{"id":33630,"date":"2022-10-27T14:14:02","date_gmt":"2022-10-27T07:14:02","guid":{"rendered":"https:\/\/www.edrugstore.com\/blog\/?p=33630"},"modified":"2024-10-01T17:36:08","modified_gmt":"2024-10-01T10:36:08","slug":"new-testosterone-replacement-therapy-drug-approved-by-fda","status":"publish","type":"post","link":"https:\/\/www.edrugstore.com\/blog\/mens-health\/new-testosterone-replacement-therapy-drug-approved-by-fda\/","title":{"rendered":"New Testosterone Replacement Therapy Drug Approved by FDA"},"content":{"rendered":"<p><b>Highlights\u00a0\u00a0<\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>Low testosterone affects the quality of life of millions of aging men.<\/b><\/li>\n<li aria-level=\"1\"><b>Testosterone replacement therapy is a solution for men suffering from testosterone deficiency.<\/b><\/li>\n<li aria-level=\"1\"><b>The FDA has recently approved a testosterone undecanoate-based oral drug called Kyzatrex.<\/b><\/li>\n<li aria-level=\"1\"><b>Kyzatrex works against hypogonadism (low testosterone), but it carries some risks and may cause adverse effects.\u00a0<\/b><\/li>\n<\/ul>\n<hr \/>\n<p><span style=\"font-weight: 400;\">The FDA <\/span><a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/213953s000lbl.pdf\"><span style=\"font-weight: 400;\">has approved<\/span><\/a><span style=\"font-weight: 400;\"> the oral testosterone replacement therapy drug Kyzatrex for the treatment of low testosterone levels in men. Kyzatrex boosts testosterone levels by introducing a testosterone prodrug called testosterone undecanoate into the body. Kyzatrex successfully boosts testosterone levels but has some side effects and risks.\u00a0<\/span><\/p>\n<h3>What Is Testosterone Undecanoate, and How Does It Work?<\/h3>\n<p><span style=\"font-weight: 400;\">The active compound in Kyzatrex is testosterone undecanoate. Testosterone undecanoate is a testosterone ester, anabolic steroid, androgen, and testosterone prodrug. It is a substance doctors and fitness enthusiasts have used since <\/span><a href=\"https:\/\/onlinelibrary.wiley.com\/doi\/abs\/10.1002\/j.1939-4640.1994.tb00433.x\"><span style=\"font-weight: 400;\">the mid-1970s<\/span><\/a><span style=\"font-weight: 400;\"> to fight hypogonadism and increase muscular gains.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The non-medical use of this drug is illicit. In the U.S., testosterone undecanoate is a <\/span><a href=\"https:\/\/www.deadiversion.usdoj.gov\/schedules\/#define\"><span style=\"font-weight: 400;\">schedule III<\/span><\/a><span style=\"font-weight: 400;\"> controlled substance. <\/span><b>It does not provide benefits for those with normal testosterone levels. <\/b><span style=\"font-weight: 400;\">Those who choose to abuse it hoping it will improve their muscularity assume all its risks and will not reap any benefits.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Intramuscular testosterone undecanoate has been in use for decades. Several oral versions of the drug have been approved in the U.S., Europe, and Canada over the last few years. Kyzatrex is the latest in this line.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">When delivered as an intramuscular injection, testosterone undecanoate has a long half-life in the body. It <\/span><a href=\"https:\/\/onlinelibrary.wiley.com\/doi\/abs\/10.1002\/j.1939-4640.1998.tb02086.x\"><span style=\"font-weight: 400;\">takes weeks<\/span><\/a><span style=\"font-weight: 400;\"> to eliminate. Therefore, doctors only give an injection every three months.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Oral Kyzatrex works differently. After you take the pills, your intestinal lymphatic system absorbs the molecule. Your thoracic duct then releases the androgen directly into your blood.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Taking testosterone orally <\/span><a href=\"https:\/\/jpet.aspetjournals.org\/content\/306\/3\/925.long\"><span style=\"font-weight: 400;\">does not work<\/span><\/a><span style=\"font-weight: 400;\"> because it must go through the liver, where the body deactivates it. However, oral <\/span><i><span style=\"font-weight: 400;\">testosterone undecanoate<\/span><\/i> <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7282712\/\"><span style=\"font-weight: 400;\">does not<\/span><\/a><span style=\"font-weight: 400;\"> pass through your liver when your body metabolizes it.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Instead, it lands in your bloodstream, where the body can break it down into testosterone and undecanoate. It further metabolizes testosterone into dihydrotestosterone and other androgens like 3-alpha-androstenediol and 3-beta-androstenediol.\u00a0<\/span><\/p>\n<h3>The Benefits of Testosterone Undecanoate<\/h3>\n<p><span style=\"font-weight: 400;\">Testosterone replacement therapy is a time-honored solution for restoring normal testosterone levels in men whose bodies can\u2019t produce enough of this essential androgen.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Low testosterone levels lead to many health problems and can ruin your quality of life. Low testosterone can cause:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.edrugstore.com\/blog\/mens-health\/can-low-testosterone-cause-depression\/\"><span style=\"font-weight: 400;\">Depression<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Loss of muscle and bone mass<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Increased body fat<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Increased likelihood of developing age-related diseases<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Low energy<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Insomnia<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Low libido and <\/span><a href=\"https:\/\/www.edrugstore.com\/blog\/erectile-dysfunction\/qa-does-ed-mean-i-have-low-testosterone\/\"><span style=\"font-weight: 400;\">loss of sexual function<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Headaches<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Acne\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">By restoring normal testosterone levels, testosterone replacement therapy drugs like Kyzatrex can counteract or prevent these problems.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The FDA approved the drug for the treatment of conditions like:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4190757\/\"><span style=\"font-weight: 400;\">Vanishing testis syndrome<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3670044\/\"><span style=\"font-weight: 400;\">Bilateral torsion<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The surgical removal of one or both testes<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/medlineplus.gov\/genetics\/condition\/klinefelter-syndrome\/\"><span style=\"font-weight: 400;\">Klinefelter syndrome<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Toxic testicular damage<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Testicular and hormonal damage resulting from chemotherapy<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Injuries from tumors or radiation\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Doctors recommend that patients suffering from hypogonadism take a 200 milligram dose of Kyzatrex twice a day with food. This regimen allows Kyzatrex <\/span><a href=\"https:\/\/www.drugs.com\/newdrugs\/fda-approves-kyzatrex-testosterone-undecanoate-male-hypogonadism-5869.html\"><span style=\"font-weight: 400;\">to mimic<\/span><\/a><span style=\"font-weight: 400;\"> the normal rhythm of testosterone production.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Before starting testosterone replacement therapy with Kyzatrex, patients should be sure that they suffer from testosterone deficiency. Measuring serum testosterone levels is now possible at home with the help of a <\/span><span style=\"font-weight: 400;\">home testosterone kit<\/span><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<h3>Kyzatrex Risks<\/h3>\n<p><span style=\"font-weight: 400;\">Testosterone replacement therapy may sound straightforward, but nothing involving hormones is simple. TRT carries many risks and side effects, and Kyzatrex is no exception.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Most people tolerate testosterone undecanoate well, but as with any medication, there is a risk of allergic reaction. If you notice allergic symptoms after taking the drug, seek medical help immediately.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The very severe side effects of the drug include:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Fainting<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Difficulty breathing<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Vision changes<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Difficulty speaking<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sudden headaches<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Pain, swelling, or warmth in the groin<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Unusual sweating<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Weakness on one side of the body\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">All these problems require immediate medical attention.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Severe side effects can include:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Anxiety, depression, sudden mood swings<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sleep apnea<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Persistent vomiting<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Abdominal pain<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Jaundice and other signs of liver disease<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Dark urine<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Frequent urination<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Irregular heartbeat<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Long erections that won\u2019t quit<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Breast enlargement and tenderness\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">According to its <\/span><a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/213953s000lbl.pdf\"><span style=\"font-weight: 400;\">FDA label<\/span><\/a><span style=\"font-weight: 400;\">, Kyzatrex can cause other serious side effects, like:\u00a0\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Increasing the number of red blood cells, raising the risk of blood clots, heart attacks, etc.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aggravating the symptoms of enlarged prostate<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Increasing the risk of prostate cancer<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Lowering sperm count in higher-than-recommended doses<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Swelling of the ankles, feet, and body<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Raising LDL (bad) cholesterol levels\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Some patients should avoid taking Kyzatrex altogether. The drug can be harmful to people:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Whose hypogonadism is not genetic or structural<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Who are hypersensitive to testosterone undecanoate<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Who have prostate cancer<\/span><\/li>\n<\/ul>\n<h4>Kyzatrex\u2019s Effects on Blood Pressure<\/h4>\n<p><span style=\"font-weight: 400;\">Hypertension is the <\/span><a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/213953s000lbl.pdf\"><span style=\"font-weight: 400;\">most common<\/span><\/a><span style=\"font-weight: 400;\"> adverse effect of the drug.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8678838\/\"><span style=\"font-weight: 400;\">2021 study<\/span><\/a><span style=\"font-weight: 400;\"> found that Kyzatrex caused the blood pressure of patients to go up slightly after 120 days of treatment. After 180 days, researchers noticed no further increases.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Patients already on medication for hypertension were the most likely to show significant blood pressure increases.\u00a0<\/span><\/p>\n<h3>What Is Hypogonadism?<\/h3>\n<p><span style=\"font-weight: 400;\">Again, Kyzatrex (and all other forms of testosterone replacement therapy) are only recommended for men who have hypogonadism. But what exactly is hypogonadism?<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Hypogonadism is another name for testosterone deficiency, or low T. Sometimes, the body does not produce sufficient amounts of testosterone. Low testosterone levels may result from problems with the testes (primary hypogonadism) or problems with the pituitary gland or hypothalamus (<\/span><a href=\"https:\/\/medlineplus.gov\/ency\/article\/000390.htm\"><span style=\"font-weight: 400;\">hypogonadotropic hypogonadism<\/span><\/a><span style=\"font-weight: 400;\">).\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Primary hypogonadism results from damage to the testes. The damage can be physical or the result of an autoimmune condition.\u00a0\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Hypogonadotropic hypogonadism can have many causes, from genetic defects to stress and substance abuse.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In some cases, testosterone deficiency results from a combination of testicular and other problems.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Doctors measure the levels of hormones like follicle-stimulating hormone, luteinizing hormone, and prolactin to determine the cause of testosterone deficiency.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Testosterone undecanoate-based solutions like Kyzatrex work in all cases.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Higher-than-normal testosterone levels do not offer people additional health benefits. Those who try to improve their physiques by abusing drugs like testosterone undecanoate find that the side effects always outweigh the temporary benefits.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Only take testosterone replacement therapy drugs if your doctor prescribes them for low T.\u00a0<\/span><\/p>\n<h3>eDrugstore Can Help You Monitor Your Testosterone<\/h3>\n<p><span style=\"font-weight: 400;\">We carry affordable <\/span><a href=\"https:\/\/www.edrugstore.com\/test-kits\/testosterone-home-test-kit\/\"><span style=\"font-weight: 400;\">home testosterone test kits<\/span><\/a><span style=\"font-weight: 400;\"> you can use to measure your testosterone levels, and it\u2019s easy!\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Order the home testosterone kit.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Follow the instructions to collect a sample.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Return the sample.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Get your results in 2-5 days.\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">If your results fall outside the optimal range, we provide a free consultation with a U.S.-licensed doctor to determine how you should proceed. When you order from eDrugstore, medical consultations and shipping are always free.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Highlights\u00a0\u00a0 Low testosterone affects the quality of life of millions of aging men. Testosterone replacement therapy is a solution for men suffering from testosterone deficiency. The FDA has recently approved a testosterone undecanoate-based oral drug called Kyzatrex. Kyzatrex works against hypogonadism (low testosterone), but it carries some risks and may cause adverse effects.\u00a0 The FDA [&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":33635,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_autoblog_aioseo_focus_keyphrase":"","_autoblog_aioseo_title":"","_autoblog_aioseo_description":"","footnotes":""},"categories":[5],"tags":[],"class_list":["post-33630","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mens-health"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO Pro 4.9.10 - aioseo.com -->\n\t<meta name=\"description\" content=\"Testosterone replacement therapy is a solution for men suffering from hypogonadism. 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