What is the generic name?

TESTOSTERONE UNDECANOATE

What is the Trade Name for TESTOSTERONE UNDECANOATE?

Aveed

What are the Indications for TESTOSTERONE UNDECANOATE?

• 1 INDICATIONS AND USAGE 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 and anaphylaxis. Limitations of Use Safety and efficacy of AVEED in men with ‚Äúage-related hypogonadism‚Äù (also referred to as ‚Äúlate-onset hypogonadism‚Äù) have not been established. Safety and efficacy of AVEED in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )]. 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 ‚Äúage-related hypogonadism‚Äù have not been established ( 1 ). Safety and efficacy of Aveed in males less than 18 years old have not been established ( 1 , 8.4 ).

References: https://open.fda.gov/