TLANDO- testosterone undecanoate capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TESTOSTERONE UNDECANOATE (UNII: H16A5VCT9C) (TESTOSTERONE - UNII:3XMK78S47O)

Available from:

Antares Pharma, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TLANDO is indicated for testosterone 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 [see Dosage and Administration (2.2 )]. - 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 [see Dosage and Administration (2.2 )]. Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use in Specific Populations (8.4) ] . TLANDO is contraindicated in: - Patients with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.4)] . - 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)] . - Known hypersensitivity to testosterone undecanoate or any of TLANDO’s ingredients [see Description ( 11)]. - Men with hypogonadal conditions, such as “age-related hypogonadism”, that are not associated with structural or genetic etiologies. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE [see Boxed Warning and Warning and Precautions (5.1 )] . Risk Summary TLANDO is contraindicated in pregnant women and not indicated for use in females [ see Contraindications (4)] . Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies (see Data) and its mechanism of action [ see 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 females and offspring in rats exposed to doses approximately twice those used for testosterone replacement therapy. Risk Summary TLANDO is not indicated for use in females. Infertility Males During treatment with large doses of exogenous androgens, including TLANDO, 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. The impact on fertility may be irreversible. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [ see Drug Abuse and Dependence (9.2) ] . The safety and effectiveness of TLANDO in pediatric patients less than 18 years old have 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 in controlled clinical studies with TLANDO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Of the 95 patients enrolled in Study 16-002, the 24-day major safety and effectiveness study utilizing TLANDO, 16 (16.8%) were over 65 years of age.  Additionally, there is insufficient long-term safety data in geriatric patients utilizing TLANDO to assess the potentially increased risk of cardiovascular disease and prostate cancer. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension [see Warnings and Precautions (5.1)] and 5.4]. TLANDO contains testosterone undecanoate, a schedule III controlled substance. 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:

TLANDO capsules for oral administration are available containing 112.5 mg of testosterone undecanoate. The capsules have a white opaque body imprinted with “112” in black ink and a grey opaque cap, banded with a colorless band. TLANDO capsules are supplied in HDPE bottles with a foil liner and a child resistant cap. Bottles of 120 capsules: NDC 54436-112-20. Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted to 15ºC to 30°C (59ºF to 86°F). [See USP Controlled Room Temperature]. Dispose of unused TLANDO via a take-back option. If a take-back option is unavailable, follow FDA instructions at www.fda.gov/drugdisposal.

Authorization status:

New Drug Application

Patient Information leaflet

Antares Pharma, Inc.
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This Medication Guide has been approved by the U.S. Food and Drug
Administration
Issued: 03/2022
MEDICATION GUIDE
TLANDO® (Tee-lan-doh)
(testosterone undecanoate) capsules, for oral use CIII
What is the most important information I should know about TLANDO?
TLANDO can cause serious side effects, including:
• Increase in blood pressure.
•
TLANDO can increase your blood pressure, which can increase your risk
of having a heart attack
or stroke and can increase your risk of death due to a heart attack or
stroke. Your risk may be
greater if you have already had a heart attack or stroke or if you
have other risk factors for heart
attack or stroke.
•
If your blood pressure increases while on TLANDO, blood pressure
medicines may need to be
started. If you are taking blood pressure medicines, new blood
pressure medicines may need to be
added or your current blood pressure medicines may need to be changed
to control your blood
pressure.
•
If your blood pressure cannot be controlled, TLANDO may need to be
stopped.
•
Your healthcare provider will monitor your blood pressure while you
are being treated with
TLANDO.
What is TLANDO?
TLANDO is a prescription medicine that contains testosterone. TLANDO
is used to treat adult men who
have low or no testosterone due to certain medical conditions.
It is not known if TLANDO is safe or effective in children younger
than 18 years old. Improper use
of TLANDO may affect bone growth in children.
TLANDO is a controlled substance (CIII) because it contains
testosterone that can be a target for people
who abuse prescription medicines. Keep your TLANDO in a safe place to
protect it. Never give your
TLANDO to anyone else, even if they have the same symptoms you have.
Selling or giving away this
medicine may harm others and is against the law.
TLANDO is not meant for use by women.
Do not take TLANDO if you:
•
have breast cancer.
•
have or might have prostate cancer.
•
are a woman who is pregnant. TLANDO may harm your unborn baby.
•
are allergic

Summary of Product characteristics

TLANDO- TESTOSTERONE UNDECANOATE CAPSULE, LIQUID FILLED
ANTARES PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TLANDO™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TLANDO.
TLANDO (TESTOSTERONE UNDECANOATE) CAPSULES, FOR ORAL USE, CIII
INITIAL U.S. APPROVAL: 1953
WARNING: BLOOD PRESSURE INCREASES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
TLANDO CAN CAUSE BLOOD PRESSURE (BP) INCREASES THAT CAN INCREASE THE
RISK OF MAJOR
ADVERSE CARDIOVASCULAR EVENTS (MACE), INCLUDING NON-FATAL MYOCARDIAL
INFARCTION,
NON-FATAL STROKE AND CARDIOVASCULAR DEATH (5.1, 5.3, 6.1).
BEFORE INITIATING TLANDO, CONSIDER THE PATIENT’S BASELINE
CARDIOVASCULAR RISK AND
ENSURE BLOOD PRESSURE IS ADEQUATELY CONTROLLED (5.1, 5.3).
PERIODICALLY MONITOR FOR AND TREAT NEW-ONSET HYPERTENSION OR
EXACERBATIONS OF PRE-
EXISTING HYPERTENSION AND RE-EVALUATE WHETHER THE BENEFITS OF TLANDO
OUTWEIGH ITS
RISKS IN PATIENTS WHO DEVELOP CARDIOVASCULAR RISK FACTORS OR
CARDIOVASCULAR DISEASE
ON TREATMENT (5.1, 5.3).
DUE TO THIS RISK, USE TLANDO ONLY FOR THE TREATMENT OF MEN WITH
HYPOGONADAL
CONDITIONS ASSOCIATED WITH STRUCTURAL OR GENETIC ETIOLOGIES (1, 4).
INDICATIONS AND USAGE
TLANDO is an androgen indicated for testosterone replacement therapy
in adult males for conditions
associated with a deficiency or absence of endogenous testosterone
(1).
Limitations of Use
Safety and efficacy of TLANDO in males less than 18 years old have not
been established (1).
DOSAGE AND ADMINISTRATION
Prior to initiating TLANDO, confirm the diagnosis of hypogonadism by
ensuring that serum testosterone
concentrations have been measured in the morning on at least two
separate days and that these
serum testosterone concentrations are below the normal range (2.2).
Recommended dosage is 225 mg orally twice daily with food (2.3).
Monitor serum testosterone after initiating TLANDO to determine if
TLANDO should be continued or
discontinued (2.3).
DOSAGE FORMS AND STRENGTHS
Ca