Kyzatrex

Testosterone Undecanoate · Capsule, Liquid Filled · Oral

Prescription (Rx) Androgen

Uses

1 INDICATIONS AND USAGE KYZATREX® is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: 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 (folliclestimulating hormone (FSH), luteinizing hormone (LH)) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations but have gonadotropins in the normal or low range. KYZATREX® is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ). Limitations of Use: Safety and efficacy of KYZATREX® in males less than 18 years old have not been established ( 1 , 8.4 ). Safety and efficacy of KYZATREX® in men with “age-related hypogonadism” have not been established (1) . Limitations of Use Safety and efficacy of KYZATREX® in males less than 18 years old have not been established [see Use in Specific Populations (8.4) ] . Safety and efficacy of KYZATREX® in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Dosage and administration

2 DOSAGE AND ADMINISTRATION - KYZATREX® is not substitutable with other oral testosterone undecanoate products ( 2.1 ). Prior to initiating KYZATREX®, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2.2 ). Take KYZATREX® with food ( 2.3 ). Starting dosage: 200 mg orally once in the morning and once in the evening ( 2.3 ). Adjust the dosage to a minimum of 100 mg once in the morning and a maximum of 400 mg twice daily based on serum testosterone drawn 3 to 5 hours after the morning dose at least 7 days after starting treatment or following dose adjustment and periodically thereafter ( 2.3 ). 2.1 Important Dosage Information KYZATREX® is not substitutable with other oral testosterone undecanoate products. 2.2 Confirmation of Hypogonadism Before Initiation of KYZATREX® Prior to initiating KYZATRE®, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these testosterone concentrations are below the normal range. 2.3 Recommended Dosage and Administration Individualize the dosage of KYZATREX® based on the patient's serum testosterone concentration response to the drug. The recommended starting dose is 200 mg orally twice daily, once in the morning and once in the evening. Take KYZATREX® with food. Dosage Adjustment Check serum testosterone concentrations 7 days after starting treatment or after dosage adjustment, 3 to 5 hours after the morning dose. Adjust the KYZATREX® dose as necessary as shown in Table 1. Thereafter, periodically monitor serum testosterone concentrations. The minimum recommended dose is 100 mg once daily in the morning. The maximum recommended dose is 400 mg twice daily. For total daily doses greater than 100 mg, administer the same dose in the morning and evening. Table 1: KYZATREX® Dosage Adjustment Scheme Serum Testosterone Concentration Current KYZATREX® Dosage New KYZATREX® Dosage Less than 460 ng/dL 100 mg with breakfast only 100 mg twice daily with meals 100 mg twice daily with meals 200 mg twice daily with meals 200 mg twice daily with meals 300 mg twice daily with meals 300 mg twice daily with meals 400 mg twice daily with meals 460 to 971 ng/dL No Dosage Change More than 971 ng/dL 400 mg twice daily with meals 300 mg twice daily with meals 300 mg twice daily with meals 200 mg twice daily with meals 200 mg twice daily with meals 100 mg twice daily with meals 100 mg twice daily with meals 100 mg with breakfast only 100 mg with breakfast only Discontinue treatment

Dosage forms and strengths

Capsules: 50 mg, oval, opaque, white, imprinted with "MP50" in red ink 100 mg, oval, opaque, white, imprinted with "MP100" in red ink 150 mg, oblong, opaque, white, imprinted with "MP150" in red ink 200 mg, oblong, opaque, white, imprinted with "MP200" in red ink Capsules: 50 mg,100 mg, 150 mg, 200 mg ( 3 ).

Contraindications

4 CONTRAINDICATIONS KYZATREX® is contraindicated in: Patients with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (5.34) ] . Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman [ see Use in Specific Populations (8.1) ]. Patients with known hypersensitivity to KYZATREX® or any of its ingredients [see Description (11) ] . Carcinoma of the breast or known or suspected carcinoma of the prostate ( 5.4 ) Women who are pregnant. Testosterone may cause fetal harm ( 4 , 5.7 , 8.1 ) Hypersensitivity to KYZATREX® or any of its ingredients ( 4 )

Warnings and precautions

Polycythemia : Monitor hemoglobin or hematocrit approximately every 3 months to detect increased red blood cell mass and polycythemia. Discontinue KYZATREX® if necessary ( 5.1 ). Venous thromboembolism (VTE) : VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone. Discontinue KYZATREX® if VTE is suspected and initiate appropriate workup and management (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 ( 5.3 ). Blood Pressure Increases: KYZATREX® can increase blood pressure, which can increase cardiovascular risk over time. Measure blood pressure periodically. Not recommended for use in men with uncontrolled hypertension ( 5.4 ) 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 ( 5.5 ). Potential for Adverse Effects on Spermatogenesis : KYZATREX® may cause azoospermia ( 5.7 ). Edema : Edema, with or without congestive heart failure (CHF), may occur in patients with pre-existing cardiac, renal, or hepatic disease. Discontinue KYZATREX® and initiate appropriate workup ( 5.9 ). Sleep Apnea : KYZATREX® may potentiate sleep apnea in those with risk factors ( 5.10 ) Lipid Changes : KYZATREX® may affect serum lipid profile. Monitor patient lipid concentrations periodically; if necessary, adjust dosage of lipid lowering drug(s) or discontinue KYZATREX® ( 5.12 ). 5.1 Polycythemia Androgens, including KYZATREX®, can cause increase in hemoglobin or hematocrit, reflective of increase in red blood cell mass. Check hematocrit prior to initiating KYZATREX®. An increase in red blood cell mass may increase the risk of thromboembolic events [see Warnings and Precautions ( 5.2 )]. Evaluate hematocrit approximately every 3 months while the patient is on KYZATREX®. If hematocrit becomes elevated, stop KYZATREX® until the hematocrit decreases to an acceptable concentration. If KYZATREX® is restarted and again causes hematocrit to become elevated, permanently discontinue KYZATREX®. 5.2 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 KYZATREX®. In the Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy Response in hypogonadal men (TRAVERSE) Study, a randomized, double-blind, placebo-controlled, cardiovascular (CV) outcomes study, compared to placebo, topical testosterone gel was associated with a numerically higher incidence of VTE (1.7% vs 1.2%) which included DVT (0.6% vs 0.5%) and PE events (0.9% vs 0.5%) [see Adverse Reactions 6.1 )]. 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 KYZATREX® and initiate appropriate workup and management [see Adverse Reactions ( 6.2 )]. 5.3 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)]. 5.4 Blood Pressure Increases KYZATREX® can increase blood pressure. Based on ambulatory blood monitoring in Study MRS-TU-2019EXT, KYZATREX® increased mean systolic/diastolic blood pressure by 1.7/0.6 mm Hg from baseline after 4 months of treatment and 1.8/0.6 mm Hg from baseline after 6 months of treatment [see Adverse Reactions (6.1) ] . In patients with hypertension on antihypertensive therapy, KYZATREX® increased the mean systolic/diastolic BP by 3.4/0.7 mm Hg from baseline after 4 months of treatment and 3.1/1.0 mm Hg from baseline after 6 months of treatment. [see Adverse Reactions (6.1) ]. Blood pressure increases can increase cardiovascular (CV) risk over time. The CV risk associated with topical testosterone gel was evaluated in TRAVERSE, a randomized, double-blind, placebo controlled, CV outcomes study in men with a history of CV disease or multiple CV risk factors. In TRAVERSE, topical testosterone gel increased mean systolic blood pressure by 1.0 mm Hg from baseline to 36 months, whereas a mean decrease from baseline of 0.5 mm Hg. However, the incidences of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction [MI] and non-fatal stroke, were similar between treatment groups (7% for topical testosterone gel vs 7.3% for placebo) [See Adverse Reactions (6.1) ] Monitor BP periodically in men using KYZATREX®, especially men with hypertension. KYZATREX® is not recommended for use in patients with uncontrolled hypertension. 5.5 Abuse of Testosterone and Monitoring of Testosterone Centrations. 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 )].

Side effects

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Polycythemia [see Warnings and Precautions (5.1) ] Venous Thromboembolism [see Warnings and Precautions (5.2) ] Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer [ see Warnings and Precautions (5.3) ] Blood Pressure Increases [see Warnings and Precautions (5.4) ] Hepatic Adverse Effects [see Warnings and Precautions (5.8) ] Edema [see Warnings and Precautions (5.9) ] Sleep Apnea [see Warnings and Precautions (5.10) ] Gynecomastia [see Warnings and Precautions (5.11) ] Lipid Changes [see Warnings and Precautions (5.12) ] Hypercalcemia [see Warnings and Precautions (5.13) ] Decreased Thyroxine-binding Globulin [see Warnings and Precautions (5.14) ] Most common adverse reactions (incidence ≥ 2%): hypertension ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Marius Pharmaceuticals at 1-833-949-5040 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of KYZATREX® was evaluated in Study MRS-TU-2019EXT in 155 hypogonadal males [see Clinical Studies (14) ]. All patients initially received KYZATREX® 200 mg orally twice daily. If needed, the dosage was titrated to 100 mg once daily in the morning or 100 mg, 300 mg, or 400 mg twice daily to achieve testosterone concentrations in the normal range . After the dosage titration period, patients continued their optimized dose for the remainder of the duration of the 6-month study. The mean duration of exposure was 168 days (range: 1 to 180 days). The median age was 52 years (range: 22 to 66 years); 77% were White, 19% were Black, 3% were Asian, and 2% were American Indian, Alaskan Native or Other. Table 2 summarizes adverse reactions reported in ≥2% of patients in this 6-month study. Table 2: Adverse Reactions in ≥ 2% of Patients Receiving KYZATREX® in STUDY MRS-TU-2019EXT Adverse Reaction N = 155 n (%) Hypertensión Based upon blood pressure cuff measurements 4 (2.6) One (0.8%) patient who received KYZATREX® experienced an adverse reaction (acne) that lead to premature discontinuation from the study. In a 12-month, open-label study in hypogonadal adult males (N=212) who received KYZATREX® 200 mg once daily to 400 mg twice daily (n=202) the following additional adverse reactions were reported: headache, arthralgia, diarrhea, hemoglobin increased, anxiety, constipation, peripheral edema, and PSA increased. Blood Pressure Increases In Study MRS-TU-2019EXT, 24-hour ambulatory blood pressure monitoring (ABPM) was conducted in 155 male patients, 135 of whom completed the study. ABPM was conducted at 3 distinct 24-hour time periods: at baseline and following approximately 4 months and 6 months of treatment with KYZATREX®. A total of 151 patients had acceptable 24-hour ABPM recordings at both time periods. In that group, the mean change in systolic BP from Baseline to 4 months and 6 months was + 1.7 mm Hg (95% CI 0.3, 3.1) and 1.8 mm Hg (95% CI 0.3, 3.2), respectively. In that group, the mean change in diastolic BP from Baseline to 4 months and 6 months was 0.6 mm Hg (95% CI -0.3, 1.6) and 0.6 mm Hg (95% CI -0.4, 1.6), respectively. In patients with a history of hypertension on antihypertensive therapy at baseline, the mean ABPM systolic blood pressure increased from Baseline to 4 months and 6 months by 3.4 mm Hg (95% CI 1.0, 5.9) and 3.1 mm Hg (95% CI 0.6, 5.6), respectively (n=49). In patients with no history of hypertension at baseline, the mean systolic blood pressure from Baseline increased by 0.7 mm Hg (95% CI -1.0, 2.4) at 4 months and 1.0 mm Hg (95% CI -0.7, 2.8), at six months respectively (n =90). Ambulatory (24-hour) blood pressure Changes from Baseline for study MRS- TU-2019EXT are presented in Table 3 with 95% confidence intervals. No significant difference was observed between the 4-month and 6-month Changes from Baseline Table 3: Blood Pressure Increases Blood Pressure Change from Baseline (95% CI) mm Hg Systolic Diastolic 24-Hour Ambulatory 4 Month 1.7 (0.3 to 3.1) 0.6 (-0.3 to 1.6) 6 Month 1.8 (0.3 to 3.2) 0.6 (-0.4 to 1.6) A history of antihypertensive treatment and diabetes mellitus at baseline were significant factors related to ambulatory SBP increases. Table 4 presents the Least Squares Mean estimates of Change from Baseline, with 95% CI’s, for sub-populations of subjects at study start either with or without hypertensive treatment or with or without diabetes mellitus. A total of 5 of 155 patients (3.2%) on KYZATREX® in Study MRS-TU-2019EXT began taking new antihypertensive medications after study start. No patient had a dose increase in their antihypertensive medication by the end of treatment. Of the 155 patients in Study MRS-TU-2019EXT who used KYZATREX®, 4 patients (2.6%) were reported to have an adverse reaction of hypertension. Cardiovascular Outcomes TRAVERSE was a randomized, double-blind, cardiovascular outcomes study to assess the cardiovascular (CV) safety of topical testosterone gel compared to placebo in 5198 hypogonadal men aged 45 to 80 years with a history of CV disease or with multiple CV risk factors. The primary outcome was the incidence of the composite endpoint of major adverse cardiovascular events (MACE), consisting of CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. The mean duration of therapy was approximately 22 months. The mean duration of follow-up was 33 months. Approximately 61% of all patients discontinued topical testosterone gel or placebo therapy.

Drug interactions

Insulin: In patients with diabetes, concomitant use with KYZATREX® may decrease blood glucose and insulin requirements ( 7.1 ). Oral Anticoagulants: Concomitant use with KYZATREX® may cause changes in anticoagulant activity. Monitor International Normalized Ratio (INR) and prothrombin time (PT) frequently ( 7.2 ). Corticosteroids: Concomitant use with KYZATREX® may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease ( 7.3 ). Drugs that May Also Increase Blood Pressure: Concomitant use with KYZATREX® may lead to additional increases in blood pressure ( 7.4 ). 7.1 Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and therefore necessitate a decrease in the dose of anti-diabetic medication. 7.2 Oral Vitamin K Antagonist Anticoagulants Changes in anticoagulant activity may be seen with androgens; therefore, more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy. 7.3 Corticosteroids The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal, or hepatic disease. 7.4 Medications that May Also Increase Blood Pressure Some prescription medications and nonprescription analgesic and cold medications contain drugs known to increase blood pressure. Concomitant administration of these medications with KYZATREX® may lead to additional increases in blood pressure [see Warnings and Precautions (5.4)] .

Use in specific populations

Geriatric Patients: Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension ( 8.5 ). See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling and Medication Guide. 8.1 Pregnancy - Risk Summary KYZATREX® is contraindicated in pregnant women and not indicated for use in females [see Contraindications (4) ]. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies (see Data ) and its mechanism of action [see Clinical Pharmacology (12.1) ]. Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies do not meet current standards for nonclinical development toxicity studies. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep, and rhesus monkeys, pregnant animals received intramuscular injections of testosterone during the period of organogenesis. Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased anogenital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. Increased pituitary weight was seen in both sexes. Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. Hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy. 8.2 Lactation - Risk Summary KYZATREX® is not indicated for use in females. 8.3 Females and Males of Reproductive Potential - Infertility Males During treatment with large doses of exogenous androgens, including KYZATREX®, spermatogenesis may be suppressed through feedback inhibition of the hypothalamicpituitary-testicular axis [see [See Warnings and Precautions (5.7) and Impairment of Fertility (13.1) ] , possibly leading to adverse effects on semen parameters including sperm count. Reduced fertility has been observed in some men taking testosterone replacement therapy. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [see Drug Abuse and Dependence (9.2) ]. With either type of use, the impact on fertility may be irreversible. 8.4 Pediatric Use The safety and efficacy of KYZATREX® in pediatric patients less than 18 years old have not been established. KYZATREX® is not recommended for use in patients less than 18 years of age because of the potential for acceleration of bone age and premature closure of epiphyses. 8.5 Geriatric Use Clinical studies of KYZATREX® did not include any patients 65 years of age and older. Therefore, it cannot be determined whether these patients respond differently from younger adult patients. Additionally, there are insufficient long-term safety data in geriatric patients to assess the potentially increased risk of cardiovascular disease and prostate cancer. Geriatric patients treated with androgens including KYZATREX® may be at risk for worsening of signs and symptoms of BPH [see (see Warnings and Precautions (5.3)] .

Pregnancy

8.1 Pregnancy - Risk Summary KYZATREX® is contraindicated in pregnant women and not indicated for use in females [see Contraindications (4) ]. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies (see Data ) and its mechanism of action [see Clinical Pharmacology (12.1) ]. Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies do not meet current standards for nonclinical development toxicity studies. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep, and rhesus monkeys, pregnant animals received intramuscular injections of testosterone during the period of organogenesis. Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased anogenital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. Increased pituitary weight was seen in both sexes. Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. Hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy.

Pediatric use

8.4 Pediatric Use The safety and efficacy of KYZATREX® in pediatric patients less than 18 years old have not been established. KYZATREX® is not recommended for use in patients less than 18 years of age because of the potential for acceleration of bone age and premature closure of epiphyses.

Geriatric use

8.5 Geriatric Use Clinical studies of KYZATREX® did not include any patients 65 years of age and older. Therefore, it cannot be determined whether these patients respond differently from younger adult patients. Additionally, there are insufficient long-term safety data in geriatric patients to assess the potentially increased risk of cardiovascular disease and prostate cancer. Geriatric patients treated with androgens including KYZATREX® may be at risk for worsening of signs and symptoms of BPH [see (see Warnings and Precautions (5.3)] .

Overdosage

There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone levels of up to 11,400 ng/dL with a cerebrovascular accident. Treatment of overdosage consists of discontinuation of KYZATREX® and appropriate symptomatic and supportive care.

Description

11 DESCRIPTION KYZATREX® is provided as a gelatin capsule containing testosterone undecanoate, a fatty-acid ester of testosterone. Testosterone undecanoate is a white to off-white yellow crystalline powder. Testosterone, an androgen, is formed by cleavage of the ester side chain of testosterone undecanoate. Testosterone undecanoate is chemically described as 17β-hydroxyandrost-4-en-3-one undecanoate. It has the empirical formula of C 30 H 48 O 3 and a molecular weight of 456.7 g/mol. The structural formula for testosterone undecanoate is presented in Figure 1. Figure 1: Testosterone Undecanoate KYZATREX® (testosterone undecanoate) capsules for oral use are available in four dosage strengths- 50 mg, 100 mg, 150 mg, and 200 mg. The 50 mg strength is an opaque, white capsule imprinted with "MP50" in red ink. The 100 mg strength is an opaque, white capsule imprinted with "MP100" in red ink. The 150 mg strength is an opaque white capsule imprinted with "MP150" in red ink. The 200 mg strength is an opaque white capsule imprinted with "MP200" in red ink. All capsule strengths also contain DL-alpha-tocopheryl acetate (Vitamin E), phytosterol esters, polyoxyl 40 hydrogenated castor oil, and propylene glycol monolaurate as inactive ingredients. Gelatin capsule shells are composed of the following inactive ingredients: gelatin, glycerin, purified water, sorbitol, and titanium dioxide. Figure 1

Mechanism of action

12.1 Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement; vocal cord thickening; alterations in body musculature; and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter syndrome or Leydig cell aplasia, whereas secondary hypogonadism (also known as hypogonadotropic hypogonadism) is the failure of the hypothalamus (or pituitary gland) to produce sufficient gonadotropins (FSH, LH).

How supplied

16 HOW SUPPLIED/STORAGE AND HANDLING KYZATREX® capsules are available in four strengths of 50 mg, 100 mg, 150 mg, and 200 mg packaged as 30, 60, 90 and 120 units in wide-mouth, round, white HDPE bottles with white, polypropylene, child resistant caps and induction-sealed liner 50 mg: Oval, opaque, white cpasules imprinted with "MP50" in red ink; NDC 80603-107-44 for 30 capsules. 100 mg: Oval, opaque, white capsules imprinted with "MP100" in red ink supplied in bottles; NDC 80603-101-11 for 90 capsules and NDC 80603-101-22 for 120 capsules. 150 mg: Oblong, opaque, white capsules imprinted with "MP150" in red ink supplied in bottles; NDC 80603-103-11 for 90 capsules and NDC 80603-103-22 for 120 capsules. 200 mg: Oblong, opaque, white capsules imprinted with "MP200" in red ink supplied in bottles; NDC 80603-105-33 for 60 capsules , NDC 80603-105-11 for 90 capsules and NDC 80603-105-22 for 120 capsules . Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store the capsules in a dry place avoiding exposure to excessive moisture and humid conditions. Dispose of unused KYZATREX® via a take-back option. If a take-back option is unavailable, follow FDA instructions at www.fda.gov/drugdisposal.

Storage

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store the capsules in a dry place avoiding exposure to excessive moisture and humid conditions. Dispose of unused KYZATREX® via a take-back option. If a take-back option is unavailable, follow FDA instructions at www.fda.gov/drugdisposal.

Patient information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Polycythemia Advise patients that KYZATREX® can cause an increase in hemoglobin/hematocrit levels that may increase the risk of thromboembolic events. Advise patients about the importance of completing laboratory testing as instructed by their health care provider while on KYZATREX® [see Warnings and Precautions (5.1)] . Venous Thromboebolisn Advise patients that KYZATREX® can cause venous thromboembolism. Advise patients of the signs and symptoms of venous thromboembolism, which may include the following: lower limb pain, edema, or erythema; and dyspnea or chest pain. Advise patients to promptly report the signs and symptoms of venous thromboembolism, discontinue use of KYZATREX® and seek urgent medical care. Worsening of Benign Prostatic Hyperplasia (BPH) Advise patients that KYZATREX® can cause increased symptoms of BPH. Advise patients to contact their health care provider if they have any prostate-related symptoms [see Warnings and Precautions (5.3)] . Blood Pressure Increases Inform patients that KYZATREX® can increase blood pressure (BP) which can increase cardiovascular risk over time Instruct patients about the importance of monitoring BP periodically while on KYZATREX®. If BP increases while on KYZATREX®, antihypertensive medications may need to be started, added, or adjusted to control BP, or KYZATREX® may need to be discontinued [see Warnings and Precautions (5.4)] Edema Advise patients that KYZATREX® can cause edema in patients with preexisting cardiac, renal, or hepatic disease. Advise patients to notify their health care provider if edema develops or worsens [see Warnings and Precautions (5.9)]. Sleep Apnea Advise patients that KYZATREX® can worsen sleep apnea especially in patients with risk factors such as obesity or chronic lung diseases ™ [see Warnings and Precautions (5.10)]. Gynecomastia Advise patients that KYZATREX® can cause gynecomastia [see Warnings and Precautions (5.11)]. Administration Instructions Advise patients to take KYZATREX® with food [see Dosage and Administration (2.3) ].

Label text from the FDA structured product label by Marius Pharmaceuticals (revised Aug 26, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Testosterone Undecanoate in 3 products

Kyzatrex NDC products (3)

NDC	Strength & form	Labeler	Type
80603-103	Testosterone Undecanoate 150 mg/1 Capsule, Liquid Filled	Marius Pharmaceuticals	NDA · DEA CIII
80603-105	Testosterone Undecanoate 200 mg/1 Capsule, Liquid Filled	Marius Pharmaceuticals	NDA · DEA CIII
80603-107	Testosterone Undecanoate 50 mg/1 Capsule, Liquid Filled	Marius Pharmaceuticals	NDA · DEA CIII

Frequently asked questions

What is Kyzatrex used for?

What are the side effects of Kyzatrex?

Who makes Kyzatrex?

Kyzatrex is listed by 1 labeler in the FDA NDC directory, including Marius Pharmaceuticals.