Testosterone enanthate

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.

Endogenous androgens, including testosterone and dihydrotestosterone (DHT) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of the prostate, seminal vesicles, penis, and scrotum, the development of male hair distribution, such as facial, pubic, chest, and axillary hair, laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

Prior to initiating XYOSTED: confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range. Starting dose: 75 mg subcutaneously in the abdominal region once weekly. Avoid intramuscular and intravascular administration. Dose Adjustment: Based upon total testosterone trough concentrations (measured 7 days after most recent dose) obtained following 6 weeks of dosing and periodically thereafter. Discard unused portion

XYOSTED is contraindicated in: Men with carcinoma of the breast or known or suspected carcinoma of the prostate. Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman. Men with known hypersensitivity to XYOSTED or any of its ingredients (testosterone enanthate and sesame oil). Men with carcinoma of the breast or known or suspected carcinoma of the prostate. Testosterone may cause fetal harm ( 4, 5.7, 8.1, and 8.2 ). Known hypersensitivity to XYOSTED or its ingredients.

Polycythemia: Monitor hematocrit approximately every 3 months to detect increased red blood cell mass and polycythemia. Venous thromboembolism (VTE): VTE including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products. Evaluate patients with signs or symptoms consistent with DVT or PE. Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Monitor patients with BPH for worsening signs and symptoms of BPH. Blood Pressure Increases: Testosterone can increase blood pressure, which can increase cardiovascular risk over time. Measure blood pressure periodically. Not recommended for use in men with uncontrolled hypertension.

The most commonly reported adverse reactions (>5%) were: hematocrit increased, hypertension, PSA increased, injection site bruising, and headache.

Androgens may decrease blood glucose, and therefore may decrease insulin requirements in diabetic patients. Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of international normalized ratio (INR) and prothrombin time is recommended in patients taking warfarin. Use of testosterone with corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease. Concomitant administration of medications that are known to increase BP with XYOSTED may lead to additional increases in BP.

Store at controlled room temperature, 20°C to 25°C (68°F - 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light (keep in carton until time of use).