What is Xyosted used for?

Indications and Usage, quoted from the label by Antares Pharma, Inc. (NDA209863). Cross-references to other label sections are left out.

XYOSTED (testosterone enanthate) 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): 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.

Limitations of Use:

• Safety and efficacy of XYOSTED in men with “age-related hypogonadism” has not been established.
• Safety and efficacy of XYOSTED in males less than 18 years old have not been established.

Source: DailyMed label, set id 8a3d204c-be26-49e0-8599-0ac12a272e81, version 16, effective July 1, 2025. NDC 54436-200, one of 3 listings for this product.