[45], CCCCCCCCCCC(=O)O[C@H]1CC[C@@H]2[C@@]1(CC[C@H]3[C@H]2CCC4=CC(=O)CC[C@]34C)C, InChI=1S/C30H48O3/c1-4-5-6-7-8-9-10-11-12-28(32)33-27-16-15-25-24-14-13-22-21-23(31)17-19-29(22,2)26(24)18-20-30(25,27)3/h21,24-27H,4-20H2,1-3H3/t24-,25-,26-,27-,29-,30-/m0/s1, CS1 maint: multiple names: authors list (, Androgen replacement therapy § Medical uses, Androgen replacement therapy § Adverse effects, Adverse Drug Reactions Advisory Committee, List of androgens/anabolic steroids available in the United States, "Safety aspects of 36 months of administration of long-acting intramuscular testosterone undecanoate for treatment of female-to-male transgender individuals", "Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement", "FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism", "Testosterone undecanoate depot injection - AdisInsight", "Testosterone undecanoate - Organon - AdisInsight", https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s000lbl.pdf, "Anaphylaxis Triggered by Benzyl Benzoate in a Preparation of Depot Testosterone Undecanoate", "Nebido Monograph – Information for Health Care Professionals", "FDA Approves Aveed Testosterone Jab, with Restrictions", "Testosterone undecanoate profile and most popular brands in USA", Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS) (TEREPINS), "Testosterone undecanoate oral twice-daily - Lipocine", "Testosterone undecanoate - Clarus Therapeutics", FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism, Clarus Therapeutics Receives U.S. FDA Approval of JATENZO® (Testosterone Undecanoate Capsules for Oral Use) (CIII) for Testosterone Replacement Therapy in Certain Adult Men, Lipocine Seeks Injunction Against the Marketing of Clarus Therapeutics' JATENZO® for Testosterone Replacement Therapy, Lipocine Announces TLANDO™ NDA PDUFA Action Date of November 9, 2019, Androgen/anabolic steroid (as a medication), Transgender hormone therapy (female-to-male), Dihydrotestosterone (DHT; androstanolone), Dehydroepiandrosterone (DHEA; prasterone), Prasterone (dehydroepiandrosterone, DHEA), Androstanolone (stanolone, dihydrotestosterone, DHT), Drostanolone propionate (dromostanolone propionate), Metenolone enanthate (methenolone enanthate), Oxabolone cipionate (oxabolone cypionate), Trenbolone hexahydrobenzylcarbonate (trenbolone cyclohexylmethylcarbonate), Metandienone (methandienone, methandrostenolone), Normethandrone (methylestrenolone, normethisterone), Adrenosterone (11-ketoandrostenedione, 11-oxoandrostenedione), DHEA (androstenolone, prasterone; 5-DHEA), 7α-Methyl-19-norandrostenedione (MENT dione, trestione), 11β-Methyl-19-nortestosterone dodecylcarbonate, Methylclostebol (chloromethyltestosterone), Andarine (acetamidoxolutamide, androxolutamide, GTx-007, S-4), Enobosarm (ostarine, MK-2866, GTx-024, S-22), 3-Methyl-19-methyleneandrosta-3,5-dien-17β-ol, 10β,17β-Dihydroxyestra-1,4-dien-3-one (DHED), 16β,17α-Epiestriol (16β-hydroxy-17α-estradiol), 17α-Epiestriol (16α-hydroxy-17α-estradiol), Epiestriol (16β-epiestriol, 16β-hydroxy-17β-estradiol), Fosfestrol (diethylstilbestrol diphosphate), Furostilbestrol (diethylstilbestrol difuroate), Triphenylmethylethylene (triphenylpropene), https://en.wikipedia.org/w/index.php?title=Testosterone_undecanoate&oldid=984423760, Articles with unsourced statements from November 2017, Chem-molar-mass both hardcoded and calculated, Articles with unsourced statements from October 2017, Creative Commons Attribution-ShareAlike License, TU; Testosterone undecylate; Testosterone 17β-undecanoate; ORG-538; CLR-610, This page was last edited on 20 October 2020, at 01:13. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. [4][5], In the late 1970s, testosterone undecanoate was introduced for oral use in Europe,[13] although intramuscular testosterone undecanoate had already been in use in China for several years. http://www.medscape.com/resource/hypogonadism, encoded search term (testosterone (Depo-Testosterone%2C Aveed%2C and Xyosted)) and testosterone (Depo-Testosterone, Aveed, and Xyosted), Erectile Dysfunction in Renal Failure and Transplant Patients, FDA Clears First Autoinjectable Testosterone, Xyosted, An Elective Course in Lesbian, Gay, Bisexual, and Transgender Health and Practice Issues. [32] However, its long-term safety is unclear.

Primary hypogonadism (congenital or acquired): Testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals; these men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above normal range, 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, Testosterone cypionate: 50-400 mg IM every 2-4 weeks, Testosterone enanthate (generic): 50-400 mg IM every 2-4 weeks, Testosterone undecanoate (restricted availability): 750 mg IM initial dose, repeat after 4 weeks, and then q10wk thereafter, Pellet: 150-450 mg SC every 3-6 months; 150 mg of pellet approximately equivalent to 25 mg of testosterone propionate weekly, Testosterone enanthate (generic): 50-200 mg IM every 2-4 weeks for 4-6 months, Testosterone enanthate (generic): 200-400 mg IM every 2-4 weeks, Physiologic testosterone replacement in androgen-deficient HIV+ patients with associated weight loss, Treatment of constitutional delay in growth and puberty in adolescent boys aged 14-17 years (testosterone undecanoate), Before initiating: Confirm diagnosis of hypogonadism by ensuring serum testosterone has been measured in the morning on at least 2 separate days and that these concentrations are below the normal range, Excessive frequency and duration of erection, Vascular Disorders: Venous thromboembolism, Reproductive system: Azoospermia, benign prostatic hyperplasia, Hypersensitivity to product or formulation components, Men with carcinoma of the breast or known or suspected carcinoma of the prostate, Men with hypogonadal conditions (eg, “age-related hypogonadism”) that are not associated with structural or genetic etiologies; efficacy has not been established for these conditions, and testosterone can increase BP which can increase the risk of MACE, Women: Pregnancy or prospect of pregnancy, May increase blood pressure (BP); before initiating, consider baseline cardiovascular (CV) risk and ensure BP is adequately controlled; check BP ~3 weeks after initiating or increasing dose and periodically thereafter; treat new-onset hypertension or exacerbations; reassess whether the benefits of continued treatment outweigh risks, Increased hematocrit (polycythemia) reflective of increases in RBC mass may require lower dose or discontinuation; evaluate hematocrit ~q3Months, and if elevated hold testosterone until hematocrit returns to normal; if testosterone restarted and again hematocrit increase, permanently discontinue testosterone; increased RBC mass may increase thromboembolic risk, Patients with BPH treated with androgens are at an increased risk for worsening of BPH signs and symptoms, Androgens may increase risk for prostate cancer; evaluate patients for prostate cancer before initiating and during treatment with testosterone, Venous thromboembolic events (VTE) reported, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement; 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 VTE suspected, discontinue testosterone and initiate appropriate workup and management, Testosterone has been subject to abuse, typically at doses higher than recommended for approved indication and in combination with other anabolic androgenic steroids; anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions; if testosterone abuse suspected, check serum testosterone concentrations to ensure they are within therapeutic range; consider possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events, Prolonged use of high dose testosterone associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice); peliosis hepatis can be life-threatening or fatal; long-term therapy with IM testosterone enanthate has produced multiple hepatic adenomas; although not reported with other administration routes, monitor for signs or symptoms of hepatic dysfunction; promptly discontinue testosterone if jaundice occurs while evaluating cause, Gynecomastia may develop and persist in patients treated for hypogonadism, May alter serum lipid profile and require dose adjustment of lipid lowering drugs or discontinuing testosterone; monitor lipid profile, especially after starting testosterone, Androgens may promote sodium and water retention; edema, with or without CHF, may be a serious complication if pre-existing cardiac, renal, or hepatic disease exists; may necessitate discontinuing drug; consider diuretic therapy, May potentiate sleep apnea in some patients, especially patients who are obese or with chronic lung disease, Use androgens cautiously in patients with cancer with risk of hypercalcemia (and associated hypercalciuria); monitor serum calcium concentrations regularly during treatment, May decrease concentrations of thyroxine-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, Due to lack of controlled evaluations in women and potential virilizing effects, not indicated for use in women, Depression and suicidal ideation and behavior, including completed suicide, have occurred during clinical trials, Aveed only: Serious POME reactions reported to occur during or immediately after IM injection of testosterone undecanoate 1000 mg (see Black Box Warnings), Testopel only: Postmarketing cases associated pellet(s) insertion with implant site infection (cellulitis and abscess), and/or pellet extrusion at or near implantation site; most reported cases occurred within the first month after implantation, Teratogenic; may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action, Exposure of a female fetus to androgens may result in varying degrees of virilization. [10][22], Side effects of testosterone undecanoate include virilization among others. Your doctor will give this shot to you every 3 months, so you don't have to worry about administering it yourself like some testosterone injections. [69] In women, testosterone can produce hirsutism (excessive facial/body hair growth), deepening of the voice, and other signs of virilization. You may report side effects to the FDA at 1-800-FDA-1088. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine. These reactions have occurred during or immediately after administration and may occur at any time during the course of therapy, including after the first dose. Please read with care. [143], This article is about testosterone as a medication. [34] Androgenic adverse effects such as acne and hirsutism were significantly greater in incidence with testosterone therapy, whereas no significant differences in "increase in facial hair, alopecia, voice deepening, urinary symptoms, breast pain, headache, site reaction to the patch, total adverse events, serious adverse events, reasons for withdrawal from the study, and the number of women who completed the study" were seen relative to controls.
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[45], CCCCCCCCCCC(=O)O[C@H]1CC[C@@H]2[C@@]1(CC[C@H]3[C@H]2CCC4=CC(=O)CC[C@]34C)C, InChI=1S/C30H48O3/c1-4-5-6-7-8-9-10-11-12-28(32)33-27-16-15-25-24-14-13-22-21-23(31)17-19-29(22,2)26(24)18-20-30(25,27)3/h21,24-27H,4-20H2,1-3H3/t24-,25-,26-,27-,29-,30-/m0/s1, CS1 maint: multiple names: authors list (, Androgen replacement therapy § Medical uses, Androgen replacement therapy § Adverse effects, Adverse Drug Reactions Advisory Committee, List of androgens/anabolic steroids available in the United States, "Safety aspects of 36 months of administration of long-acting intramuscular testosterone undecanoate for treatment of female-to-male transgender individuals", "Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement", "FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism", "Testosterone undecanoate depot injection - AdisInsight", "Testosterone undecanoate - Organon - AdisInsight", https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s000lbl.pdf, "Anaphylaxis Triggered by Benzyl Benzoate in a Preparation of Depot Testosterone Undecanoate", "Nebido Monograph – Information for Health Care Professionals", "FDA Approves Aveed Testosterone Jab, with Restrictions", "Testosterone undecanoate profile and most popular brands in USA", Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS) (TEREPINS), "Testosterone undecanoate oral twice-daily - Lipocine", "Testosterone undecanoate - Clarus Therapeutics", FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism, Clarus Therapeutics Receives U.S. FDA Approval of JATENZO® (Testosterone Undecanoate Capsules for Oral Use) (CIII) for Testosterone Replacement Therapy in Certain Adult Men, Lipocine Seeks Injunction Against the Marketing of Clarus Therapeutics' JATENZO® for Testosterone Replacement Therapy, Lipocine Announces TLANDO™ NDA PDUFA Action Date of November 9, 2019, Androgen/anabolic steroid (as a medication), Transgender hormone therapy (female-to-male), Dihydrotestosterone (DHT; androstanolone), Dehydroepiandrosterone (DHEA; prasterone), Prasterone (dehydroepiandrosterone, DHEA), Androstanolone (stanolone, dihydrotestosterone, DHT), Drostanolone propionate (dromostanolone propionate), Metenolone enanthate (methenolone enanthate), Oxabolone cipionate (oxabolone cypionate), Trenbolone hexahydrobenzylcarbonate (trenbolone cyclohexylmethylcarbonate), Metandienone (methandienone, methandrostenolone), Normethandrone (methylestrenolone, normethisterone), Adrenosterone (11-ketoandrostenedione, 11-oxoandrostenedione), DHEA (androstenolone, prasterone; 5-DHEA), 7α-Methyl-19-norandrostenedione (MENT dione, trestione), 11β-Methyl-19-nortestosterone dodecylcarbonate, Methylclostebol (chloromethyltestosterone), Andarine (acetamidoxolutamide, androxolutamide, GTx-007, S-4), Enobosarm (ostarine, MK-2866, GTx-024, S-22), 3-Methyl-19-methyleneandrosta-3,5-dien-17β-ol, 10β,17β-Dihydroxyestra-1,4-dien-3-one (DHED), 16β,17α-Epiestriol (16β-hydroxy-17α-estradiol), 17α-Epiestriol (16α-hydroxy-17α-estradiol), Epiestriol (16β-epiestriol, 16β-hydroxy-17β-estradiol), Fosfestrol (diethylstilbestrol diphosphate), Furostilbestrol (diethylstilbestrol difuroate), Triphenylmethylethylene (triphenylpropene), https://en.wikipedia.org/w/index.php?title=Testosterone_undecanoate&oldid=984423760, Articles with unsourced statements from November 2017, Chem-molar-mass both hardcoded and calculated, Articles with unsourced statements from October 2017, Creative Commons Attribution-ShareAlike License, TU; Testosterone undecylate; Testosterone 17β-undecanoate; ORG-538; CLR-610, This page was last edited on 20 October 2020, at 01:13. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. [4][5], In the late 1970s, testosterone undecanoate was introduced for oral use in Europe,[13] although intramuscular testosterone undecanoate had already been in use in China for several years. http://www.medscape.com/resource/hypogonadism, encoded search term (testosterone (Depo-Testosterone%2C Aveed%2C and Xyosted)) and testosterone (Depo-Testosterone, Aveed, and Xyosted), Erectile Dysfunction in Renal Failure and Transplant Patients, FDA Clears First Autoinjectable Testosterone, Xyosted, An Elective Course in Lesbian, Gay, Bisexual, and Transgender Health and Practice Issues. [32] However, its long-term safety is unclear.

Primary hypogonadism (congenital or acquired): Testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals; these men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above normal range, 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, Testosterone cypionate: 50-400 mg IM every 2-4 weeks, Testosterone enanthate (generic): 50-400 mg IM every 2-4 weeks, Testosterone undecanoate (restricted availability): 750 mg IM initial dose, repeat after 4 weeks, and then q10wk thereafter, Pellet: 150-450 mg SC every 3-6 months; 150 mg of pellet approximately equivalent to 25 mg of testosterone propionate weekly, Testosterone enanthate (generic): 50-200 mg IM every 2-4 weeks for 4-6 months, Testosterone enanthate (generic): 200-400 mg IM every 2-4 weeks, Physiologic testosterone replacement in androgen-deficient HIV+ patients with associated weight loss, Treatment of constitutional delay in growth and puberty in adolescent boys aged 14-17 years (testosterone undecanoate), Before initiating: Confirm diagnosis of hypogonadism by ensuring serum testosterone has been measured in the morning on at least 2 separate days and that these concentrations are below the normal range, Excessive frequency and duration of erection, Vascular Disorders: Venous thromboembolism, Reproductive system: Azoospermia, benign prostatic hyperplasia, Hypersensitivity to product or formulation components, Men with carcinoma of the breast or known or suspected carcinoma of the prostate, Men with hypogonadal conditions (eg, “age-related hypogonadism”) that are not associated with structural or genetic etiologies; efficacy has not been established for these conditions, and testosterone can increase BP which can increase the risk of MACE, Women: Pregnancy or prospect of pregnancy, May increase blood pressure (BP); before initiating, consider baseline cardiovascular (CV) risk and ensure BP is adequately controlled; check BP ~3 weeks after initiating or increasing dose and periodically thereafter; treat new-onset hypertension or exacerbations; reassess whether the benefits of continued treatment outweigh risks, Increased hematocrit (polycythemia) reflective of increases in RBC mass may require lower dose or discontinuation; evaluate hematocrit ~q3Months, and if elevated hold testosterone until hematocrit returns to normal; if testosterone restarted and again hematocrit increase, permanently discontinue testosterone; increased RBC mass may increase thromboembolic risk, Patients with BPH treated with androgens are at an increased risk for worsening of BPH signs and symptoms, Androgens may increase risk for prostate cancer; evaluate patients for prostate cancer before initiating and during treatment with testosterone, Venous thromboembolic events (VTE) reported, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement; 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 VTE suspected, discontinue testosterone and initiate appropriate workup and management, Testosterone has been subject to abuse, typically at doses higher than recommended for approved indication and in combination with other anabolic androgenic steroids; anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions; if testosterone abuse suspected, check serum testosterone concentrations to ensure they are within therapeutic range; consider possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events, Prolonged use of high dose testosterone associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice); peliosis hepatis can be life-threatening or fatal; long-term therapy with IM testosterone enanthate has produced multiple hepatic adenomas; although not reported with other administration routes, monitor for signs or symptoms of hepatic dysfunction; promptly discontinue testosterone if jaundice occurs while evaluating cause, Gynecomastia may develop and persist in patients treated for hypogonadism, May alter serum lipid profile and require dose adjustment of lipid lowering drugs or discontinuing testosterone; monitor lipid profile, especially after starting testosterone, Androgens may promote sodium and water retention; edema, with or without CHF, may be a serious complication if pre-existing cardiac, renal, or hepatic disease exists; may necessitate discontinuing drug; consider diuretic therapy, May potentiate sleep apnea in some patients, especially patients who are obese or with chronic lung disease, Use androgens cautiously in patients with cancer with risk of hypercalcemia (and associated hypercalciuria); monitor serum calcium concentrations regularly during treatment, May decrease concentrations of thyroxine-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, Due to lack of controlled evaluations in women and potential virilizing effects, not indicated for use in women, Depression and suicidal ideation and behavior, including completed suicide, have occurred during clinical trials, Aveed only: Serious POME reactions reported to occur during or immediately after IM injection of testosterone undecanoate 1000 mg (see Black Box Warnings), Testopel only: Postmarketing cases associated pellet(s) insertion with implant site infection (cellulitis and abscess), and/or pellet extrusion at or near implantation site; most reported cases occurred within the first month after implantation, Teratogenic; may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action, Exposure of a female fetus to androgens may result in varying degrees of virilization. [10][22], Side effects of testosterone undecanoate include virilization among others. Your doctor will give this shot to you every 3 months, so you don't have to worry about administering it yourself like some testosterone injections. [69] In women, testosterone can produce hirsutism (excessive facial/body hair growth), deepening of the voice, and other signs of virilization. You may report side effects to the FDA at 1-800-FDA-1088. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine. These reactions have occurred during or immediately after administration and may occur at any time during the course of therapy, including after the first dose. Please read with care. [143], This article is about testosterone as a medication. [34] Androgenic adverse effects such as acne and hirsutism were significantly greater in incidence with testosterone therapy, whereas no significant differences in "increase in facial hair, alopecia, voice deepening, urinary symptoms, breast pain, headache, site reaction to the patch, total adverse events, serious adverse events, reasons for withdrawal from the study, and the number of women who completed the study" were seen relative to controls.
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testopel vs aveed


We comply with the HONcode standard for trustworthy health information -, Drug class: androgens and anabolic steroids, Allergy to benzyl benzoate, refined castor oil, or sesame oil or. [123] There is a medical condition called late-onset hypogonadism; according to Thomas Perls and David J. Handelsman, writing in a 2015 editorial in the Journal of the American Geriatrics Society, it appears that this condition is overdiagnosed and overtreated. Testosterone and other AAS were designated a "controlled substance" by the United States Congress in 1990, with the Anabolic Steroid Control Act. Monitor patients in a healthcare setting for 30 minutes after each injection . If you or your caregiver notice any of these side effects, tell your doctor right away.

[45], CCCCCCCCCCC(=O)O[C@H]1CC[C@@H]2[C@@]1(CC[C@H]3[C@H]2CCC4=CC(=O)CC[C@]34C)C, InChI=1S/C30H48O3/c1-4-5-6-7-8-9-10-11-12-28(32)33-27-16-15-25-24-14-13-22-21-23(31)17-19-29(22,2)26(24)18-20-30(25,27)3/h21,24-27H,4-20H2,1-3H3/t24-,25-,26-,27-,29-,30-/m0/s1, CS1 maint: multiple names: authors list (, Androgen replacement therapy § Medical uses, Androgen replacement therapy § Adverse effects, Adverse Drug Reactions Advisory Committee, List of androgens/anabolic steroids available in the United States, "Safety aspects of 36 months of administration of long-acting intramuscular testosterone undecanoate for treatment of female-to-male transgender individuals", "Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement", "FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism", "Testosterone undecanoate depot injection - AdisInsight", "Testosterone undecanoate - Organon - AdisInsight", https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s000lbl.pdf, "Anaphylaxis Triggered by Benzyl Benzoate in a Preparation of Depot Testosterone Undecanoate", "Nebido Monograph – Information for Health Care Professionals", "FDA Approves Aveed Testosterone Jab, with Restrictions", "Testosterone undecanoate profile and most popular brands in USA", Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS) (TEREPINS), "Testosterone undecanoate oral twice-daily - Lipocine", "Testosterone undecanoate - Clarus Therapeutics", FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism, Clarus Therapeutics Receives U.S. FDA Approval of JATENZO® (Testosterone Undecanoate Capsules for Oral Use) (CIII) for Testosterone Replacement Therapy in Certain Adult Men, Lipocine Seeks Injunction Against the Marketing of Clarus Therapeutics' JATENZO® for Testosterone Replacement Therapy, Lipocine Announces TLANDO™ NDA PDUFA Action Date of November 9, 2019, Androgen/anabolic steroid (as a medication), Transgender hormone therapy (female-to-male), Dihydrotestosterone (DHT; androstanolone), Dehydroepiandrosterone (DHEA; prasterone), Prasterone (dehydroepiandrosterone, DHEA), Androstanolone (stanolone, dihydrotestosterone, DHT), Drostanolone propionate (dromostanolone propionate), Metenolone enanthate (methenolone enanthate), Oxabolone cipionate (oxabolone cypionate), Trenbolone hexahydrobenzylcarbonate (trenbolone cyclohexylmethylcarbonate), Metandienone (methandienone, methandrostenolone), Normethandrone (methylestrenolone, normethisterone), Adrenosterone (11-ketoandrostenedione, 11-oxoandrostenedione), DHEA (androstenolone, prasterone; 5-DHEA), 7α-Methyl-19-norandrostenedione (MENT dione, trestione), 11β-Methyl-19-nortestosterone dodecylcarbonate, Methylclostebol (chloromethyltestosterone), Andarine (acetamidoxolutamide, androxolutamide, GTx-007, S-4), Enobosarm (ostarine, MK-2866, GTx-024, S-22), 3-Methyl-19-methyleneandrosta-3,5-dien-17β-ol, 10β,17β-Dihydroxyestra-1,4-dien-3-one (DHED), 16β,17α-Epiestriol (16β-hydroxy-17α-estradiol), 17α-Epiestriol (16α-hydroxy-17α-estradiol), Epiestriol (16β-epiestriol, 16β-hydroxy-17β-estradiol), Fosfestrol (diethylstilbestrol diphosphate), Furostilbestrol (diethylstilbestrol difuroate), Triphenylmethylethylene (triphenylpropene), https://en.wikipedia.org/w/index.php?title=Testosterone_undecanoate&oldid=984423760, Articles with unsourced statements from November 2017, Chem-molar-mass both hardcoded and calculated, Articles with unsourced statements from October 2017, Creative Commons Attribution-ShareAlike License, TU; Testosterone undecylate; Testosterone 17β-undecanoate; ORG-538; CLR-610, This page was last edited on 20 October 2020, at 01:13. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. [4][5], In the late 1970s, testosterone undecanoate was introduced for oral use in Europe,[13] although intramuscular testosterone undecanoate had already been in use in China for several years. http://www.medscape.com/resource/hypogonadism, encoded search term (testosterone (Depo-Testosterone%2C Aveed%2C and Xyosted)) and testosterone (Depo-Testosterone, Aveed, and Xyosted), Erectile Dysfunction in Renal Failure and Transplant Patients, FDA Clears First Autoinjectable Testosterone, Xyosted, An Elective Course in Lesbian, Gay, Bisexual, and Transgender Health and Practice Issues. [32] However, its long-term safety is unclear.

Primary hypogonadism (congenital or acquired): Testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals; these men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above normal range, 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, Testosterone cypionate: 50-400 mg IM every 2-4 weeks, Testosterone enanthate (generic): 50-400 mg IM every 2-4 weeks, Testosterone undecanoate (restricted availability): 750 mg IM initial dose, repeat after 4 weeks, and then q10wk thereafter, Pellet: 150-450 mg SC every 3-6 months; 150 mg of pellet approximately equivalent to 25 mg of testosterone propionate weekly, Testosterone enanthate (generic): 50-200 mg IM every 2-4 weeks for 4-6 months, Testosterone enanthate (generic): 200-400 mg IM every 2-4 weeks, Physiologic testosterone replacement in androgen-deficient HIV+ patients with associated weight loss, Treatment of constitutional delay in growth and puberty in adolescent boys aged 14-17 years (testosterone undecanoate), Before initiating: Confirm diagnosis of hypogonadism by ensuring serum testosterone has been measured in the morning on at least 2 separate days and that these concentrations are below the normal range, Excessive frequency and duration of erection, Vascular Disorders: Venous thromboembolism, Reproductive system: Azoospermia, benign prostatic hyperplasia, Hypersensitivity to product or formulation components, Men with carcinoma of the breast or known or suspected carcinoma of the prostate, Men with hypogonadal conditions (eg, “age-related hypogonadism”) that are not associated with structural or genetic etiologies; efficacy has not been established for these conditions, and testosterone can increase BP which can increase the risk of MACE, Women: Pregnancy or prospect of pregnancy, May increase blood pressure (BP); before initiating, consider baseline cardiovascular (CV) risk and ensure BP is adequately controlled; check BP ~3 weeks after initiating or increasing dose and periodically thereafter; treat new-onset hypertension or exacerbations; reassess whether the benefits of continued treatment outweigh risks, Increased hematocrit (polycythemia) reflective of increases in RBC mass may require lower dose or discontinuation; evaluate hematocrit ~q3Months, and if elevated hold testosterone until hematocrit returns to normal; if testosterone restarted and again hematocrit increase, permanently discontinue testosterone; increased RBC mass may increase thromboembolic risk, Patients with BPH treated with androgens are at an increased risk for worsening of BPH signs and symptoms, Androgens may increase risk for prostate cancer; evaluate patients for prostate cancer before initiating and during treatment with testosterone, Venous thromboembolic events (VTE) reported, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement; 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 VTE suspected, discontinue testosterone and initiate appropriate workup and management, Testosterone has been subject to abuse, typically at doses higher than recommended for approved indication and in combination with other anabolic androgenic steroids; anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions; if testosterone abuse suspected, check serum testosterone concentrations to ensure they are within therapeutic range; consider possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events, Prolonged use of high dose testosterone associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice); peliosis hepatis can be life-threatening or fatal; long-term therapy with IM testosterone enanthate has produced multiple hepatic adenomas; although not reported with other administration routes, monitor for signs or symptoms of hepatic dysfunction; promptly discontinue testosterone if jaundice occurs while evaluating cause, Gynecomastia may develop and persist in patients treated for hypogonadism, May alter serum lipid profile and require dose adjustment of lipid lowering drugs or discontinuing testosterone; monitor lipid profile, especially after starting testosterone, Androgens may promote sodium and water retention; edema, with or without CHF, may be a serious complication if pre-existing cardiac, renal, or hepatic disease exists; may necessitate discontinuing drug; consider diuretic therapy, May potentiate sleep apnea in some patients, especially patients who are obese or with chronic lung disease, Use androgens cautiously in patients with cancer with risk of hypercalcemia (and associated hypercalciuria); monitor serum calcium concentrations regularly during treatment, May decrease concentrations of thyroxine-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, Due to lack of controlled evaluations in women and potential virilizing effects, not indicated for use in women, Depression and suicidal ideation and behavior, including completed suicide, have occurred during clinical trials, Aveed only: Serious POME reactions reported to occur during or immediately after IM injection of testosterone undecanoate 1000 mg (see Black Box Warnings), Testopel only: Postmarketing cases associated pellet(s) insertion with implant site infection (cellulitis and abscess), and/or pellet extrusion at or near implantation site; most reported cases occurred within the first month after implantation, Teratogenic; may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action, Exposure of a female fetus to androgens may result in varying degrees of virilization. [10][22], Side effects of testosterone undecanoate include virilization among others. Your doctor will give this shot to you every 3 months, so you don't have to worry about administering it yourself like some testosterone injections. [69] In women, testosterone can produce hirsutism (excessive facial/body hair growth), deepening of the voice, and other signs of virilization. You may report side effects to the FDA at 1-800-FDA-1088. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine. These reactions have occurred during or immediately after administration and may occur at any time during the course of therapy, including after the first dose. Please read with care. [143], This article is about testosterone as a medication. [34] Androgenic adverse effects such as acne and hirsutism were significantly greater in incidence with testosterone therapy, whereas no significant differences in "increase in facial hair, alopecia, voice deepening, urinary symptoms, breast pain, headache, site reaction to the patch, total adverse events, serious adverse events, reasons for withdrawal from the study, and the number of women who completed the study" were seen relative to controls.

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