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Androgel 1% Ciii: (Testosterone Gel)

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0% found this document useful (0 votes)
40 views4 pages

Androgel 1% Ciii: (Testosterone Gel)

Uploaded by

The Cedar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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cause a disproportionate advancement in bone maturation.

Use

AndroGel 1% over long periods may result in fusion of the epiphyseal growth
centers and termination of the growth process. Androgens have
been reported to stimulate the production of red blood cells by

(testosterone gel)
DESCRIPTION
CIII enhancing erythropoietin production.
During exogenous administration of androgens, endogenous
testosterone release may be inhibited through feedback
inhibition of pituitary luteinizing hormone (LH). At large doses
of exogenous androgens, spermatogenesis may also be
AndroGel™ (testosterone gel) is a clear, colorless hydroalcoholic suppressed through feedback inhibition of pituitary follicle-
gel containing 1% testosterone. AndroGel™ provides continuous stimulating hormone (FSH).
transdermal delivery of testosterone, the primary circulating
endogenous androgen, for 24 hours following a single There is a lack of substantial evidence that androgens are
application to intact, clean, dry skin of the shoulders, upper arms effective in accelerating fracture healing or in shortening post-
and/or abdomen. surgical convalescence.
A daily application of AndroGel™ 5 G, 7.5 G, or 10 G delivers Pharmacokinetics
50 mg, 75 mg, or 100 mg of testosterone, respectively, per day, to Absorption
the skin’s surface. Approximately 10% of the applied testosterone AndroGel™ is a hydroalcoholic formulation that dries quickly
dose is absorbed across skin of average permeability during a when applied to the skin surface. The skin serves as a reservoir for
24-hour period. the sustained release of testosterone into the systemic circulation.
In a study with the 10 G dose (to deliver 100 mg testosterone), all
The active pharmacologic ingredient in AndroGel™ is patients showed an increase in serum testosterone within
testosterone. Testosterone USP is a white to practically white 30 minutes, and eight of nine patients had a serum testosterone
crystalline powder chemically described as 17-beta concentration within the normal range by 4 hours after the initial
hydroxyandrost-4-en-3-one. application. Absorption of testosterone into the blood continues
for the entire 24-hour dosing interval. Serum concentrations
H approximate the steady state level by the end of the first 24 hours
H3C OH and are at steady state by the second or third day of dosing.
With single daily applications of AndroGel,™ follow-up
H3C H measurements 30, 90 and 180 days after starting treatment
have confirmed that serum testosterone concentrations are
generally maintained within the eugonadal range. Figure 1
H H summarizes the 24-hour pharmacokinetic profiles of
testosterone for patients maintained on 5 G or 10 G of
O AndroGel™ (to deliver 50 or 100 mg of testosterone,
respectively) for 30 days. The average (±SD) daily testosterone
concentration produced by AndroGel™ 10 G on Day 30 was
Testosterone 792 (±294) ng/dL and by AndroGel™ 5 G 566 (±262) ng/dL.

1400
C19H28O2 MW 288.42
5 G AndroGel™
1200 10 G AndroGel™
Testosterone Concentration (ng/dL)

Inactive ingredients in AndroGel™ are ethanol 68.9%, purified 1000


High Normal

water, sodium hydroxide, Carbomer 940 and isopropyl myristate;


800
these ingredients are not pharmacologically active.
CLINICAL PHARMACOLOGY 600

AndroGel™ (testosterone gel) delivers physiologic amounts of 400


testosterone, producing circulating testosterone concentrations Low Normal
that approximate normal levels (298–1043 ng/dL) seen in healthy 200

men. 0
0 4 8 12 16 20 24
Testosterone—General Androgen Effects:
Time (Hours) After Application
Endogenous androgens, including testosterone and
dihydrotestosterone (DHT), are responsible for the normal Figure 1. Mean (±SD) Steady-State Serum Testosterone
growth and development of the male sex organs and for Concentrations on Day 30 in Patients Applying AndroGel™
maintenance of secondary sex characteristics. These effects Once Daily
include the growth and maturation of prostate, seminal vesicles,
penis, and scrotum; the development of male hair distribution, When AndroGel™ treatment is discontinued after achieving
such as facial, pubic, chest, and axillary hair; laryngeal steady state, serum testosterone levels remain in the normal
enlargement, vocal cord thickening, alterations in body range for 24 to 48 hours but return to their pretreatment levels
musculature, and fat distribution. Testosterone and DHT are by the fifth day after the last application.
necessary for the normal development of secondary sex Distribution
characteristics. Male hypogonadism results from insufficient Circulating testosterone is chiefly bound in the serum to sex
secretion of testosterone and is characterized by low serum hormone-binding globulin (SHBG) and albumin. The albumin-
testosterone concentrations. Symptoms associated with male bound fraction of testosterone easily dissociates from albumin
hypogonadism include impotence and decreased sexual desire, and is presumed to be bioactive. The portion of testosterone
fatigue and loss of energy, mood depression, regression of bound to SHBG is not considered biologically active. The amount
secondary sexual characteristics and osteoporosis. of SHBG in the serum and the total testosterone level will
Hypogonadism is a risk factor for osteoporosis in men. determine the distribution of bioactive and nonbioactive
Drugs in the androgen class also promote retention of nitrogen, androgen. SHBG-binding capacity is high in prepubertal children,
sodium, potassium, phosphorus, and decreased urinary excretion declines during puberty and adulthood, and increases again
of calcium. Androgens have been reported to increase protein during the later decades of life. Approximately 40% of
anabolism and decrease protein catabolism. Nitrogen balance is testosterone in plasma is bound to SHBG, 2% remains unbound
improved only when there is sufficient intake of calories and (free) and the rest is bound to albumin and other proteins.
protein. Metabolism
Androgens are responsible for the growth spurt of adolescence There is considerable variation in the half-life of testosterone as
and for the eventual termination of linear growth brought reported in the literature, ranging from ten to 100 minutes.
about by fusion of the epiphyseal growth centers. In children, Testosterone is metabolized to various 17-keto steroids through
exogenous androgens accelerate linear growth rates but may two different pathways. The major active metabolites of
testosterone are estradiol and DHT. DHT binds with greater Table 1: Mean (±SD) Steady-State Serum Testosterone
affinity to SHBG than does testosterone. In many tissues, the Concentrations During Therapy (Day 180)
activity of testosterone depends on its reduction to DHT, which
binds to cytosol receptor proteins. The steroid-receptor complex is 5G 7.5 G 10 G
transported to the nucleus where it initiates transcription and N = 44 N = 37 N = 48
cellular changes related to androgen action. In reproductive
tissues, DHT is further metabolized to 3- and 3-ß androstanediol. Cavg 555 ± 225 601 ± 309 713 ± 209
DHT concentrations increased in parallel with testosterone Cmax 830 ± 347 901 ± 471 1083 ± 434
concentrations during AndroGel™ treatment. After 180 days of Cmin 371 ± 165 406 ± 220 485 ± 156
treatment, mean DHT concentrations were within the normal
range with 5 G AndroGel™ and were about 7% above the
normal range after a 10 G dose. The mean steady state DHT/T Of 129 hypogonadal men who were appropriately titrated with
ratio during 180 days of AndroGel™ treatment remained within AndroGel™ and who had sufficient data for analysis,
normal limits (as determined by the analytical laboratory 87% achieved an average serum testosterone level within the
involved with this clinical trial) and ranged from 0.23 to normal range on Treatment Day 180.
0.29 (5 G/day) and from 0.27 to 0.33 (10 G/day).
AndroGel™ 5 G/day and 10 G/day resulted in significant
Excretion increases over time in total body mass and total body lean mass,
About 90% of a dose of testosterone given intramuscularly is while total body fat mass and the percent body fat decreased
excreted in the urine as glucuronic and sulfuric acid conjugates significantly. These changes were maintained for 180 days of
of testosterone and its metabolites; about 6% of a dose is treatment. Changes in the 7.5 G dose group were similar. Bone
excreted in the feces, mostly in the unconjugated form. mineral density in both hip and spine increased significantly
Inactivation of testosterone occurs primarily in the liver. from Baseline to Day 180 with 10 G AndroGel.™
Special Populations AndroGel™ treatment at 5 G/day and 10 G/day for 90 days
In patients treated with AndroGel,™ there are no observed produced significant improvement in libido (measured by sexual
differences in the average daily serum testosterone motivation, sexual activity and enjoyment of sexual activity as
concentration at steady-state based on age, cause of assessed by patient responses to a questionnaire). The degree of
hypogonadism or body mass index. No formal studies were penile erection as subjectively estimated by the patients,
conducted involving patients with renal or hepatic insufficiencies. increased with AndroGel™ treatment, as did the subjective score
Clinical Studies for “satisfactory duration of erection.” AndroGel™ treatment at
AndroGel™ 1% was evaluated in a multicenter, randomized, 5 G/day and 10 G/day produced positive effects on mood and
parallel-group, active-controlled, 180-day trial in 227 hypogonadal fatigue. Similar changes were seen after 180 days of treatment
men. The study was conducted in 2 phases. During the Initial and in the group treated with the 7.5 G dose.
Treatment Period (Days 1-90), 73 patients were randomized to DHT concentrations increased in parallel with testosterone
AndroGel™ 5 G daily (to deliver 50 mg testosterone), 78 patients concentrations at AndroGel™ doses of 5 G/day and 10 G/day,
to AndroGel™ 10 G daily (to deliver 100 mg testosterone), and but the DHT/T ratio stayed within the normal range, indicating
76 patients to a non-scrotal testosterone transdermal system enhanced availability of the major physiologically active
(5 mg daily). The study was double-blind for dose of AndroGel™ androgen. Serum estradiol (E2) concentrations increased
but open-label for active control. Patients who were originally significantly within 30 days of starting treatment with
randomized to AndroGel™ and who had single-sample serum AndroGel™ 5 or 10 G/day and remained elevated throughout
testosterone levels above or below the normal range on Day 60 the treatment period but remained within the normal range for
were titrated to 7.5 G daily (to deliver 75 mg testosterone) on eugonadal men. Serum levels of SHBG decreased very slightly
Day 91. During the Extended Treatment Period (Days 91-180), (1 to 11%) during AndroGel™ treatment. In men with
51 patients continued on AndroGel™ 5 G daily, 52 patients hypergonadotropic hypogonadism, serum levels of LH and FSH
continued on AndroGel™ 10 G daily, 41 patients continued on a fell in a dose- and time-dependent manner during treatment
non-scrotal testosterone transdermal system (5 mg daily), and with AndroGel.™
40 patients received AndroGel™ 7.5 G daily.
Mean peak, trough and average serum testosterone Potential for testosterone transfer:
concentrations within the normal range (298-1043 ng/dL) were The potential for dermal testosterone transfer following
achieved on the first day of treatment with doses of 5 G and AndroGel™ use was evaluated in a clinical study between males
10 G. In patients continuing on AndroGel™ 5 G and 10 G, these dosed with AndroGel™ and their untreated female partners.
mean testosterone levels were maintained within the normal Two to 12 hours after AndroGel™ (10 G) application by the
range for the 180-day duration of the study. Figure 2 male subjects, the couples (N=38 couples) engaged in daily,
summarizes the 24-hour pharmacokinetic profiles of 15-minute sessions of vigorous skin-to-skin contact so that the
testosterone administered as AndroGel™ for 30, 90 and female partners gained maximum exposure to the AndroGel™
180 days. Testosterone concentrations were maintained as long application sites. Under these study conditions, all unprotected
as the patient continued to properly apply the prescribed female partners had a serum testosterone concentration
AndroGel™ treatment. >2 times the baseline value at some time during the study.
When a shirt covered the application site(s), the transfer of
testosterone from the males to the female partners was
1100
Upper Limit of completely prevented.
Normal Range
1000
INDICATIONS AND USAGE
Testosterone Concentration (ng/dL)

900
AndroGel™ is indicated for replacement therapy in males for
800 AndroGel™ 10 G conditions associated with a deficiency or absence of
700
Day 30
endogenous testosterone:
Day 90
600 Day 180
1. Primary hypogonadism (congenital or acquired)—testicular
500 AndroGel™ 5 G failure due to cryptorchidism, bilateral torsion, orchitis,
400 vanishing testis syndrome, orchiectomy, Klinefelter’s
300 Lower Limit of
Normal Range
syndrome, chemotherapy, or toxic damage from alcohol or
200
heavy metals. These men usually have low serum testosterone
0 2 4 6 8 10 12 14 16 18 20 22 24 levels and gonadotropins (FSH, LH) above the normal range.
Time (Hours) After Application
2. Hypogonadotropic hypogonadism (congenital or acquired)—
Figure 2. Mean Steady-State Testosterone Concentrations in idiopathic gonadotropin or luteinizing hormone-releasing
Patients with Once-Daily AndroGel™ Therapy hormone (LHRH) deficiency or pituitary-hypothalamic injury
from tumors, trauma, or radiation. These men have low
Table 1 summarizes the mean testosterone concentrations on testosterone serum levels but have gonadotropins in the
Treatment Day 180 for patients receiving 5 G, 7.5 G, or 10 G of normal or low range.
AndroGel.™ The 7.5 G dose produced mean concentrations
intermediate to those produced by 5 G and 10 G of AndroGel.™ AndroGel™ has not been clinically evaluated in males under
18 years of age.
CONTRAINDICATIONS Advise patients of the following:
Androgens are contraindicated in men with carcinoma of the • AndroGel™ should not be applied to the scrotum.
breast or known or suspected carcinoma of the prostate. • AndroGel™ should be applied once daily to clean dry skin.
AndroGel™ is not indicated for use in women, has not been • After application of AndroGel,™ it is currently unknown for how
evaluated in women, and must not be used in women. long showering or swimming should be delayed. For optimal
absorption of testosterone, it appears reasonable to wait at least
Pregnant women should avoid skin contact with AndroGel™
5-6 hours after application prior to showering or swimming.
application sites in men. Testosterone may cause fetal harm. In
Nevertheless, showering or swimming after just 1 hour should
the event that unwashed or unclothed skin to which
have a minimal effect on the amount of AndroGel™ absorbed if
AndroGel™ has been applied does come in direct contact with
done very infrequently.
the skin of a pregnant woman, the general area of contact on
the woman should be washed with soap and water as soon as Laboratory Tests
possible. In vitro studies show that residual testosterone is 1. Hemoglobin and hematocrit levels should be checked
removed from the skin surface by washing with soap and water. periodically (to detect polycythemia) in patients on long-term
androgen therapy.
AndroGel™ should not be used in patients with known
hypersensitivity to any of its ingredients. 2. Liver function, prostatic specific antigen, cholesterol, and
high-density lipoprotein should be checked periodically.
WARNINGS
1. Prolonged use of high doses of orally active 17-alpha-alkyl 3. To ensure proper dosing, serum testosterone concentrations
androgens (e.g., methyltestosterone) has been associated with should be measured (see DOSAGE AND ADMINISTRATION).
serious hepatic adverse effects (peliosis hepatitis, hepatic Drug Interactions
neoplasms, cholestatic hepatitis, and jaundice). Peliosis Oxyphenbutazone: Concurrent administration of oxyphenbutazone
hepatitis can be a life-threatening or fatal complication. and androgens may result in elevated serum levels of
Long-term therapy with testosterone enanthate, which oxyphenbutazone.
elevates blood levels for prolonged periods, has produced
multiple hepatic adenomas. Testosterone is not known to Insulin: In diabetic patients, the metabolic effects of androgens
produce these adverse effects. may decrease blood glucose and, therefore, insulin requirements.
2. Geriatric patients treated with androgens may be at an Propranolol: In a published pharmacokinetic study of an
increased risk for the development of prostatic hyperplasia injectable testosterone product, administration of testosterone
and prostatic carcinoma. cypionate led to an increased clearance of propranolol in the
majority of men tested.
3. Geriatric patients and other patients with clinical or
demographic characteristics that are recognized to be associated Corticosteroids: The concurrent administration of testosterone
with an increased risk of prostate cancer should be evaluated with ACTH or corticosteroids may enhance edema formation;
for the presence of prostate cancer prior to initiation of thus these drugs should be administered cautiously, particularly
testosterone replacement therapy. In men receiving testosterone in patients with cardiac or hepatic disease.
replacement therapy, surveillance for prostate cancer should be Drug/Laboratory Test Interactions
consistent with current practices for eugonadal men (see Androgens may decrease levels of thyroxin-binding globulin,
PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of resulting in decreased total T4 serum levels and increased resin
Fertility and Laboratory Tests). uptake of T3 and T4. Free thyroid hormone levels remain
4. Edema with or without congestive heart failure may be a unchanged, however, and there is no clinical evidence of thyroid
serious complication in patients with preexisting cardiac, dysfunction.
renal, or hepatic disease. In addition to discontinuation of the Carcinogenesis, Mutagenesis, Impairment of Fertility
drug, diuretic therapy may be required. Animal Data: Testosterone has been tested by subcutaneous
5. Gynecomastia frequently develops and occasionally persists in injection and implantation in mice and rats. In mice, the implant
patients being treated for hypogonadism. induced cervical-uterine tumors, which metastasized in some
cases. There is suggestive evidence that injection of testosterone
6. The treatment of hypogonadal men with testosterone esters into some strains of female mice increases their susceptibility to
may potentiate sleep apnea in some patients, especially those hepatoma. Testosterone is also known to increase the number
with risk factors such as obesity or chronic lung diseases. of tumors and decrease the degree of differentiation of
PRECAUTIONS chemically induced carcinomas of the liver in rats.
Transfer of testosterone to another person can occur when Human Data: There are rare reports of hepatocellular carcinoma
vigorous skin-to-skin contact is made with the application site in patients receiving long-term oral therapy with androgens in
(see Clinical Studies). The following precautions are high doses. Withdrawal of the drugs did not lead to regression
recommended to minimize potential transfer of testosterone of the tumors in all cases.
from AndroGel™-treated skin to another person:
Geriatric patients treated with androgens may be at an increased
• Patients should wash their hands immediately with soap and risk for the development of prostatic hyperplasia and prostatic
water after application of AndroGel.™ carcinoma.
• Patients should cover the application site(s) with clothing after Geriatric patients and other patients with clinical or
the gel has dried (e.g. a shirt). demographic characteristics that are recognized to be associated
• In the event that unwashed or unclothed skin to which with an increased risk of prostate cancer should be evaluated
AndroGel™ has been applied does come in direct contact with for the presence of prostate cancer prior to initiation of
the skin of another person, the general area of contact on the testosterone replacement therapy.
other person should be washed with soap and water as soon as In men receiving testosterone replacement therapy, surveillance
possible. In vitro studies show that residual testosterone is for prostate cancer should be consistent with current practices
removed from the skin surface by washing with soap and water. for eugonadal men.
Changes in body hair distribution, significant increase in acne, or Pregnancy Category X (see Contraindications)—Teratogenic
other signs of virilization of the female partner should be Effects: AndroGel™ is not indicated for women and must not be
brought to the attention of a physician. used in women.
General Nursing Mothers: AndroGel™ is not indicated for women and
The physician should instruct patients to report any of the must not be used in women.
following: Pediatric Use: Safety and efficacy of AndroGel™ in pediatric
• Too frequent or persistent erections of the penis. patients have not been established.
• Any nausea, vomiting, changes in skin color, or ankle swelling. ADVERSE REACTIONS
• Breathing disturbances, including those associated with sleep. In a controlled clinical study, 154 patients were treated with
AndroGel™ for up to 6 months (see Clinical Studies). Adverse
Information for Patients Events possibly, probably or definitely related to the use of
Advise patients to carefully read the information brochure that AndroGel™ and reported by ≥1% of the patients are listed in
accompanies each carton of 30 AndroGel™ single-use packets. Table 2.
Table 2. Adverse Events Possibly, Probably or Definitely Related **Prostate disorders included enlarged prostate, elevated PSA
to Use of AndroGel™ in the Controlled Clinical Trial results, and in one patient, a new diagnosis of prostate
cancer; three patients (one taking 7.5 G daily and two taking
Adverse Event 5G 7.5 G 10 G 10 G daily) discontinued AndroGel™ treatment during the
Acne 1% 3% 8% long-term study because of such disorders.
Alopecia 1% 0% 1% DRUG ABUSE AND DEPENDENCE
Application Site Reaction 5% 3% 4% AndroGel™ contains testosterone, a Schedule III controlled
Asthenia 0% 3% 1% substance as defined by the Anabolic Steroids Control Act.
Depression 1% 0% 1% Oral ingestion of AndroGel™ will not result in clinically
Emotional Lability 0% 3% 3% significant serum testosterone concentrations due to extensive
Gynecomastia 1% 0% 3% first-pass metabolism.
Headache 4% 3% 0%
Hypertension 3% 0% 3% OVERDOSAGE
Lab Test Abnormal* 6% 5% 3% There is one report of acute overdosage by injection of
testosterone enanthate: testosterone levels of up to
Libido Decreased 0% 3% 1%
11,400 ng/dL were implicated in a cerebrovascular accident.
Nervousness 0% 3% 1%
Pain Breast 1% 3% 1% DOSAGE AND ADMINISTRATION
Prostate Disorder** 3% 3% 5% The recommended starting dose of AndroGel™ 1% is 5 G
Testis Disorder 3% 0% 0% (to deliver 50 mg of testosterone) applied once daily (preferably
in the morning) to clean, dry, intact skin of the shoulders and
*Lab test abnormal occurred in nine patients with one or more upper arms and/or abdomen. Upon opening the packet(s), the
of the following events: elevated hemoglobin or hematocrit, entire contents should be squeezed into the palm of the hand
hyperlipidemia, elevated triglycerides, hypokalemia, and immediately applied to the application sites. Application
decreased HDL, elevated glucose, elevated creatinine, or sites should be allowed to dry for a few minutes prior to
elevated total bilirubin. dressing. Hands should be washed with soap and water after
**Prostate disorders included five patients with enlarged AndroGel™ has been applied.
prostate, one patient with BPH, and one patient with Do not apply AndroGel™ to the genitals.
elevated PSA results.
Serum testosterone levels should be measured approximately
The following adverse events possibly related to the use of 14 days after initiation of therapy to ensure proper dosing. If
AndroGel™ occurred in fewer than 1% of patients: amnesia, the serum testosterone concentration is below the normal
anxiety, discolored hair, dizziness, dry skin, hirsutism, hostility, range, or if the desired clinical response is not achieved, the
impaired urination, paresthesia, penis disorder, peripheral daily AndroGel™ 1% dose may be increased from 5 G to 7.5 G
edema, sweating, and vasodilation. and from 7.5 G to 10 G as instructed by the physician.
In this clinical trial of AndroGel,™ skin reactions at the site of HOW SUPPLIED
application were occasionally reported with AndroGel,™ but AndroGel™ contains testosterone, a Schedule III controlled
none was severe enough to require treatment or substance as defined by the Anabolic Steroids Control Act.
discontinuation of drug.
AndroGel™ is supplied in unit-dose aluminum foil packets in
Six (4%) patients in this trial had adverse events that led to cartons of 30. Each packet contains 2.5 G or 5.0 G of gel to
discontinuation of AndroGel.™ These events included the deliver 25 mg or 50 mg of testosterone, respectively, and is
following: cerebral hemorrhage, convulsion (neither of which supplied as follows:
were considered related to AndroGel™ administration), NDC Number Strength Package Size
depression, sadness, memory loss, elevated prostate specific
antigen and hypertension. No AndroGel™ patients discontinued 0051-8425-30 1% (25 mg) 30 packets: 2.5 G per packet
due to skin reactions. 0051-8450-30 1% (50 mg) 30 packets: 5 G per packet
In an uncontrolled pharmacokinetic study of 10 patients, two Storage
had adverse events associated with AndroGel™; these were Store at controlled room temperature 20-25°C (68-77°F)
asthenia and depression in one patient and increased libido and [see USP].
hyperkinesia in the other. Among 17 patients in foreign clinical
studies there was 1 instance each of acne, erythema and benign Disposal
prostate adenoma associated with a 2.5% testosterone gel Used AndroGel™ packets should be discarded in household
formulation applied dermally. trash in a manner that prevents accidental application or
ingestion by children or pets.
One hundred six (106) patients have received AndroGel™ for up
to 12 months in a long-term follow-up study for patients who Rx Only
completed the controlled clinical trial. The preliminary safety Manufactured by Laboratoires Besins Iscovesco
results from this study are consistent with those reported for the Montrouge, France
controlled clinical trial. Table 3 summarizes those adverse events
possibly, probably or definitely related to the use of AndroGel™ For:
and reported by at least 1% of the total number of patients Unimed Pharmaceuticals, Inc.
during long-term exposure to AndroGel.™ Buffalo Grove, IL 60089-1864, USA

Table 3. Incidence of Adverse Events Possibly, Probably or


Definitely Related to the Use of AndroGel™ in the Long-Term,
Follow-up Study
Dose of AndroGel™
Adverse Event 5G 7.5 G 10 G
Lab Test Abnormal* 4.2% 0.0% 6.3%
Peripheral Edema 1.4% 0.0% 3.1%
Acne 2.8% 0.0% 12.5%
Application Site Reaction 9.7% 10.0% 3.1%
Prostate Disorder** 2.8% 5.0% 18.8%
Urination Impaired 2.8% 0.0% 0.0%

*Lab test abnormal included one patient each with elevated


GGTP, elevated hematocrit and hemoglobin, increased total
bilirubin, worsened hyperlipidemia, decreased HDL, and
hypokalemia. AG01-032700-01

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