JATENZO- 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:

TOLMAR Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

JATENZO (testosterone undecanoate) is an androgen 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 cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter 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 JATENZO in males less than 18 years old have not been established [see U

Product summary:

JATENZO (testosterone undecanoate) capsules are available in three strengths of 158 mg, 198 mg, and 237 mg. Capsules are packaged as 120 units in wide-mouth, round, white HDPE bottles with white, polypropylene, child resistant caps and induction-sealed liner. 158 mg capsules are opaque red capsules imprinted with “158” in white ink and are supplied in bottles: NDC 69087-158-12. 198 mg capsules are opaque white capsules imprinted with “198” in red ink and are supplied in bottles: NDC 69087-198-12. 237 mg capsules are opaque orange capsules imprinted with “237” in white ink and are supplied in bottles: NDC 69087-237-12. Keep JATENZO out of reach of children. Store at 20°C to 25ºC (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Avoid exposing the capsules to moisture (store in a dry place).

Authorization status:

New Drug Application

Patient Information leaflet

TOLMAR Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Issued: 01/2023
MEDICATION GUIDE
JATENZO® (juh-TEN-zoh)
(testosterone undecanoate) capsules, for oral use CIII
What is the most important information I should know about JATENZO?
JATENZO can cause serious side effects, including:
•
JATENZO 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 JATENZO, 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, JATENZO may need to be
stopped.
•
Your healthcare provider will monitor your blood pressure while you
are being treated with
JATENZO.
What is JATENZO?
JATENZO is a prescription medicine that contains testosterone. JATENZO
is used to treat adult men who
have low or no testosterone due to certain medical conditions.
It is not known if JATENZO is safe or effective in children younger
than 18 years old. Improper use of
JATENZO may affect bone growth in children.
JATENZO is a controlled substance (CIII) because it contains
testosterone that can be a target for people
who abuse prescription medicines. Keep your JATENZO in a safe place to
protect it. Never give your
JATENZO 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.
JATENZO is not meant for use by women.
Do not take JATENZO if you:
•
have breast cancer.
•
have or might have prostate cancer.
•
are a woman who is pregnant. JATENZO may harm your unborn baby.
•
are allergic to JATENZO or any ingr

Summary of Product characteristics

JATENZO- TESTOSTERONE UNDECANOATE CAPSULE, LIQUID FILLED
TOLMAR INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JATENZO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JATENZO.
JATENZO (TESTOSTERONE UNDECANOATE) CAPSULES, FOR ORAL USE CIII
INITIAL U.S. APPROVAL: 1953
WARNING: INCREASES IN BLOOD PRESSURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
_ _
JATENZO 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 JATENZO, CONSIDER THE PATIENT'S BASELINE
CARDIOVASCULAR RISK AND
ENSURE BLOOD PRESSURE IS ADEQUATELY CONTROLLED.
PERIODICALLY MONITOR FOR AND TREAT NEW-ONSET HYPERTENSION OR
EXACERBATIONS OF PRE-
EXISTING HYPERTENSION AND RE-EVALUATE WHETHER THE BENEFITS OF JATENZO
OUTWEIGH ITS
RISKS IN PATIENTS WHO DEVELOP CARDIOVASCULAR RISK FACTORS OR
CARDIOVASCULAR DISEASE
ON TREATMENT.
DUE TO THIS RISK, USE JATENZO ONLY FOR THE TREATMENT OF MEN WITH
HYPOGONADAL
CONDITIONS ASSOCIATED WITH STRUCTURAL OR GENETIC ETIOLOGIES (1, 4).
INDICATIONS AND USAGE
JATENZO (testosterone undecanoate) 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 JATENZO in males less than 18 years old have
not been established (1, 8.4).
DOSAGE AND ADMINISTRATION
Prior to initiating JATENZO, 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 concentrations are below the normal range (2.1).
Take JATENZO with food (2.2).
Starting dose: 237 mg orally once in the morning and once in the
evening.
Adjust the dose to a minimum of 158 mg twice daily and a maximum of
396 mg twice daily based on
serum testostero