AVEED- testosterone undecanoate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Endo Pharmaceuticals Inc.

INN (International Name):

TESTOSTERONE UNDECANOATE

Composition:

TESTOSTERONE UNDECANOATE 250 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AVEED 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 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. AVEED should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of POME

Product summary:

AVEED, NDC 67979-511-43: 750 mg/3 mL (250 mg/mL) testosterone undecanoate sterile injectable solution is provided in an amber glass vial with silver-colored crimp seal and gray plastic cap.  Each vial is individually packaged in a carton box. Store at controlled room temperature 25ºC (77ºF); excursions permitted to 15ºC - 30ºC (59ºF - 86ºF) [See USP controlled room temperature] in its original carton until the date indicated. Before use, each vial should be visually inspected.  Only vials free from particles should be used.  Single Use Vial.  Discard unused portion.

Authorization status:

New Drug Application

Patient Information leaflet

Endo Pharmaceuticals Inc.
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AVEED® (Uh-Veed)
(testosterone undecanoate)
injection
Read this Medication Guide before you receive AVEED and before each
injection. There may be new
information. This Medication Guide does not take the place of talking
with your doctor about your
medical condition or your treatment.
What is the most important information I should know about AVEED?
AVEED may cause serious side effects, including:
•
A serious lung problem. AVEED can cause a serious lung problem called
a pulmonary oil
microembolism (POME) reaction. POME is caused by tiny droplets of oil
that have traveled to the
lungs. Symptoms of a POME reaction may include:
o cough or urge to cough
o difficulty breathing
o sweating
o tightening of your throat
o chest pain
o dizziness
o fainting
•
Serious allergic reactions (anaphylaxis). AVEED can cause a serious
allergic reaction right after
receiving the injection. Some of these allergic reactions may be life
threatening.
These reactions can happen after you receive your first dose of AVEED
or may happen after
receiving more than 1 dose.
You may need emergency treatment in a hospital, especially if these
symptoms get worse over
the 24 hours after
your AVEED injection.
These side effects may happen during or right after each injection. To
be sure that you are not
having one
of these reactions:
o You need to stay in the doctor’s office, clinic, or hospital for
30 minutes after having your
AVEED injection so
that your doctor can watch you for symptoms of POME or a serious
allergic reaction.
o You can only get AVEED at your doctor’s office, clinic, or
hospital.
AVEED is only available through a restricted program called the AVEED
Risk Evaluation and Mitigation
Strategy (REMS) Program. For more information about the AVEED REMS
Program go to
www.AveedREMS.com or call 1-855-755-0494.
What is AVEED?
AVEED is a prescription medicine that contains testosterone. AVEED is
used to treat adult males who
have low or no testosterone due to certain medical conditions.
AVEED is only

Summary of Product characteristics

AVEED- TESTOSTERONE UNDECANOATE INJECTION
ENDO PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AVEED SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AVEED .
AVEED (TESTOSTERONE UNDECANOATE) INJECTION, FOR INTRAMUSCULAR USE
CIII
INITIAL U.S. APPROVAL: 1953
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND
ANAPHYLAXIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
SERIOUS POME REACTIONS, INVOLVING URGE TO COUGH, DYSPNEA, THROAT
TIGHTENING, CHEST
PAIN, DIZZINESS, AND SYNCOPE; AND EPISODES OF ANAPHYLAXIS, INCLUDING
LIFE-
THREATENING REACTIONS, HAVE BEEN REPORTED TO OCCUR DURING OR
IMMEDIATELY AFTER THE
ADMINISTRATION OF TESTOSTERONE UNDECANOATE INJECTION. THESE REACTIONS
CAN OCCUR
AFTER ANY INJECTION OF TESTOSTERONE UNDECANOATE DURING THE COURSE OF
THERAPY,
INCLUDING AFTER THE FIRST DOSE (5.1).
FOLLOWING EACH INJECTION OF AVEED, OBSERVE PATIENTS IN THE HEALTHCARE
SETTING FOR 30
MINUTES IN ORDER TO PROVIDE APPROPRIATE MEDICAL TREATMENT IN THE EVENT
OF SERIOUS
POME REACTIONS OR ANAPHYLAXIS (5.1).
AVEED IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED THE AVEED
REMS
PROGRAM (5.2).
RECENT MAJOR CHANGES
Dosage and Administration (2.2) 08/2021
INDICATIONS AND USAGE
Aveed (testosterone undecanoate) injection 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) (1)
Hypogonadotropic hypogonadism (congenital or acquired) (1)
Aveed should only be used in patients who require testosterone
replacement therapy and in whom the
benefits of the product outweigh the serious risks of pulmonary oil
microembolism and anaphylaxis (1).
Limitations of Use
Safety and efficacy of Aveed in men with “age-related
hypogonadism” have not been established (1).
Safety and efficacy of Aveed in males less than 18 years old have not
been established (1, 8.4).
DOSA