TESTOSTERONE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)

Available from:

Alembic Pharmaceuticals Inc.

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Testosterone gel, 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. - Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. Limitations of use: - Safety and efficacy of testosterone gel, 1.62% in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. - Safety and efficacy of testosterone gel, 1.62% 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 [see Indications and Usage (1), and Clinical Pharmacology (12.3)]. - Testosterone gel, 1.62% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.1) and Adverse Reactions (6.1)]. - Testosterone gel, 1.62% is contraindicated in women who are pregnant. Testosterone gel, 1.62% can cause virilization of the female fetus when administered to a pregnant woman. Pregnant women need to be aware of the potential for transfer of testosterone from men treated with testosterone gel, 1.62%. If a pregnant woman is exposed to testosterone gel, 1.62%, she should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1)]. Risk Summary Testosterone gel, 1.62% is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action [see Contraindications (4) and Clinical Pharmacology (12.1)]. Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis. Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased ano-genital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. Increased pituitary weight was seen in both sexes. Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. Hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy. Risk Summary Testosterone gel, 1.62% is not indicated for use in women. Infertility Testis disorder, testicular atrophy, and oligospermia have been identified during use of testosterone gel, 1.62% [see Adverse Reactions (6.1, 6.2)]. During treatment with large doses of exogenous androgens, including testosterone gel, 1.62%, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see Warnings and Precautions (5.8)]. Reduced fertility is observed in some men taking testosterone replacement therapy. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [see Drug Abuse and Dependence (9.2)]. With either type of use, the impact on fertility may be irreversible. The safety and effectiveness of testosterone gel, 1.62% in pediatric patients less than 18 years old has not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses. There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone gel, 1.62% to determine whether efficacy in those over 65 years of age differs from younger subjects. Of the 234 patients enrolled in the clinical trial utilizing testosterone gel, 1.62%, 21 were over 65 years of age. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potentially increased 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. No studies were conducted involving patients with renal impairment. No studies were conducted in patients with hepatic impairment. Testosterone gel, 1.62% contains testosterone, a Schedule III controlled substance in the Controlled Substances Act. Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. Abuse-Related Adverse Reactions Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Behaviors Associated with Addiction Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: -   Taking greater dosages than prescribed -   Continued drug use despite medical and social problems due to drug use -   Spending significant time to obtain the drug when supplies of the drug are interrupted -   Giving a higher priority to drug use than other obligations -   Having difficulty in discontinuing the drug despite desires and attempts to do so -   Experiencing withdrawal symptoms upon abrupt discontinuation of use Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

Product summary:

Testosterone gel, 1.62% is supplied in non-aerosol, metered-dose pumps that deliver 20.25 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 a polypropylene cap. Each 88 g metered-dose pump is capable of dispensing 75 g of gel or 60-metered pump actuations; each pump actuation dispenses 1.25 g of gel. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Used testosterone gel, 1.62% pumps should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Alembic Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Testosterone (tes-TOS-te-rone) Gel, 1.62% CIII
for topical use
1. What is the most important information I should know about
testosterone gel, 1.62%?
Testosterone gel, 1.62% can transfer from your body to others
including, children and women.
Children and women should avoid contact with the unwashed or not
covered (unclothed) areas where
testosterone gel, 1.62% has been applied to your skin. Early signs and
symptoms of puberty have
occurred in young children who have come in direct contact with
testosterone by touching areas
where men have used testosterone gel, 1.62%.
•
Children
•
Signs and symptoms of early puberty in a child when they come in
direct contact with
testosterone gel, 1.62% may include:
•
Abnormal sexual changes:
•
enlarged penis or clitoris.
•
early growth of hair near the vagina or around the penis (pubic hair).
•
erections or acting out sexual urges (sex drive).
•
Behavior problems:
•
acting aggressively, behaving in an angry or violent way.
•
Women
•
Signs and symptoms in women when they come in direct contact with
testosterone gel, 1.62%
may include:
•
changes in body hair.
•
an abnormal increase in pimples (acne).
Stop using testosterone gel, 1.62% and call your healthcare provider
right away if you see any signs
and symptoms in a child or a woman that may have happened through
accidental touching of the area
where you have applied testosterone gel, 1.62%.
2. To lower the risk of transfer of testosterone gel, 1.62% from your
body to others, follow these
important instructions:
•
Apply testosterone gel, 1.62% only to your shoulders and upper arms
that will be covered by
a short sleeve t-shirt.
•
Wash your hands right away with soap and water after applying
testosterone gel, 1.62%.
•
After the gel has dried, cover the application area with clothing.
Keep the area covered until
you have washed the application area well or have showered.
•
If you expect to have skin-to-skin contact with another person, first

Summary of Product characteristics

TESTOSTERONE- TESTOSTERONE GEL
ALEMBIC PHARMACEUTICALS INC.
----------
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 TESTOSTERONE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
VIRILIZATION HAS BEEN REPORTED IN CHILDREN WHO WERE SECONDARILY
EXPOSED TO
TESTOSTERONE GEL (5.2, 6.2).
CHILDREN SHOULD AVOID CONTACT WITH UNWASHED OR UNCLOTHED APPLICATION
SITES IN MEN
USING TESTOSTERONE GEL (2.2, 5.2).
HEALTHCARE PROVIDERS SHOULD ADVISE PATIENTS TO STRICTLY ADHERE TO
RECOMMENDED
INSTRUCTIONS FOR USE (2.2, 5.2, 17).
INDICATIONS AND USAGE
Testosterone gel, 1.62 % is indicated for replacement therapy in males
for conditions associated with a
deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired) (1)
Hypogonadotropic hypogonadism (congenital or acquired) (1)
Limitations of use:
Safety and efficacy of testosterone gel, 1.62 % in men with
"age-related hypogonadism" have not
been established. (1)
Safety and efficacy of testosterone gel, 1.62 % in males less than 18
years old have not been
established. (1, 8.4)
Topical testosterone products may have different doses, strengths, or
application instructions that
may result in different systemic exposure. (1, 12.3)
DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION FOR TESTOSTERONE GEL, 1.62% DIFFERS FROM
TESTOSTERONE GEL,
1%. FOR DOSAGE AND ADMINISTRATION OF TESTOSTERONE GEL, 1% REFER TO ITS
FULL PRESCRIBING
INFORMATION. (2)
Prior to initiating testosterone gel, 1.62%, confirm the diagnosis of
hypogonadism by ensuring that
serum testosterone has been measured in the morning on at least two
separate days and that these
concentrations are below the normal range (2).
Starting dose of testosterone gel, 1.62% is 40.5 mg of testosterone (2
pump actuations), applied
topically once da