Testosteronedrug info
0.5 ML testosterone enanthate 100 MG/ML Auto-Injector [Xyosted]
What it is used for
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. 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.
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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 1, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
XYOSTED (testosterone enanthate) injection contains testosterone enanthate, an ester derivative of an endogenous androgen, testosterone. Testosterone enanthate is a white to creamy white crystalline powder described by the chemical name (17β)-17-[(1-Oxoheptyl) oxy]-androst-4-en-3-one. Testosterone enanthate has the molecular formula C 26 H 40 O 3, the molecular weight 400.59, and the molecular structure with the chemical formula: XYOSTED (testosterone enanthate) injection is a sterile, preservative-free, and nonpyrogenic colorless to pale yellow solution supplied in a single-dose syringe assembled in a pressure-assisted autoinjector for subcutaneous administration. Each XYOSTED autoinjector contains 50 mg, 75 mg, or 100 mg of testosterone in sesame oil to form 0.5 mL solution providing three product strengths of 50 mg/0.5 mL, 75 mg/0.5 mL, and 100 mg/0.5 mL. Testosterone enanthate structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 1, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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