Initiating Therapy

Four steps to help initiate treatment

Patients with adult male hypogonadism due to an associated medical condition may face uncertainty when beginning testosterone replacement therapy (TRT). That’s why it’s important to have a clear and comprehensive treatment initiation plan for patients starting AndroGel 1.62%.¹

When starting a patient on AndroGel 1.62%, be sure to:

1. Specify the starting dose of AndroGel 1.62%: 40.5 mg¹

Explain that 40.5 mg is 2 pump actuations per day or one 40.5 mg packet per day

2. Set expectations¹

Talk specifically with patients about what to expect during treatment, including:
- The amount of time it may take for testosterone levels to normalize
- The need for ongoing monitoring to ensure patients are on the right dose
- The need to properly apply AndroGel 1.62% daily
- The potential risks of using TRT

3. Clarify application instructions¹

Provide clear instructions on how to apply AndroGel 1.62% every morning
- Instruct patients not to apply AndroGel 1.62% to any other parts of the body, including the abdomen, genitals, chest, armpits (axillae), or knees
Emphasize strict adherence to safety precautions in order to minimize the potential for secondary exposure to testosterone from skin treated with AndroGel 1.62%

4. Establish a monitoring plan¹

Schedule follow-up visits to monitor your patient’s pre-dose morning serum total testosterone (TT) concentration at 14 and 28 days after starting treatment or following dose adjustment and periodically thereafter
Titrate as necessary based on TT level
Follow up with your patient to ensure he is comfortable with daily application

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 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.

Writing a prescription for
AndroGel 1.62%

Whether you are completing an electronic or written prescription for AndroGel 1.62% it’s important to know what to specify. Use the prescribing tool below to get the information you need.

Prescribing AndroGel 1.62%¹

Choose pump or packets based on
your patient’s needs.

Select the dose (mg).¹

(Starting Dose)

AndroGel 1.62% Pump - 40.5 mg

Electronic
Prescription

For 20.25 mg testosterone, choose:

AndroGel^® pump 20.25 mg/1.25 g gel/ACT (1.62%)
Quantity: 1 x 75 g pump bottle
Days: 60
Apply 1 pump press to one upper arm and shoulder once daily in the morning

For 40.5 mg testosterone, choose:

AndroGel^® pump 20.25 mg/1.25 g gel/ACT (1.62%)
Quantity: 1 x 75 g pump bottle
Days: 30
Apply 1 pump press to one upper arm and shoulder and then apply 1 pump press to the opposite upper arm and shoulder once daily in the morning

For 60.75 mg testosterone, choose:

AndroGel^® pump 20.25 mg/1.25 g gel/ACT (1.62%)
Quantity: 2 x 75 g pump bottle
Days: 40
Apply 2 pump presses to one upper arm and shoulder and then apply 1 pump press to the opposite upper arm and shoulder once daily in the morning

For 81 mg testosterone, choose:

AndroGel^® pump 20.25 mg/1.25 g gel/ACT (1.62%)
Quantity: 2 x 75 g pump bottle
Days: 30
Apply 2 pump presses to one upper arm and shoulder and then apply 2 pump presses to the opposite upper arm and shoulder once daily in the morning

For 20.25 mg testosterone, choose:

AndroGel^® packets 20.25 mg/1.25 g gel (1.62%)
Quantity: 30 packets/box
Days: 30
Apply 1 packet of AndroGel 1.62% to 1 upper arm and shoulder once daily in the morning

For 40.5 mg testosterone, choose:

AndroGel^® packets 40.5 mg/2.5 g gel (1.62%)
Quantity: 30 packets/box
Days: 30
Apply half of the 40.5 mg packet of AndroGel 1.62% to 1 upper arm and shoulder and then apply the remaining packet contents to the opposite upper arm and shoulder once daily in the morning

For 60.75 mg testosterone, choose:

AndroGel^® packets 40.5 mg/2.5 g gel (1.62%)
Quantity: 30 packets/box
Days: 30

and

AndroGel^® packets 20.25 mg/1.25 g gel (1.62%)
Quantity: 30 packets/box
Days: 30
Apply one 40.5 mg packet of AndroGel 1.62% to 1 upper arm and shoulder and then apply one 20.25 mg packet of AndroGel 1.62% to the opposite upper arm and shoulder once daily in the morning

For 81 mg testosterone, choose:

AndroGel^® packets 40.5 mg/2.5 g gel (1.62%)
Quantity: 30 packets x 2 boxes
Days: 30
Apply one 40.5 mg packet of AndroGel 1.62% to 1 upper arm and shoulder and then apply one 40.5 mg packet of AndroGel 1.62% to the opposite upper arm and shoulder once daily in the morning

Written
Prescription

For 20.25 mg testosterone, write:

AndroGel^® 1.62%
Apply 1 pump press to one upper arm and shoulder once daily in the morning
Dispense: 1 bottle

For 40.5 mg testosterone, write:

AndroGel^® 1.62%
Apply 1 pump press to one upper arm and shoulder and then apply 1 pump press to the opposite upper arm and shoulder once daily in the morning
Dispense: 1 bottle

For 60.75 mg testosterone, write:

AndroGel^® 1.62%
Apply 2 pump presses to one upper arm and shoulder and then apply 1 pump press to the opposite upper arm and shoulder once daily in the morning
Dispense: 2 bottles

For 81 mg testosterone, write:

AndroGel^® 1.62%
Apply 2 pump presses to one upper arm and shoulder and then apply 2 pump presses to the opposite upper arm and shoulder once daily in the morning
Dispense: 2 bottles

For 20.25 mg testosterone, write:

AndroGel^® 1.62% 20.25 mg/1.25 g packets
Apply 1 packet of AndroGel 1.62% to 1 upper arm and shoulder once daily in the morning
Dispense: 1 box (20.25 mg packets)

For 40.5 mg testosterone, write:

AndroGel^® 1.62% 40.5 mg/2.5 g packets
Apply half of the 40.5 mg packet of AndroGel 1.62% to 1 upper arm and shoulder and then apply the remaining packet contents to the opposite upper arm and shoulder once daily in the morning
Dispense: 1 box (40.5 mg packets)

For 60.75 mg testosterone, write:

AndroGel^® 1.62% 40.5 mg/2.5 g packets

and

AndroGel 1.62% 20.25 mg/1.25 g packets
Apply one 40.5 mg packet of AndroGel 1.62% to 1 upper arm and shoulder and then apply one 20.25 mg packet of AndroGel 1.62% to the opposite upper arm and shoulder once daily in the morning
Dispense: 1 box of each (40.5 mg packets and 20.25 mg packets)

For 81 mg testosterone, write:

AndroGel^® 1.62% 40.5 mg/2.5 g packets
Apply one 40.5 mg packet of AndroGel 1.62% to 1 upper arm and shoulder and then apply one 40.5 mg packet of AndroGel 1.62% to the opposite upper arm and shoulder once daily in the morning
Dispense: 2 boxes (40.5 mg packets)

Safety Considerations^1,2

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. AndroGel is not indicated for use in women. Avoid unintentional exposure of women or children to AndroGel. Patients treated with AndroGel also may be at risk for development of worsening benign prostatic hyperplasia; prostate cancer; polycythemia; venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE); major adverse cardiovascular events (MACE) including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death; azoospermia; edema; gynecomastia; changes in lipid profile; sleep apnea; and has been subject to abuse particularly with high doses or in combination with other anabolic steroids.

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.

Initiating Therapy

Four steps to help initiate treatment

1. Specify the starting dose of AndroGel 1.62%: 40.5 mg1

2. Set expectations1

3. Clarify application instructions1

4. Establish a monitoring plan1

Limitations of use:

Writing a prescription for AndroGel 1.62%

Prescribing AndroGel 1.62%1

AndroGel 1.62% Pump - 40.5 mg

For 20.25 mg testosterone, choose:

For 40.5 mg testosterone, choose:

For 60.75 mg testosterone, choose:

For 81 mg testosterone, choose:

For 20.25 mg testosterone, choose:

For 40.5 mg testosterone, choose:

For 60.75 mg testosterone, choose:

For 81 mg testosterone, choose:

For 20.25 mg testosterone, write:

For 40.5 mg testosterone, write:

For 60.75 mg testosterone, write:

For 81 mg testosterone, write:

For 20.25 mg testosterone, write:

For 40.5 mg testosterone, write:

For 60.75 mg testosterone, write:

For 81 mg testosterone, write:

Safety Considerations1,2

RELATED TOPICS

1. Specify the starting dose of AndroGel 1.62%: 40.5 mg¹

2. Set expectations¹

3. Clarify application instructions¹

4. Establish a monitoring plan¹

Writing a prescription for
AndroGel 1.62%

Prescribing AndroGel 1.62%¹

Safety Considerations^1,2