Dosage & Administration
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AndroGel Prescribing Information
- 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 unwashed or unclothed application sites in men using testosterone gel [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), Warnings and Precautions ( 5.2) and Patient Counseling Information ( 17)].
AndroGel 1.62% 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 AndroGel 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
- Safety and efficacy of AndroGel 1.62% 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 [see Indications and Usage ( 1), and Clinical Pharmacology ( 12.3)].
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)
Prior to initiating AndroGel 1.62%, 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 AndroGel 1.62% is 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet) 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 or a single 20.25 mg packet) and a maximum of 81 mg of testosterone (4 pump actuations or two 40.5 mg packets). 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 or the equivalent of one 20.25 mg packet) |
| 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 or the equivalent of one 20.25 mg packet) |
The application site and dose of AndroGel 1.62% are not interchangeable with other topical testosterone products.
2.2 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, genitals, chest, armpits (axillae), or knees [see Clinical Pharmacology ( 12.3)]. 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 (for pump) and Table 3 (for packets) and in Figure 1.
Table 2: Application Sites for AndroGel 1.62%, Pump
| 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 |
Table 3: Application Sites for AndroGel 1.62%, Packets
| Total Dose of Testosterone | Total packets | Gel Applications Per Upper Arm and Shoulder | |
| Upper Arm and Shoulder #1 | Upper Arm and Shoulder #2 | ||
| 20.25 mg | One 20.25 mg packet | One 20.25 mg packet | 0 |
| 40.5 mg | One 40.5 mg packet | Half of contents of One 40.5 mg packet | Half of contents of One 40.5 mg packet |
| 60.75 mg | One 20.25 mg packet AND One 40.5 mg packet | One 40.5 mg packet | One 20.25 mg packet |
| 81 mg | Two 40.5 mg packets | One 40.5 mg packet | One 40.5 mg packet |
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%
Once the application site is dry, the site should be covered with clothing [see Clinical Pharmacology ( 12.3)]. 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 ( 12.3)].
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.
When using packets, the entire contents should be squeezed into the palm of the hand and immediately applied to the application sites. When 40.5 mg packets need to be split between the left and right shoulder, 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. Alternatively, AndroGel 1.62% can be applied directly to the application sites from the pump or packets.
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.
AndroGel (testosterone gel) 1.62% for topical use only, is available as follows:
- A metered-dose pump. Each pump actuation delivers 20.25 mg of testosterone in 1.25 g of gel.
- A unit dose packet containing 20.25 mg of testosterone in 1.25 g of gel.
- A unit dose packet containing 40.5 mg of testosterone in 2.5 g of gel.
8.1 Pregnancy
Risk Summary
AndroGel 1.62% is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action [see Contraindications ( 4) and Clinical Pharmacology ( 12.1)]. Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies.
Data
Animal Data
In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis. Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased ano-genital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. Increased pituitary weight was seen in both sexes.
Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. Hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy.
8.2 Lactation
Risk Summary
AndroGel 1.62% is not indicated for use in women.
8.3 Females and Males of Reproductive Potential
Infertility
Testis disorder, testicular atrophy, and oligospermia have been identified during use of AndroGel 1.62% [see Adverse Reactions ( 6.1, 6.2)].
During treatment with large doses of exogenous androgens, including AndroGel 1.62%, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see Warnings and Precautions ( 5.8)]. Reduced fertility is observed in some men taking testosterone replacement therapy. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [see Drug Abuse and Dependence ( 9.2)]. With either type of use, the impact on fertility may be irreversible.
8.4 Pediatric Use
The safety and effectiveness of AndroGel 1.62% in pediatric patients less than 18 years old has not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
8.5 Geriatric Use
There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing AndroGel 1.62% to determine whether efficacy in those over 65 years of age differs from younger subjects. Of the 234 patients enrolled in the clinical trial utilizing AndroGel 1.62%, 21 were over 65 years of age. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer.
Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH.
8.6 Renal Impairment
No studies were conducted involving patients with renal impairment.
8.7 Hepatic Impairment
No studies were conducted in patients with hepatic impairment.
- AndroGel 1.62% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.1) and Adverse Reactions ( 6.1)].
- AndroGel 1.62% is contraindicated in women who are pregnant. AndroGel 1.62% can cause virilization of the female fetus when administered to a pregnant woman. Pregnant women need to be aware of the potential for transfer of testosterone from men treated with AndroGel 1.62%. If a pregnant woman is exposed to AndroGel 1.62%, she should be apprised of the potential hazard to the fetus [see Warnings and Precautions ( 5.2) and Use in Specific Populations ( 8.1)].