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KYZATREX®
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General Questions

Diddly Health is your guide along the path of lifelong wellness, with convenient virtual care from experienced providers. Our service provides easily accessible educational resources to illuminate all clinical and nutritional options and inform decision-making, empowering you to take control of your health and wellness journey.

Testosterone Replacement Therapy (TRT) is a treatment for men with low testosterone levels, a condition known as hypogonadism. Symptoms of hypogonadism can include decreased libido, fatigue, and loss of muscle mass. To qualify for TRT, you need to have low serum testosterone levels (below 300 to 350 ng/dL) on two separate morning tests and show symptoms of hypogonadism. TRT comes in different forms, such as topical gels and intramuscular injections, and the choice depends on factors like cost and your preference.

While TRT can effectively improve symptoms and enhance quality of life, it requires careful selection, shared decision-making with your doctor, and close monitoring due to potential risks. Studies have shown that TRT can help improve symptoms and quality of life in men with low testosterone levels, but there are concerns about possible cardiovascular risks and long-term safety. Guidelines for TRT emphasize the need for personalized treatment plans and following clinical recommendations to avoid misuse. Despite some controversies, TRT is a commonly used treatment for hypogonadism, with ongoing research to better understand its benefits and risks[1][2][3].

References:

[1] Snow, L. (2023). Hormone Therapy: Testosterone Replacement Therapy. FP Essentials, 531, 7–14. https://pubmed.ncbi.nlm.nih.gov/37603880/

[2] Park, H., Ahn, S., & Moon, D. (2019). Evolution of Guidelines for Testosterone Replacement Therapy. Journal of Clinical Medicine, 8(3), 410. https://doi.org/10.3390/jcm8030410

[3] Skiba, R., Rymarz, A., Matyjek, A., Dymus, J., Woźniak-Kosek, A., Syryło, T., Zieliński, H., & Niemczyk, S. (2022). Testosterone Replacement Therapy in Chronic Kidney Disease Patients. Nutrients, 14(16), 3444. https://doi.org/10.3390/nu14163444

Verifying low testosterone levels involves both clinical evaluation and laboratory testing. Clinically, symptoms such as fatigue, reduced muscle mass, increased body fat, decreased bone density, reduced libido, erectile dysfunction, mood changes, depression, and cognitive decline are assessed. A thorough medical history, including chronic illnesses and medications that might affect hormone levels, is reviewed. Reference ranges typically consider total testosterone levels below 300 ng/dL and free testosterone below 50 pg/mL as low. Results should be correlated with symptoms to make an accurate diagnosis. It's also crucial to investigate and manage any underlying conditions that might contribute to low testosterone [1][2][3][4]. A laboratory panel containing Testosterone, Free Testosterone, SHBG, PSA, Estradiol, and CBC is collected at initial, three months, six months, and every 6 months thereafter.

References:

[1] Infante, M., Pieri, M., S Lupisella, L D'Amore, Bernardini, S., Fabbri, A., Iannetta, M., Andreoni, M., & Morello, M. (2021). Low testosterone levels and high estradiol to testosterone ratio are associated with hyperinflammatory state and mortality in hospitalized men with COVID-19. DOAJ (DOAJ: Directory of Open Access Journals)25(19), 5889–5903. https://doi.org/10.26355/eurrev_202110_26865

[2] Maggi, M., Rastrelli, G., & Corona, G. (2020). Both comorbidity burden and low testosterone can explain symptoms and signs of testosterone deficiency in men consulting for sexual dysfunction. Asian Journal of Andrology22(3), 265. https://doi.org/10.4103/aja.aja_61_19

[3] Rivas, A. M., Mulkey, Z., Lado-Abeal, J., & Yarbrough, S. (2014). Diagnosing and Managing Low Serum Testosterone. Baylor University Medical Center Proceedings27(4), 321–324. https://doi.org/10.1080/08998280.2014.11929145

[4] Cunningham, G. R., Stephens-Shields, A. J., Rosen, R. C., Wang, C., Ellenberg, S. S., Matsumoto, A. M., Bhasin, S., Molitch, M. E., Farrar, J. T., Cella, D., Barrett-Connor, E., Cauley, J. A., Cifelli, D., Crandall, J. P., Ensrud, K. E., Fluharty, L., Gill, T. M., Lewis, C. E., Pahor, M., & Resnick, S. M. (2015). Association of Sex Hormones With Sexual Function, Vitality, and Physical Function of Symptomatic Older Men with Low Testosterone Levels at Baseline in the Testosterone Trials. The Journal of Clinical Endocrinology & Metabolism100(3), 1146–1155. https://doi.org/10.1210/jc.2014-3818

Low testosterone, or hypogonadism, can cause a range of symptoms in men that affect physical, sexual, emotional, and cognitive health. Physically, men may experience fatigue, reduced muscle mass, decreased bone density, increased body fat, and lower urinary tract symptoms. Sexually, low testosterone can lead to reduced libido, erectile dysfunction, and fewer morning erections. Emotionally and cognitively, men might face depression, mood changes, and difficulties with concentration and memory. Other signs include loss of body hair, development of breast tissue (gynecomastia), and infertility. These symptoms can significantly impact a man's quality of life, so it is important to seek medical advice if these signs are present [1][2][3][4][5].

References:

[1] Culbert, K. M., Shope, M. M., Sisk, C. L., & Klump, K. L. (2020). Low testosterone is associated with dysregulated eating symptoms in young adult men. International Journal of Eating Disorders53(9), 1469–1479. https://doi.org/10.1002/eat.23320

[2] Machado, F. P., Rhoden, E. L., Pioner, S. R., Halmenschlager, G., de Souza, L. V. B., Lisot, B. C., & Drachler, I. P. (2021). Weight Loss Through Bariatric Surgery in Men Presents Beneficial Effects on Sexual Function, Symptoms of Testosterone Deficiency, and Hormonal Profile. Sexual Medicine9(4), 100400. https://doi.org/10.1016/j.esxm.2021.100400

[3] Kalra, S., Jacob, J., Unnikrishnan, A. G., Bantwal, G., Sahoo, A., Sahay, R., Jindal, S., Agrawal, M. S., Kapoor, N., Saboo, B., Tiwaskar, M., & Kochhar, K. (2023). Expert Opinion on the Diagnosis and Management of Male Hypogonadism in India. International Journal of Endocrinology2023, 1–10. https://doi.org/10.1155/2023/4408697

[4] Maggi, M., Rastrelli, G., & Corona, G. (2020). Both comorbidity burden and low testosterone can explain symptoms and signs of testosterone deficiency in men consulting for sexual dysfunction. Asian Journal of Andrology22(3), 265. https://doi.org/10.4103/aja.aja_61_19

[5] Grossmann, M. (2023). Towards optimising diagnosis and management of male hypogonadism: Commentary on CEN‐2023‐000285 “Standardising the biochemical confirmation of adult male hypogonadism; a joint position statement by the Society for Endocrinology and Association of Clinical Biochemistry and Laboratory Medicine.” Clinical Endocrinology (Oxford. Print)99(4), 396–397. https://doi.org/10.1111/cen.14932

[6] Pencina, K. M., Travison, T. G., Cunningham, G. R., A Michael Lincoff, Nissen, S. E., Khera, M., Miller, M. G., Panagiotis Flevaris, Li, X., Wannemuehler, K., & Bhasin, S. (2023). Effect of Testosterone Replacement Therapy on Sexual Function and Hypogonadal Symptoms in Men with Hypogonadism. The Journal of Clinical Endocrinology & Metabolism109(2), 569–580. https://doi.org/10.1210/clinem/dgad484

Diagnosing Low T involves simple lab tests to measure your Total Testosterone (Total T) and Free Testosterone (Free T), along with Sex Hormone Binding Globulin (SHBG), which affects Free T availability. Total T gives an overall level, while Free T shows the testosterone available for your body’s use. High SHBG can lower Free T, impacting its availability. Your doctor may suggest these tests and follow-up labs to monitor your testosterone levels over time, ensuring your treatment is accurately tailored to your needs.

At this time, the assessment questionnaire can only be completed by the person seeking care.

Yes, a virtual consultation with your provider is required to go over the results of your labs and must be completed in order to ensure Rx approval.

The KYZATREX® program is available in 49 States. The program is currently not available in New York. However, New Jersey, Rhode Island, and Connecticut are currently limited to at home labs only (walk-in labs are not an option).

Your privacy and the safety of your data are extremely important to us at Whole Health Rx. We adhere to strict privacy policies and employ advanced security measures to protect your information. Your Protected Health Information (PHI) is encrypted end-to-end and stored only by our Electronic Medical Record (EMR) provider. Whole Health Rx does not collect or store your PHI directly. We use industry standard TLS 1.2 encryption for all sensitive data in transit to be compliant with HIPAA regulations and SOC 2 certification standards, ensuring that your health information is handled with the utmost care and confidentiality. For further information, please review our Privacy Policy.

Customer support can be reached at (888) 958-9620, or by emailing [email protected]

Medication Questions

KYZATREX® is an FDA-approved, twice-daily oral capsule for testosterone replacement therapy in adult males with conditions associated with deficiency or absence of endogenous testosterone, also known as hypogonadism. It helps increase testosterone levels, addressing issues like reduced libido, fatigue, and muscle loss. Studies show small increases in systolic blood pressure, especially in those on antihypertensive therapy, with minimal changes in diastolic blood pressure and heart rate. Careful monitoring is recommended for patients with hypertension. Overall, KYZATREX® is effective for testosterone replacement with manageable impacts on blood pressure [1][2].

References:

[1] White, W. B., Bernstein, J. S., Rittmaster, R., & Dhingra, O. (2021). Effects of the oral testosterone undecanoate KYZATREX® on ambulatory blood pressure in hypogonadal men. The Journal of Clinical Hypertension23(7), 1420–1430. https://doi.org/10.1111/jch.14297

[2] Why KYZATREX®| Safe to Use, Easy to Take, and Up to 96% Effective. (n.d.). KYZATREX®. Retrieved May 17, 2024, from https://www.kyzatrex.com/why-kyzatrex/

KYZATREX testosterone therapy is administered orally, with two doses a day alongside food in pill form. This method is designed to be convenient and maintain stable testosterone levels in the body. Oral testosterone undecanoate is effective for increasing testosterone levels in individuals with hypogonadism. Compared to traditional methods like injections, patches, or gels, the oral form is less invasive and can improve compliance and comfort [1].

See Important Safety Information here

References:
[1] Miller, J., Nguyen, T., Loeb, C., Khera, M., & Yafi, F. A. (2023). Oral testosterone therapy: past, present, and future. Sexual Medicine Reviews, 11(2), 124–138. https://doi.org/10.1093/sxmrev/qead003

KYZATREX® is an oral testosterone replacement therapy. It is absorbed through the lymphatic system, avoiding the liver's initial breakdown, which helps maintain stable testosterone levels. Once in the body, KYZATREX® converts to active testosterone, which binds to receptors in muscles, bones, and other tissues, improving energy, sex drive, and muscle mass. Testosterone works by binding to androgen receptors, which then regulate genes involved in male health and development. This process supports muscle growth, bone density, and sexual function, making KYZATREX® effective in treating low testosterone levels [1][2][3][4][5][6].

References:

[1] Kim, Y., Lee, D., Jo, H., Go, C., Yang, J., Kang, D., & Kang, J. S. (2021). GV1001 interacts with androgen receptor to inhibit prostate cell proliferation in benign prostatic hyperplasia by regulating expression of molecules related to epithelial-mesenchymal transition. Aging13(3), 3202–3217. https://doi.org/10.18632/aging.202242

[2] Ayoub, R., Page, S. T., Swerdloff, R. S., Liu, P. Y., Amory, J. K., Leung, A., Hull, L., Blithe, D., Christy, A., Chao, J. H., Bremner, W. J., & Wang, C. (2016). Comparison of the single dose pharmacokinetics, pharmacodynamics, and safety of two novel oral formulations of dimethandrolone undecanoate (DMAU): a potential oral, male contraceptive. Andrology5(2), 278–285. https://doi.org/10.1111/andr.12303

[3] Thomas, P. (2019). Membrane Androgen Receptors Unrelated to Nuclear Steroid Receptors. Endocrinology160(4), 772–781. https://doi.org/10.1210/en.2018-00987

[4] White, W. B., Bernstein, J. S., Rittmaster, R., & Dhingra, O. (2021). Effects of the oral testosterone undecanoate KYZATREX®on ambulatory blood pressure in hypogonadal men. The Journal of Clinical Hypertension23(7), 1420–1430. https://doi.org/10.1111/jch.14297

[5] A. Michael Lincoff, Bhasin, S., Panagiotis Flevaris, Mitchell, L. M., Shehzad Basaria, Boden, W. E., Cunningham, G. R., Granger, C. B., Khera, M., Thompson, I. M., Wang, Q., Wolski, K., Davey, D., Vidyasagar Kalahasti, Khan, N., Miller, M. G., Snabes, M. C., Chan, A., Dubcenco, E., & Li, X. (2023). Cardiovascular Safety of Testosterone-Replacement Therapyhttps://doi.org/10.1056/nejmoa2215025

[6] Why KYZATREX®| Safe to Use, Easy to Take, and Up to 96% Effective. (n.d.). KYZATREX®. Retrieved May 17, 2024, from https://www.kyzatrex.com/why-kyzatrex/

An undecanoate is a type of chemical compound used to make testosterone last longer in the body. Specifically, testosterone undecanoate is testosterone attached to an undecanoate ester, which slows down its release into the bloodstream. This means it provides a steady and prolonged effect, making it useful for testosterone replacement therapy. The undecanoate helps testosterone be absorbed through the lymphatic system when taken orally, avoiding rapid breakdown in the liver and maintaining stable testosterone levels [1][2][3].

References:

[1] Edelstein, D., & Basaria, S. (2010). Testosterone undecanoate in the treatment of male hypogonadism. Expert Opinion on Pharmacotherapy, 11(12), 2095–2106. https://doi.org/10.1517/14656566.2010.505920

[2] Testosterone undecanoate--oral therapy for male hypogonadism. (1985). Drug and therapeutics bulletin, 23(2), 7–8.

[3] Kapoor, A. (2016). What’s new in testosterone deficiency research? Canadian Urological Association Journal, 10(5-6S), 130. https://doi.org/10.5489/cuaj.3915

KYZATREX (oral testosterone) can slightly raise blood pressure, especially in people on blood pressure medication, with little effect on heart rate[1]. Intranasal testosterone gel (Natesto) has minimal impact on blood tests and low risk of increasing red blood cell count[6]. Intramuscular testosterone cypionate raises red blood cell levels more significantly, which can be risky[2][6]. Transdermal testosterone gel and long-acting intramuscular testosterone don't significantly increase heart problems[3][5]. Overall, KYZATREX works well but needs blood pressure monitoring, especially for those with high blood pressure[1][4][5].

References:

[1] White, W. B., Bernstein, J. S., Rittmaster, R., & Dhingra, O. (2021). Effects of the oral testosterone undecanoate KYZATREX on ambulatory blood pressure in hypogonadal men. The Journal of Clinical Hypertension, 23(7), 1420–1430. https://doi.org/10.1111/jch.14297
[2] Rivero, M.-J., Ory, J., Diaz, P., Nannan Thirumavalavan, Han, S., Reis, I. M., & Ramasamy, R. (2023). Comparison of Hematocrit Change in Testosterone-deficient Men Treated with Intranasal Testosterone Gel vs Intramuscular Testosterone Cypionate: A Randomized Clinical Trial. The Journal of Urology, 210(1), 162–170https://doi.org/10.1097/ju.0000000000003487
[3] A. Michael Lincoff, Bhasin, S., Panagiotis Flevaris, Mitchell, L. M., Shehzad Basaria, Boden, W. E., Cunningham, G. R., Granger, C. B., Khera, M., Thompson, I. M., Wang, Q., Wolski, K., Davey, D., Vidyasagar Kalahasti, Khan, N., Miller, M. G., Snabes, M. C., Chan, A., Dubcenco, E., & Li, X. (2023). Cardiovascular Safety of Testosterone-Replacement Therapyhttps://doi.org/10.1056/nejmoa2215025
[4] Kovac, J. R., Rajanahally, S., Smith, R. P., Coward, R. M., Lamb, D. J., & Lipshultz, L. I. (2014). Patient Satisfaction with Testosterone Replacement Therapies: The Reasons Behind the Choices. The Journal of Sexual Medicine, 11(2), 553–562. https://doi.org/10.1111/jsm.12369
[5] Zitzmann, M., Cremers, J. F., Krallmann, C., & Kliesch, S. (2022). The HEAT-Registry (HEmatopoietic Affection by Testosterone): comparison of a transdermal gel vs long-acting intramuscular testosterone undecanoate in hypogonadal men. The Aging Male, 25(1), 134–144. https://doi.org/10.1080/13685538.2022.2063830
[6] Best, J., Gonzalez, D., Masterson, T., Blachman-Braun, R., Pai, R., & Ramasamy, R. (2020). A cross-sectional comparison of secondary polycythemia in testosterone-deficient men treated with nasal testosterone gel vs. intramuscular testosterone cypionate. Canadian Urological Association Journal, 15(2). https://doi.org/10.5489/cuaj.6651

KYZATREX® effectively increases serum testosterone levels, with 87.8% of participants reaching normal levels. It alleviates symptoms like fatigue, reduced libido, and muscle loss, and improves overall well-being and psychosexual health [1]. The drug has a stable cardiovascular profile, causing only small increases in systolic blood pressure, with minimal impact on diastolic blood pressure and heart rate [2]. KYZATREX® is well tolerated, with no serious adverse events reported in clinical trials [3].

References:

[1] Dhingra, O. P., Bernstein, J., Barnes, S. D., VanLaanen, H., Wadlington, N., & Chang, J. (2021). Novel Oral Testosterone Formulation Improves Male Well Being Without Compromising International Prostate Symptom Scores. Journal of the Endocrine Society5(Supplement_1), A760–A760. https://doi.org/10.1210/jendso/bvab048.1546

[2] White, W. B., Bernstein, J. S., Rittmaster, R., & Dhingra, O. (2021). Effects of the oral testosterone undecanoate KYZATREX®on ambulatory blood pressure in hypogonadal men. The Journal of Clinical Hypertension23(7), 1420–1430. https://doi.org/10.1111/jch.14297

[3] Bernstein, J. S., & Dhingra, O. P. (2024). A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product. Therapeutic Advances in Urology16. https://doi.org/10.1177/17562872241241864

KYZATREX testosterone therapy can offer several benefits for individuals with testosterone deficiency. It can improve sexual function by enhancing libido and erectile function, and it can boost mood and emotional well-being by alleviating symptoms of depression, irritability, and fatigue. Benefits of TRT for men can also include an increase muscle mass and strength, improved bone density, and help with the prevention of osteoporosis. For individuals with type 2 diabetes, TRT can improve glycemic control and insulin sensitivity. Additionally, TRT may positively impact cardiovascular health, cognitive functions like memory and processing speed, and overall quality of life. However, TRT should be administered under medical supervision, with regular monitoring to ensure safety and manage potential risks such as increased red blood cell count and cardiovascular concerns[1][2][3][4][5].

See Important Safety Information here.

References:
[1] Renke, G., & Tostes, F. (2023). Cardiovascular Safety and Benefits of Testosterone Implant Therapy in Postmenopausal Women: Where Are We? Pharmaceuticals, 16(4), 619. https://doi.org/10.3390/ph16040619
[2] Lawton, J., & Amjad, M. (2023). Weighing the Benefits and Drawbacks of Testosterone Replacement Therapy. Sciential - McMaster Undergraduate Science Journal, 10. https://doi.org/10.15173/sciential.v1i10.3364
[3] Yeo, S., Holl, K., Peñaherrera, N., Wissinger, U., Anstee, K., & Wyn, R. (2021). Burden of Male Hypogonadism and Major Comorbidities, and the Clinical, Economic, and Humanistic Benefits of Testosterone Therapy: A Narrative Review. ClinicoEconomics and Outcomes Research, Volume 13, 31–38. https://doi.org/10.2147/ceor.s285434
[4] Kumari, K., Kumar, R., Memon, A., Kumari, B., Tehrim, M., Kumari, P., Shehryar, M., Islam, H., Islam, R., Khatri, M., Kumar, S., & Kumar, A. (2023). Treatment with Testosterone Therapy in Type 2 Diabetic Hypogonadal Adult Males: A Systematic Review and Meta-Analysis. Clinics and Practice, 13(2), 454–469. https://doi.org/10.3390/clinpract13020041
[5] Fatih Aktoz, Ali Can Gunes, & Cemal Tamer Erel. (2023). What is the Role of Testosterone Therapy in Postmenopausal Women? A SWOT Analysis. Clinical and Experimental Obstetrics & Gynecology, 50(8), 159–159https://doi.org/10.31083/j.ceog5008159

KYZATREX testosterone therapy can be used to treat erectile dysfunction (ED), particularly in men with low testosterone levels (hypogonadism). Studies show that testosterone therapy can significantly improve ED symptoms in hypogonadal men, with 91.9% of young men with organic ED reporting improvement after therapy[1]. Combining testosterone therapy with PDE5 inhibitors, like sildenafil, has proven effective for men who do not respond to PDE5 inhibitors alone, restoring erectile function in 70% of diabetic participants[2]. Long-term testosterone therapy has shown benefits in improving erectile function in men with functional hypogonadism and obesity, with significant improvements noted over up to 13 years[5]. Testosterone therapy has also been effective in men with venous leakage, with some reporting significant improvement within 12-20 weeks of treatment[3]. Additionally, in men with type 2 diabetes and hypogonadism, long-acting testosterone undecanoate improved sexual function and quality of life, including better IIEF scores[4]. Regular monitoring and a tailored approach by healthcare providers are essential to maximize benefits and manage potential risks.

See Important Safety Information here.

References:
[1] Song, J., G Saffati, Naeem, T., Biles, B., Pierce, H., Lipshultz, L., & Khera, M. (2024). (160) Improving Symptoms in Young Men with Erectile Dysfunction: Testosterone Therapy with or Without PDE5 Inhibitors. ̃the œJournal of Sexual Medicine, 21(Supplement_1). https://doi.org/10.1093/jsxmed/qdae001.151
[2] Kalinchenko, S. Y., Kozlov, G. I., Gontcharov, N. P., & Katsiya, G. V. (2003). Oral testosterone undecanoate reverses erectile dysfunction associated with diabetes mellitus in patients failing on sildenafil citrate therapy alone. The Aging Male: The Official Journal of the International Society for the Study of the Aging Male, 6(2), 94–99. https://pubmed.ncbi.nlm.nih.gov/12898793/
[3] Yassin, A., Saad, F., & Traish, A. M. (2006). Testosterone Undecanoate Restores Erectile Function in a Subset of Patients with Venous Leakage: A Series of Case Reports. The Journal of Sexual Medicine, 3(4), 727–735. https://doi.org/10.1111/j.1743-6109.2006.00267.x
[4] Hackett, G., Cole, N., Bhartia, M., Kennedy, D., Raju, J., & Wilkinson, P. (2013). Testosterone Replacement Therapy with Long‒Acting Testosterone Undecanoate Improves Sexual Function and Quality‒of‒Life Parameters vs. Placebo in a Population of Men with Type 2 Diabetes. The Journal of Sexual Medicine, 10(6), 1612–1627. https://doi.org/10.1111/jsm.12146
[5] Saad, F., Haider, K. S., Haider, A., Doros, G., & A Traish. (2023). (396) Effects of Long-term Testosterone Therapy in Men with Functional Hypogonadism and Obesity on Weight, Waist Circumference, and Erectile Function – Results from a Registry Study. ̃the œ Journal of Sexual Medicine, 20(Supplement_1). https://doi.org/10.1093/jsxmed/qdad060.370

KYZATREX may cause a small increase in 24-hour ambulatory systolic blood pressure, especially in those on antihypertensive therapy. Diastolic blood pressure and heart rate changes are minimal. Other potential side effects include headaches, mood changes, and increased red blood cell count. Monitoring is recommended for patients with hypertension or those on antihypertensive drugs to manage potential risks[1][2].

KYZATREX may cause other serious side effects including:

  1. Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
  2. If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night, trouble starting your urine stream, urinating many times during the day, urge to go to the bathroom right away, a urine accident, inability to pass urine or weak urine flow.
  3. Increased risk of prostate cancer
  4. Blood clots in the legs or lungs: Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
  5. Abuse: Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
  6. In large doses, KYZATREX may lower your sperm count
  7. Liver problems: Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
  8. Swelling of your ankles, feet, or body (edema), with or without heart failure
  9. Enlarged or painful breasts
  10. Breathing problems while you sleep: TRT in men with hypogonadism may have increased potential of experiencing sleep apnea.

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels. These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by visiting www.mariuspharma.com.

See Full Prescribing Information and Medication Guide for KYZATREX.

References:
[1] White, W. B., Bernstein, J. S., Rittmaster, R., & Dhingra, O. (2021). Effects of the oral testosterone undecanoate KYZATREX on ambulatory blood pressure in hypogonadal men. The Journal of Clinical Hypertension, 23(7), 1420–1430. https://doi.org/10.1111/jch.14297
[2] Österbrand, M., Fors, H., & Ensio Norjavaara. (2023). Pharmacological treatment for pubertal progression in boys with delayed or slow progression of puberty: A small-scale randomized study with testosterone enanthate and testosterone undecanoate treatment. Frontiers in Endocrinology, 14. https://doi.org/10.3389/fendo.2023.1158219

Stopping KYZATREX testosterone therapy should not be done abruptly or without medical supervision, even if you feel better. Consult your healthcare provider before making any changes, as sudden discontinuation can lead to the return of symptoms like fatigue, decreased libido, mood swings, and reduced muscle mass, as well as hormonal imbalances. If discontinuation is necessary, a gradual reduction in dosage under medical supervision is recommended. Regular follow-up appointments and monitoring are essential to manage discontinuation safely. Additionally, incorporating lifestyle changes such as weight management, regular exercise, a balanced diet, and stress reduction can help maintain health after stopping therapy. Always seek medical advice before altering your therapy regimen.

Please report any side effects to your medical provider immediately. They may adjust your treatment or take additional measures to manage side effects.

If you miss a dose of KYZATREX, take the missed dose as soon as possible if you remember shortly after. However, if it is nearly time for your next scheduled dose, skip the missed dose and do not take a double dose to make up for it. Continue with your regular dosing schedule after taking the missed dose or skipping it. If you are unsure about what to do after missing a dose, or if you miss multiple doses, contact your healthcare provider for specific advice. Always refer to the specific instructions provided by your healthcare provider or the medication's prescribing information.

Billing and Payment Questions

The initial cost for the KYZATREX program is $129. If approved for the program based on the medical provider's analysis of your blood results, the cost of medication is included in your first month of treatment. After the first month, there is a recurring cost of $219 which includes the cost of medication and any additional required lab tests (walk-ins) and provider visits.

The initial payment will be authorized after checkout following your initial treatment protocol questionnaire.

Once you've made a payment, the outcome will be communicated to you on-screen and via email. Our platform for processing payments will send you notifications for successful transactions. Billing emails will include a copy of your invoice in PDF format. For failed transactions, the failure reason will be presented to you on-screen.

When it’s time for your refill, we’ll email you a link to complete payment for your next month of medication. Over the course of your treatment plan, you may also be asked to answer a short questionnaire to see how your treatment is going.

KYZATREX is a cash-pay medication, removing the complications of insurance. Your doctor will provide you with instructions on how to fill your KYZATREX prescription. Experience the difference twice-daily KYZATREX can make in managing Low T.

In the event of a payment failure, you'll be notified via email for your next steps. Additionally, our support team will be informed and will reach out to you to assist in resolving the issue to prevent disruption in your treatment plan.

Fulfilment and Shipping Questions

Complete a brief questionnaire and we will determine if you qualify for this type of treatment. You will then be directed to get lab work completed. Once completed, you will meet with one of our providers virtually online who will then issue an Rx and forward your prescription to our pharmacy for fulfilment and shipping.

To schedule routine lab work, visit LabCorp's website. Select "Routine Lab Work," then choose a lab. Finally, enter your zip code in the search bar to find a nearby location.

Labs include tests for T/Free T, CBC, SHBG, PSA, and Estradiol.

Initial lab tests are conducted at the start, followed by additional tests at 90, 180 days, and then every 180 days.

You will need your personal details and contact information.

You’ll choose the “I have already paid or someone else is responsible” option, as your payment to us covers your labs.

After reviewing all the entered information, click "Create Appointment." You’ll receive a confirmation screen with your appointment details.

Follow the instructions sent via email for scheduling lab work at designated LabCorp facilities. You must ensure all scheduled tests are completed as instructed.

No, fasting is not required for the lab work you’ll need for TRT.

Once approved to start treatment, your prescription is generated after the first consultation and sent to your address from one of our partnered pharmacies. The initial prescription includes a 30-day supply.

After the initial period, you'll receive communication about refilling your prescription. When necessary, you’ll get instructions on required additional lab work and when to schedule a follow-up visit with your medical provider.

Your medication will be refilled after the initial 30-day supply. Subsequent refills are scheduled to ensure there is no interruption in your therapy. Refills are processed 27 days after your initial visit and each subsequent refill, aligning with your treatment plan.

After the initial prescription and two refills, you will need to be reassessed by your medical provider. This will align with your scheduled follow-up visits. During these visits, your medical provider will review your progress and lab results to determine if your prescription should be continued or adjusted.

Once your refill is processed, the pharmacy will ship your medication directly to the address that you provide. You do not need to take any action to initiate the shipping process; however, ensuring your address details are current in our system will help avoid any delivery issues.

Manual refill requests are not necessary and are not encouraged, as they can disrupt the carefully planned treatment protocol. If you believe you are running low on your medication due to unforeseen circumstances, please contact our support team to discuss your situation.

If you encounter any issues with your refill, such as not receiving it on time or receiving incorrect quantities, please contact our customer support immediately. Our team is here to ensure your treatment proceeds smoothly and will help resolve any issues promptly.

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