|
AndroGel ® (testosterone gel) 1% for topical use CIII
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use AndroGel 1% safely and effectively. See full prescribing information for AndroGel 1%.
AndroGel ® (testosterone gel) 1% for topical use CIII
Initial U.S. Approval: 1953
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
See full prescribing information for complete boxed warning.
-
Virilization has been reported in children who were secondarily exposed to testosterone gel. (5.2, 6.2)
-
Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. (2.2, 5.2)
-
Healthcare providers should advise patients to strictly adhere to recommended instructions for use. (2.2, 5.2, 17)
RECENT MAJOR CHANGES
|
Indications and Usage (1) |
5/2015 |
|
Dosage and Administration (2) |
5/2015 |
|
Dosage and Administration (2.2) |
11/2014 |
|
Warnings and Precautions (5.4) |
6/2014 |
|
Warnings and Precautions (5.5) |
5/2015 |
INDICATIONS AND USAGE
AndroGel 1% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
-
Primary hypogonadism (congenital or acquired). (1)
-
Hypogonadotropic hypogonadism (congenital or acquired). (1)
Limitations of use:
-
Safety and efficacy of AndroGel 1% in men with “age-related hypogonadism” have not been established. (1)
-
Safety and efficacy of AndroGel 1% in males less than 18 years old have not been established. (8.4)
-
Topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure. (1, 12.3)
DOSAGE AND ADMINISTRATION
-
Dosage and Administration for AndroGel 1% differs from AndroGel 1.62 %. For dosage and administration of AndroGel 1.62% refer to its full prescribing information. (2)
-
Prior to initiating AndroGel 1%., confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range (2).
-
Starting dose of AndroGel 1% is 50 mg of testosterone (4 pump actuations, two 25 mg packets, or one 50 mg packet), applied once daily in the morning. (2.1)
-
Apply to clean, dry, intact skin of shoulders and upper arms and/or abdomen. Do NOT apply AndroGel 1% to any other parts of the body including the genitals, chest, armpits (axillae), knees, or back. (2.2)
-
Dose adjustment: AndroGel 1% can be dose adjusted using 50 mg, 75 mg, or 100 mg of testosterone on the basis of total serum testosterone concentration. The dose should be titrated based on the serum testosterone concentration. Additionally, serum testosterone concentration should be assessed periodically. (2.1)
-
Patients should wash hands immediately with soap and water after applying AndroGel 1% and cover the application site(s) with clothing after the gel has dried. Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated. (2.2)
DOSAGE FORMS AND STRENGTHS
AndroGel (testosterone gel) 1% for topical use is available as follows:
-
Metered-dose pump that delivers 12.5 mg of testosterone per actuation. (3)
-
Packets containing 25 mg of testosterone. (3)
-
Packets containing 50 mg of testosterone. (3)
CONTRAINDICATIONS
-
Men with carcinoma of the breast or known or suspected prostate cancer. (4, 5.1)
-
Pregnant or breastfeeding women. Testosterone may cause fetal harm. (4, 8.1, 8.3)
WARNINGS AND PRECAUTIONS
-
Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. (5.1)
-
Avoid unintentional exposure of women or children to AndroGel 1%. Secondary exposure to testosterone can produce signs of virilization. AndroGel 1% should be discontinued until the cause of virilization is identified. (5.2)
-
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. eva luate patients with signs or symptoms consistent with DVT or PE. (5.4)
-
Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy. (5.5)
-
Exogenous administration of androgens may lead to azoospermia. (5.7)
-
Edema, with or without congestive heart failure (CHF), may be a complication in patients with preexisting cardiac, renal, or hepatic disease. (5.9, 6.2)
-
Sleep apnea may occur in those with risk factors. (5.11)
-
Monitor serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests, and lipid concentrations periodically. (5.1, 5.3, 5.8, 5.12)
-
AndroGel 1% is flammable until dry. (5.15)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 5%) are acne, application site reaction, abnormal lab tests, and prostatic disorders. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
-
Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients. (7.1)
-
Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of INR and prothrombin time is recommended. (7.2)
-
Use of testosterone with adrenocorticotrophic hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease. (7.3)
USE IN SPECIFIC POPULATIONS
There are insufficient long-term safety data in geriatric patients using AndroGel 1% to assess the potential risks of cardiovascular disease and prostate cancer. (8.5)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 5/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
AndroGel 1% 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% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
-
Safety and efficacy of AndroGel 1% 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
Dosage and Administration for AndroGel 1% differs from AndroGel 1.62%. For dosage and administration of AndroGel 1.62% refer to its full prescribing information. (2)
Prior to initiating AndroGel 1%, 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% 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 concentrations should be measured at intervals. If the serum testosterone concentration is below the normal range, the daily AndroGel 1% 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 AndroGel 1%). If the serum testosterone concentration exceeds the normal range, the daily AndroGel 1% dose may be decreased. If the serum testosterone concentration consistently exceeds the normal range at a daily dose of 50 mg, AndroGel 1% therapy should be discontinued. In addition, serum testosterone concentrations should be assessed periodically.
The application site and dose of AndroGel 1% are not interchangeable with other topical testosterone products.
2.2 Administration Instructions
AndroGel 1% 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 AndroGel 1% to any other part of the body including the genitals, chest, armpits (axillae), knees, or back. AndroGel 1% should be evenly distributed between the right and left upper arms/shoulders or both sides of the abdomen.
The prescribed daily dose of AndroGel 1% 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.
After applying the gel, the application site should be allowed to dry prior to dressing. Hands should be washed thoroughly with soap and water after application. Avoid fire, flames or smoking until the gel has dried since alcohol based products, including AndroGel 1%, are flammable.
The patient should be advised to avoid swimming or showering for at least 5 hours after the application of AndroGel 1%.
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, AndroGel 1% can be applied directly to the application sites. Table 1 provides dosing information for adult males.
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 AndroGel 1%-treated skin:
-
Children and women should avoid contact with unwashed or unclothed application site(s) of men using AndroGel 1%.
-
Patients should wash hands with soap and water immediately after application of AndroGel 1%.
-
Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the gel has dried.
-
Prior to situation in which direct skin-to-skin contact is anticipated, patients should wash the application site thoroughly with soap and water to remove any testosterone residue.
-
In the event that unwashed or unclothed skin to which AndroGel 1% 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.
3 DOSAGE FORMS AND STRENGTHS
AndroGel (testosterone gel) 1% 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
-
AndroGel 1% 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)].
-
AndroGel 1% is contraindicated in women who are or may become pregnant, or who are breastfeeding. AndroGe
|
|
