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Testim
Overview
What is Testim?
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What does Testim look like?
What are the available doses of Testim?
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What should I talk to my health care provider before I take Testim?
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How should I use Testim?
Testim is indicated for testosterone
replacement therapy in adult males for conditions associated with a deficiency
or absence of endogenous testosterone:
Testim has not been clinically evaluated in males
under 18 years of age.
The recommended starting dose of Testim
is 5 g of gel (one tube) containing 50 mg of testosterone applied once daily
(preferably in the morning) to clean, dry intact skin of the shoulders and/or
upper arms. Morning serum testosterone levels should then be measured
approximately 14 days after initiation of therapy to ensure proper serum
testosterone levels are achieved. If the serum testosterone concentration is
below the normal range, or if the desired clinical response is not achieved, the
daily Testim dose may be increased from 5 g (one tube)
to 10 g (two tubes) as instructed by the physician.
Upon opening the tube the entire contents should be squeezed into the palm of
the hand and immediately applied to the shoulders and/or upper arms. Application
sites should be allowed to dry for a few minutes prior to dressing. Hands should
be washed thoroughly with soap and water after Testim
has been applied.
In order to prevent transfer to another person, clothing should be worn to
cover the application sites. If direct skin-to-skin contact with another person
is anticipated, the application sites must be washed thoroughly with soap and
water.
In order to maintain serum testosterone levels in the normal range, the sites
of application should not be washed for at least two hours after application of
Testim.
Do not apply Testim to the genitals or to the
abdomen.
What interacts with Testim?
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What are the warnings of Testim?
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What are the precautions of Testim?
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What are the side effects of Testim?
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What should I look out for while using Testim?
Androgens are contraindicated in men with carcinoma of the breast
or known or suspected carcinoma of the prostate. Testim
is not indicated for use in women, has not been evaluated for use in women, and
must not be used in women.
Pregnant and nursing women should avoid skin contact with Testim application sites on men. Testosterone may cause fetal harm.
Testosterone exposure during pregnancy has been reported to be associated with
fetal abnormalities. In the event that unwashed or unclothed skin to which
Testim has been applied comes in direct contact with the
skin of a pregnant or nursing woman, the general area of contact on the woman
should be immediately washed with soap and water.
Testim should not be used in patients with known
hypersensitivity to any of its ingredients, including testosterone USP that is
chemically synthesized from soy.
What might happen if I take too much Testim?
There were no reports of overdose in the Testim clinical trials. There is one report of acute overdosage by
injection of testosterone enanthate: testosterone levels of up to 11,400 ng/dL
were implicated in a cerebrovascular accident.
How should I store and handle Testim?
Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:StorageStore at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].DisposalUsed Testim tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable.RX OnlyManufactured for:Auxilium Pharmaceuticals, Inc.Norristown, PA, 19401 USABy: Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Labeling Code: AA2500.09Issued: January 20050105-001.a127997
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Testim 1% (testosterone gel) delivers
physiologic amounts of testosterone, producing circulating testosterone levels
that approximate normal levels (e.g., 300 - 1000 ng/dL) seen in healthy
men.
Testosterone and dihydrotestosterone (DHT), endogenous androgens,
are responsible for normal growth and development of the male sex organs and for
maintenance of secondary sex characteristics. These effects include the growth
and maturation of the prostate, seminal vesicles, penis, and scrotum; the
development of male hair distribution, such as facial, pubic, chest, and
axillary hair; laryngeal enlargement; vocal cord thickening; alterations in body
musculature; and fat distribution.
Male hypogonadism results from insufficient secretion of testosterone and is
characterized by low serum testosterone concentrations. Symptoms associated with
male hypogonadism include decreased sexual desire with or without impotence,
fatigue and loss of energy, mood depression, regression of secondary sexual
characteristics, and osteoporosis. Hypogonadism is a risk factor for
osteoporosis in men.
Drugs in the androgen class also promote retention of nitrogen, sodium,
potassium, phosphorus, and decreased urinary excretion of calcium.
Androgens have been reported to increase protein anabolism and decrease
protein catabolism. Nitrogen balance is improved only when there is sufficient
intake of calories and protein. Androgens have been reported to stimulate the
production of red blood cells by enhancing erythropoietin production.
Androgens are responsible for the growth spurt of adolescence and for the
eventual termination of linear growth brought about by fusion of the epiphyseal
growth centers. In children, exogenous androgens accelerate linear growth rates
but may cause a disproportionate advancement in bone maturation. Use over long
periods may result in fusion of the epiphyseal growth centers and termination of
the growth process.
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
suppressed through feedback inhibition of pituitary follicle-stimulating hormone
(FSH).
There is a lack of substantial evidence that androgens are effective in
accelerating fracture healing or in shortening post-surgical
convalescence.
The pharmacokinetics of Testim have been
evaluated with administration of doses containing 50 mg and 100 mg of
testosterone to adult males with morning testosterone levels ≤300 ng/dL.
Testim is a topical 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 applied on the skin surface is absorbed
into the systemic circulation during a 24-hour period.
In single dose studies, when either Testim 50 mg or 100 mg was administered, absorption of testosterone
into the blood continued for the entire 24 hour dosing period. Also, mean peak
and average serum concentrations within the normal range were achieved within 24
hours.
With single daily applications of Testim
50 mg and 100 mg, follow-up measurements at 30 and 90 days after starting
treatment have confirmed that serum testosterone and DHT concentrations are
generally maintained within the normal range.
Figure 1 summarizes the 24-hour pharmacokinetic profile of testosterone for
patients maintained on Testim® 50 mg or Testim® 100 mg for 30 days.
Figure 1
Mean Steady-State Serum Testosterone (±SD) (ng/dL)
Concentrations on Day 30 in Patients Applying Testim® Once Daily
The average daily testosterone concentration produced by Testim 100 mg at Day 30 was 612 (± 286) ng/dL and by Testim 50 mg at Day 30 was 365 (± 187) ng/dL.
Figure 2 summarizes the 24-hour pharmacokinetic profile of DHT for patients
maintained on Testim 50 mg or Testim 100 mg for 30 days.
Figure 2
Mean Steady-State Serum Dihydrotestosterone (±SD) (pg/mL)
Concentrations on Day 30 in Patients Applying Testim® Once Daily
The average daily DHT concentration produced by Testim 100 mg at Day 30 was 555 (± 293) pg/mL and by Testim 50 mg at Day 30 was 346 (± 212) pg/mL.
The effect of showering (with mild soap) at 1, 2 and 6 hours post
application of Testim 100 mg was evaluated in a clinical
trial in 12 men. The study demonstrated that the overall effect of washing was
to lessen testosterone levels; however, when washing occurred two or more hours
post drug application, serum testosterone levels remained within the normal
range.
Circulating testosterone is chiefly bound in the serum to sex
hormone-binding globulin (SHBG) and albumin. The albumin-bound fraction of
testosterone easily dissociates from albumin and is presumed to be bioactive.
The portion of testosterone bound to SHBG is not considered biologically active.
Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound
(free) and the rest is bound to albumin and other proteins. The amount of SHBG
in the serum and the total testosterone level will determine the distribution of
bioactive and nonbioactive androgen.
There is considerable variation in the half-life of testosterone
as reported in the literature, ranging from ten to 100 minutes.
Testosterone is metabolized to various 17-keto steroids through two different
pathways. The major active metabolites of testosterone are estradiol and DHT.
Testosterone is metabolized to DHT by steroid 5α-reductase located in the skin,
liver, and the urogenital tract of the male. DHT binds with greater affinity to
SHBG than does testosterone. In many tissues, the activity of testosterone
depends on its reduction to DHT, which binds to cytosol receptor proteins. The
steroid-receptor complex is transported to the nucleus where it initiates
transcription and cellular changes related to androgen action. In reproductive
tissues, DHT is further metabolized to 3α and 3β androstanediol. Inactivation of
testosterone occurs primarily in the liver.
DHT concentrations increased in parallel with testosterone concentrations
during Testim treatment. After 90 days of treatment,
mean DHT concentrations remained generally within the normal range for
Testim-treated subjects.
About 90% of a testosterone dose given intramuscularly is
excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone
and metabolites; about 6% of a dose is excreted in the feces, mostly in the
unconjugated form.
In patients treated with Testim there are
no observed differences in the average daily serum testosterone concentration at
steady-state based on age or cause of hypogonadism. No formal studies were
conducted in a pediatric age population or in patients with renal or hepatic
insufficiencies.
Non-Clinical Toxicology
Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. Testim is not indicated for use in women, has not been evaluated for use in women, and must not be used in women.Pregnant and nursing women should avoid skin contact with Testim application sites on men. Testosterone may cause fetal harm. Testosterone exposure during pregnancy has been reported to be associated with fetal abnormalities. In the event that unwashed or unclothed skin to which Testim has been applied comes in direct contact with the skin of a pregnant or nursing woman, the general area of contact on the woman should be immediately washed with soap and water.
Testim should not be used in patients with known hypersensitivity to any of its ingredients, including testosterone USP that is chemically synthesized from soy.
The rate and extent of perindopril absorption and elimination are not affected by concomitant diuretics. The bioavailability of perindoprilat was reduced by diuretics, however, and this was associated with a decrease in plasma ACE inhibition.
Transfer of testosterone to another person can occur when vigorous skin-to-skin contact is made with the application site (See Clinical Studies).
The following precautions are recommended to minimize potential transfer of testosterone from Testim-treated skin to another person:
Changes in body hair distribution, significant increase in acne, or other signs of virilization of the female partner should be brought to the attention of a physician.
The physician should instruct patients to report any of the following:
In a controlled clinical study, 304 patients were treated with Testim 50 mg or 100 mg or placebo gel for up to 90 days. Two hundred-five (205) patients received Testim 50 mg or 100 mg daily and 99 patients received placebo. Patients with adverse events that were possibly or probably related to study drug and reported by ≥1% of the Testim patients and greater than placebo are listed in Table 3.
The following adverse events possibly or probably related to Testim occurred in fewer than 1% of patients but were greater in Testim groups compared to the placebo group: activated partial thromboplastin time prolonged, blood creatinine increased, prothrombin time prolonged, appetite increased, sensitive nipples, and acne.
In this clinical trial of Testim, six patients had adverse events that led to their discontinuation. These events included: vertigo, coronary artery disease, depression with suicidal ideation, urinary tract infection/pneumonia (none of which were considered related to Testim administration), mood swings and hypertension. No Testim patients discontinued due to skin reaction.
In one foreign Phase 3 trial, one subject discontinued due to a skin-related adverse event. In the pivotal U.S. and European Phase 3 trials combined, at the 50 mg dosage strength, the percentage of subjects reporting clinically notable increases in hematocrit or hemoglobin were similar to placebo. However, in the 100 mg dose group, 2.3% and 2.8% of patients had a clinically notable increase in hemoglobin (≥ 19 gm/dL) or hematocrit (≥ 58%), respectively.
In the combined ongoing U.S. and European open label extension studies, approximately 140 patients received Testim for at least 6 months. The preliminary results from these studies are consistent with those reported for the U.S. controlled clinical trial.
Testim contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Oral ingestion of Testim will not result in clinically significant serum testosterone concentrations due to extensive first-pass metabolism.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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