This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TESTOSTERONE gel safely and effectively. See full prescribing
information for TESTOSTERONE gel.
TESTOSTERONE gel, for topical use, CIII
Initial U.S. Approval: 1953
WARNING: SECONDARY EXPOSURE TO TESTOSTERONESee 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).
--------------------------INDICATIONS AND USAGE-------------------------­
Testosterone is an androgen indicated for replacement therapy in males forconditions associated with a deficiency or absence of endogenous
testosterone:• Primary Hypogonadism (Congenital or Acquired) (1)• Hypogonadotropic Hypogonadism (Congenital or Acquired) (1)Important limitations of use:
• Safety and efficacy of testosterone gel in males less than 18 years oldhave not been established. (8.4)• Topical testosterone products may have different doses, strengths, orapplication instructions that may result in different systemic exposure.
(1, 12.3)---------------------DOSAGE AND ADMINISTRATION---------------------• Starting dose of testosterone gel is 50 mg of testosterone (4 pumpactuations, 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 testosterone gel to any other parts of the body
including the genitals, chest or back. (2.2).
• Dose adjustment: Testosterone gel can be dose adjusted using 50 mg,
75 mg, or 100 mg of testosterone on the basis of total serum
testosterone concentration.. Additionally, serum testosterone
concentration should be assessed periodically. (2.1).
• Patients should wash hands immediately with soap and water after
applying testosterone gel 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 theapplication site with another person is anticipated. (2.2)--------------------DOSAGE FORMS AND STRENGTHS--------------------Testosterone gel 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 prostatecancer (4, 5.1).
• Pregnant or breast feeding women. Testosterone may cause
fetal/neonatal 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 testosterone gel.
Secondary exposure to testosterone can produce signs of virilization.
Testosterone gel should be discontinued until the cause of virilization is
identified. (5.2).
• Exogenous administration of androgens may lead to azoospermia (5.5).
• Edema, with or without congestive heart failure (CHF), may be acomplication in patients with preexisting cardiac, renal, or hepaticdiseases (5.7, 6.2).
• Sleep apnea may occur in those with risk factors (5.9).
•
Monitor serum testosterone, prostatic specific antigen (PSA),
hemoglobin, hematocrit, liver function tests and lipid concentrations
periodically (5.1, 5.3, 5.6, 5.10).
• Testosterone gel is flammable until dry (5.13).
------------------------------ADVERSE REACTIONS---------------------------­
Most common adverse reactions (incidence  5%) are acne, application site
reactions, abnormal lab tests, and prostatic disorders (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at
1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
-----------------------------DRUG INTERACTIONS----------------------------­• 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. Morefrequent monitoring of International Normalized Ratio (“INR”) andprothrombin time is recommended (7.2).
• Use of testosterone with adrenocorticotropic hormone (“ACTH”) or
corticosteroids may result in increased fluid retention. Use withcaution, 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
testosterone gel to assess the potential risks of cardiovascular disease andprostate cancer. (8.5)
See 17 for PATIENT COUNSELING INFORMATION and
Medication Guide
Revised: 01/2013

FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing and Dose Adjustment
2.2 Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Worsening of Benign Prostatic Hyperplasia (BPH) and Potential
Risk of Prostate Cancer
5.2 Potential for Secondary Exposure to Testosterone
5.3 Polycythemia
5.4 Use In Women
5.5 Potential for Adverse Effects on Spermatogenesis
5.6 Hepatic Adverse Effects
5.7 Edema
5.8 Gynecomastia
5.9 Sleep Apnea

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5.10 Lipids
5.11 Hypercalcemia
5.12 Decreased Thyroxine-binding Globulin
5.13 Flammability
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Insulin
7.2 Oral Anticoagulants
7.3 Corticosteroids
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment

This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES
14.1 Clinical Trials in Adult Hypogonadal Males
14.2 Skin Irritation Study
14.3 Skin Sensitization Study
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Use in Men with Known or Suspected Prostate or Breast Cancer
17.2 Potential for Secondary Exposure to Testosterone and Steps toPrevent Secondary Exposure
17.3 Potential Adverse Reactions with Androgens
17.4 Patients Should Be Advised of the Following Instructions for Use* Sections or subsections omitted from the full prescribing information are
not listed.

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FULL PRESCRIBING INFORMATIONWARNING: SECONDARY EXPOSURE TO TESTOSTERONE• Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings andPrecautions (5.2) and Adverse Reactions (6.2)].
• Children should avoid contact with any unwashed or unclothed application sites in men using testosterone gel[see Dosage and Administration (2.2), 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)].
1

INDICATIONS AND USAGE
Testosterone is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absenceof 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),
lutenizing 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 testosterone gel 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
2.1 Dosing and Dose Adjustment
The recommended starting dose of testosterone gel 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 sametime every day).
Dose Adjustment
To ensure proper dosing, serum testosterone levels should be measured at intervals. If the serum testosterone concentration is
below the normal range, the daily testosterone gel dose may be increased from 50 mg to 75 mg and from 75 mg to 100 mg for adultmales as instructed by the physician (see Table 1, Dosing Information for testosterone gel). If the serum testosterone concentration
exceeds the normal range, the daily testosterone gel dose may be decreased. If the serum testosterone concentration consistently
exceeds the normal range at a daily dose of 50 mg, testosterone gel therapy should be discontinued. In addition, serum testosterone
concentration should be assessed periodically.
2.2 Administration Instructions
Testosterone gel 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
testosterone gel to any other part of the body including the genitals, chest or back. Testosterone gel should be evenly distributed
between the right and left upper arms/shoulders or both sides of the abdomen.
The prescribed daily dose of testosterone gel 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.

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Figure 1: Application Sites for Testosterone gel
After applying the gel, the application site should be allowed to dry prior to dressing. Hands should be washed with soap and water
after testosterone gel has been applied. Avoid fire, flames or smoking until the gel has dried since alcohol based products, including
testosterone gel, are flammable.
The patient should be advised to avoid swimming or showering for at least 5 hours after the application of testosterone gel.
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 andfully depress the actuator three times. Safely discard the gel from the first three actuations. It is only necessary to prime the pumpbefore 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 thehand and then applied to the desired application sites. Alternatively, testosterone gel can be applied directly to the application sites.
Table 1 provides dosing information for adult males.
Table 1: Dosing Guidelines for Using the Multi-Dose Pump
Prescribed Daily Dose
50 mg
75 mg
100 mgNumber of Pump Actuations
4 (once daily)
6 (once daily)
8 (once daily)

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 testosterone gel-treated skin:• Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel.
• Patients should wash their hands immediately with soap and water after applying testosterone gel.
• Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the gel has dried.
• Prior to any situation in which skin-to-skin contact with the application site is anticipated, patients should wash the applicationsite(s) thoroughly with soap and water to remove any testosterone residue.
• In the event that unwashed or unclothed skin to which testosterone gel 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
Testosterone gel for topical use is available as follows:4•

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.

CONTRAINDICATIONS• Testosterone gel is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [seeWarnings and Precautions (5.1), Adverse Reactions (6.1), and Nonclinical Toxicology (13.1)].
• Testosterone gel is contraindicated in women who are or may become pregnant, or who are breastfeeding. Testosterone gel may
cause fetal harm when administered to a pregnant woman. Testosterone gel may cause serious adverse reactions in nursing

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infants. Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant womenor those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated withtestosterone gel. If a pregnant woman is exposed to testosterone gel, she should be apprised of the potential hazard to the fetus[see Warnings and Precautions (5.2) and Use in Specific Populations (8.1, 8.3)].
5

WARNINGS AND PRECAUTIONS
5.1 Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer•

Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor
patients with BPH for worsening signs and symptoms.

•

Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior toinitiating and during treatment with androgens [see Contraindications (4), Adverse reactions (6.1) and Nonclinical Toxicology(13.1)].

5.2 Potential for Secondary Exposure to Testosterone
Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance. Signs andsymptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive
behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosteronegel. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly
greater than chronological age. The risk of transfer was increased in some of these cases by not adhering to precautions for theappropriate use of testosterone gel. Children and women should avoid contact with unwashed or unclothed application sites in men
using testosterone gel [see Dosage and Administration (2.2), Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].
Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution,
significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and thepossibility of secondary exposure to testosterone gel should also be brought to the attention of a physician. Testosterone gel should
be promptly discontinued until the cause of virilization has been identified.
5.3 Polycythemia
Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone.
Check hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after
starting treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptableconcentration. An increase in red blood cell mass may increase the risk of thromboembolic events.
5.4 Use in Women
Due to lack of controlled evaluations in women and potential virilizing effects, testosterone gel is not indicated for use in women[see Contraindications (4) and Use in Specific Populations (8.1, 8.3)].
5.5 Potential for Adverse Effects on Spermatogenesis
At large doses of exogenous androgens, including testosterone gel; spermatogenesis may be suppressed through feedback inhibitionof pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm
count.
5.6 Hepatic Adverse Effects
Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious
hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a lifethreatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic
adenomas. Testosterone gel is not known to produce these adverse effects.
5.7 Edema
Androgens, including testosterone gel, may promote retention of sodium and water. Edema with or without congestive heart failure
may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease [see Adverse Reactions (6.2)].
5.8 Gynecomastia
Gynecomastia may develop and may persist in patients being treated with androgens, including testosterone gel, for hypogonadism.
5.9 Sleep Apnea
The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those withrisk factors such as obesity or chronic lung diseases [see Adverse Reactions (6.2)].

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5.10 Lipids
Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy.
5.11 Hypercalcemia
Androgens, including testosterone gel, should be used with caution in cancer patients at risk of hypercalcemia (and associatedhypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
5.12 Decreased Thyroxine-binding Globulin
Androgens, including testosterone gel, may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum
concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, andthere is no clinical evidence of thyroid dysfunction.
5.13 Flammability
Alcohol based products including testosterone gel are flammable; therefore patients should be advised to avoid fire, flameor smoking until the testosterone gel has dried.
6

ADVERSE REACTIONS
6.1 Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug
cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trials in Hypogonadal Men
Table 2 shows the incidence of all adverse reactions with testosterone gel and reported by > 1% of patients in a 180 Day, Phase 3
study.
Table 2: Adverse Reactions to Testosterone Gel in the 180 Day Controlled Clinical Trial
Dose of Testosterone
Adverse Reaction

50 mg

75 mg

100 mgAcne
Alopecia
Application Site Reaction
Asthenia
Depression
Emotional Lability
Gynecomastia
HeadacheHypertension
Abnormal Lab Tests *Libido Decreased
Nervousness
Pain Breast
Prostate Disorder**Testis Disorder***

N = 77
1%
1%
5%
0%
1%
0%
1%
4%
3%
6%
0%
0%
1%
3%
3%

N = 40
3%
0%
3%
3%
0%
3%
0%
3%
0%
5%
3%
3%
3%
3%
0%

N = 78
8%
1%
4%
1%
1%
3%
3%
0%
3%
3%
1%
1%
1%
5%
0%

*Abnormal lab tests occurred in nine patients with one or more of the following events reported: elevated hemoglobin orhematocrit, hyperlipidemia, elevated triglycerides, hypokalemia, decreased HDL, elevated glucose, elevated creatinine,elevated total bilirubin.
**Prostate disorders included five patients with enlarged prostate, one with BPH, and one with elevated PSA results.
***Testis disorders were reported in two patients: one with left varicocele and one with slight sensitivity of left testis.
Other less common adverse reactions, reported in fewer than 1% of patients included: amnesia, anxiety, discolored hair, dizziness,
dry skin, hirsutism, hostility, impaired urination, paresthesia, penis disorder, peripheral edema, sweating, and vasodilation.
In this 180 day clinical trial, skin reactions at the site of application were reported with testosterone gel, but none was severe enoughto require treatment or discontinuation of drug.
Six patients (4%) in this trial had adverse reactions that led to discontinuation of testosterone gel. These reactions included: cerebral
hemorrhage, convulsion, depression, sadness, memory loss, elevated prostate specific antigen, and hypertension. No patients on
testosterone gel discontinued due to skin reactions.

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In a separate uncontrolled pharmacokinetic study of 10 patients, two had adverse reactions; these were asthenia and depression in
one patient and increased libido and hyperkinesia in the other.
In a 3 year, flexible dose, extension study, the incidence of all adverse reactions to testosterone gel and reported by > 1% of patientsis shown in Table 3:
Table 3: Adverse Reactions to Testosterone gel in the 3 Year, Flexible Dose, Extension Study
Adverse Reaction

Percent of Subjects

Abnormal Lab Tests+
Skin dry
Application Site Reaction
Acne
Pruritus
Enlarged Prostate
Carcinoma of Prostate
Urinary Symptoms*
Testis Disorder**Gynecomastia
Anemia(N = 162)
9.3
1.9
5.6
3.1
1.9
11.7
1.2
3.7
1.9
2.5
2.5

+Abnormal lab tests occurred in 15 patients with one or more of the following events reported: elevated AST, elevated ALT,
elevated testosterone, elevated hemoglobin or hematocrit, elevated cholesterol, elevated cholesterol/LDL ratio, elevatedtriglycerides, elevated HDL, elevated serum creatinine.
*Urinary symptoms included nocturia, urinary hesitancy, urinary incontinence, urinary retention, urinary urgency and weakurinary stream.
**Testis disorders included three patients. There were two with a non-palpable testis and one with slight right testiculartenderness.
Two patients reported serious adverse reactions considered possibly related to treatment: deep vein thrombosis (DVT) and prostate
disorder requiring a transurethral resection of the prostate (TURP).
Discontinuation for adverse reactions in this study included: two patients with application site reactions, one with kidney failure,and five with prostate disorders (including increase in serum PSA in 4 patients, and increase in PSA with prostate enlargement in a
fifth patient).
Increases in Serum PSA Observed in Clinical Trials of Hypogonadal Men
During the initial 6-month study, the mean change in PSA values had a statistically significant increase of 0.26 ng/mL. Serum PSA
was measured every 6 months thereafter in the 162 hypogonadal men on testosterone gel in the 3 year extension study. There was no
additional statistically significant increase observed in mean PSA from 6 months through 36 months. However, there were increases
in serum PSA observed in approximately 18% of individual patients. The overall mean change from baseline in serum PSA values
for the entire group from month 6 to 36 was 0.11 ng/mL.
Twenty-nine patients (18%) met the per-protocol criterion for increase in serum PSA, defined as > 2X the baseline or any single
serum PSA > 6 ng/mL. Most of these (25/29) met this criterion by at least doubling of their PSA from baseline. In most cases where
PSA at least doubled (22/25), the maximum serum PSA value was still < 2 ng/mL. The first occurrence of a pre-specified, postbaseline increase in serum PSA was seen at or prior to Month 12 in most of the patients who met this criterion (23 of 29; 79%).
Four patients met this criterion by having a serum PSA > 6 ng/mL and in these, maximum serum PSA values were 6.2 ng/mL, 6.6
ng/mL, 6.7 ng/mL, and 10.7 ng/mL. In two of these patients, prostate cancer was detected on biopsy. The first patient’s PSA levels
were 4.7 ng/mL and 6.2 ng/mL at baseline and at Month 6/Final, respectively. The second patient’s PSA levels were 4.2 ng/mL, 5.2
ng/mL, 5.8 ng/mL, and 6.6 ng/mL at baseline, Month 6, Month 12, and Final, respectively.
6.2 Postmarketing Experience
The following adverse reactions have been identified during post approval use of testosterone gel. Because the reactions arereported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a
causal relationship to drug exposure (Table 4):

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Table 4: Adverse Reactions from Postmarketing Experience of Testosterone Gel by MedDRA System Organ Class
Blood and the lymphatic system disorders:Elevated Hgb, Hct (polycythemia)

Endocrine disorders:Hirsutism

Gastrointestinal disorders:

NauseaGeneral disorders and administration site reactions:

Asthenia, edema, malaise

Genitourinary disorders:

Impaired urination

Hepatobiliary disorders:Abnormal liver function tests (e.g., transaminases, elevated
GGTP, bilirubin)

Investigations:Elevated PSA, electrolyte changes (nitrogen, calcium, potassium,
phosphorus, sodium), changes in serum lipids (hyperlipidemia,
elevated triglycerides, decreased HDL), impaired glucose
tolerance, fluctuating testosterone levels, weight increase

Neoplasms benign, malignant and unspecified (cysts andpolyps):

Prostate cancer

Nervous system:

Headache, dizziness, sleep apnea, insomnia

Psychiatric disorders:Depression, emotional lability, decreased libido, nervousness,hostility, amnesia, anxiety

Reproductive system and breast disorders:

Gynecomastia, mastodynia, prostatic enlargement, testicularatrophy, oligospermia, priapism (frequent or prolonged erections)

Respiratory disorders:

Dyspnea

Skin and subcutaneous tissue disorders:Acne, alopecia, application site reaction (pruritus, dry skin,erythema, rash, discolored hair, paresthesia), sweating

Vascular disorders:

Hypertension, vasodilation (hot flushes)

Secondary Exposure to Testosterone in Children
Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarket surveillance.
Signs and symptoms of these reported cases have included enlargement of the clitoris (with surgical intervention) or the penis,
development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases with areported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure. In a
few cases, however, enlarged genitalia did not fully return to age appropriate normal size, and bone age remained modestly greaterthan chronological age. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel
was reported. In at least one reported case, the reporter considered the possibility of secondary exposure from items such as the
testosterone gel user’s shirts and/or other fabric, such as towels and sheets [see Warnings and Precautions (5.2)].
7

DRUG INTERACTIONS
7.1 Insulin
Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic
effects of androgens may decrease blood glucose and, therefore, may decrease insulin requirements.
7.2 Oral Anticoagulants
Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of International Normalized
Ratio (INR) and prothrombin time are recommended in patients taking anticoagulants, especially at the initiation and termination ofandrogen therapy.
7.3 Corticosteroids
The concurrent use of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid
retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.

8

USE IN SPECIFIC POPULATIONS
8.1

Pregnancy

Pregnancy Category X [see Contraindications (4)]:Testosterone gel is contraindicated during pregnancy or in women who may become pregnant. Testosterone is teratogenic and may
cause fetal harm. Exposure of a female fetus to androgens, such as testosterone, may result in varying degrees of virilization. If thisReference ID: 3253437

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drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of thepotential hazard to a fetus.
8.3 Nursing Mothers
Although it is not known how much testosterone transfers into human milk, testosterone gel is contraindicated in nursing women
because of the potential for serious adverse reactions in nursing infants. Testosterone and other androgens may adversely affectlactation. [see Contraindications (4)].
8.4 Pediatric Use
Safety and efficacy of testosterone gel in pediatric males less than 18 years old has not been established. Improper use may result inacceleration 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 testosterone gel todetermine whether efficacy in those over 65 years of age differs from younger subjects. Additionally, there is insufficient long-term
safety data in geriatric patients to assess the potential 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.
9

DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Testosterone gel contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.
9.2 AbuseAnabolic steroids, such as testosterone, are abused. Abuse is often associated with adverse physical and psychological effects.
9.3 Dependence
Although drug dependence is not documented in individuals using therapeutic doses of anabolic steroids for approved indications,dependence is observed in some individuals abusing high doses of anabolic steroids. In general, anabolic steroid dependence ischaracterized by any three of the following:• Taking more drug than intended• Continued drug use despite medical and social problems• Significant time spent in obtaining adequate amounts of drug
• Desire for anabolic steroids when supplies of the drugs are interrupted

10•

Difficulty in discontinuing use of the drug despite desires and attempts to do so•Experience of a withdrawal syndrome upon discontinuation of anabolic steroid use.

OVERDOSAGE

There is one report of acute overdosage with use of an approved injectable testosterone product: This subject had serum testosterone
concentrations of up to 11, 400 ng/dL with a cerebrovascular accident.
Treatment of overdosage would consist of discontinuation of testosterone gel, washing the application site with soap and water, andappropriate symptomatic and supportive care.
11

DESCRIPTION

Testosterone gel is a clear, colorless hydroalcoholic gel containing testosterone.

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The active pharmacologic ingredient in testosterone gel is testosterone, an androgen. Testosterone USP is a white to practically white
crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is:

Testosterone
C19H28O2
MW 288.42
Inactive ingredients in testosterone gel are carbomer 980, ethanol 67.0%, isostearic acid, purified water, and sodium hydroxide. These
ingredients are not pharmacologically active.
12

CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth anddevelopment of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth andmaturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest
and axillary hair; laryngeal enlargement, vocal chord thickening, alterations in body musculature and fat distribution. Testosterone
and DHT are necessary for the normal development of secondary sex characteristics. Male hypogonadism results from insufficientsecretion of testosterone and is characterized by low serum testosterone concentrations. Signs/symptoms associated with male
hypogonadism include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of
secondary sexual characteristics and osteoporosis.
Male hypogonadism can present as primary hypogonadism caused by defects of the gonads, such as Klinefelter’s Syndrome or
Leydig cell aplasia, while secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient
gonadotropins (FSH, LH).
12.2 Pharmacodynamics
No specific pharmacodynamic studies were conducted using testosterone gel.
12.3 Pharmacokinetics
Absorption
In a single-dose, crossover clinical study conducted in 24 hypogonadal males under fasting conditions, the serum testosterone
exposure (AUC0-72) and maximum testosterone concentration (Cmax) following a topical administration of 100 mg testosterone
administered as 2 x 5 g testosterone gel packets (2 packets applied to the shoulder/upper arm) were bioequivalent to those following
a topical administration of an approved testosterone gel product.
Testosterone gel delivers physiologic amounts of testosterone, producing circulating testosterone concentrations that approximate
normal concentrations (298 to 1043 ng/dL) seen in healthy men.
Testosterone gel provides continuous transdermal delivery of testosterone for 24 hours following a single application to intact,clean, dry skin of the shoulders, upper arms and/or abdomen.
Testosterone gel is a hydroalcoholic formulation that dries quickly when applied to the skin surface. The skin serves as a reservoir
for the sustained release of testosterone into the systemic circulation. Approximately 10% of the testosterone dose applied on theskin surface from testosterone gel is absorbed into systemic circulation. In a study with testosterone gel 100 mg, all patients showed
an increase in serum testosterone within 30 minutes, and eight of nine patients had a serum testosterone concentration within normal
range by 4 hours after the initial application. Absorption of testosterone into the blood continues for the entire 24 hour dosinginterval. Serum concentrations approximate the steady-state concentration by the end of the first 24 hours and are at steady state by
the second or third day of dosing.
With single daily applications of testosterone gel, follow-up measurements 30, 90, and 180 days after starting treatment haveconfirmed that serum testosterone concentrations are generally maintained within the eugonadal range. Figure 2 summarizes the
24-hour pharmacokinetic profiles of testosterone for hypogonadal men (< 300 ng/dL) maintained on testosterone gel 50 mg or 100
mg of for 30 days. The average (± SD) daily testosterone concentration produced by 100 mg on Day 30 was 792 (± 294) ng/dL andby testosterone gel 50 mg was 566 (± 262) ng/dL.

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Figure 2: Mean (± SD) Steady-State Serum Testosterone Concentrations on Day 30 in Patients Applying Testosterone Gel
Once Daily

Distribution
Circulating testosterone is primarily bound in the serum to sex hormone-binding globulin (SHBG) and albumin. Approximately
40% of testosterone inplasma is bound to SHBG, 2% remains unbound (free) and the rest is bound to albumin and other proteins.
Metabolism
Testosterone is metabolized to various 17-keto steroids through two different pathways. The major active metabolites of
testosterone are estradiol and DHT.
DHT concentrations increased in parallel with testosterone concentrations during testosterone gel treatment. The mean steady-state
DHT/T ratio during 180 days of testosterone gel treatment remained within normal limits and ranged from 0.23 to 0.29 (5 g/day)and from 0.27 to 0.33 (10 g/day).
Excretion
There is considerable variation in the half-life of testosterone concentration as reported in the literature, ranging from 10 to 100
minutes. About 90% of a dose of testosterone given intramuscularly is excreted in the urine as glucuronic and sulfuric acidconjugates of testosterone and its metabolites. About 6% of a dose is excreted in the feces, mostly in the unconjugated form.
Inactivation of testosterone occurs primarily in the liver.
When testosterone gel treatment is discontinued after achieving steady state, serum testosterone concentrations remain in thenormal range for 24 to 48 hours but return to their pretreatment concentrations by the fifth day after the last application.
Testosterone Transfer from Male Patients to Female Partners
The potential for dermal testosterone transfer following testosterone gel use was evaluated in a clinical study between males dosedwith testosterone gel and their untreated female partners. Two (2) hours after application of 100 mg of testosterone from 10 g (2 x
5 g packets) of testosterone gel to upper arm and shoulder of one side by the male subjects, the couples (N = 20 couples) engaged ina 15 minute session of vigorous skin-to-skin contact so that the female partners gained maximum exposure to the testosterone gelapplication sites. Serum concentrations of testosterone were monitored in the female subjects for 24 hours after the transfer
procedure. Under these study conditions, unprotected female partners had a mean testosterone AUC0-24 and Cmax that were morethan 2 times greater than their mean baseline values. When a shirt covered the application site, study results showed a 16% and
48% increase in testosterone AUC0-24 and Cmax, respectively, compared to baseline in these females. The potential for dermal
testosterone transfer following testosterone gel application on the abdomen has not been evaluated.
Effect of Hand Washing and Showering
In a separate clinical study conducted to evaluate the effect of hand washing on the residual amount of testosterone, 33 healthy malesubjects received 100 mg of testosterone from 10 g (2 x 5 g packets) of testosterone gel on a hand and applied testosterone gel tothe upper arm and shoulder of one side. Subjects washed their hands with liquid soap and warm tap water immediately after drug
application. Then the hand was wiped with 3 ethanol dampened gauzes which were then combined together and analyzed for

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testosterone content. A mean (SD) of 0.40 (0.20) mg of residual testosterone (i.e., approximately 0.4% of the theoretical dose of
100 mg testosterone administered) was recovered after washing hands with liquid soap and warm tap water.
The same study also evaluated the effect of showering on the residual amount of testosterone on the application site. Subjects
washed the application site by showering two hours after drug application. The application site was then wiped with 3 ethanol
dampened gauzes which were then combined together and analyzed for testosterone content. A mean (SD) of 5.80 (2.77) mg ofresidual testosterone (i.e., approximately 5.8% of the theoretical dose of 100 mg testosterone administered) was recovered after
showering.
13

NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervicaluterine tumors, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains offemale mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease
the degree of differentiation of chemically induced carcinomas of the liver in rats.
Mutagenesis
Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays.
Impairment of Fertility
The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non-humanprimates, which was reversible on cessation of the treatment

14

CLINICAL STUDIES
14.1 Clinical Trials in Adult Hypogonadal Males
Testosterone gel was evaluated in a multi-center, randomized, parallel-group, active-controlled, 180 day trial in 227 hypogonadal
men. The study was conducted in 2 phases. During the Initial Treatment Period (Days 1 to 90), 73 patients were randomized to
testosterone gel 50 mg daily, 78 patients to testosterone gel 100 mg daily, and 76 patients to a non-scrotal testosterone transdermal
system. The study was double-blind for dose of testosterone gel but open-label for active control. Patients who were originallyrandomized to testosterone gel and who had single-sample serum testosterone levels above or below the normal range on Day 60
were titrated to 75 mg daily on Day 91. During the Extended Treatment Period (Days 91 to 180), 51 patients continued on
testosterone gel 50 mg daily, 52 patients continued on testosterone gel 100 mg daily, 41 patients continued on a non-scrotal
testosterone transdermal system (5 mg daily), and 40 patients received testosterone gel 75 mg daily. Upon completion of the initialstudy, 163 enrolled and 162 patients received treatment in an open-label extension study of testosterone gel for an additional periodof up to 3 years.
Mean peak, trough and average serum testosterone concentrations within the normal range (298 to 1043 ng/dL) were achieved on
the first day of treatment with doses of 50 mg and 100 mg of testosterone gel. In patients continuing on testosterone gel 50 mg and
100 mg, these mean testosterone levels were maintained within the normal range for the 180-day duration of the original study.
Figure 3 summarizes the 24 hour pharmacokinetic profiles of testosterone administered as testosterone gel for 30, 90 and 180 days.
Testosterone concentrations were maintained as long as the patient continued to properly apply the prescribed testosterone geltreatment.
Figure 3: Mean Steady State Testosterone Concentrations in Patients with Once-Daily Testosterone Gel Therapy

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Table 5 summarizes the mean testosterone concentrations on Treatment Day 180 for patients receiving 50 mg, 75 mg, or 100 mg,
of testosterone. The 75 mg dose produced mean concentrations intermediate to those produced by 50 mg and 100 mg of
testosterone.
Table 5: Mean (± SD) Steady-State Serum Testosterone Concentrations During Therapy (Day 180)

Cavg
Cmax
Cmin

50 mg
N = 44555 ± 225830 ± 347
371 ± 165

75 mg
N = 37601 ± 309
901 ± 471
406 ± 220

100 mgN = 48713 ± 209
1083 ± 434
485 ± 156

Of 129 hypogonadal men who were appropriately titrated with testosterone gel and who had sufficient data for analysis, 87%
achieved an average serum testosterone level within the normal range on Treatment Day 180.
In patients treated with testosterone gel, there were no observed differences in the average daily serum testosterone concentrations
at steady-state based on age, cause of hypogonadism, or body mass index.
14.2 Skin Irritation Study
Testosterone gel was evaluated in a randomized, five-treatment, single-center, controlled, within-subject comparison study withhealthy subjects using a cumulative irritation patch test design. Thirty-three (33) subjects completed the study involving
testosterone gel, a comparator control product, vehicle, and positive and negative controls. All five treatments were applied to theskin separately with an occlusive patch. Each subject received a set of 5 patches, once daily for 21 consecutive days. Evaluation ofdermal reactions at the application sites were assessed every day at the time of removal of each patch using an established ordinal(6-point) scoring system. Testosterone gel showed no evidence of significant irritation and was statistically significantly lessirritating than the positive control (P<0.001).
14.3 Skin Sensitization Study
Testosterone gel was evaluated in a randomized, five-treatment, single-center, controlled, within-subject study to evaluate thesensitizing potential on healthy volunteers, using a Repeat Insult Patch Test design. Two hundred three (203) subjects completed
the study involving Testosterone Gel, a comparator control product, vehicle, and positive and negative controls. All five treatments
were applied to the skin separately with an occlusive patch. Each subject received a set of 5 patches, every 48-72 hours for 21
consecutive days. Evaluation of dermal reactions at the application sites were assessed clinically every day at the time of removalof each patch using an established ordinal (6-point) scoring system. Observations at the naïve site during challenge and the patternof reactivity during induction provided bases for an interpretation of contact sensitizations. Under these conditions there was noevidence of sensitization to testosterone gel, In the cumulative irritancy analysis, testosterone gel was statistically significantly lessirritating than the positive control (P<0.001).
16

HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Testosterone gel is supplied in non-aerosol, metered-dose pumps that deliver 12.5 mg of testosterone per complete pump actuation.
The pumps are composed of plastic and stainless steel and an LDPE/aluminum foil inner liner encased in rigid plastic with apolypropylene cap. Each 88 g metered-dose Pump is capable of dispensing 75 g of gel or 60 metered pump actuations; each pumpactuation dispenses 1.25 g of gel containing 12.5 mg of testosterone.
NDC Number
45802-116-02

Package Size
2 x 75 g pumps (each pump dispenses 60 metered pump actuations with each pump actuation
containing 12.5 mg of testosterone in 1.25 g of gel)

Testosterone gel is also supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5 g or 5 g gel contains 25 mg
or 50 mg testosterone, respectively.
NDC Number
45802-116-65
45802-116-39

Package Size
30 packets (25 mg of testosterone in 2.5 g of gel per packet)
30 packets (50 mg of testosterone in 5 g of gel per packet)

16.2 Storage and HandlingStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.]
16.3 Disposal
Used testosterone gel pumps or used testosterone gel packets should be discarded in household trash in a manner that preventsaccidental application or ingestion by children or pets.

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17

PATIENT COUNSELING INFORMATION

See FDA-Approved patient labeling (Medication Guide)
Patients should be informed of the following:
17.1 Use in Men with Known or Suspected Prostate or Breast Cancer
Men with known or suspected prostate or breast cancer should not use testosterone gel [see Contraindications (4) and Warnings
and Precautions (5.1)].
17.2 Potential for Secondary Exposure to Testosterone and Steps to Prevent Secondary Exposure
Secondary exposure to testosterone in children and women can occur with the use of testosterone gel in men. Cases of secondary
exposure to testosterone have been reported in children
Physicians should advise patients of the reported signs and symptoms of secondary exposure which may include the following:• In children; unexpected sexual development including inappropriate enlargement of the penis or clitoris, premature developmentof pubic hair, increased erections, and aggressive behavior• In women; changes in hair distribution, increase in acne, or other signs of testosterone effects• The possibility of secondary exposure to testosterone gel should be brought to the attention of a healthcare provider• Testosterone Gel should be promptly discontinued until the cause of virilization is identified
Strict adherence to the following precautions is advised to minimize the potential for secondary exposure to testosterone fromtestosterone gel in men .
• Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel• Patients using testosterone gel should apply the product as directed and strictly adhere to the following:oWash hands with soap and water after applicationoCover the application site(s) with clothing after the gel has driedoWash the application site(s) thoroughly with soap and water prior to any situation where skin-to-skin contact of theapplication site with another person is anticipatedoIn the event that unwashed or unclothed skin to which testosterone gel has been applied comes in contact with theskin of another person, the general area of contact on the other person should be washed with soap and water as soon
as possible [see Dosage and Administration (2.2), Warnings and Precautions (5.2) and Clinical Pharmacology(12.3)].

17.3 Potential Adverse Reactions with Androgens
Patients should be informed that treatment with androgens may lead to adverse reactions which include:• Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing urine many times
during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to passurine and weak urine flow.
• Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness.
• Too frequent or persistent erections of the penis.
• Nausea, vomiting, changes in skin color, or ankle swelling.
17.4 Patients Should Be Advised of the Following Instructions for Use:•

Read the Medication Guide before starting testosterone gel therapy and reread it each time the prescription is renewed•

Testosterone gel should be applied and used appropriately to maximize the benefits and to minimize the risk of
secondary exposure in children and women•

Keep testosterone gel out of the reach of children

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Testosterone gel is an alcohol based product and is flammable; therefore avoid fire, flame or smoking until the gel has
dried

•

It is important to adhere to all recommended monitoring•

Report any changes in their state of health, such as changes in urinary habits, breathing, sleep, and mood•

Testosterone gel is prescribed to meet the patient’s specific needs; therefore, the patient should never share testosterone gel withanyone.

•Wait 5 hours before showering or swimming. This will ensure that the greatest amount of testosterone gel is absorbed into theirsystem.

Made in Israel
Manufactured by Perrigo-Israel Pharmaceuticals Ltd., Yeruham 80500, Israel
Distributed by Perrigo, Allegan, MI 49010

Rev: 01/20131C200 RC J1

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MEDICATION GUIDE
testosterone gel
Testosterone (tes-TOS-te-rone gel) CIII
Read this Medication Guide that comes with testosterone gel before you start
using it and each time you get a refill. There may be new information. This
Medication Guide does not take the place of talking to your healthcare provider
about your medical condition or your treatment.
What is the most important information I should know about
testosterone gel?
1. Early signs and symptoms of puberty have happened in young
children who were accidentally exposed to testosterone throughcontact with men using testosterone gel.
Signs and symptoms of early puberty in a child may include:

enlarged penis or clitorisearly development of pubic hairincreased erections or sex driveaggressive behavior

Testosterone gel can transfer from your body to others.
2. Women and children should avoid contact with the unwashed or
unclothed area where testosterone gel has been applied to yourskin.
Stop using testosterone gel and call your healthcare provider rightaway if you see any signs and symptoms in a child or a woman that may
have occurred through accidental exposure to testosterone gel.
Signs and symptoms of exposure to testosterone gel in children
may include:

enlarged penis or clitorisearly development of pubic hairincreased erections or sex driveaggressive behavior

Signs and symptoms of exposure to testosterone gel in women may
include:changes in body haira large increase in acne

To lower the risk of transfer of testosterone gel from your body toothers, you should follow these important instructions:

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Apply testosterone gel only to areas that will be covered by ashort sleeve T-shirt. These areas are your shoulders and upper arms,
or stomach area (abdomen), or shoulders, upper arms and stomach
area.



Wash your hands right away with soap and water after applying
testosterone gel.

After the gel has dried, cover the application area with clothing.
Keep the area covered until you have washed the application area wellor have showered.



If you expect to have skin-to-skin contact with another person,
first wash the application area well with soap and water.



If a woman or child makes contact with the testosterone gelapplication area, that area on the woman or child should be
washed well with soap and water right away.

What is testosterone gel?
Testosterone gel is a prescription medicine that contains testosterone.
Testosterone gel is used to treat adult males who have low or no testosterone.
Your healthcare provider will test your blood before you start and while you
are using testosterone gel.
It is not known if testosterone gel is safe or effective in children younger than
18 years old. Improper use of testosterone gel may affect bone growth inchildren.
Testosterone gel is a controlled substance (CIII) because it contains
testosterone that can be a target for people who abuse prescription medicines.
Keep your testosterone gel in a safe place to protect it. Never give yourtestosterone gel to anyone else, even if they have the same symptoms you
have. Selling or giving away this medicine may harm others and is against thelaw.
Testosterone gel is not meant for use in women.
Who should not use testosterone gel?
Do not use testosterone gel if you:

have breast cancerhave or might have prostate cancer•

are pregnant or may become pregnant or breast-feeding. Testosterone
gel may harm your unborn or breast-feeding baby.
Women who are pregnant or who may become pregnant should avoid
contact with the area of skin where testosterone gel has been applied.

Talk to your healthcare provider before taking this medicine if you have any of
the above conditions.

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What should I tell my healthcare provider before using testosterone
gel?
Before you use testosterone gel, tell your healthcare provider if you:

have breast cancerHave or might have prostate cancerhave urinary problems due to an enlarged prostatehave heart problems

have liver or kidney problems

have problems breathing while you sleep (sleep apnea)have any other medical conditions

Tell your healthcare provider about all the medicines you take, including
prescription and non-prescription medicines, vitamins, and herbal
supplements.
Using testosterone gel with certain other medicines can affect each other.
Especially, tell your healthcare provider if you take:

insulin

corticosteroids

medicines that decrease blood clotting

Know the medicines you take. Ask your healthcare provider or pharmacist for alist of these medicines, if you are not sure. Keep a list of them and show it toyour healthcare provider and pharmacist when you get a new medicine.
How should I use testosterone gel?
•

It is important that you apply testosterone gel exactly as your healthcare
provider tells you to.

•Your healthcare provider will tell you how much testosterone gel to apply
and when to apply it.

•Your healthcare provider may change your testosterone gel dose. Do notchange your testosterone gel dose without talking to your healthcare
provider.

•Testosterone gel is to be applied to the area of your shoulders,
upper arms, or abdomen that will be covered by a short sleeve tshirt. Do not apply testosterone gel to any other parts of your body suchas your penis, scrotum, or back.

•

Apply testosterone gel at the same time each morning. Testosterone gelshould be applied after showering or bathing.

•

Wash your hands right away with soap and water after applying
testosterone gel.

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Avoid showering, swimming, or bathing for at least 5 hours after you apply
testosterone gel.

•

Testosterone gel is flammable until dry. Let testosterone gel dry before
smoking or going near an open flame.

•

Let the application areas dry before putting on a t-shirt.

Applying testosterone gel:
Testosterone gel comes in a pump or in packets.
•

Before applying testosterone gel, make sure that your shoulders,
upper arms, and abdomen are clean, dry, and there is no broken
skin.



The application sites for testosterone gel are the shoulders, upper arms, orabdomen that will be covered by a t-shirt (See Figure A).

(Figure A)
If you are using the testosterone gel pump:•

Before using a new bottle of testosterone gel for the first time, you willneed to prime the pump. To prime the testosterone gel pump, slowly push
the pump all the way down 3 times.

•

Do not use any testosterone gel that came out while priming. Wash it
down the sink to avoid accidental exposure to others. Your testosterone gel
pump is now ready to use.

•

Remove the cap from the pump. Then, position the nozzle over the palm of
your hand and slowly push the pump all the way down. Apply testosterone
gel to the application site. You may also apply testosterone gel directly tothe application site.

•

Wash your hands with soap and water right away.

•

Your healthcare provider will tell you the number of times to press thepump for each dose.

If you are using testosterone gel packets:•

Tear open the packet completely at the dotted line. Squeeze from thebottom of the packet to the top.

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Squeeze all of the testosterone gel out of the packet into the palm of yourhand. Apply testosterone gel to the application site. You may also apply
testosterone gel from the packet directly to the application site.

•

Testosterone gel should be applied right away.

•

Wash your hands with soap and water right away.

What are the possible side effects of testosterone gel?
Testosterone gel can cause serious side effects including:•See “What is the most important information I should know about
testosterone gel?”•If you already have enlargement of your prostate gland your signs
and symptoms can get worse while using testosterone gel. This can
include:oincreased urination at nightotrouble starting your urine streamohaving to pass urine many times during the dayohaving an urge that you have to go to the bathroom right awayohaving a urine accidentobeing unable to pass urine or weak urine flow•

Possible increased risk of prostate cancer. Your healthcare provider
should check you for prostate cancer or any other prostate problems before
you start and while you use testosterone gel.

•In large doses testosterone gel may lower your sperm count.

•

Swelling of your ankles, feet, or body, with or without heart failure.

•

Enlarged or painful breasts.

•

Have problems breathing while you sleep (sleep apnea).

•

Blood clots in the legs. This can include pain, swelling or redness of yourlegs.

Call your healthcare provider right away if you have any of the serious
side effects listed above.
The most common side effects of testosterone gel include:
•

acne

•

skin irritation where testosterone gel is applied•

lab test changes• increased prostate specific antigen (a test used to screen for prostatecancer)

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Other side effects include more erections than are normal for you or
erections that last a long time.
Tell your healthcare provider if you have any side effect that bothers you orthat does not go away.
These are not all the possible side effects of testosterone gel. For more
information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
How should I store testosterone gel?
•Store testosterone gel between 68ºF to 77ºF (20ºC to 25ºC).

•

Safely throw away used testosterone gel in household trash. Be careful
to prevent accidental exposure of children or pets.

•

Keep testosterone gel away from fire.

Keep testosterone gel and all medicines out of the reach of children.
General information about the safe and effective use of testosterone
gel.
Medicines are sometimes prescribed for purposes other than those listed in a
Medication Guide. Do not use testosterone gel for a condition for which it was
not prescribed. Do not give testosterone gel to other people, even if they havethe same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about
testosterone gel. If you would like more information, talk to your healthcare
provider. You can ask your pharmacist or healthcare provider for information
about testosterone gel that is written for health professionals.
For more information, go to www.perrigo.com or call 1-866-634-9120
What are the ingredients in testosterone gel?
Active ingredient: testosterone
Inactive ingredients: carbomer 980, ethyl alcohol 67.0%, isostearic acid,
purified water and sodium hydroxide.
Made in Israel
Manufactured by Perrigo,
Yeuham 80500, Israel
Distributed By[graphic] PERRIGO®
Allegan, MI 49010

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www.perrigo.com
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Issued: Jan/2013

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