Tlando

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE TLANDO 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 conditions such as 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 [see Dosage and Administration ( 2.2 )]. 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 [see Dosage and Administration ( 2.2 )]. Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . Safety and efficacy of TLANDO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established [see Use in Specific Populations ( 8.5 )] . TLANDO is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ). Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established ( 1 ). Safety and efficacy of TLANDO in men with “age-related hypogonadism” have not been established ( 1 ). Dosage and administration 2 DOSAGE AND ADMINISTRATION Prior to initiating TLANDO, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range ( 2.2 ). Recommended dosage is 225 mg orally twice daily with food ( 2.3 ). Monitor serum testosterone after initiating TLANDO to determine if TLANDO should be continued or discontinued ( 2.3 ). 2.1 Important Dosage Information TLANDO is not substitutable with other oral testosterone undecanoate products. 2.2 Confirmation of Hypogonadism Before Initiation of TLANDO Prior to initiating TLANDO, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. 2.3 Recommended Dosage The recommended dosage of TLANDO is 225 mg (taken as two 112.5 mg capsules), orally twice daily, once in the morning and once in the evening. Take with food. Monitoring for Continued Use or Discontinuation Monitor serum testosterone (8 to 9 hours after the morning dose) 3 to 4 weeks after initiating TLANDO, and periodically thereafter. Based on serum testosterone measurements, determine if TLANDO should be continued or discontinued: Serum testosterone 300 - 1080 ng/dL: continue TLANDO Serum testosterone 1080 ng/dL: discontinue TLANDO Warnings and cautions 5 WARNINGS AND PRECAUTIONS Polycythemia : Monitor hematocrit approximately every 3 months during the first year after beginning TLANDO and then every 6 months thereafter during treatment. Discontinue TLANDO if necessary ( 5.1 ). Venous thromboembolism (VTE) : VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Discontinue TLANDO if VTE is suspected and initiate appropriate workup and management ( 5.2 ). Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer : Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Evaluate patients for prostate cancer, including monitoring prostate specific antigen (PSA) prior to initiating and during treatment with androgens ( 5.3 ) Blood Pressure Increases: TLANDO can increase blood pressure, which can increase cardiovascular risk over time. Measure blood pressure periodically. Not recommended for use in men with uncontrolled hypertension ( 5.4 ) Abuse of Testosterone and Monitoring of Serum Testosterone : If testosterone use at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids is suspected, check serum testosterone concentration ( 5.5 ). Potential for Adverse Effects on Spermatogenesis : TLANDO may cause azoospermia ( 5.7 , 8.3 ). Edema : Edema, with or without congestive heart failure (CHF) may occur in patients with preexisting cardiac, renal, or hepatic disease. Discontinue TLANDO and initiate appropriate workup ( 5.9 ). Sleep Apnea: TLANDO may potentiate sleep apnea in those with risk factors ( 5.10 ). Lipid Changes : Testosterone may affect serum lipid p