openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
5 WARNINGS AND PRECAUTIONS Polycythemia : Monitor hemoglobin or hematocrit approximately every 3 months to detect increased red blood cell mass and polycythemia. Discontinue Testosterone Undecanoate Capsules if necessary ( 5.2 ). Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer : Monitor patients 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 ( 5.4 ). Venous thromboembolism (VTE) : VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone. Discontinue Testosterone Undecanoate Capsules if VTE is suspected and initiate appropriate workup and management ( 5.5 ). 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 ( 5.6 ). Potential for Adverse Effects on Spermatogenesis : Testosterone Undecanoate Capsules may cause azoospermia ( 5.8 ). Edema : Edema, with or without congestive heart failure (CHF), may occur in patients with pre-existing cardiac, renal, or hepatic disease. Discontinue Testosterone Undecanoate Capsules and initiate appropriate workup ( 5.10 ). Sleep Apnea : Testosterone Undecanoate Capsules may potentiate sleep apnea in those with risk factors ( 5.11 ) Lipid Changes : Testosterone Undecanoate Capsules may affect serum lipid profile. Monitor patient lipid concentrations periodically; if necessary, adjust dosage of lipid lowering drug(s) or discontinue Testosterone Undecanoate Capsules ( 5.13 ). 5.1 Increase in Blood Pressure In Study MRS-TU-2019EXT, Testosterone Undecanoate Capsules increased 24-hour average systolic blood pressure (SBP) measured by ambulatory blood pressure monitoring (ABPM) by 1.7 mmHg from baseline after 4 months of treatment and 1.8 mmHg from baseline after 6 months of treatment [see Adverse Reactions (6.1) ] . Three percent of Testosterone Undecanoate Capsules treated patients were started on antihypertensive medications during the 6-month trial. A history of antihypertensive treatment and diabetes mellitus at baseline were significant factors related to ambulatory SBP increases [see Adverse Reactions (6.1) ] . Blood pressure (BP) increases can increase the risk of major adverse cardiovascular events (MACE), with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease. In some patients, the increase in BP with Testosterone Undecanoate Capsules may be too small to detect but can still increase the risk for MACE. Before initiating Testosterone Undecanoate Capsules, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled. Check BP periodically after initiating Testosterone Undecanoate Capsules or increasing the dose and thereafter. Treat new-onset hypertension or exacerbations of pre-existing hypertension. Re-evaluate whether the benefits of continued treatment with Testosterone Undecanoate Capsules outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease. 5.2 Polycythemia Androgens, including Testosterone Undecanoate Capsules, can cause increase in hemoglobin or hematocrit, reflective of increase in red blood cell mass. Check hematocrit prior to initiating Testosterone Undecanoate Capsules. An increase in red blood cell mass may increase the risk of thromboembolic events [see Warnings and Precautions (5.5) ] . Evaluate hematocrit approximately every 3 months while the patient is on Testosterone Undecanoate Capsules. If hematocrit becomes elevated, stop Testosterone Undecanoate Capsules until the hematocrit decreases to an acceptable concentration. If Testosterone Undecanoate Capsules is restarted and again causes hematocrit to become elevated, permanently discontinue Testosterone Undecanoate Capsules. 5.3 Cardiovascular Risk Long-term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of MACE, such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with testosterone use compared to non-use. Some studies have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Testosterone Undecanoate Capsules can cause BP increases that can increase the risk of MACE [see Warnings and Precautions (5.1) ] . Patients should be informed of this possible risk when deciding whether to use or to continue to use Testosterone Undecanoate Capsules. 5.4 Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer Patients with BPH who are treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens [see Contraindications (4) ] . 5.5 Venous Thromboembolism There have been post-marketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement products such as Testosterone Undecanoate Capsules. Evaluate patients who report symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue Testosterone Undecanoate Capsules and initiate appropriate workup and management [ see Adverse Reactions (6.2) ] . 5.6 Abuse of Testosterone and Monitoring of Testosterone Concentrations Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions [see Drug Abuse and Dependence (9) ] . If testosterone abuse is suspected, check testosterone concentrations to ensure they are within therapeutic range [see Dosage and Administration (2.2) ]. Testosterone levels may remain in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Also consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. 5.7 Not for Use in Women Due to lack of controlled studies in women and potential virilizing effects,Testosterone Undecanoate Capsules is not indicated for use in women [see Contraindications (4) and Use in Specific Populations (8.1 , 8.2) ]. 5.8 Potential for Adverse Effects on Spermatogenesis With large doses of exogenous androgens, including Testosterone Undecanoate Capsules, spermatogenesis may be suppressed through feedback inhibition of pituitary FSH, possibly leading to adverse effects on semen parameters including sperm count [see Use in Specific Populations (8.3) ] . Inform patients of this possible risk when deciding whether to use or to continue to use Testosterone Undecanoate Capsules. 5.9 Hepatic Adverse Effects Testosterone Undecanoate is not a 17-alpha-alkyl androgen and is not known to cause hepatic adverse effects. However, prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. Patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue Testosterone Undecanoate Capsules while the cause is evaluated. 5.10 Edema Androgens, including Testosterone Undecanoate, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease [see Adverse Reactions (6.1) ] . In addition to discontinuation of the drug, diuretic therapy may be required. 5.11 Sleep Apnea The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung disease. 5.12 Gynecomastia Gynecomastia may develop and persist in patients being treated for hypogonadism. 5.13 Lipid Changes In clinical trials, patients receiving Testosterone Undecanoate Capsules experienced reductions in lipid parameters, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides [see Adverse Reactions (6.1) ] . Changes in the serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly after starting testosterone therapy. 5.14 Hypercalcemia Androgens, including Testosterone Undecanoate, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Monitor serum calcium concentrations periodically during treatment with Testosterone Undecanoate Capsules in these patients. 5.15 Decreased Thyroxine-binding Globulin Androgens, including Testosterone Undecanoate, may decrease concentrations of thyroxin-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.