DEPO-TESTOSTERONE (testosterone cypionate injection) Indications And Clinical Use

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DEPO-TESTOSTERONE (testosterone cypionate injection) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).

DEPO-TESTOSTERONE (testosterone cypionate injection) should not be used to treat non-specific symptoms suggestive of hypogonadism if testosterone deficiency has not been demonstrated and if other etiologies responsible for the symptoms have not been excluded. Testosterone deficiency should be clearly demonstrated by clinical features and confirmed by two separate validated biochemical assays (morning testosterone) before initiating therapy with any testosterone replacement, including DEPO-TESTOSTERONE treatment.

Safety and efficacy of Depo-Testosterone (testosterone cypionate injection) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Geriatrics (> 65 years of age):

There are no controlled clinical trial data to support the use of DEPO-TESTOSTERONE in the geriatric population (see WARNINGS AND PRECAUTIONS – Special Populations, Geriatrics, and CLINICAL TRIALS).

Pediatrics (< 18 years of age):

DEPO-TESTOSTERONE is not indicated for use in children < 18 years of age since safety and efficacy have not been established in this patient population (see WARNINGS AND PRECAUTIONS – Special Populations, Pediatrics).