Generic Name
Undecanoate
Brand Names
Tlando, Jatenzo, Kyzatrex, Aveed
FDA approval date: March 05, 2014
Classification: Androgen
Form: Injection, Capsule
What is Tlando (Undecanoate)?
TLANDO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism : 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 , luteinizing hormone ) above the normal range [see Dosage and Administration.
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Brand Information
Tlando (testosterone undecanoate)
1INDICATIONS AND USAGE
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
- 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 TLANDO in males less than 18 years old have not been established
2DOSAGE FORMS AND STRENGTHS
Capsules: 112.5 mg, white opaque body imprinted with “112” in black ink and grey opaque cap, banded with a colorless gelatin band.
3CONTRAINDICATIONS
TLANDO is contraindicated in:
- Patients with carcinoma of the breast or known or suspected carcinoma of the prostate
- Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman
- Known hypersensitivity to testosterone undecanoate or any of TLANDO’s ingredients
- 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
4OVERDOSAGE
There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone levels of up to 11,400 ng/dL with a cerebrovascular accident.
Treatment of overdosage consists of discontinuation of TLANDO and appropriate symptomatic and supportive care.
5DESCRIPTION
TLANDO (testosterone undecanoate) capsules contain 112.5 mg testosterone undecanoate, an ester of testosterone, for oral administration. Testosterone, an androgen, is formed by cleavage of the ester side chain of testosterone undecanoate.
The chemical name of testosterone undecanoate is 17β-undecanoyloxy-4-androsten-3-one. It has an empirical formula of C
Testosterone undecanoate is a white to off-white crystalline substance.
The inactive ingredients in TLANDO capsules are ascorbyl palmitate, glyceryl monolinoleate, polyethylene glycol 8000, and polyoxyl 40 hydrogenated castor oil. The capsule shell contains black iron oxide, gelatin, and titanium dioxide. The capsule is imprinted with black ink that contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac.
6HOW SUPPLIED/STORAGE AND HANDLING
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.
7PATIENT COUNSELING INFORMATION
Advise the patients to read the FDA-approved patient labeling (
8PRINCIPAL DISPLAY PANEL - 112.5 mg Bottle Label - 120 Capsules
NDC 54436-112-20 Rx Only
TLANDO
(testosterone undecanoate)
Capsules 112.5 mg CIII
Dispense accompanying
Medication Guide to each patient
Medication Guide to each patient
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