Dosing & Titration

The maintenance of normal testosterone levels

With AndroGel 1.62%, the total dose of testosterone can be adjusted between 20.25 mg and 81 mg in 20.25 mg increments based on the patient's response to therapy.

Dosing for Daily Application of AndroGel 1.62%¹
20.25 mg
PUMP: One pump actuation (once daily) in the morning	PACKETS: One 20.25 mg packet (once daily) in the morning
40.5 mg (Recommended Starting Dose)
PUMP: Two pump actuations (once daily) in the morning	PACKETS: One 40.5 mg packet (once daily) in the morning
60.75 mg
PUMP: Three pump actuations (once daily) in the morning	PACKETS: One 40.5 mg packet and one 20.25 mg packet (once daily) in the morning
81 mg
PUMP: Four pump actuations (once daily) in the morning	PACKETS: Two 40.5 mg packets (once daily) in the morning

Testosterone levels should be checked at 14 and 28 days after starting treatment and periodically thereafter.¹

Applying AndroGel 1.62%

The AndroGel 1.62% pump inside a bathroom cabinet

AndroGel 1.62% is a daily therapy. This means that patients with hypogonadism due to associated medical conditions need to commit to applying it every morning. Remind them that applying daily helps keep testosterone levels in a normal range. If therapy is stopped, testosterone levels could return to baseline in 48-72 hours.¹

APPLY¹

AndroGel 1.62% should be applied at the same time each morning to clean, dry, intact skin
Patients should apply AndroGel 1.62% only to the upper arm(s) and shoulder(s)
Instruct patients not to apply AndroGel 1.62% to any other parts of the body, including the abdomen, genitals, chest, armpits (axillae), or knees
The application area should be limited to the area that will be covered by a short-sleeve T-shirt

WASH¹

Patients should wash their hands with soap and water immediately after application
Patients should wash the application site(s) thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated

COVER¹

Patients should cover the application site(s) with clothing after the gel has dried
Children and women should avoid contact with unwashed or unclothed application site(s) of men using AndroGel 1.62%
In the event that AndroGel 1.62% 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

Safety Considerations¹

When you prescribe AndroGel 1.62% to your patients, it’s important to remind them of these steps for daily application to avoid unintentional exposure of women or children to AndroGel 1.62%. Secondary exposure to testosterone can produce signs of virilization. Exposure of a pregnant woman to AndroGel may result in potential hazard to the fetus. AndroGel 1.62% should be promptly discontinued until the cause of virilization is identified.

Titration guidelines for AndroGel 1.62%

Pre-dose morning serum total testosterone concentration

Dose titration

>750 ng/dL

Decrease daily dose by 20.25 mg

350-750 ng/dL

Continue on current dose

<350 ng/dL

Increase daily dose by 20.25 mg

Clinical trial titration rates: In the 182-day clinical study, 74% of patients had their dose titrated based on treatment response. Patients’ total serum testosterone levels were assessed on Days 14, 28, and 42, and dosing adjustments were made when indicated.³

Additional considerations for titration¹

Increase in hematocrit:

Monitor hematocrit prior to and periodically during treatment. Monitor hemoglobin periodically. Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone replacement therapy. An increase in red blood cell mass may increase the risk of thromboembolic events

Changes in serum lipid profile:

Monitor lipid concentrations periodically. Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy

AndroGel 1.62% and 1%: understanding the differences^1,2

There are differences between AndroGel 1.62% and AndroGel 1%. AndroGel 1.62% offers patients a more concentrated formulation of testosterone than AndroGel 1%.^1,2 The chart below shows other key differences, including application areas and dose adjustment.

AndroGel 1.62%¹	AndroGel 1%²
Packaging options (products are self-applied)
PUMP AND PACKETS: Pump (20.25 mg per pump press) AND Packets (20.25 mg or 40.5 mg testosterone gel)	PACKETS ONLY: (25 mg and 50 mg testosterone gel)
Amount of daily gel at starting dose^1,2
2.5 g of gel (40.5 mg)	5 g of gel (50 mg)
Application sites
2 application sites (shoulders and upper arms) Instruct patients not to apply AndroGel 1.62% to any other parts of the body, including the abdomen, genitals, chest, armpits (axillae), or knees. The application sites and dosage of AndroGel 1% and 1.62% are not interchangeable.	4 application sites (shoulders and upper arms, and/or stomach area) Instruct patients not to apply AndroGel 1% to any other part of the body including the genitals, chest, armpits (axillae), knees, or back. The application sites and dosage of AndroGel 1% and 1.62% are not interchangeable.
Dosing and application
AndroGel 1.62% AndroGel 1.62% recommended starting dose: 40.5 mg (2 pumps) applied to the shoulders and upper arms once daily in the morning AndroGel 1.62% should not be applied to any other areas of the body, including the abdomen or genitals AndroGel 1.62% is supplied in a single package including 1 metered-dose pump. AndroGel 1.62% is also supplied in 20.25 mg and 40.5 mg packets Dose adjustment: Titrate based on pre-dose morning serum testosterone levels from a single blood draw at approximately 14 days and 28 days after starting treatment or following dose adjustment, and assess serum testosterone levels periodically thereafter Dosing 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) Each 1.25 g pump actuation contains 20.25 mg of testosterone gel	AndroGel 1% AndroGel 1% recommended starting dose: 50 mg (5 grams of gel) applied to the shoulders and upper arms and/or stomach area once daily in the morning AndroGel 1% should not be applied to any other areas of the body, including the genitals AndroGel 1% is available in 25 mg and 50 mg testosterone packets Dose adjustment: Monitor serum testosterone levels initially and periodically during treatment and adjust dosing as needed Dosing can be adjusted between 50 mg (5 grams of gel) and 100 mg (10 grams of gel) of testosterone. If serum testosterone levels consistently exceed the normal range at a daily dose of 50 mg (5 grams of gel), AndroGel 1% therapy should be discontinued Each 1.25 g of gel contains 12.5 mg of testosterone

Safety Considerations for AndroGel 1% and AndroGel 1.62%^1,2

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

Children and women should avoid contact with unwashed or unclothed application site(s) of men using AndroGel.
Apply AndroGel 1% only to the shoulders, upper arms, or abdomen. Do not apply AndroGel 1% to any other part of the body including the genitals, chest, armpits (axillae), knees, or back. Apply AndroGel 1.62% to 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. The application area 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 application.
Cover the application site(s) with clothing after the gel has dried.
Wash the application site(s) thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated.
In the event that AndroGel 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.

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

In This Section

INDICATION AND IMPORTANT SAFETY INFORMATION

AndroGel^® (testosterone gel) 1% and 1.62% CIII are 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% and 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Safety and efficacy of AndroGel in males less than 18 years old have not been established.
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

IMPORTANT SAFETY INFORMATION^1,2

AndroGel^® (testosterone gel) 1% and 1.62% CIII are 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% and 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Safety and efficacy of AndroGel in males less than 18 years old have not been established.
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

IMPORTANT SAFETY INFORMATION^1,2

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

Virilization has been reported in children who were secondarily exposed to testosterone gel.
Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

AndroGel is contraindicated in men with breast cancer or known or suspected prostate cancer, and in women who are pregnant, as testosterone can cause virilization of the female fetus and is teratogenic and may cause fetal harm.
Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH.
Patients treated with androgens may be at increased risk for prostate cancer and should be evaluated prior to initiating and during treatment with androgens. Monitor prostate specific antigen (PSA) levels periodically.
Avoid unintentional exposure of women or children to AndroGel. Secondary exposure to testosterone can produce signs of virilization. AndroGel should be promptly discontinued until the cause of virilization is identified. Exposure of a pregnant woman to AndroGel may result in potential hazard to the fetus.
Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. An increase in red blood cell mass may increase the risk of thromboembolic events. Monitor hematocrit prior to and periodically during treatment. Monitor hemoglobin periodically.
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products such as AndroGel. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue AndroGel and initiate appropriate workup and management.
Some studies, but not all, have reported an increased risk of major cardiovascular events (MACE) in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use AndroGel.
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. If abuse is suspected, check serum testosterone concentrations and counsel patients concerning the serious adverse reactions associated with abuse. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
AndroGel is not indicated for use in women.
Treatment with AndroGel may lead to azoospermia; edema, which may be serious in patients with preexisting cardiac, renal, or hepatic disease or in patients taking adrenocorticotropic hormone (ACTH) or corticosteroids; gynecomastia; sleep apnea, especially in those with risk factors; changes in insulin sensitivity or glycemic control; and changes in anticoagulant activity.
Treatment with androgens may lead to serious hepatic effects. AndroGel is not known to cause these adverse effects. Monitor liver function tests (LFTs) periodically.
Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy. Monitor lipid concentrations periodically.
Androgens should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
Most common adverse reaction of AndroGel 1.62% (incidence ≥5%) is an increase in prostate specific antigen (PSA). Most common adverse reactions of AndroGel 1% (incidence ≥5%) are acne, application site reactions, abnormal lab tests, and prostatic disorders.
Dosage and administration for AndroGel 1.62% differs from AndroGel 1%. AndroGel is not interchangeable with other topical testosterone products.

Use in specific populations:

There are insufficient long-term safety data in geriatric patients using AndroGel to assess the potentially increased risks of cardiovascular disease and prostate cancer.

Please click here for full Prescribing Information, including BOXED WARNING on Secondary Exposure, for AndroGel 1% and AndroGel 1.62%.

INDICATION AND IMPORTANT SAFETY INFORMATION

AndroGel^® (testosterone gel) 1% and 1.62% CIII are 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% and 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Safety and efficacy of AndroGel in males less than 18 years old have not been established.
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

IMPORTANT SAFETY INFORMATION^1,2

AndroGel^® (testosterone gel) 1% and 1.62% CIII are 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% and 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Safety and efficacy of AndroGel in males less than 18 years old have not been established.
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

IMPORTANT SAFETY INFORMATION^1,2

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

Virilization has been reported in children who were secondarily exposed to testosterone gel.
Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

AndroGel is contraindicated in men with breast cancer or known or suspected prostate cancer, and in women who are pregnant, as testosterone can cause virilization of the female fetus and is teratogenic and may cause fetal harm.
Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH.
Patients treated with androgens may be at increased risk for prostate cancer and should be evaluated prior to initiating and during treatment with androgens. Monitor prostate specific antigen (PSA) levels periodically.
Avoid unintentional exposure of women or children to AndroGel. Secondary exposure to testosterone can produce signs of virilization. AndroGel should be promptly discontinued until the cause of virilization is identified. Exposure of a pregnant woman to AndroGel may result in potential hazard to the fetus.
Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. An increase in red blood cell mass may increase the risk of thromboembolic events. Monitor hematocrit prior to and periodically during treatment. Monitor hemoglobin periodically.
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products such as AndroGel. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue AndroGel and initiate appropriate workup and management.
Some studies, but not all, have reported an increased risk of major cardiovascular events (MACE) in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use AndroGel.
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. If abuse is suspected, check serum testosterone concentrations and counsel patients concerning the serious adverse reactions associated with abuse. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
AndroGel is not indicated for use in women.
Treatment with AndroGel may lead to azoospermia; edema, which may be serious in patients with preexisting cardiac, renal, or hepatic disease or in patients taking adrenocorticotropic hormone (ACTH) or corticosteroids; gynecomastia; sleep apnea, especially in those with risk factors; changes in insulin sensitivity or glycemic control; and changes in anticoagulant activity.
Treatment with androgens may lead to serious hepatic effects. AndroGel is not known to cause these adverse effects. Monitor liver function tests (LFTs) periodically.
Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy. Monitor lipid concentrations periodically.
Androgens should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
Most common adverse reaction of AndroGel 1.62% (incidence ≥5%) is an increase in prostate specific antigen (PSA). Most common adverse reactions of AndroGel 1% (incidence ≥5%) are acne, application site reactions, abnormal lab tests, and prostatic disorders.
Dosage and administration for AndroGel 1.62% differs from AndroGel 1%. AndroGel is not interchangeable with other topical testosterone products.

Use in specific populations:

There are insufficient long-term safety data in geriatric patients using AndroGel to assess the potentially increased risks of cardiovascular disease and prostate cancer.

Dosing & Titration

The maintenance of normal testosterone levels

Applying AndroGel 1.62%

APPLY1

WASH1

COVER1

Safety Considerations1

Titration guidelines for AndroGel 1.62%

Pre-dose morning serum total testosterone concentration

Dose titration

Additional considerations for titration1

Increase in hematocrit:

Changes in serum lipid profile:

AndroGel 1.62% and 1%: understanding the differences1,2

Safety Considerations for AndroGel 1% and AndroGel 1.62%1,2

RELATED TOPICS

APPLY¹

WASH¹

COVER¹

Safety Considerations¹

Additional considerations for titration¹

AndroGel 1.62% and 1%: understanding the differences^1,2

Safety Considerations for AndroGel 1% and AndroGel 1.62%^1,2