AndroGel 1.62

INDICATIONS

AndroGel 1.62% is an androgen 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): idiopathic 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.

Important limitations of use: Safety and efficacy of AndroGel 1.62% in males < 18 years old have not been established [See Use In Specific Populations].

DOSAGE AND ADMINISTRATION

Dosage and Administration for AndroGel 1.62% differs from AndroGel 1%. For dosage and administration of AndroGel 1% refer to its full prescribing information. (2)

Dosing and Dose Adjustment

The recommended starting dose of AndroGel 1.62% is 40.5 mg of testosterone (2 pump actuations) applied topically once daily in the morning to the shoulders and upper arms.

The dose can be adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation) and a maximum of 81 mg of testosterone (4 pump actuations). To ensure proper dosing, the dose should be titrated based on the pre-dose morning serum testosterone concentration from a single blood draw at approximately 14 days and 28 days after starting treatment or following dose adjustment. In addition, serum testosterone concentration should be assessed periodically thereafter. Table 1 describes the dose adjustments required at each titration step.

Table 1: Dose Adjustment Criteria

Pre-Dose Morning Total Serum Testosterone Concentration Dose Titration
Greater than 750 ng/dL Decrease daily dose by 20.25 mg (1 pump actuation)
Equal to or greater than 350 and equal to or less than 750 ng/dL No change: continue on current dose
Less than 350 ng/dL Increase daily dose by 20.25 mg (1 pump actuation)

The application site and dose of AndroGel 1.62% are not interchangeable with other topical testosterone products.

Administration Instructions

AndroGel 1.62% should be applied to clean, dry, intact skin of the upper arms and shoulders. Do not apply AndroGel 1.62% to any other parts of the body, including the abdomen or genitals [see CLINICAL PHARMACOLOGY]. Area of application should be limited to the area that will be covered by the patient's short sleeve t-shirt. Patients should be instructed to use the palm of the hand to apply AndroGel 1.62% and spread across the maximum surface area as directed in Table 2 and in Figure 1.

Table 2: Application Sites for AndroGel 1.62%

Total Dose of Testosterone Total Pump Actuations Pump Actuations Per Upper Arm and Shoulder
Upper Arm and Shoulder #1 Upper Arm and Shoulder #2
20.25 mg 1 1 0
40.5 mg 2 1 1
60.75 mg 3 2 1
81 mg 4 2 2

The prescribed daily dose of AndroGel 1.62% should be applied to the right and left upper arms and shoulders as shown in the shaded areas in Figure 1.

Figure 1: Application Sites for AndroGel 1.62%

Application Sites - Illustration

Once the application site is dry, the site should be covered with clothing [see CLINICAL PHARMACOLOGY]. Wash hands thoroughly with soap and water. Avoid fire, flames or smoking until the gel has dried since alcohol based products, including AndroGel 1.62%, are flammable.

The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application [see CLINICAL PHARMACOLOGY].

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, fully depress the actuator once for every 20.25 mg of AndroGel 1.62%. AndroGel 1.62% should be delivered directly into the palm of the hand and then applied to the application sites. Alternatively, AndroGel 1.62% can be applied directly to the application sites.

Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from AndroGel 1.62%-treated skin:

  • Children and women should avoid contact with unwashed or unclothed application site(s) of men using AndroGel 1.62%.
  • AndroGel 1.62% should only be applied to the upper arms and shoulders. The area of application should be limited to the area that will be covered by a short sleeve t-shirt.
  • Patients should wash their hands with soap and water immediately after applying AndroGel 1.62%.
  • Patients should cover the application site(s) with clothing (e.g., a t-shirt) after the gel has dried.
  • Prior to situations in which direct skin-to-skin contact 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 AndroGel 1.62% 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.

HOW SUPPLIED

Dosage Forms And Strengths

AndroGel (testosterone gel) 1.62% for topical use only, is supplied in a metered-dose pump. One pump actuation delivers 20.25 mg of testosterone.

Storage And Handling

AndroGel 1.62% is supplied in a metered-dose pump that delivers 20.25 mg of testosterone per complete pump actuation. The pump is composed of plastic and stainless steel and an LDPE/aluminum foil inner liner encased in rigid plastic with a polypropylene cap. The metered-dose pump is capable of dispensing 60 metered pump actuations. One pump actuation delivers 1.25 g of gel.

NDC 0051-8462-33

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature].

Used AndroGel 1.62% pumps should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Marketed by: Abbott Laboratories, North Chicago, IL, 60064, U.S.A. Revised: 04/2011

Last reviewed on RxList: 6/8/2011
This monograph has been modified to include the generic and brand name in many instances.

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