1 provides dosing information for adult males.

Table 1
(click image for full-size original)

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-treated skin:

  • Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel.
  • Patients should wash their hands immediately with soap and water after applying testosterone gel.
  • Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the gel has dried.
  • Prior to any situation in which skin-to-skin contact with the application site is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue.
  • In the event that unwashed or unclothed skin to which testosterone gel 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.
Figure 1Table 1

3 DOSAGE FORMS AND STRENGTHS

Testosterone gel for topical use is available as follows:

  • A metered-dose pump. Each pump actuation delivers 12.5 mg of testosterone in 1.25 g of gel.
  • A unit dose packet containing 25 mg of testosterone provided in 2.5 g of gel.
  • A unit dose packet containing 50 mg of testosterone provided in 5 g of gel.

4 CONTRAINDICATIONS

  • Testosterone gel is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [ see Warnings and Precautions (5.1), Adverse Reactions (6.1), and Nonclinical Toxicology (13.1) ].
  • Testosterone gel is contraindicated in women who are or may become pregnant, or who are breastfeeding. Testosterone gel may cause fetal harm when administered to a pregnant woman. Testosterone gel may cause serious adverse reactions in nursing infants. Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with testosterone gel. If a pregnant woman is exposed to testosterone gel, she should be apprised of the potential hazard to the fetus [ see Warnings and Precautions (5.2) and Use in Specific Populations (8.1, 8.3) ].

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