FORTESTA- testosterone gel, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Endo Pharmaceuticals Inc.

INN (International Name):

TESTOSTERONE

Composition:

TESTOSTERONE 10 mg in 0.5 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FORTESTA is indicated for replacement therapy in 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, heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone [FSH] and 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 serum testosterone concentrations but have gonadotropins in the normal or low range. Limitations of Use - Safety and efficacy of FORTESTA in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - Safety and efficacy of FORTESTA in males <18 years old have not been established [see Use in Specific Populations (8.4)] . - FORTESTA 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)] . - FORTESTA is contraindicated in women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman [see Use in Specific Populations (8.1, 8.2)] . Risk Summary FORTESTA is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm 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 anogenital 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 FORTESTA is not indicated for use in females. Infertility During treatment with large doses of exogenous androgens, including FORTESTA, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see Warnings and Precautions (5.8)] , possibly leading to adverse effects on semen parameters including sperm count. 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 efficacy of FORTESTA in pediatric patients <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 FORTESTA to determine whether efficacy in those over 65 years of age differs from younger subjects. Of the 149 patients enrolled in the pivotal clinical study utilizing FORTESTA, 20 were over 65 years of age. Additionally, there are 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. No studies were conducted in patients with renal impairment. No studies were conducted in patients with hepatic impairment. FORTESTA 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 of 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. INSTRUCTIONS FOR USE FORTESTA® (FOR-tes-ta) CIII (testosterone) Gel for topical use Read this Instructions for Use for FORTESTA before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. Applying FORTESTA: - Apply FORTESTA only to areas that will be covered by shorts or pants. - FORTESTA should be applied to the front and inner part of your thighs only. Do not apply FORTESTA to the area of the thigh closest to the scrotum. Do not apply FORTESTA to any other parts of your body such as your stomach area (abdomen), penis, scrotum, shoulders or upper arms. - Apply FORTESTA in the morning. If you shower or bathe, FORTESTA should be applied afterwards. - Avoid swimming, showering, or bathing for at least 2 hours after you apply FORTESTA. - FORTESTA is flammable until dry. Let FORTESTA dry before smoking or going near an open flame. - Wash your hands with soap and water right after you apply FORTESTA. - Before using a new canister of FORTESTA for the first time, you will need to prime the pump. To prime the FORTESTA pump, gently push down on the pump 8 times. Do not use any FORTESTA that comes out while priming. Wash it down the sink or throw it in the trash to avoid accidental exposure to others. Your FORTESTA pump is now ready to use. - Use FORTESTA exactly as your healthcare provider tells you to use it. Your healthcare provider will tell you the dose of FORTESTA that is right for you. - Press down on the pump to apply the medicine directly on clean, dry, skin that is not broken on the front and inner part of your thighs. Use 1 finger to gently rub FORTESTA evenly onto the front and inner part of each thigh. - Let the application site dry completely before putting on shorts or pants. - Wash your hands right away with soap and water. How should I store FORTESTA? - Store FORTESTA at room temperature between 68ºF to 77ºF (20ºC to 25ºC). - When it is time to throw away the canister, safely throw away used FORTESTA in the household trash. Be careful to prevent accidental exposure of children or pets. - Keep FORTESTA away from fire. - Do not freeze FORTESTA. Keep FORTESTA and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 05/2019

Product summary:

FORTESTA is supplied in 60 g canisters with a metered dose pump that delivers 10 mg of testosterone per complete pump actuation. The metered dose pump is capable of dispensing 120 metered pump actuations. One (1) pump actuation dispenses 0.5 g of gel. FORTESTA is available in packages of 1, 2, and 3 canisters (NDC 63481-183-16, NDC 63481-183-17, and NDC 63481-183-18, respectively). Store at controlled room temperature 20o C-25o C (68o F-77o F); excursions permitted to 15o C-30o C (59o F-86o F). [See USP]. Do Not Freeze. Used FORTESTA canisters should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Authorization status:

New Drug Application

Patient Information leaflet

Endo Pharmaceuticals Inc.
----------
MEDICATION GUIDE
FORTESTA® (FOR-tes-ta) CIII
(testosterone)
Gel for topical use
What is the most important information I should know about FORTESTA?
1. FORTESTA 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 FORTESTA 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 FORTESTA.
Children
Signs and symptoms of early puberty in a child when they come in
direct contact with FORTESTA 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
FORTESTA may include:
•
changes in body hair.
•
an abnormal increase in pimples (acne).
Stop using FORTESTA 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 FORTESTA.
2. To lower the risk of transfer of FORTESTA from your body to others,
follow these important
instructions:
•
Apply FORTESTA only to the front and inside area of your thighs that
will be covered by
clothing.
•
Wash your hands right away with soap and water after applying
FORTESTA.
•
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
wash the application area well
with soap and water.
•
If a child or woman touches the area where you have applied FORTESTA,
that area on the child
or woman should be washed well with soap and

Summary of Product characteristics

FORTESTA- TESTOSTERONE GEL, METERED
ENDO PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FORTESTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FORTESTA.
FORTESTA (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 FORTESTA. (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
FORTESTA is an androgen 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 FORTESTA in men with “age-related
hypogonadism” have not been established.
(1)
Safety and efficacy of FORTESTA in males less than 18 years old have
not been established. (8.4)
DOSAGE AND ADMINISTRATION
Prior to initiating FORTESTA, 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 FORTESTA is 40 mg of testosterone (4 pump actuations)
applied topically once daily in
the morning. (2.1)
Apply to clean, dry, intact skin of the thighs. Do not apply FORTESTA
to the genitals or other parts of the
body. (2.2)
Dose adjustment: FORTESTA can be dose adjusted between a minimum of 10
mg of testosterone (1
pump actuation) and a maximum of 70 mg of testosterone (7 pump
actuations) on the basis of total
serum testosterone concentrations 2 hours post FORTESTA application.
The dose should be