TLANDO CIII

Not substitutable with other oral testosterone undecanoate products. Not for use in women. Increases in BP can increase risk of major adverse cardiovascular events (MACE), including non-fatal MI, non-fatal stroke, CV death. Prior to treatment, consider baseline CV risk and ensure BP adequately controlled. Monitor BP approx. 3 weeks after initiation or dose increase and periodically thereafter; treat new-onset hypertension or exacerbations of preexisting hypertension. Reevaluate for continued treatment if CV risk factors or disease develops. Monitor hematocrit prior to initiation and approx. every 3 months during the 1^st year of treatment, then every 6 months thereafter; if elevation occurs, withhold until acceptable level. Increased risk of worsening BPH; monitor. Evaluate for prostate cancer prior to and during treatment. Monitor for venous thromboembolism; discontinue if suspected. Preexisting cardiac, renal or hepatic disease (discontinue if edema occurs). Discontinue and evaluate if signs/symptoms of hepatic dysfunction (eg, jaundice) occur. Possible sleep apnea in patients with obesity or chronic lung disease. Testosterone and/or other anabolic androgenic steroid abuse. Monitor serum testosterone, PSA, liver function, lipid profile, serum calcium (in cancer patients at risk for hypercalcemia/hypercalciuria) periodically. Monitor serum prolactin levels prior to initiation and 3–4 months after starting; discontinue if serum prolactin levels remain elevated. Risk of depression, suicidal ideation. Elderly.